November/December 2015 by McMahon Group

Bridging the gap between the hospital and alternate-site care Volume 4 • Number 5 • November/December 2015 • specialtypharmacycontinuum.com

In This Issue Ask The Expert

Q&A: Mike Ellis on why Walgreens is “Lighting the Night.”

Horizon/Duexis link ‘misleading’

Despite barriers to entry ...

Specialty in Crosshairs Over Price-Gouging Talk

Retail Pharmacy Eyes Bigger Piece Of SP Juggernaut National Harbor, Md.—Everyone wants a piece of the growing juggernaut that is specialty pharmacy. This has been particularly evident at recent industry events such as the National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo in September, and the Armada Specialty Pharmacy Summit in May, where throngs of representatives from local retail pharmacies attended, eager to learn more about how to make specialty work for them. At the NASP annual meeting, a session on developing a community specialty pharmacy practice played to a packed house. Participants had been warned

Clinical

4 8 11

Poor compliance imperils HCV “cure.” Early HIV therapy gains momentum. Long-acting hemophilia drugs bolster prophylaxis.

see RETAIL PHARMACY, page 27

Policy

28 32 34

Why specialty should heed new sterile compounding rules. Is fee-for-service an endangered practice model? Stakeholders split over biosimilars naming proposal.

Technology

Boosting drug adherence through mobile apps.

Don’t call them specialty pharmacies. In late October, an article in The New York Times detailed the widespread criticism triggered by Horizon Pharma’s decision to charge approximately $1,500 a month for Duexis—a combination of ibuprofen and famotidine that, if prescribed and purchased separately, cost no more than $40 per month. Muliple news outlets depicted the Duexis pricing model as little more than profiteering—which would be fine, if it weren’t for the fact that Horizon’s use of an affiliated mail-order “specialty pharmacy” to deliver the arthritis medication cast full-service, patient-focused specialty pharmacy providers in a negative light. Those established players clearly are not pleased to be implicated in the price-gouging kerfuffle. “Just because somebody puts specialty in their name, or mails a medication, that doesn’t make them a specialty pharmacy,” said Phil Hagerman, RPh, the CEO and chairman of Diplomat Pharmacy Inc. “Specialty pharmacy—an industry that should be proud of what we do for people—has gotten a little dirt thrown on it for things that were completely unrelated to our [business model].” Rebecca Shanahan, Esq., the CEO of Avella Specialty Pharmacy, agreed. “Unfortunately, in this initial rush to comment, you have market makers and research analysts who don’t understand how specialty pharmacies really function.”

A Flood of Drugs, Profit To Come From Rx Pipeline Orlando, Fla.—The FDA approved more specialty medications than traditional ones in the past five years, even though less than 1% of Americans require a specialty medication. At 32% of the drug spend and growing, this trend is likely to continue as manufacturers find blockbuster profits in the specialty market, according to Aimee Tharaldson, PharmD. The pipeline is rich, said the senior clinical consultant for emerging therapeutics at Express Scripts in Bloomington, Minn. At the Academy of Managed Care Pharmacy’s AMCP 2015 Nexus meeting, Dr. Tharaldson highlighted

see CROSSHAIRS, page 30

see PIPELINE, page 12

Disease State Spotlight

FDA Approval

Psoriasis and Psoriatic P Arthritis: Ensuring Optimal Outcomes

DA approves Genvoya for HIV-1 infection.

See specialtypharmacy continuum.com/DSPsoriasis

See page 10.

Enhancing Your Patient Engagement Clinical Therapy herap h erap p Management nag nagem ag m IMPROVE MPROVE E ttient Ed Education ducation ducation ti Reporting R eepppoortin oort rtin rting rt rtin tiinng ti ng Solutions SSolu Solut luutttiions atient Track T rack rac cckk Outcomes Measure Adherence Clinical Th Therapy T herapy Management M Optimize Op O pptimize mii Persistency PPersist r tencyy

OPTIMIZE PERSISTENCY Clinical Clin C l nic iicall Pathway Pathwa P h ay ay

Clin Clinical li Pathway MEASURE ADHER ADHERENCE DHE E Patient Pa attie t eent Edu Ed Education ducation du d ucation n

TRACKK OUTCOMES

Reporting Solutions

MHA Specialty Pharmacy Solutions:

Delivering technology-based solutions, resources and expert services that help specialty pharmacies and business partners enrich their patient engagements, support improved outcomes and drive business efficiency. We offer a full spectrum of specialty service solutions, including: • Clinical Therapy Management (CTM)

• Data-driven specialty pharmaceutical contracting

• Prior authorization solutions

• Accreditation resources

• Data collection and reporting

• Legislative resources

• Clinical services and education

• Association and strategic partnerships

Specialty Pharmacy Continuum • November/December 2015

ASK THE EXPERT

Q&A with Mike Ellis

Why Walgreens Is Lighting the Night On Saturday, Oct. 24, Walgreens Specialty Pharmacy corporate vice president Mike Ellis joined thousands of Leukemia & Lymphoma Society supporters in nationwide “Light the Night” fundraising walks, as the event’s inaugural National Chairman of Specialty Pharmacy. More than 175 “Light the Night” walks were held this year. Specialty Pharmacy Continuum recently spoke with Mr. Ellis about the event and why it is such an important cause for him, both personally and professionally. SPC: Why did you decide to take on this honorary role? Mr. Ellis: I’ve been in this industry for many, many years, and cancer always seems to dominate everything we do. It’s really hard to find someone not affected by cancer, either personally overall or [as] a friend. My mother died of cervical cancer, and I’ve lost many friends [to cancer]. Clinically, it’s a huge part of what we in specialty pharmacy do on a daily basis.

approach that goes into how you treat these cancers is being extrapolated to other malignancies, such as solid tumors, as well as other disease states like autoimmune diseases. The key is getting funding for the research at a time when our own government has cut back on [National Institutes of Health] funding. “Light the Night” helps the Leukemia & Lymphoma Society continue to fund hundreds of research projects throughout the country.

SPC: Why the focus on blood cancers?

SPC: Why is a partnership with the Leukemia & Lymphoma Society so important to Walgreens?

Mr. Ellis: Blood cancers are the third leading cause of cancer-related deaths, and affect more than 1 million Americans. And the personalized research

Mr. Ellis: If you look back at every drug for blood cancers since 1992, you can see the fingerprints of the Leuke-

mia & Lymphoma Society. They’ve been there when others haven’t, and they put so much money into research. In the 20 years they’ve been doing this, they’ve raised over 1 billion dollars. Matt Farber, our senior director of oncology, works closely with the society to help drive Walgreens’ volunteer efforts each year. We had literally thousands of Walgreens employees walking with “Light the Night” this year, in areas like northern California, New Orleans and southern Alabama. So many of our stores are in underserved areas with disadvantaged communities, and our employees have the passion to get out and raise money to help bring better therapies to them. SPC: What would you say to your colleagues at other specialty pharmacies about events like these? Mr. Ellis: Part of what makes specialty pharmacy “special” is what we do with the patient community. This event, and our involvement, is an example in blood cancers, but you see it in many other disease states as well, like cystic fibro-

sis, multiple sclerosis and rheumatoid arthritis. There’s also so much grassroots support for smaller patient populations in the rare and ultra-orphan space as well. I want to thank our competition for that, and encourage them to keep challenging each other to do more. The Oct. 24 event is over for this year, but that’s just one weekend. There are many other events, and if you can’t sign up for a walk, make your presence known online at the Leukemia & Lymphoma Society website (www.lls.org). A few dollars go a long way. —Reported by Gina Shaw

EDITORIAL BOARD

ART/PRODUCTION STAFF

HOME INFUSION

Michele McMahon Velle, MAX Graphics/Creative Director

Jay Bryant-Wimp, RPh Owner/CEO Accurate Rx Pharmacy Columbia, MO

Frank Tagarello, Senior Art Director/Managing / Director, r MAX Graphics James O’Neill, Senior Systems Manager

Randy Fasnacht, RPh Director of Pharmacy Advanced Infusion Services Akron, OH

Dan Radebaugh, Director of Production and Technical Operations

Volume 4 • Number 5 • November/December 2015

specialtypharmacycontinuum.com

Marty Barbieri, Production Manager Brandy Wilson, Circulation Manager

SPECIALTY PHARMACY N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL Randy Falkenrath, MBA Senior Vice President CVS Health Woonsocket, RI

McMAHON PUBLISHING Michael Sicilian President, Managed Health Care Associates Inc. Florham Park, NJ Donald J. Vidic, RPh, MBA Vice President of Operations and Pharmacy Services Walgreens Specialty Pharmacy Carnegie, PA

Stephanie Holliday, PharmD Clinical Pharmacy Specialist Prosperity Specialty Pharmacy Falls Church, VA Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL Hetty Lima, RPh, FASHP Vice President of Specialty Infusion Services Diplomat Specialty Pharmacy Flint, MI

CHANGE YOUR ADDRESS? HERE’S HOW Selected U.S. hospital pharmacists and health care personnel receive Specialty Pharmacy Continuum free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address

A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.

Marie Rosenthal, Senior Editor mrosenthal@mcmahonmed.com Kevin Horty, Don Pizzi, Adam Marcus, Contributing Editors James Prudden, Group Editorial Director Elizabeth Zhong, Senior Copy Editor Kristin Jannacone, Copy Editor

HEALTH-SYSTEM PHARMACY Ernest R. Anderson Jr., MS, RPh Brockton, MA

REIMBURSEMENT Bonnie Kirschenbaum, MS Breckenridge, CO

EDITORIAL STAFF

SALES David Kaplan, Group Publication Director dkaplan@mcmahonmed.com Matt Spoto, Senior Account Manager mspoto@mcmahonmed.com Lillie Onday, Account Manager londay@mcmahonmed.com

David Bronstein, Editorial Director davidb@mcmahonmed.com

Craig Wilson, Sales Associate, Classified Advertising cwilson@mcmahonmed.com

or make your address change directly with Specialty Pharmacy Continuum, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (212) 977-3645, or send it via email, circulation@ mcmahonmed.com. If you are not a hospital pharmacist but would like to receive Specialty Pharmacy Continuum, please send a check for $70.00 (U.S.) or $90.00 (outside

U.S.) for a year’s subscription payable to Specialty Pharmacy Continuum to McMahon Publishing, 545 West 45th St., 8th Floor, New York, NY 10036. Please allow 8 to 12 weeks for delivery of the first issue. Individual issues are $7.00 (U.S.) or $10.00 (outside U.S.). McMahon Publishing is a 43-year-old, first-generation, family-owned publishing company dedicated to providing

Raymond E. McMahon, Publisher and Managing Partner Van Velle, President, Partner Matthew McMahon, General Manager, Partner Lauren McMahon Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

MCMAHON PUBLISHING MCMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036 Telephone: (212) 957-5300 Copyright © 2015 McMahon Publishing, New York, NY 10036. All rights reserved. Specialty Pharmacy Continuum (ISSN 0886-988x) is published quarterly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Specialty Pharmacy Continuum, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

medical professionals with essential, up-to-date news. As the second largest publisher of medical newspapers, McMahon produces Anesthesiology News, Clinical Oncology News, Gastroenterology & Endoscopy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News and Pharmacy Practice News.

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

Hepatitis C: Don’t Squander the Cure National Harbor, Md.—With — the extraordinary pace of advances in hepatitis C virus (HCV) therapy, you might think that getting most HCV patients to achieve a sustained virologic response (SVR) has become fairly easy. The sobering news is that adherence remains a significant challenge— and one that can jeopardize patients’ chances of a sustained cure, experts said at the 2015 National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo. The good news is that the potential for sustained cures has never been better: Even for more complicated HCVinfected patients, such as those with advanced cirrhosis or kidney disease, new investigational agents and combinations are reaching SVR rates near 100%, according to the latest published studies ((BMC Infect Dis 2015;15:19. doi: 10.1186/s12879-015-0748-8). “Once patients are on treatment with these new combinations, side effect management is pretty easy,” said gastroenterologist Imtiaz Alam, MD, the founder of the Austin Hepatitis Center, in Texas. But here’s the catch: “It can seem too easy sometimes, and the patients can become complacent and fail to stick to the regimen as they should.”

‘Some [HCV] patients hear “cure” and they think they don’t ever need to come back.’ —Jason Lynn, PharmD Missing doses for as little as 24 to 48 hours can inhibit response to the newer regimens, Dr. Alam said. “With Medicaid restricting this therapy to a once-in-a-lifetime treatment, and most—although not all—insurance companies requiring week 4 RNA levels before renewal, it’s essential to keep on top of adherence. If patients are taking these medications correctly, they all should be negative by the end of week 4 of therapy.” Resistance is a critical consideration when managing HCV-positive patients, Dr. Alam said. Historically, with the interferon–ribavirin based therapies, he noted, there was no worry about developing resistance. The newer direct-acting antiviral agents, in contrast, pose a significant risk for resistance developing if they are not taken as prescribed, Dr. Alam said. These agents include ledipasvir-sofosbuvir (Harvoni, Gilead); ombitasvir-paritaprevir-ritonavir tablets plus dasabuvir tablets ((Viekira Pak, AbbVie); the FDA-approved combination of sofosbuvir (Sovaldi, Gilead) and simeprevir

(Olysio, Janssen); and Sovaldi used in combination with daclatasvir (Daklinza, Bristol Myers-Squibb). Here’s what’s at stake, he noted: With a poorly managed HCV treatment regimen, patients (and/or their insurance companies) could be spending thousands off dollars on a highly effective drug or drug combination, only to squander the cure, perhaps permanently, with just a couple of missed doses. It’s also essential to monitor drug–drug interactions, according to Jason Lynn, PharmD, the vice president for clinical services and trade at ReCept, which has specialty pharmacies located throughout the Southwest. Such reactions “are a significant problem with these complex [HCV] regimens—and you get one chance on the treatment with a lot of the companies today.” Indeed, Dr. Lynn noted, payors have become “tougher” again about authorizing patients for therapy. “At one point, many payors were authorizing coverage of the new therapies for patients with F3 or F4 cirrhosis only; then it loosened up in the spring, and it was getting easier to get authorized for patients with HIV or hepatitis B coinfection or type 2 diabetes. Now, that seems to have changed, and some of those patients are unfortunately being denied treatment again.”

Help From New Guidelines The current guidelines from the American Association for the Study of Liver Diseases (AASLD), updated in August 2015, now contain a detailed discussion of cost-effectiveness, and place patients with F3 and F4 cirrhosis at “highest priority” for treatment (http://goo.gl/fLH7yc). Those with diabetes, HIV, hepatitis B or F2 cirrhosis are one category down at “high priority”—which may be what payors are using as a justification for some of these denials, even though the guidelines recommend treatment for all patients with chronic HCV infection

except those with short life expectancies owing to comorbid conditions. But deferring treatment may prove to be shortsighted, Dr. Lynn said: “Studies show that patients who are treated earlier, while they are noncirrhotic, respond better to treatment” ((N Engl J Med d 2011;364[13]:1195-1206; N Engl J Med 2011;364[25]:2405-2416). Achieving a cure is not the end of the story. Specialty pharmacies, GI physicians and primary care providers should also work closely together to make sure patients are not lost to follow-up after successfully completing treatment, Dr. Lynn stressed. “Some patients hear ‘cure,’ and they think they don’t ever need to come back,” he said. “But hepatitis C is a multisystem disease, and we need to think globally. Diseases like diabetes and cirrhosis should improve once the virus is cured, but they need to be monitored.” Patient education is essential to reduce the risk for reinfection, the experts added. “There is some data coming out on so-called ‘late relapses’ after successful treatment, and genetic studies show that for most people, it’s not the same virus. It’s reinfection, not a relapse,” Dr. Alam said. “If you go out and have too much fun, you can get the disease back.” And few, if any, payors will fork out $80,000 to treat a reinfection in someone who already grabbed the brass ring of a cure. The NASP session also included an update on the latest HCV drug regi-

mens, which are changing almost daily. Daclatasvir was approved by the FDA in July 2015, in conjunction with sofosbuvir, solely for patients diagnosed with HCV genotype 3. The approval was based in part on the results of the open-label ALLY-3 clinical trial. But an August update to the AASLD guidelines recommends daclatasvir for genotypes 1 and 2 as well, despite its yetunapproved status in those genotypes. (Daclatasvir is the first drug that demonstrated safety and efficacy to treat HCV genotype 3 infections without the need for coadministration of interferon or ribavirin, according to the FDA.) In genotype 1, there had been a push toward eight weeks of therapy instead of 12, but Dr. Lynn noted that new trial results are calling that strategy into question. “The OPTIMIST-1 trial found 97% SVR at 12 weeks with simeprevir and sofosbuvir in this group, but only 83% at eight weeks [International Liver Congress 2015; abstract LP14],” he said. “A lot of people grabbed onto an eightweek regimen as more cost-effective, but it may not be if it doesn’t achieve the same cure rates. We will undoubtedly see more data on this coming out.” For more information on HCV infection and treatment trends, see page 6. —Gina Shaw The presenters reported no relevant ﬁnancial relationships.

BD PhaSeal™ Closed System Drug Transfer Device Work safe. Enjoy life.

Protecting Jacob the pharmacist, and Jacob the cyclist. Pharmacists often tell us how satisfying it is to be such an important part of a patient’s treatment. But, you’re also important to many other people in your life—so please take care of your health, too. Studies connect hazardous drug exposure to serious health risks for pharmacists. We’re helping to change that, by protecting thousands of pharmacists every day from the hazardous drugs they handle. We can’t do what you do, but we can help you do it safely.

Work safe. Enjoy life. bd.com/phaseal

BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 www.bd.com

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

Incorporating Immunotherapies Into Practice National Harbor, Md.—Novel immunotherapies have been touted as game-changing for patients with cancer. Programmed cell death protein 1 (PD-1) inhibitors, one type of immunotherapy, have produced dramatic results in some malignancies. Pharmacists can play an important role in how PD-1 inhibitors are incorporated into practice, experts noted at the annual meeting of the National Association of Specialty Pharmacy Annual Meeting & Expo. “We should make sure that pharmacists and the clinical team accurately and thoroughly review the orders that we receive, especially to make sure the order is appropriate and the dosing is appropriate,” said David Kwasny, PharmD, BCOP, the director of clinical oncology services at Onco360 Oncology Pharmacy, in Louisville, Ky. “We should remain optimistic about the treatment advances that these molecules provide, but we need to maintain a realistic view with where we are currently and understand that this is not a therapy that is ready for prime time in all disease states.”

is approved in patients with advanced or metastatic NSCLC with progression on or after platinum-based doublet chemotherapy. Patients with epidermal growth factor receptor ((EGFR) or anaplastic lymphoma kinase ((ALK K) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations before receiving nivolumab. Nivolumab is also approved for the treatment of unresectable or metastatic melanoma as either first-line therapy in combination with ipilimumab (Yervoy, Bristol-Myers Squibb) in BRAF F wild-type patients or as a single

‘A dedicated nursing line, 24-hour access and Web-based portals are key methods to maintain communication directly with the patient.’ —David Kwasny, PharmD, BCOP Dr. Kwasny recently received an order for a PD-1 inhibitor for bladder cancer. “Bladder cancer is one of the malignancies that responds very well to these drugs, but we are not quite there yet,” he said. “While you may get requests for marketed products across all sorts of malignancies, there is still an appropriateness that we need to follow.” Immunotherapy activates the immune system to target tumors. After a T cell is activated, the cell increases the expression of PD-1 on its surface, allowing it to receive a shutdown signal. Cancer cells take advantage of this system by expressing binding partners of PD-1, prematurely shutting down T cells. PD-1 is involved in 50% of squamous nonsmall cell lung cancers (NSCLC), 45% of non-small cell adenocarcinomas, 45% of colon cancers, 40% of melanomas and 20% of renal cell carcinomas ((Annu Rev Immunoll 2008;26:677-704). PD-1 inhibitors bind to PD-1, preventing tumor cells from binding. The inhibitors do this without activating PD-1, allowing the T cells to stay active and kill cancer cells. Currently, two PD-1 inhibitors are on the market: nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck). Nivolumab is dosed at 3 mg/kg IV infusion over one hour every two weeks. It

agent in patients with progression following ipilimumab, and if BRAF F V600 mutation–positive, a BRAF inhibitor. Pembrolizumab is given at 2 mg/kg IV infusion over 30 minutes every three weeks. It is approved for unresectable or metastatic melanoma following ipilimumab, and if BRAF F V600 mutation–positive, a BRAF inhibitor. Pembrolizumab also has been approved for patients with metastatic NSCLC whose disease is PDL1-positive (a ligand of PD-1) and progressed during or after platinum-based chemotherapy. It is approved in all histologies. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations before receiving pembrolizumab. The Phase III data leading to the approvals of these two drugs showed remarkable responses in some patients. Whereas patients who respond to chemotherapy do so immediately, patients on immunotherapy can respond early or late. The immune-related response criteria are designed to adequately assess tumor response to immunotherapy. Megan Brafford, PharmD, BCOP, an oncology pharmacy specialist at Baptist Health Lexington, in Kentucky, pointed out that assessing response to immunotherapy is tricky, given that tumor flare

Restoration of normal immune response following PD-1 immune checkpoint inhibition. Schematic shows T cell reactivation and decreased tumor growth in syngeneic mouse tumor model. Source: Bristol Myers-Squibb (http://goo.gl/JaUSY4).

or pseudoprogression can occur. Patients should have their first evaluation scan done at nine weeks and then every eight weeks thereafter. “Usually providers will continue the immunotherapy after suspected disease progression, until you get a subsequent scan, approximately four weeks later, that shows it is no longer working,” Dr. Brafford said. The key to managing side effects with immunotherapy is early detection and appropriate treatment. Patients on PD-1 inhibitors should undergo tests to evaluate liver function, serum creatinine, thyroid function and, if on pembrolizumab, hypoglycemia, Dr. Brafford said. Clinicians and patients should be on the lookout for signs of pneumonitis, colitis and hypophysitis. “A dedicated nursing line, 24-hour access and Web-based portals are key methods to maintain communication directly with the patient,” Dr. Kwasny said. Dr. Brafford said pharmacists should prepare patients for immune-mediated side effects. “Most are mild, grade 1 or 2, and most are reversible,” she said. “They differ greatly from what we would expect with cytotoxic chemotherapy. It’s important to educate our patients that it is going to be a lot different.” Common adverse effects associated with nivolumab include pruritus, rash, electrolyte abnormalities, constipation, appetite suppression, nausea/vomiting, cough, musculoskeletal pain and fatigue. Severe adverse effects associated with the drug include colitis, hepatitis, hypo-/hyperthyroidism, renal dysfunction, dyspnea and pneumonitis. Common adverse events associated with pembrolizumab are pruritus, rash, constipation, nausea/vomiting, diarrhea, muscle aches, cough and fatigue. Severe adverse effects associated with nivolumab are anemia, pneumonitis, infusion reaction, hepatitis,

renal dysfunction and erythroderma. “The adverse event time line for these agents is very unique,” Dr. Kwasny said. “It follows a very predictable time line, so if we can educate the patient, providers and nursing staff up front about when to expect these side effects, we can often have a very positive effect on outcome.” Rash and mucosal irritation from immunotherapy occur roughly four weeks after treatment, diarrhea/colitis occurs roughly six weeks after the start of therapy and hepatotoxicity occurs eight to 12 weeks into therapy, she noted. Both presenters said nivolumab and pembrolizumab have revolutionized the treatment of metastatic melanoma and NSCLC. Further research will focus on identifying a biomarker for the drugs and determining the long-term benefits of these PD-1 inhibitors. “Validation of long-term response is needed to understand the full benefit and optimal role of these new treatments,” Dr. Brafford said. “Right now, these therapies as monotherapy are only approved in metastatic settings and second line. If we move these up earlier in treatment, are we going to have that durable response?” Only time will tell. —Kate O’Rourke Drs. Kwasny and Brafford reported no relevant ﬁnancial relationships.

Web Exclusive For a table of selected clinical trials of nivolumab and pembrolizumab, scan the adjacent QR code or visit specialtypharmacy continuum.com/ CheckMateTrials.

PYROSATE

RAPID ENDOTOXIN DETECTION KIT

Visit at Bo Us oth #606

nse e c i L FDA

New Sensitivities Of 0.03, 0.125 and 0.25 EU/mL Final Product Release Easy-To-Use Method Rapid Test Results Bacterial Endotoxin Testing USP Chapter <85> Compliant Associates of Cape Cod, Incorporated 124 Bernard E. Saint Jean Dr., East Falmouth, MA 02536 USA 888.395.2221 • INFO@ACCIUSA.COM • WWW.ACCIUSA.COM

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

The Debate Is Over: Start ART Early

Starting ART early in HIV-infected individuals, before the CD4 count falls below 500 cells/mm3, results in a reduction of AIDS-related illnesses, and reduces the risk for developing cancer, cardiovascular disease and other non–AIDS-related diseases, said Dr. Lundgren, a professor at Rigshospitalet, Department of Infectious Diseases and Rheumatology, University of Copenhagen in Denmark. Although earlier work had hinted at this finding, physicians were concerned that the studies were not rigorous enough to change prescribing because there were concerns that the benefits of early treatment did not outweigh the risks for adverse events, the difficulty of adherence due to the pill burden and

Table. Effect of ART Timing on Serious AIDS Events

AIDS Event

Immediate ART, n

Deferred ART, n

Tuberculosisa

Lymphoma

Kaposi’s sarcoma

Pneumocystis Pneumonia

Herpes zoster

Otherb

Participants from Africa: 16 of 26 (62%) of tuberculosis cases.

Cervical carcinoma, extrapulmonary cryptococcosis, cytomegalovirus, recurrent bacterial pneumonia.

ART, antiretroviral therapy Source: N Engl J Med. 2015;373(9):808-822.

the worry that patients might develop resistance, he explained. However, recent long-term, controlled, large studies have demonstrated clear evidence of the advantages of early ART; regimens are easier to manage; and the risks of adverse events no longer outweigh the benefits of early therapy. “Early initiation of antiretroviral therapy leads to a 57% reduction in risk of serious AIDS, serious non-AIDS or death events,” said Dr. Lundgren, who is the co-chair of the INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) START (Strategic Timing of AntiRetroviral Treatment) Study Group, which has provided landmark research on the topic of ART ((N Engl J Med 2015;373[9]:795-807). The study results were the same regardless of age, race, sex, smoking status and other health parameters. During the START trial, most processes, including AIDSrelated events, occurred when patients still had relatively high CD4 counts, when their immune systems were presumably still intact and functioning, Dr. Lundgren said. “HIVinduced immunodeficiency occurs early in HIV infection.” He called on researchers to find a better biomarker than CD4 count to measure the progress of patients with HIV. “We need to identify novel markers of impaired immune function,” he said.

A Multicenter START The START trial enrolled 4,685 HIVinfected men and women aged 18 years and older, from 250 clinical sites in 35 countries. Participants were treatment naive and enrolled in the trial when their CD4 counts were in the normal range, above 500 cells/mm3. About half of the participants (2,326) started taking ART immediately, and the rest (2,359) deferred treatment until their CD4 counts fell below 350 cells/mm3. Participants were followed on average for three years. The effect of treatment timing on CD4 counts (Table) was so striking that a decision was made to unblind the study early, and results were released early this year at the International AIDS Society (IAS) meeting in Vancouver, British Columbia, as

1,000 Immediate initiation

Mean CD4 Counts, cells/mm3

San Diego—The START trial definitively answers the question of when to begin antiretroviral therapy (ART), which has been debated for decades. ART should begin immediately when a person is diagnosed, according to Jens Lundgren, MD, DMSc, who spoke during a special lecture at the 2015 Interscience Conference of Antimicrobial Agents and Chemotherapy.

900

800

700

Deferred initiation

600 0

Figure. CD4 counts and the effect of treatment delays. Source: N Engl J Med. 2015;373(9):808-822.

well as published in The New England Journal of Medicine. He said there were two reasons to unblind the data: “The benefit of early treatment was more pronounced than what we had anticipated, and the seri-

or lower and the IAS recommending treatment after CD4 counts fell to 500 cells/mm.3 Starting ART while an HIV-positive individual still has a high CD4 count and an intact immune system is better

‘We have treatment guidelines in place, but this has been the first trial that really demonstrated that starting ART early has positive impact on AIDS-related events, non–AIDS-related events and even allcause death.’ —Eric Sredzinski, PharmD ous AIDS events as part of the primary end point [Figure] were seen more than we had predicted.” Another study, by the TEMPRANO ANRS 12136 Study Group, found a clear advantage in the prevention of tuberculosis among sub-Saharan Africans who received early ART plus isoniazid prophylaxis ((N Engl J Med d 2015;373[9]:808822; Table). These two studies taken together are game changers in the treatment of HIV, according to Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, who spoke at the IAS meeting. There had been some wavering on this issue, Dr. Lundgren said, with the Department of Health & Human Services recommending ART to all HIV-infected individuals, the World Health Organization recommending ART for those with 350 cells/mm3

than delaying treatment, Dr. Lundgren stressed. “HIV in many people is a slowly deteriorating condition. Many people are left with a relatively high CD4 count for a considerable period,” he said. Individuals who receive ART can raise their CD4 counts. But the lower they are when treatment begins, the harder it is to do so.

Specialty’s Perspective “The benefit of starting antiretroviral therapy with CD4+ counts above 350 cells/mm3 has been somewhat controversial,” said Eric Sredzinski, PharmD, the executive vice president of clinical affairs and quality assurance at Avella Specialty Pharmacy. “We have treatment guidelines in place, but this has been the first trial that really demonstrated that starting ART early has positive impact see EARLY ART, page 10

NOW APPROVED REPATHA

™

A NEW PCSK9 INHIBITOR FOR INTENSIVE, PREDICTABLE LDL-C REDUCTION in adults with clinical ASCVD or HeFH on maximally tolerated statin therapy as an adjunct to diet

Indication • Repatha™ is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor antibody indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol (LDL-C). • Limitations of Use: The effect of Repatha™ on cardiovascular morbidity and mortality has not been determined.

Important Safety Information • Contraindication: Repatha™ is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha™. • Allergic reactions: Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha™, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha™, treat according to the standard of care, and monitor until signs and symptoms resolve. • Adverse Reactions: The most common adverse reactions (> 5% of Repatha™-treated patients and more common than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. • In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha™treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha™ treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha™ and placebo, respectively). • Adverse reactions from a pool of the 52-week trial and seven 12-week trials, included: Local injection site reactions that occurred in 3.2% and 3.0% of Repatha™-treated and placebotreated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha™-treated patients and placebo-treated patients were 0.1% and 0%, respectively. References: 1. Repatha™ (evolocumab) Prescribing Information v2, Amgen. 2. Data on file, Amgen;[1]; 2015. 3. Data on file, Amgen;[2]; 2015. © 2015 Amgen Inc. All rights reserved. Not for reproduction. USA-145-109360

Allergic reactions occurred in 5.1% and 4.7% of Repatha™-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha™ and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%). Neurocognitive events were reported in less than or equal to 0.2% in Repatha™-treated and placebo-treated patients. In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1,988 patients treated with Repatha™ had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and Repatha™ dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the longterm effects of very low levels of LDL-C induced by Repatha™ are unknown. Musculoskeletal adverse reactions were reported in 14.3% of Repatha™-treated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for Repatha™ and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%). • Immunogenicity: Repatha™ is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha™.

Please see Brief Summary of full Prescribing Information on adjacent page.

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

EARLY ART

‘I know here in San Francisco, a lot of clinicians who are very well versed in HIV were already starting [antiviral] therapy in everybody if they were willing to take it.’

continued from page 8

on AIDS-related events, non–AIDSrelated events and even all-cause death. We will end up seeing a consensus from all organizations probably in the near future on a global scale, not just in the United States,” said Dr. Sredzinski, who was asked to comment on the study. Betty Dong, PharmD, a professor of clinical pharmacy at the University of California, San Francisco, commented that many experts in HIV treatment,

REPATHA™ (evolocumab) BRIEF SUMMARY OF PRESCRIBING INFORMATION Please see package insert for full Prescribing Information 1. INDICATIONS AND USAGE 1.1 Primary Hyperlipidemia REPATHA is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C). 1.2 Homozygous Familial Hypercholesterolemia REPATHA is indicated as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. 1.3 Limitations of Use The effect of REPATHA on cardiovascular morbidity and mortality has not been determined. 4. CONTRAINDICATIONS REPATHA is contraindicated in patients with a history of a serious hypersensitivity reaction to REPATHA [[see Warnings and Precautions (5.1) ]. 5. WARNINGS AND PRECAUTIONS 5.1 Allergic Reactions Hypersensitivity reactions (e.g., rash, urticaria) have been reported in patients treated with REPATHA, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with REPATHA, treat according to the standard of care, and monitor until signs and symptoms resolve. 6. ADVERSE REACTIONS The following adverse reactions are also discussed in other sections of the label: • Allergic Reactions [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Patients with Primaryy Hyperlipidemia yp p and in Patients with Heterozygous yg Familial Hypercholesterolemia yp REPATHA is not indicated for use in patients without familial hypercholesterolemia or atherosclerotic CVD [see Indications and Usage (1.1)]. ) The data described below reflect exposure to REPATHA in 8 placebocontrolled trials that included 2651 patients treated with REPATHA, including 557 exposed for 6 months and 515 exposed for 1 year (median treatment duration of 12 weeks). The mean age of the population was 57 years, 49% of the population were women, 85% White, 6% Black, 8% Asians, and 2% other races. Adverse Reactions in a 52-Week Controlled Trial In a 52-week, double-blind, randomized, placebo-controlled trial (Study 2), 599 patients received 420 mg of REPATHA subcutaneously once monthly [see Clinical Studies (14.1)]. The mean age was 56 years (range: 22 to 75 years), 23% were older than 65 years, 52% women, 80% White, 8% Black, 6% Asian, and 6% Hispanic. Adverse reactions reported in at least 3% of REPATHA-treated patients, and more frequently than in placebo-treated patients in Study 2, are shown in Table 1. Adverse reactions led to discontinuation of treatment in 2.2% of REPATHA-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to REPATHA treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for REPATHA and placebo, respectively). Table 1. Adverse Reactions Occurring in Greater than or Equal to 3% of REPATHA-treated Patients and More Frequently than with Placebo in Study 2

Nasopharyngitis Upper respiratory tract infection Influenza Back pain Injection site reactions† Cough Urinary tract infection Sinusitis Headache Myalgia Dizziness Musculoskeletal pain Hypertension Diarrhea Gastroenteritis

Placebo (N=302) %

REPATHA (N=599) %

9.6 6.3 6.3 5.6 5.0 3.6 3.6 3.0 3.6 3.0 2.6 3.0 2.3 2.6 2.0

10.5 9.3 7.5 6.2 5.7 4.5 4.5 4.2 4.0 4.0 3.7 3.3 3.2 3.0 3.0

† includes erythema, pain, bruising Adverse Reactions in Seven Pooled 12-Week Controlled Trials In seven pooled 12-week, double-blind, randomized, placebo-controlled trials, 993 patients received 140 mg of REPATHA subcutaneously every 2 weeks and 1059 patients received 420 mg of REPATHA subcutaneously monthly. The mean age was 57 years (range: 18 to 80 years), 29% were older than 65 years, 49% women, 85% White, 5% Black, 9% Asian, and 5% Hispanic. Adverse reactions reported in at least 1% of REPATHA-treated patients, and more frequently than in placebo-treated patients, are shown in Table 2.

—Betty Dong, PharmD especially in cities such as San Francisco, have been advocating the use of early ART. Such clinicians “have been doing this for a really long time,” she

Table 2. Adverse Reactions Occurring in Greater than 1% of REPATHAtreated Patients and More Frequently than with Placebo in Pooled 12Week Studies

Nasopharyngitis Back pain Upper respiratory tract infection Arthralgia Nausea Fatigue Muscle spasms Urinary tract infection Cough Influenza Contusion

Placebo (N=1224) %

REPATHA† (N=2052) %

3.9 2.2 2.0 1.6 1.2 1.0 1.2 1.2 0.7 1.1 0.5

4.0 2.3 2.1 1.8 1.8 1.6 1.3 1.3 1.2 1.2 1.0

†

140 mg every 2 weeks and 420 mg once monthly combined Adverse Reactions in Eight Pooled Controlled Trials (Seven 12-Week Trials and One 52-Week Trial) The adverse reactions described below are from a pool of the 52-week trial (Study 2) and seven 12-week trials. The mean and median exposure durations of REPATHA in this pool of eight trials were 20 weeks and 12 weeks, respectively. Local Injection Site Reactions Injection site reactions occurred in 3.2% and 3.0% of REPATHA-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in REPATHAtreated patients and placebo-treated patients were 0.1% and 0%, respectively. Allergic Reactions Allergic reactions occurred in 5.1% and 4.7% of REPATHA-treated and placebotreated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for REPATHA and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%). Neurocognitive Events In placebo-controlled trials, neurocognitive events were reported in less than or equal to 0.2% in REPATHA-treated and placebo-treated patients. Low LDL-C Levels In a pool of placebo- and active-controlled trials, as well as open-label extension studies that followed them, a total of 1988 patients treated with REPATHA had at least one LDL-C value < 25 mg/dL. Changes to background lipid-altering therapy were not made in response to low LDL-C values, and REPATHA dosing was not modified or interrupted on this basis. Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by REPATHA are unknown. Musculoskeletal Events Musculoskeletal adverse reactions were reported in 14.3% of REPATHAtreated patients and 12.8% of placebo-treated patients. The most common adverse reactions that occurred at a rate greater than placebo were back pain (3.2% versus 2.9% for REPATHA and placebo, respectively), arthralgia (2.3% versus 2.2%), and myalgia (2.0% versus 1.8%). Adverse Reactions in Patients with Homozygous yg Familial Hypercholesterolemia yp In a 12-week, double-blind, randomized, placebo-controlled trial of 49 patients with HoFH (Study 4), 33 patients received 420 mg of REPATHA subcutaneously once monthly [see Clinical Studies (14.3)]. ) The mean age was 31 years (range: 13 to 57 years), 49% were women, 90% White, 4% Asian, and 6% other. The adverse reactions that occurred in at least two (6.1%) REPATHA-treated patients, and more frequently than in placebo-treated patients, included: • Upper respiratory tract infection (9.1% versus 6.3%) • Influenza (9.1% versus 0%) • Gastroenteritis (6.1% versus 0%) • Nasopharyngitis (6.1% versus 0%) 6.2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of REPATHA has been evaluated using an electrochemiluminescent bridging screening immunoassay for the detection of binding anti-drug antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies. In a pool of placebo- and active-controlled clinical trials, 0.1% of patients treated with at least one dose of REPATHA tested positive for binding antibody development. Patients whose sera tested positive for binding antibodies were further evaluated for neutralizing antibodies; none of the patients tested positive for neutralizing antibodies. There was no evidence that the presence of anti-drug binding antibodies impacted the pharmacokinetic profile, clinical response, or safety of REPATHA, but the long-term consequences of continuing REPATHA treatment in the presence of anti-drug binding antibodies are unknown. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to REPATHA with the incidence of antibodies to other products may be misleading. 8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summaryy There are no data available on use of REPATHA in pregnant women to inform a drug-associated risk. In animal reproduction studies, there were no effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dose of 420 mg every month. In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses. The exposures where immune suppression occurred in infant monkeys were greater than those expected clinically. No assessment for immune suppression was conducted with evolocumab in infant monkeys. © 2015 Amgen Inc. All rights reserved. Not for reproduction. v2 09/15

said. “They were not even looking at the CD4 count but just starting ART when patients are first infected.” How one treats HIV “probably depends

Measurable evolocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that evolocumab, like other IgG antibodies, crosses the placental barrier. FDA’s experience with monoclonal antibodies in humans indicates that they are unlikely to cross the placenta in the first trimester; however, they are likely to cross the placenta in increasing amounts in the second and third trimester. Consider the benefits and risks of REPATHA and possible risks to the fetus before prescribing REPATHA to pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 1520%, respectively. Data Animal Data In cynomolgus monkeys, no effects on embryo-fetal or postnatal development (up to 6 months of age) were observed when evolocumab was dosed during organogenesis to parturition at 50 mg/kg once every 2 weeks by the subcutaneous route at exposures 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. No test of humoral immunity in infant monkeys was conducted with evolocumab. 8.2 Lactation Risk Summaryy There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for REPATHA and any potential adverse effects on the breastfed infant from REPATHA or from the underlying maternal condition. Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. 8.4 Pediatric Use The safety and effectiveness of REPATHA in combination with diet and other LDL-C-lowering therapies in adolescents with HoFH who require additional lowering of LDL-C were established based on data from a 12-week, placebocontrolled trial that included 10 adolescents (ages 13 to 17 years old) with HoFH [see Clinical Studies (14.3)]. ) In this trial, 7 adolescents received REPATHA 420 mg subcutaneously once monthly and 3 adolescents received placebo. The effect of REPATHA on LDL-C was generally similar to that observed among adult patients with HoFH. Including experience from open-label, uncontrolled studies, a total of 14 adolescents with HoFH have been treated with REPATHA, with a median exposure duration of 9 months. The safety profile of REPATHA in these adolescents was similar to that described for adult patients with HoFH. The safety and effectiveness of REPATHA have not been established in pediatric patients with HoFH who are younger than 13 years old. The safety and effectiveness of REPATHA have not been established in pediatric patients with primary hyperlipidemia or HeFH. 8.5 Geriatric Use In controlled studies, 1420 patients treated with REPATHA were ≥ 65 years old and 171 were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal Impairment No dose adjustment is needed in patients with mild to moderate renal impairment. No data are available in patients with severe renal impairment [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment No dose adjustment is needed in patients with mild to moderate hepatic impairment (Child-Pugh A or B). No data are available in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)]. 13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of evolocumab was evaluated in a lifetime study conducted in the hamster at dose levels of 10, 30, and 100 mg/kg administered every 2 weeks. There were no evolocumab-related tumors at the highest dose at systemic exposures up to 38- and 15-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. The mutagenic potential of evolocumab has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes. There were no adverse effects on fertility (including estrous cycling, sperm analysis, mating performance, and embryonic development) at the highest dose in a fertility and early embryonic developmental toxicology study in hamsters when evolocumab was subcutaneously administered at 10, 30, and 100 mg/kg every 2 weeks. The highest dose tested corresponds to systemic exposures up to 30- and 12-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. In addition, there were no adverse evolocumab-related effects on surrogate markers of fertility (reproductive organ histopathology, menstrual cycling, or sperm parameters) in a 6-month chronic toxicology study in sexually mature monkeys subcutaneously administered evolocumab at 3, 30, and 300 mg/ kg once weekly. The highest dose tested corresponds to 744- and 300-fold the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. 13.2 Animal Toxicology and/or Pharmacology During a 3-month toxicology study of 10 and 100 mg/kg once every 2 weeks evolocumab in combination with 5 mg/kg once daily rosuvastatin in adult monkeys, there were no effects of evolocumab on the humoral immune response to keyhole limpet hemocyanin (KLH) after 1 to 2 months exposure. The highest dose tested corresponds to exposures 54- and 21-fold higher than the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. Similarly, there were no effects of evolocumab on the humoral immune response to KLH (after 3 to 4 months exposure) in a 6-month study in cynomolgus monkeys at dose levels up to 300 mg/kg once weekly evolocumab corresponding to exposures 744- and 300-fold greater than the recommended human doses of 140 mg every 2 weeks and 420 mg once monthly, respectively, based on plasma AUC. This Brief Summary is based on the REPATHA™ Prescribing Information v2, 09/15

REPATHA™ (evolocumab) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 U.S. License Number 1080 Patent: http://pat.amgen.com/repatha/

on where you practice, but I know here in San Francisco, a lot of clinicians who are very well versed in HIV were already starting [antiviral] therapy in everybody if they were willing to take it,” Dr. Dong said, adding that the new studies support such an approach. Dr. Sredzinski agreed with Dr. Dong that some HIV clinicians were early adopters of early ART, whereas other physicians were waiting for more evidence. “When we’re managing patients, our goal is to use evidence-based medicine to treat those patients, and so historically there was quite a bit of ambiguity in the data of when to initiate ART in patients with CD4+ counts above 350 cells/mm3,” he said. There were several observational studies that found very different results. “Because of this, I think clinicians wanted some clear guidance about what to do, and that’s what the START trial has been able to demonstrate for us.” Dr. Dong said treatments today are much less toxic, are well tolerated and have lower pill burdens, so there really is no reason not to provide early ART if the patient is willing and is motivated to adhere. “We’re down to one pill once daily ... versus the old days when you had to take like eight or 10 pills a day to start,” she said. “This has made patients [much more accepting of early ART].” —Marie Rosenthal

FDA Approval FDA OKs First TAF-Based HIV Regimen

he FDA approved a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (Genvoya, Gilead) for the treatment of HIV infection in adults and pediatric patients 12 years of age and older. Genvoya is the first tenofovir alafenamide (TAF)-based regimen to gain FDA approval. TAF is a targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (Viread, Gilead). In data submitted to the FDA, Genvoya achieved comparable efficacy when compared with a reference medication, based on achieving HIV-1 RNA levels less than 50 copies/mL at week 48 of observation. Genvoya carries a boxed warning on the risks for lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of hepatitis B. Gilead’s U.S. Advancing Access program provides assistance to patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Genvoya. For more information, visit www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5.

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

Long-Acting Clotting Factors Good at Nearly Any Age Las Vegas—Prophylactic therapy with one of the newer long-acting clotting factor concentrates significantly benefits individuals with hemophilia no matter their age or stage of disease, according to Sheh-Li Chen, PharmD, BCOP, a clinical pharmacy specialist in benign hematology at the University of North Carolina Medical Center in Chapel Hill. Biogen’s Eloctate (Antihemophilic Factor [Recombinant], Fc Fusion Protein), approved in June 2014 for hemophilia A, and the company’s Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein), approved in March 2014 for hemophilia B, require less frequent injections than other, shorter-acting clotting factors—a boost to adherence, especially among younger patients who may resist repeated shots, Dr. Chen noted. After a 2007 multicenter study of primary prophylaxis in young boys (<30 months) demonstrated that 93% of prophylaxis patients and only 55% of episodic-treatment patients had normal index-joint structure by 6 years of age ((N Engl J Med 2007;357[6]:535-544), the National Hemophilia Foundation issued a recommendation that prophylactic factor therapy should be instituted early, before the onset of frequent bleeding.

episodes per year in patients on prophylaxis, and 30.5 mean episodes among patients receiving on-demand treatment” ((J Thromb Haemost 2013;11[6]:1119-1127). “The younger you start prophylaxis,

Significantly Reduced Bleeds But subsequent studies have demonstrated that even when this goal is missed, it’s not too late. ESPRIT (European/Australasian Stroke Prevention in Reversible Ischaemia Trial), a study of secondary prophylaxis in boys aged 1 to 7 years who had already had one or two hemorrhages into the same joint, found a significant reduction in bleeding (fewer than one joint bleed per year among 52% of the prophylaxis patients, but just 21% of the episodic patients), and dramatically reduced radiologic signs of joint damage (29% vs. 74%; J Thromb Haemost 2011;9[4]:700-710), Dr. Chen pointed out. Studies of tertiary prophylaxis have also shown benefits, Dr. Chen noted. “The SPINART [Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment] study found two mean bleeding

the more benefit you can get, but it is still not too late to start prophylaxis if the boy is older,” Dr. Chen said during a session on hemophilia at the 2015 Armada Specialty Pharmacy Summit.

M AMCP

19-22 APRIL

• MO

—Gina Shaw The sources reported no relevant ﬁnancial relationships.

ARMA H P Y LT SPECIA

6 1 0 2 g n i t Mee

ARE & C D E ANAG

l a u n An

“Nor is it too late to start prophylaxis in an adult. By reducing damage from joint bleeds, the patient may not need surgery to correct joint damage. There is evidence for benefit across the board, no matter how old a hemophilia patient is.”

RANC SAN F • T S WE SCONE

∙

ISCO

Thousands of Managed Care Professionals. Hundreds of Sessions, Abstracts, Special Events and Exhibits. One Great Destination. . .

And a new name to reflect our expanding world! The world of managed care and specialty pharmacy is growing…and AMCP is responding.

Web Only Hemophilia is the eighth most expensive specialty drug class when ranked by permember, per-year cost, according to one recent trend report. For more details on the report, as well as additional patient management tips, scan the adjacent QR code or load the following URL into a browser: specialtypharmacycontinuum.com/ LimaArmada.

The AMCP Annual Meeting is still the only event that brings together all the voices and visions of managed care pharmacy, health care, and breakthrough drug therapies. But the new name brings into focus the ingrained and expanding role of specialty pharmacy. Indeed, it’s increasingly said that managed care pharmacy is specialty pharmacy. We will spotlight new developments in a dedicated track and pre-meeting programming, while still bringing you up to date on legislation and regulation, research, formulary management and other concerns of our profession. You can’t afford to miss the Annual Meeting— where all the facets of our growing field come into focus. www.amcpmeetings.org

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

PIPELINE continued from page 1

some of the products that are likely to be approved in the next two years.

Cancer Cancer has seen the most development, but the drug spend in specialty for cancer therapy is only No. 3 behind inflammatory conditions and multiple sclerosis (MS). This is primarily because approximately 80% of the cancer drug spend is under the medical benefit, Dr. Tharaldson explained. Nine new cancer drugs were approved by November 2015, and several more were expected by press time, most notably Lilly’s necitumumab for non-small cell lung cancer (NSCLC). Dr. Tharaldson expected a rise in the number of oral cancer treatments, more breakthrough therapies, as well as increased targeted and immunotherapy development. An estimated 50% of all cancers will be treated with immunotherapy by the end of the decade, she said. One of the first specialty cancer drugs approved in 2016 will likely be AstraZeneca’s osimertinib, a once-daily, selective, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The drug is designed to target EGFR mutation positive (EGFR ( m) NSCLC, as well as NSCLC caused by T790M, M a genetic mutation that is implicated in a majority of cases of EGFR TKI treatment resistance. Data from the ongoing AURA study of osimertinib in patients with advanced NSCLC, who also have the T790M M resistance mutation, demonstrated a median progression-free survival of 13.5 months.

This drug will likely be approved in February 2016, followed by a second EGFR inhibitor, rociletinib (Clovis Oncology), for the same indication in March, Dr. Tharaldson said. Both oral drugs are breakthrough therapies. Several multiple myeloma (MM) drugs are likely to be approved in the first quarter of 2016, with elotuzumab (Empliciti, Bristol-Myers Squibb [BMS]/AbbVie) being the first, expected in March. Elotuzumab will be indicated for relapsed or refractory MM, followed by daratumumab (Janssen). Both of these are IV medications, but the oral medication ixazomib (Takeda) is also expected to be approved for the same patient population. Cancer drugs expected to be approved in the near term include 10 that will be considered breakthrough therapies, including rindopepimut (Rintega, Celldex Therapeutics) for adults with EGFRvIII-positive glioblastoma and entinostat (Syndax), a novel histone deacetylase (HDAC) inhibitor that is being researched for several cancers, including to reverse resistance to hormonal therapies in patients with advanced estrogen receptor–positive breast cancer. Some of the breakthrough therapies, such as rindopepimut, are also immunotherapies. About half of the near-term cancer pipeline drugs are oral therapies, according to Dr. Tharaldson.

Inflammatory Conditions The pipeline for inflammatory conditions is healthy, with several drugs or expanded indications expected to be approved in 2016. Many are for rheumatoid arthritis (RA), including the first biosimilar to etanercept (Enbrel, Amgen). Etanercept is a tumor necrosis factor–α

Etanercept (Enbrel, Amgen), indicated for rheumatoid arthritis (RA) and other related conditions, binds to tumor necrosis factor (TNF), a naturally occurring cytokine that plays an important role in the inflammatory processes of RA. Expect a biosimilar version of the drug in 2016. Source: Amgen.

AstraZeneca’s osimertinib is projected to be one of the first specialty cancer drugs approved in 2016. The once-daily treatment targets the epidermal growth factor receptor (EGFR) axis, above. Source: Seton Hall University (https://goo.gl/zSS9F3).

(TNF-α) α inhibitor that is indicated for RA, psoriasis, plaque psoriasis, ankylosing spondylitis and juvenile idiopathic arthritis. Sandoz’s biosimilar, which is expected to be approved in June 2016, will likely be indicated for RA and psoriasis. However, there will be a protracted legal battle over patents, as there was for Sandoz’s first U.S. biosimilar Zarxio, a biosimilar to Neupogen (Amgen), which will delay its availability. There will be several interleukin (IL) inhibitors approved, most notably ixekizumab (Lilly), an IL-17A inhibitor, and brodalumab (Valeant), an IL-17 inhibitor, both for psoriasis, and sarilumab (Regeneron/Sanofi), an IL-6 inhibitor, for RA. In clinical trials, one-third of patients taking ixekizumab saw clear skin after three months. Approval is expected in April. Brodalumab has also had positive results in clinical trials; however, suicide ideation will likely restrict the labeling of this product, according to Dr. Tharaldson. A Phase III study of sarilumab met its coprimary efficacy end points of improvements in signs and symptoms of RA at 24 weeks and physical function at 12 weeks, compared with placebo. The study, called SARIL-RA-TARGET, evaluated the safety and efficacy of two subcutaneous sarilumab doses versus placebo, added to nonbiologic diseasemodifying antirheumatic drug therapy in RA patients who were inadequate responders to or intolerant of TNF-α inhibitors. Another RA treatment, baricitinib (Incyte/Lilly), an oral Janus kinase (JAK) inhibitor that will be taken once a day, will also be approved in the second half of 2016, Dr. Tharaldson predicted. There are four known JAK enzymes:

JAK1, JAK2, JAK3 and TYK2. JAKdependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for a wide range of inflammatory conditions. Baricitinib will compete with the JAK inhibitor tofacitinib (Xeljanz, Pfizer), which is currently available, but taken twice a day. However, Pfizer is expected to come out with once-daily dosing in February.

Multiple Sclerosis Patients with MS have several options, including immunomodulators, monoclonal antibodies and oral therapies, and there is a fairly strong pipeline for MS drugs. But most will not be approved until 2018, according to Dr. Tharaldson. Glatopa (Sandoz), a generic of Copaxone, was approved earlier this year as a 20-mg daily subcutaneous injection. However, 75% of the market share for Copaxone has shifted to the 40-mg strength that is dosed three times a day. Dr. Tharaldson said a 40-mg generic is likely in 2017. Approval of daclizumab (Zinbryta, Biogen/AbbVie), an IL-2 antagonist, is expected in the second quarter of 2016 for the treatment of relapsing forms of MS. In clinical trials, daclizumab reduced relapse rates by 45% compared with interferon β-1a (Avonex, Biogen). There are safety concerns with the new product, she said, mostly increased risk for infection, liver toxicity and dermatologic reactions. Ocrelizumab (Genentech), which is expected in early 2017, is a humanized anti-CD20 monoclonal antibody that targets CD20 on murine B cells. It will see PIPELINE, page 14

Specialty Pharmacy Continuum • November/December 2015

CLINICAL

PIPELINE continued from page 12

be indicated for both relapsing and primary progressive MS. About 10% to 15% of patients with MS have primary progressive disease, for which there currently are no treatments, Dr. Tharaldson pointed out. Given that treatment gap, ocrelizumab will have “an important place in therapy,” she stressed. Although it will be some time before more oral products enter the market, several are planned, including ponesimod (Actelion), which should be approved in 2017 and four more for 2018, she noted.

Hepatitis C Virus Although several oral interferonfree regimens are available to treat the 3.2 million Americans with hepatitis C virus (HCV), the pipeline for HCV drugs is fairly robust. The current medications treat HCV genotype 1, which represents 70% to 75% of cases. However, there are five other genotypes, and much of the research on new drug development is focused on creating

will be BMS’s daclatasvir-asunaprevirbeclabuvir, an oral regimen for genotype 1, and the first pangenotype regimen Sovaldi-velpatasvir from Gilead, which will be approved for all genotypes. Sovaldi-velpatasvir will be a single, once-daily tablet taken for eight to 12 weeks. Dr. Tharaldson expected Gilead to promote its use for genotypes 2 to 6, and promote Harvoni for patients with genotype 1.

Muscle-fiber membrane Proteins Muscle-fiber membrane

HIV Dr. Tharaldson predicted that 2016 will end with the approval of two HIV medications, including the first HIV therapeutic vaccine (Remune, Immune Response BioPharma), which is expected right before Christmas. About 1 million Americans live with HIV, and an estimated 200,000 have never been diagnosed, she said. Another 300,000 have been diagnosed but are not yet on therapy, so this market will continue to expand, according to Dr. Tharaldson. The trend is more toward single-tablet regimens because adherence is very important. She also expect new mechanism-based agents against HIV, such as the new TAF regimen that

Dystrophin Duchenne muscular dystrophy (DMD) is an x-linked genetic disorder that occurs in individuals who lack the dystrophin protein, causing muscle weakness and early death. Three new drugs are in the pipeline for DMD, offerring a rare set of new treatment options for this disabling condition, which affects approximately 20,000 male individuals in the United States.

tidrug resistance, and a prodrug called PRO-140, which will be a subcutaneous injection that can be given once a week.

Asthma and Allergy With the approval of mepolizumab (Nucala, GlaxoSmithKline) this November, specialty pharmacy moves into asthma and allergy. This biologic drug was approved for the treatment of severe eosinophilic asthma that is not controlled with standard medications. Another biologic, reslizumab from Teva, is expecting approval in March to treat the same patient population. Three more agents are expecting approval in 2016, 2018 and 2019. Regeneron and Sanofi are developing dupilumab for the treatment of atopic dermatitis, which was very effective in clinical trials. Dupilumab should be approved in 2016. Amgen biotech manufacturing facility in Rhode Island.

Source: Amgen.

Bleeding Disorders pangenotypic medications. “We are going to have more competition among these interferon-free regimens. The focus is on more niche, difficult-to-treat populations, as well as developing a pangenotypic regimen with a shorter treatment duration that can cure HCV patients with any genotype,” Dr. Tharaldson said. The new year should start with the approval of grazoprevir-elbasvir from Merck for genotypes 1, 4 and 6. Grazoprevir will be a single tablet dosed once a day without ribavirin. “This is a breakthrough therapy for patients with genotype 4 HCV or kidney disease on dialysis,” she said. Also expected in 2016

was approved in November. The FDA approved elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide (TAF) (Genvoya, Gilead), which is a prodrug of tenofovir and should have a better sideeffect profile than Gilead’s other tenofovir drug, Stribild. Expected in 2016 are Edurant-Emtriva-TAF and Emtriva-TAF from Gilead. In 2017, look for fostemsavir (BMS), which is an attachment inhibitor that will be approved for patients with multidrug-resistant HIV. Another breakthrough therapy will be ibalizumab (TaiMed Biologics), which will be a biologic given as an IV infusion every two weeks for patients experiencing mul-

The pipeline for medications to treat bleeding disorders is also active, with four expected to be approved this December as Specialty Pharmacy Continuum goes to press, and three more expected in 2016. The trend is toward longer-acting factors, Dr. Tharaldson said. Adynovate (BAX-855) from Baxalta and Kovaltry (BAY 81-8973) from Bayer will be indicated for hemophilia A. Albutrepenonacog alfa from CSL Behring will be approved for hemophilia B, and Vonicog α (BAX-111) from Baxalta will be approved this December for von Willebrand disease. In 2016, expect more hemophilia A and B medications with lonoctocog alfa

from CSL Behring for hemophilia A, nonacog β pegol from Novo Nordisk for hemophilia B and rFVIIa from Baxalta for hemophilia A and B.

Duchenne Muscular Dystrophy Duchenne muscular dystrophy is a genetic disorder that affects about 20,000 male individuals who lack the dystrophin protein, causing muscle weakness and early death. Treatment options are limited, but three new drugs are in the pipeline for this disease. Drisapersen (BioMarin) is expected to be approved in December 2015, and eteplirsen (Sarepta) and Ataluren (PTC Therapeutics) are expected in 2016. The first two are antisense oligonucleotides and the last is a gene transcription modulator and protein restorer. This is just a glimpse of the specialty drug pipeline, according to Dr. Tharaldson. Orphan drugs, biosimilars and new products for nonalcoholic steatophepatitis are all expected in the next couple of years. In addition, patents will expire for 30 chemical specialty medications through 2019, and for 54 biosimilars, creating a $55.5 billion opportunity for pharmaceutical companies, she said. —Marie Rosenthal

Web Exclusive For a table of specialty drugs in the pipeline for 2016, scan the QR code or visit www.specialty pharmacycontinuum. com/SPPipeline.

Special Advertising Section

Acute Care Pharmaceuticals Armada Health Care Associates of Cape Cod, Inc. BD Diplomat Pharmacy, Inc. Equashield KeyCentrixTM Medi-Dose/EPS MHA Specialty Pharmacy Solutions Specialty Pharmacy Continuum Temptime Corporation

The profiles in this section were submitted and/or reviewed by the advertisers.

Acute Care Pharmaceuticals AT A GLANCE 12225 World Trade Drive D Ste. A San Diego, CA 92128 8 Website: www.Pharm ma-Choice.com Phone: (888) 909-77 700 Fax: (858) 675-9380 0

Product Line: Pharma-Choice™ Bra and Email: Info@acuteca areonline.com

Acute Care Pharmaceuticals has been servicing the healthcare industry for over 18 years by delivering exceptional products and services to healthcare providers nationwide. We offer a wide range of USP Chapter <797> and USP Chapter <800> compliant disposable products that are manufactured under the highest standards. All wipers are ISO Class 5 and USP <161> endotoxin limits for medical devices of 0.06 EU/mL. Our sterile alcohol is manufactured with USP grade water for injection and is available in a variety of sizes.

As a One-Stop Shop we can supply your facility with not only Sterile Alcohol and Wipers, but everything else your facility may need, including: Media Test Kits, Disinfectants, Apparel, Tacky Mats, Cleanroom Paper, Chemo Products, Sterile IV Seals and more. The quality manufacturing of Acute Care Pharmaceuticals’ PharmaChoice™ Brand of cleanroom disposables demonstrate our commitment to the future success of USP <797> and USP <800>. Acute Care Pharmaceuticals holds over 20 GPO and IDN Contracts and our products are used in, and trusted by, over 2,000 hospital systems nationwide. In addition, most of Acute Care Pharmaceuticals’ products are loaded and stocked at AmerisourceBergen, Cardinal and McKesson taking the hassle out of purchasing. If you want quality products and customer service that you can count on, call us today at 1.888.909.7700 for more information and your GPO contracted pricing.

Pharma-Hol Pharma-D Surface Disinfectant Pharma-Wipe Pharma-Sat Pharma-Surface Guard Pharma-Glove Pharma-Chemo Mat Pharma-Mop Covers Pharma-Mini Mop Covers Pharma-Mat Pharma-Notes Pharma-Paper Pharma-Coat Pharma-Cap Pharma-Shoe Cover

Corporate Profiles 2015

Special Advertising Section Specialty Pharmacy Continuum

Armada Health Care Armada Health Care Introduces ArmadaOne—A Comprehensive Specialty Pharmacy Technology Solution Developed for Today’s Complex Medication Needs The nation’s largest specialty pharmacy group purchasing organization (GPO) and channel management solutions provider, Armada Health Care, continues to be the leading supplier of manufacturer commercialization strategies and patient support services in the rapidly expanding specialty pharmacy marketplace.

A Devoted Focus Armada’s portfolio of offerings includes a full range of therapeutic categories, first-in-class specialty product contracting programs, hub services and innovative technology solutions. By offering this suite of services, Armada remains the only national contracting organization exclusively focused on specialty pharmaceutical programs.

Introducing ArmadaOne Recently, Armada introduced the ArmadaOne Specialty Pharmacy Workflow platform, a comprehensive new offering comprised of its existing suite of technology products along with several new patient modules. ArmadaOne works in conjunction with pharmacies’ existing dispensing systems and provides key functionalities to manage patients with complex therapeutic needs. ArmadaOne also offers users the ability to onboard specialty patients, streamline prior authorization management, connect with copay and patient assistance programs, and ongoing clinical consultation and compliance monitoring. Real-time data reporting enables pharma/biotech manufacturers, health plans and prescribers to measure results using the best data available and generate medication management and productivity reports.

AT A GLANCE

“Launching ArmadaOne was a natural evolution for our company and the convergence of several initiatives we have been working on for many years,” explained Lawrence Irene, RPh, co-founder and chief executive officer for Armada. “We understand the critical role technology plays when it comes to specialty pharmacy, and as a company at the epicenter of this industry, we are excited to launch ArmadaOne and deliver this new solution to the market.”

Expansion of Hub Services

100 Campus Drive e, Suite 300 Florham Park, NJ 07932 Phone: (973) 564--8004 Website: armadah healthcare.com

Products and d Services • Market accesss & commercializ zation • Comprehensive hub services • Integrated te echnology platforms • Data reportin ng & analytics

In addition to releasing ArmadaOne, Armada • Scalable pharmacy has continued to expand its hub services networks capabilities, by providing a complete solution • Therapy man nagement for patient support, reimbursement services systems and prescription intake/triage for dispensing pharmacies. “Whether for a complex orphan • GPO contracting programs product or a more broadly utilized medication, • Prior authorization support we understand the importance of putting the patient first while merging white-glove service • Annual speciialty pharmacy and real-time data reporting to our industry summit partners,” stated Arpan Patel, RPh, SVP, Clinical Services for Armada. “Via the intersection of our innovative technology platforms, URACaccredited call center, network of specialty pharmacy partners and high-touch support services, we ensure patients have access to products and initiate therapy in a timely manner for the medications they are prescribed.”

Unique Programs & Contracts As the specialty pharmacy market expands and Armada’s pharmacy membership grows, Armada continues to deliver significant value through unique manufacturer contracts and incentive programs for brand/generic pharmaceuticals, ancillary products and services.

Annual Specialty Pharmacy Summit For four days each May, Armada hosts the nation’s largest specialty pharmacy conference. Attendees gain an in-depth understanding of all aspects of specialty pharmacy from more than 125 renowned industry speakers who share the latest insights and trends impacting the industry. Nearly 100 hours of seminars, educational sessions and business workshops are offered at the Summit, along with vendor exhibits, expert panel discussions and a broad range of relevant business topics. Contact us today to learn more about how we can support your business at info@armadahealthcare.com.

Special Advertising Section Specialty Pharmacy Continuum

Corporate Profiles 2015

Associates of Cape Cod, Inc. AT A GLANCE Corporate Headqu uarters - USA Associates of Cape C Cod, Inc. 124 Bernard E. Saint Jean Drive East Falmouth, MA 0 02536-4445 Phone: (888) 395–AC CC1 (2221) or (508) 540–3444 Fax: (508) 540–8680 0 Website: www.acciussa.com

Germany Associates of Cape C Cod, Inc. European Subsidiary y PYROQUANT DIAGN NOSTIK GmbH Opelstrasse 14 64546 Mörfelden-Wa alldorf, Germany Phone: (49) 61 05–96 10 0 Fax: (49) 61 05–96 10 15 E-mail: service@acciiusa.de www.acciusa.de

Company Background Our corporate headquarters are located in East Falmouth, Mass., with offices in the UK and Germany. Founded in 1974, our company was the first to be licensed by the FDA to manufacture Limulus Amebocyte Lysate (LAL) for use as a quality control test for endotoxin detection in the pharmaceutical and medical device markets. Over the years, we have grown to be an internationally recognized leader in endotoxin detection, with more than 150 employees and a distribution network servicing 80 countries.

Products, Services & Capabilities

United Kingdom Associates of Cape C Cod Int’l., Inc. Deacon Park, Moorgate Road Knowsley, Liverpool L33 7RX United Kingdom m Phone: (44) 151–547–7444 Fax: (44) 151–547–74 400 E-mail: info@acciuk.co.uk www.acciuk.co.uk Company Registratio on Number: BR002906

Associates of Cape Cod, Inc. (ACC) is one of the world’s largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1Æ3)-β-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products and medical devices.

Chromogenic Endotoxin Detection System Combining enhanced Pyrochrome® chromogenic reagent with the Pyros Kinetix® Flex Incubating Kinetic tube reader and Pyros® EQS Software, this system offers diverse options for conducting endotoxin testing. Pyrochrome is a versatile quantitative reagent for performing kinetic or endpoint assays. It is a sensitive and flexible reagent that can be used for testing in compliance with the United States Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia bacterial endotoxins test chapter. Pyrochrome is offered

Corporate Profiles 2015

with either Pyrochrome Buffer or for endotoxin-specific testing, with Glucashield® Buffer. Pyrochrome can be used with the Pyros Kinetix® Flex tube reader at a 1:1 and economical 4:1 sample to LAL ratio.

Turbidimetric Endotoxin Testing using Pyrotelll®-T Pyrotell-T is used to quantify endotoxin in kinetic turbidimetric tests. Pyrotell-T can be used with the Pyros Kinetix® Flex tube reader and incubating microplate readers. When used with the Pyros Kinetix Flex tube reader, Pyrotell-T gives a highly economical, flexible and sensitive LAL assay. It can be used for a wide variety of endotoxin tests, ranging from standard water testing to samples requiring high sensitivity, such as intrathecal products and those requiring high dilutions to overcome interference.

Contract Testing Service (CTS) Our CTS laboratory was established more than 25 years ago to specialize in testing for endotoxin and glucan contamination and has the most extensive experience of any endotoxin and glucan testing laboratory in the world. CTS performs all LAL assay methods: gel-clot, chromogenic and turbidimetric, depending on client requirements.

Special Advertising Section Specialty Pharmacy Continuum

BD Since our founding in 1897, BD has sought to make healthcare more effective, efficient and safer through innovation in areas that leverage the company’s clinical knowledge and expertise. Our focus on Pharmacy builds on the company’s legacy and commitment to supporting safety and efficiency. Our expanded portfolio, including solutions from the recent acquisition of CareFusion, allows our customers to manage quality improvements, compounding legislation changes and drug shortages with cost-reduction expectations. BD’s comprehensive portfolio of medication management and preparation products as well as pharmacy disposal solutions is specifically designed to enhance patient and healthcare worker safety, improve efficiencies and help facilitate compliance to existing guidelines and standards.

Patient Safety Despite best efforts, patient safety can be compromised during medication preparation and delivery. BD’s broad, innovative portfolio can help. BD Cato™ Medication Workflow Solutions is an innovative gravimetric-based, barcode verification-enabled workflow solution that helps enhance safety and workflow efficiency of preparation of IV medications by detecting wrong drug and wrong dose errors in real time. BD Simplist™ Ready-to-Administer, Prefilled Injectables, supplied by BD Rx from its state-of-the-art pharmaceutical plant, are designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence,1 reducing the potential risk of medication error.

Healthcare Worker Safety OSHA reports that a hospital is one of the most hazardous places to work.2 BD offers solutions to help prevent occupational exposure. BD PhaSeal™ Closed System Drug Transfer Device (CSTD) is an airtight and leak-proof CSTD that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, minimizing individual and environmental exposure to drug vapor aerosols and spills. The BD PhaSeal System has been clinically shown to reduce healthcare workers’ exposure to hazardous parenteral medications from preparation to administration to disposal.3 SmartSite® VialShield Chemo System is an intuitive needle-free system indicated for reconstitution or dispensing of medications, including chemotherapy agents. BD Disposal Solutions include collectors in a variety of colors and size specifically designed to safely contain Sharps, Non-hazardous Pharmaceutical, Chemotherapy and Hazardous RCRA waste.

Workflow Efficiency and Cost Containment As healthcare evolves, there will be increasing demand for better outcomes, while still controlling costs. Workflow efficiency will play a critical role in your success—and BD can help you get there, today. BD Cato™ Medication Workflow Solutions help improve efficiency and contain cost by standardizing the medication preparation workflow, automating documentation and help facilities optimize drug utilization to reduce drug waste. BD PhaSeal™ CSTDs prevent microbial ingress for up to 168 hours* (within an ISO Class V environment following aseptic technique),4-8 thus protecting the sterility of drug vials, which may facilitate drug vial optimization.9 Costly drugs that are still chemically stable may not have to be discarded after partial use, potentially leading to better drug utilization, lower overall cost of operations and reduced waste. The Chemo Safety System provides hospitals with a cost-effective solution to help protect healthcare workers from exposure to hazardous drugs. The system’s bonded Texium syringes and IV administration sets with no component assembly required, help to streamline workflow throughout the continuum of care. BD Simplist™ (see above).

Special Advertising Section Specialty Pharmacy Continuum

AT A GLANCE 1 Becton Drive Franklin Lakes, NJ J 07417 Phone: (201) 847-6800 Website: www.bd..com

Products Medical supplies, devices, laboratory instruments, antib bodies, reagents and diagnostic pro oducts

Vincent A. Forle enza Chairman, Chief Executive Officer and President

About BD

BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes.

About BD Rx Inc. BD Rx Inc. is a wholly-owned subsidiary of BD (Becton, Dickinson and Company). Based on a strategic decision and long-term investment in the acute care generic injectables category BD applied its expertise in manufacturing excellence, high-quality products and service delivery to the manufacturing of high-demand generic pharmaceuticals. This is a logical extension of BD’s demonstrated 12-year history of continuous, reliable supply of our Flush platform and existing leadership position in glass prefillable syringe manufacturing and should be seen as an addition to our current pharmaceutical offerings, as it will enable us to offer a broader range of treatment options for customers. With the BD Simplist™ ready-to-administer, prefilled injectables, BD Rx is aiming to redefine injectable drug administration practice. We envision safe patient care and efficient clinical applications and believe this is the future of injectables. For more information, please visit www.bdrxinc.com. BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. ©2015 BD. 07/15 MSS0649-1 BDRx0166-1 * Drug stability per manufacturers’ labeling.

References 1.

Potter P, Perry A, Stockert P, Hall A. Vial & Syringe Injection Steps. Basic Nursing, 7th ed. (St. Louis, MO: Mosby, 2010) 442-447.

2. United States Department of Labor. Occupational Safety and Health Administration (OSHA). “Safety and Health Topics.” https://www.osha.gov/SLTC/healthcarefacilities. 3. Wick C, Slawson MH, Jorgenson JA, et al. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J HealthSyst Pharm. 2003;60(22):2314-2320. 4. McMichael D, Jefferson D, Carey E, et al. Utility of the PhaSeal closed system drug transfer device. Am J Pharm Benefits. 2011;3(1):9-16. 5. Carey ET, Forrey RA, Haughs D, et al. Second look at utilization of a closedsystem transfer device (BD PhaSeal). Am J Pharm Benefits. 2011;3(6):311-318. 6. Sanchez-Rubio J, Vargas B, Sanchez-Rubio L, et al. CSTDs and microbiological stability of cytostatics. Hosp Pharm Eur. 2013;69, July/August. 7. Wickham Laboratories Limited. Hampshire, UK. August 2013. Prevention of Microbial Ingress Into Vials and IV Bags Using the PhaSeal System. 8. Wickham Laboratories Limited. Hampshire, UK. Sept 2013. Microbial Integrity Testing (Whole Immersion) of BD PhaSeal Protectors. 9. Edwards MS, Solimando DA, Grollman FR, et al. Cost savings realized by use of the PhaSeal® closed-system transfer device for preparation of antineoplastic agents. J Oncol Pharm Pract. 2013;19(4):338-347.

Corporate Profiles 2015

Diplomat Pharmacy, Inc. Diplomat is the largest independent specialty pharmacy in the United States. We offer a broad range of innovative solutions to address the dispensing, 4100 S. Saginaw St. delivery, dosing and reimbursement of clinFlint, MI 48507 ically intensive, high-cost specialty drugs. Phone (toll-free): 877-977-9118 We see ourselves as a part of our patients’ Fax (toll-free): 800-5 550-6272 health care team. By working with payors, Website: http://diplo omat.is pharmaceutical manufacturers, physicians and retail/outpatient pharmacies, we deliver high-touch care that meets patients’ needs—as well as the needs of our teammates.

AT A GLANCE

When Diplomat opened its doors in 1975, it had one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues. For us, patients are not a number, nor are they their condition. At Diplomat, our mission is to blend clinical excellence with a personal touch—for happier lives and health that lasts.

Patient-centric Care We don’t stop working once the prescription is filled. At Diplomat, we focus on medication management programs for people in complex therapeutic categories—including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Through our Centers of Excellence, we provide comprehensive, patient-focused services, ensuring a superior standard of care. Services include assistance with complicated medication therapies, refill processing, side-effect management and adherence monitoring. An example of our innovative approach to helping patients achieve maximal adherence is Diplomat’s proprietary CarePak™. The medication CarePak™ provides patients with each day’s dose based on the prescriber’s written orders. We can customize the CarePak™ to accommodate nearly any patient need, making prescriptions that require combinations of treatments easier for patients to manage. Clinical studies even show that the CarePak™ improves the average duration of therapy.1 We pride ourselves on breaking down barriers to access medication for our patients. This includes securing prior authorizations for treatment. Our prior authorization (PA) success rate stands at 86%.2 In the event that a prior authorization request is denied, our appeals team is successful in 83% of cases.2 Once medications are approved, Diplomat’s dedicated funding team helps secure third-party support for patients in need. In 2014, we connected patients with over $55 million in copay assistance.3

A Flexible Teammate in Health Care We have grown our business in recent years by strengthening our clinical expertise in key therapeutic categories such as oncology and immunology. In addition to broadening the scope of our services, we continue to work at strengthening our relationships with patients, payors, pharmaceutical manufacturers and physicians. As a part of our calling to improve patient care, we also provide support services to a national network of retailers, independent pharmacy groups, hospitals and health systems.

Phil Hagerman, RPh, CEO and Chairman of Diplomat Pharmacy, Inc., in the company’s distribution center.

In this network, Diplomat contracts with retail and hospital outpatient pharmacies to offer specialty service programs. Through comprehensive back-end clinical services and care management, we enable our partners to meet the requirements of third-party payors to dispense specialty pharmaceuticals. This drives engagement for partnered pharmacies while maintaining the high-touch commitment that patients and clients have come to expect from us. Our position as an independent specialty pharmacy allows us to enter highly flexible relationships, so we can customize our offerings to our partners’ true needs.

Nationwide Network of Support With 18 locations, Diplomat provides specialty solutions from coast to coast—including Alaska, Hawaii and Puerto Rico. As of Dec. 31, 2014, our managed lives under contract stood at approximately 13 million. Since Dec. 2013, we have acquired American Homecare Federation, MedPro Rx, BioRx and Burman’s Specialty Pharmacy—three of which specialize in specialty infusion therapies. Burman’s, the exception among the four, specializes in hepatitis C treatment. Our repertoire of services—as well as our proactive engagement with pharmaceutical manufacturers early in their drug development process—has helped us build out our access to limited-distribution drugs. Through the changes in specialty pharmacy as the industry evolves, Diplomat is always ahead of the curve. While we’ve grown and expanded our services, we remain focused on service as it should be: one patient at a time.

References 1.

Abstract #55688. The effectiveness of CarePak: Adherence packaging in increasing lenalidomide therapy duration. Rice G, Nolan R, Grigorian M Diplomat Specialty Pharmacy, Flint, MI, USA. 2014.

2. Across all benefits investigations performed. Diplomat Prior Authorizations and Appeals, 2014. 3. Diplomat Funding Results, 2014.

Corporate Profiles 2015

Special Advertising Section Specialty Pharmacy Continuum

Equashield Hazardous drugs, such as chemotherapy antineoplastic agents, present an occupational hazard to those who handle them. Occupational exposure to hazardous drugs can lead to both acute and chronic effects, ranging from skin irritation to more serious reproductive complications and even some forms of cancer. The Centers for Disease Control and Prevention’s (CDC’s) National Institute for Occupational Safety and Health (NIOSH), the US Pharmacopeia (USP) Chapter <797>, the recently added USP Chapter <800>, the American Society of Health-System Pharmacists (ASHP), the International Society of Oncology Pharmacy Practitioners (ISOPP) and the Oncology Nursing Society (ONS) have all recognized and made recommendations to take additional measures based on the potential health risks associated with occupational exposure to hazardous drugs. While the dangers are often invisible to the naked eye, common practice when handling hazardous drugs creates multiple routes of exposure that can lead to contamination of the environment despite the use of standard personal protective equipment (PPE), Biological Safety Cabinets and associated handling procedures. Since hazardous drugs have adhesive characteristics, traces can often be carried out of the workspace, and are often found on unlikely surfaces such as keyboards, doorknobs and elevator buttons, outside of the designated areas for drug compounding and administration. NIOSH defines closed system transfer devices (CSTDs) as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system,” and the FDA recently created the ONB category that clears devices as “closed antineoplastic and hazardous drug reconstitution and transfer system.” CSTDs, which typically encapsulate the syringe and vial into one closed system, provide a vital layer of protection against hazardous drug exposure. In fact, studies have shown that using a CSTD has significantly reduced the levels of surface contamination in labs, pharmacies and hospitals.1

However, not every CSTD provides the same level of protection, and not every CSTD is equally effective at closing off the major routes of exposure. Equashield’s closed systems are among the 99 Seaview Blvd. only CSTDs in the world cleared under the Port Washington, NY 11050 FDA’s ONB code, confirming that they meet the Phone: (516) 684-8200 Website: www.equ uashield.com requirements of a truly closed system. Equashield’s first- and second-generation systems are also the first to be substantiated to Products FDA and defined in FDA-cleared labeling as preEQUASHIELD® II - Closed System venting microbial ingress up to 7 days. Transfer Device Equashield’s system was created with a simpliFor medical inquirries related to fied, elegant design that provides ease of use, Equashield, contac ct Tammy Balzer, and covers more routes of exposure to hazardDirector of Clinica al Services USA ous drugs. tammyb@equashield.com One of the major routes of exposure, the syringe plunger, is uniquely covered by Equashield’s system. Studies show that a typical standard syringe plunger is contaminated many times after a drug transfer when it is drawn back out. When pharmacists use standard syringes, and even when they use standard syringes that are found in other closed systems, they can be exposed to hazardous drugs due to plunger contamination, and they risk major spills, as these plastic syringes can be pulled out of the barrel completely. Equashield’s flagship CSTD, EQUASHIELD® II, introduced in late 2013, uses a metal plunger instead of a standard plastic plunger. The metal rod runs through the center of the barrel, and is fully encapsulated and sealed in. This design prevents plunger contamination and it cannot be removed from the barrel, so it also prevents potential spills. The metal rod plunger cannot come in contact with the inner walls of the barrel, and therefore remains uncontaminated by the barrel sides. In this way, Equashield’s CSTD is the only CSTD to cover this major route of exposure by minimizing plunger contamination to undetectable levels.2 Equashield developed its fully encapsulated syringe system with an internal, self-contained pressure equalizer and sterile air chamber found within the syringe barrel. This feature allows for a more streamlined design that is intuitive for those using it in the compounding, transferring and administration of hazardous drugs. Equashield’s CSTD design also innovates with its connection mechanism. Whether connecting the syringe to a vial adapter, infusion bag or infusion tubing, each Equashield adapter and syringe are designed for safe and easy connections made in one smooth motion. Committed to protecting healthcare professionals, Equashield’s devices are qualified to the highest industry standards. Equashield’s CSTD is simple, with an elegant design and ease of use, which make it the CSTD of choice by hundreds of healthcare facilities in North America, Europe, Asia-Pacific and the Middle East. Equashield is a privately held medical device company with more than 140 employees. With offices located in Port Washington, N.Y., and its manufacturing facilities located internationally, the company has a growing global footprint, and is committed to continuing to protect healthcare professionals from exposure to hazardous drugs.

AT A GLANCE

References 1.

www.ncbi.nlm.nih.gov/pubmed/19965949.

2. http://opp.sagepub.com/content/early/2014/03/05/1078155214526428.full. pdf+html.

Special Advertising Section Specialty Pharmacy Continuum

Corporate Profiles 2015

KeyCentrix™ KeyCentrix™ is dedicated to the pharmacy industry by offering best-in-class technology, thought leadership, solutions consulting and hands-on support, ensuring our customers are equipped with solutions to advance pharmacy practice.

AT A GLANCE For more information about New Leaf Rx pharmacy so oftware or other KeyCentrix productss or services, please contact the K KeyCentrix team: 2420 N Woodlawn, B Bldg 500 Wichita, KS 67220 Phone: (800) 444-84 486 E-mail: info@keycentrix.com Website: Keycentrix..com

Social Media: https://www.faceboo ok.com/ KeyCentrix/ https://twitter.com/k keycentrix https://plus.google.c com/+Keycentrix/ posts https://www.linkedin n.com/company/ keycentrix-inc.

Beginning in 1973 KeyCentrix and its parent, Computer, Inc., have been supporting the industry with leading software solutions for over 40 years. Current KeyCentrix product offerings include RxKey® Pharmacy Software, flexTRAX Point of Sale and New Leaf Rx® Pharmacy Software. KeyCentrix technology and service solutions have been designed to transform pharmacy management by streamlining operations and providing the power of actionable data to make better decisions and grow profitably.

New Leaf Rx – Pharmacy Software for the Next Level of Patient Care Leverage the power of order-based, exceptiondriven workflow with New Leaf Rx by KeyCentrix. This unique combination enables custom configuration of your software to support ideal throughput and enforces best practices for single or multi-location pharmacy environments. New

Leaf Rx’s easy-to-use, fully customizable workflow and order manager are tailored for pharmacies and pharmaceutical manufacturers that are looking to innovate, increase efficiency and maximize their footprint in the specialty and more advanced high-margin pharmaceutical market. New Leaf Rx software, combined with our consultative and comprehensive implementation approach, offers pharmacies a level of resources and service unlike anything else available in the industry.

The New Leaf Rx Difference • Configurable Workflow Stages – Configurable workflow stages support your specific business needs and operations. Stages include: ° Data Entry ° Adjudication

° Dispensing ° PV2

° PV1 ° Scheduling

° Packing ° Will Call

• Order-Based Solution – New Leaf Rx’ order manager allows your pharmacy processing efficiencies by logically grouping prescriptions into orders based on patient, facility or prescriber. • Exception-driven Workflow – Ensure compliance adherence by requiring activities on complex therapies driven by: ° Manufacturer reporting ° Business objectives

° Disease state ° Lab values

° Stage validations ° Cost to patient

° Specific drugs ° Sales/marketing needs

• Consultative Implementation Approach - The KeyCentrix implementation team works with each customer to evaluate current and future state operations to ensure the most efficient configuration of the New Leaf Rx software for your specific business goals. In addition, a complete training curriculum is developed and implemented to ensure the pharmacy team is go-live ready, and onsite support during the first week provides an extra layer of assistance and confidence.

• External System Integrations – Through KeyCentrix’ consultative services, new and existing applications will be evaluated for replacement or integration, streamlining your operation and reducing long-term costs. The extensive list of current interfaces includes shipping interfaces with FedEx and UPS, as well as an integration with TherigySTM. • Data Extraction and Analysis – New Leaf Rx offers a powerful centralized reporting engine, as well as the ability to add custom fields specific to the needs of each location. Built on a SQL database, data can be easily extracted for reporting and compliance. • Document Management – Reduce errors and streamline the data entry process with document management. Faxes can be queued for fast processing of incoming prescriptions or quick storage of customer documents.

° Credit Review

Corporate Profiles 2015

Special Advertising Section Specialty Pharmacy Continuum

Medi-Dose/EPS For more than 40 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory. Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, President and Director of Marketing, remembers, “My dad was acutely aware of the requirements of hospital pharmacy. He saw the need for inexpensive, manual unit-dose packaging allowing hospitals to convert from traditional dispensing. He developed systems to package, handle and dispense predetermined amounts of medication so they would be accessible for one regular dose.” Although familiar today, launching the idea of unit dose was a huge problem the new company faced. “We were one of the pioneers, the innovators promoting unit dose in hospitals,” Robert Braverman recalled. “Due in part to Medi-Dose’s educational efforts, pharmacists and nurses accepted the validity of unit dose.” Inexpensive, Easy and Flexible: Because of its unique Cold-Seal technology, the Medi-Dose System is simple to use and requires no special in-service training or additional space. Medi-Cup blisters are available in a variety of sizes and styles to accommodate virtually any medication or storage system. Ultraviolet-inhibitant blisters provide additional protection from light. Plus, a combination of special blister plastics with aggressive tamper-evident label adhesives provides either six-month or one-year beyond-use dating for all your unit-dose packaging needs. • Sealed units can be left in sheets or easily torn down to individual doses.

• Medi-Cup Blisters are available in five sizes to accommodate the largest medications or the smallest storage spaces. • Lid-Label Covers are available in 8 1/2˝ × 11˝ laser sheets of 25 doses or 4˝ × 6 1/4˝ direct thermal sheets of five doses. • Laser Lid-Label Cover Sheets are available in 12 colors to facilitate color-coding of medications. • New Oval Blisters and Lid-Label Covers have been designed to fit your dispensing machines and storage cabinets. • All Medi-Cup Blisters and Lid-Label Covers work with our MILT 4 software, which can be used for all your barcoding and labeling needs. Adapts to Your Needs: With our new 64 bit– compatible MILT 4 software, you can design your labels any way you want (for solids, liquids, syringes, ampules, IVs—even equipment and supplies). In addition to the ability to use graphics, special fonts, tall man lettering, shapes— even logos and symbols—to better identify your medications, MILT 4 has been designed to easily create barcodes with the information that your barcode-enabled point-of-care and barcode medication administration systems require. Popular 1-D and 2-D barcode formats can be created with National Drug Code numbers, expiration dates, lot numbers and special codes.

AT A GLANCE 70 Industrial Drive e Ivyland, PA 18974 Phone: (800) 523--8966 Fax: (800) 323-89 966 Email: info@medid dose.com Website: www.medidose.com

Products Medi-Dose® (Solid d) and TampAlerT® (Liquid) Oral Unit-Dose Packaging Medi-Cup® PLUS packaging for extended beyond--use dating MILT® by Medi-Do ose unit-dose and bar-coding softwa are LiquiDose® labelin ng, IV additive and filtration productss Nultraviolet® ultraviolet light inhibitant bags Steri-Dropper sterrile ophthalmic dropper bottles High Alert and IV Line Tracing Labels Resealable bags, bottles and other pharmacy suppliess and disposables

To get started, all you will need is: 1. Medi-Cup Blisters: 13 styles to suit your packaging needs. 2. Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters. 3. MILT 4 software: Design and manage Lid-Label Cover printing. 4. Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to the Medi-Cup Blisters and ensures a positive seal between labels and blisters. Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or barcoding needs, then the Medi-Dose System is a perfect fit for you!

Using our MILT 4 software, you can label and identify all your medication, complete with graphics and a bar code.

NEW 64 bit–compatible MILT 4 software. Medi-Dose is simple to use and requires no special in-service training.

Special Advertising Section Specialty Pharmacy Continuum

Corporate Profiles 2015

MHA Specialty Pharmacy Solutions AT A GLANCE 25-A Vreeland Road, Suite 200 Florham Park, NJ 07 7932 Phone: (800) 642-30 020 x 2940 Email: MHASpecialty y@mhainc.com Website: mhainc.com m

Collaborating with business partners and specialty pharmacies to capture, understand and act on data that help them drive patient engagement, adherence and persistence

The need for specialty medications is rising, and so is the need to create greater engagement with patients who could benefit from life-changing specialty therapies. What can drug manufacturers and specialty pharmacies do to cultivate patient engagement that leads to improved patient outcomes? One solution is to partner with an organization that has in-depth health care and clinical expertise, technological know-how and extensive analytics capabilities. A proven partner is Managed Health Care Associates, Inc. Specialty Pharmacy Solutions (MHA SPS). With MHA’s more than 25 years of experience with manufacturers and providers and an ever-expanding portfolio of technology-based solutions, MHA SPS is assisting business partners and specialty pharmacy members with generating deep data insights and analytics that lead to stronger patient adherence and persistence and contract compliance. “Our commitment is to provide commercial, clinical and technology solutions that deliver significant value for pharmaceutical and biotechnology companies and for specialty pharmacy members who are on the front lines engaging with patients every day,” said Erik Halstrom, Vice President, MHA SPS.

Solutions that Empower Patients and Deliver Broad Benefits MHA SPS creates strategic partnerships and develops and introduces new solutions that support specialty pharmacies in their goal to engage patients and optimize care. In doing so, patients benefit and so do other key stakeholders: • Pharmaceutical manufacturers gain actionable insights into deidentified patient data that more clearly demonstrates the value their therapies bring to patient outcomes. This data can also help manufacturers identify gaps in care, better understand adherence, provide insights into the competitive landscape and create innovative solutions for patients. • Specialty pharmacy members can access a broad selection of tools and resources created to help them engage with patients, identify and reduce barriers to treatment success, review therapy goals and treatment expectations, and provide patients with therapy-specific education and treatment support.

Deep Insights, Analytics to Support Adherence, Persistence and More In 2013, MHA SPS introduced Clinical Therapy Management (CTM), a powerful software application that tracks patient outcomes and interventions, measures adherence and persistence, and provides rich patient and treatment insights. The application also generates clinical reporting that meets the complex contracting needs of specialty pharmacy medications and helps elevate adherence. In fact, a recent study determined that implementation of the CTM program by a member specialty pharmacy enabled the pharmacy to achieve a significant positive impact on patient adherence. CTM provides a clinical support pathway to help specialty pharmacies

Contact Us Today The MHA SPS team is part of Managed Health Care Associates, Inc. (MHA), a leading health care services and technology company focused on the alternate site health care provider marketplace. To learn more about the services and solutions that help business partners and members maximize success, visit www. mhainc.com or contact 800.642.3020 x2940 or email us at MHASpecialty@mhainc.com.

Corporate Profiles 2015

engage with and clinically manage their patients. CTM is based upon identified pharmacy outreaches to the patient at key intervals within the patient’s treatment regimen, to provide timely therapy and disease state education and treatment support, including reviewing goals of therapy, treatment expectations and individualized patient counseling. This valuable application addresses a range of complex specialty therapeutics and provides a host of centralized tools for reporting essential clinical and dispensing metrics required by payers, manufacturers, accreditation and referral sources, and to manage patient care.

Streamlining the Prior Authorization Process In May 2015, MHA SPS launched a web-based prior authorization (PA) reporting platform for MHAuthorizeRx™ powered by CoverMyMeds, a leader in electronic PA solutions. MHAuthorizeRx automates the PA process and helps pharmacies fill prescriptions with improved efficiency. The addition of an exclusive reporting suite provides MHA pharmacy members with an easily accessible analytics platform to help drive visibility into their PA activities and trends. The streamlined information helps pharmacies navigate the complex ePA process and helps ensure patients receive the therapy they need faster.

Specialty Contracting Experience and Flexibility Specialty contracting is multi-faceted and heavily reliant on rich data and insights. As a leading health care services and technology company, MHA has a lengthy and strong track record of executing contracting strategies and data capture initiatives with pharmaceutical manufacturers. To create the most beneficial contracting agreement for the parties involved, MHA SPS goes to great lengths to understand the business needs and circumstances of both the manufacturer and the specialty pharmacy member. What data would help manufacturers deliver new and improved solutions for patients? What data are—or could be—captured by the pharmacy? What insights could evolve from that data and through patient engagement that occurs at the pharmacy? “Our unique perspective with our pharmacy members has allowed us to develop successful and beneficial contracting solutions with pharmaceutical companies for over two decades,” says John Campo, Vice President, Specialty Pharmacy Trade Relations & Contracting. “We are able to provide multiple levels of valuable information, including insights into complex disease states, such as hepatitis C, HIV and inflammatory conditions.”

Helping Partners and Members Navigate A Difficult Environment “The specialty landscape is complicated and perpetually evolving, and patients are originating and receiving ongoing treatment from within all of MHA’s alternate site health care membership,” Mr. Halstrom said. “Our Account team and Clinical Services colleagues are proven industry experts who are passionate about helping partners skillfully manage through this difficult environment and achieve success for their businesses and the patients they serve.”

Special Advertising Section Specialty Pharmacy Continuum

Specialty Pharmacy Continuum Specialty Pharmacy Continuum (SPC) is a dynamic addition to the Pharmacy Practice News editorial franchise, featuring essential clinical and business information for specialty pharmacies, home infusion providers, insurers and group purchasing organizations. Specialty pharmacy continues to experience explosive, double-digit growth, and for the past five years, SPC C has been tracking this trend and its effect on patients and providers. Topics covered over the course of our bimonthly print issues include biosimilars, site-of-care optimization strategies, drug adherence aids, best practices in home infusion and nutrition, and the use of cutting-edge technology to improve patient care. Our coverage also reflects the growing role that specialty pharmacists are playing in transitions of care, hence our focus on the entire patient-care continuum—from the hospital to the home and other community-based care settings.

Features SPC C includes a number of recurring features to meet the informational needs of our readers: Ask the Experts. One recent Q&A installment featured an interview with Mike Ellis, corporate vice president of Walgreens Specialty Pharmacy, on his personal and professional support of the Leukemia & Lymphoma Society’s “Light the Night” fundraising walks. Disease State Spotlight. Recent topics include psoriasis and psoriatic arthritis; and a two-part series on immune disorders, focusing on multiple sclerosis and rheumatoid arthritis. Practice Profiles. This feature includes in-depth examples of “best

Special Advertising Section Specialty Pharmacy Continuum

practices” in home infusion therapy, specialty pharmacy and other key patient care settings. Policy Update. Health care reform, REMS (Risk Evaluation and Mitigation Strategies), and Joint Commission compliance and accreditation are among the topics we track as needed.

Meeting Coverage

AT A GLANCE 545 W. 45th Stree et, 8th Floor New York, NY 100 036 Phone: (212) 957-5 5300 Fax: (212) 957-723 30 Website: www.spe ecialtypharmacycontinuum.com

SPC C editors and writers attend a wide range of conferences throughout the year, including the Armada Specialty Pharmacy Summit, MHA Annual Editorial Directo or Business Summit, and the National Association David Bronstein of Specialty Pharmacy’s Annual Meeting & Expo. davidb@mcmahon nmed.com These meetings primarily target established specialty Publication Dire ector pharmacy providers. However, we also help readers stay abreast of relatively new, nontraditional comDave Kaplan petitors in specialty pharmacy. Health systems are a dkaplan@mcmaho onmed.com prime example: Many of these entities are adding milSenior Editor lions of dollars in new revenue annually by expandMarie Rosenthal ing their specialty pharmacy offerings. Hence our mrosenthal@mcm mahonmed.com coverage of the American Society of Health-System Pharmacists’ Summer Meeting and Midyear Clinical Sales Account Manager Meetings, each of which included specialty pharmacy Lillie Onday topics in their 2015 programming. Londay@mcmahonmed.com We also welcome contributed articles, so if you are a clinical expert or operational whiz—regardless of which specialty pharmacy segment you represent—we’d like to hear from you. Send your topic ideas to davidb@mcmahonmed.com, and we will help you share your insights and lessons learned.

Corporate Profiles 2015

Temptime Corporation AT A GLANCE 116 The American Ro oad Morris Plains, NJ 079 950 Website: www.tempttimecorp.com Phone: (973) 630-60 051 Email: info@temptim mecorp.com

Stakeholders involved in the manufacture, distribution and reimbursement of specialty pharmaceuticals seek ways to increase support to patients while realizing cost advantages.

However, few integrate a simple tool into their processes that can help meet these objectives: • 7-fold return on investment for TransTracker® was reported due to reduced returns when TransTracker was included in every shipment to patients. • 50% reduction in call center time when TransTracker was used as a patient-facing decision-making tool to signal whether patients’ specialty medications experienced appropriate temperatures during transit. • 98% of patients surveyed want a temperature indicator to be included with specialty medications shipped to them.

The Temptime Difference—Expertise and Worldwide Leadership Temptime is the world’s leading provider of scientifically based time-temperature indicators that alert people if a product has been exposed to potentially damaging heat or freeze events. For nearly 30 years, our devices have helped healthcare workers confidently immunize millions of children around the world and extend care to regions previously thought to be unreachable. More than five billion of our time-temperature indicators have been used in 150 countries. Temptime is deeply committed to improving global public health. Founded in 1987, our scientists developed the first miniaturized technology to monitor temperature exposure of vials containing the oral polio vaccine. This device continues to be the only technology that meets the strict specifications of the world’s leading health organizations, including the World Health Organization, for distributing vaccines to developing countries. Today, pharmaceutical corporations, biotechnology companies and hospitals are using our devices to help improve storing and handling thousands of medical products that improve and save lives. It is our mission to monitor these products with 100 percent accuracy to ensure they have not been exposed to temperature events that could damage their effectiveness. We are honored to serve the world’s leading health organizations and contribute to improving the health of millions of people. We are dedicated to continually developing new technologies that will meaningfully improve global health for years to come.

TransTracker® Heat and Freeze Indicators for Secondary Packaging or Shipping Parcels TransTracker single-use, irreversible visual indicators monitor the temperature environment inside small and large parcels of temperature-sensitive products during shipping. • TransTracker F: visually shows when a specified maximum peak temperature threshold has been exceeded for a short duration of time. • TransTracker C: visually shows when a specified minimum lowtemperature threshold has been exceeded for a short duration of time. • TransTracker D: immediately shows when a specified maximum peak temperature threshold has been exceeded. • Multiple indicators can often be combined on a single TransTracker card to bracket both peak heat and low temperature thresholds.

LIMITmarker® Peak Heat Threshold Indicators • Single-use, irreversible threshold indicators that identify when a peak threshold heat excursion has been exceeded. • A range of indicators from 25°C to 50°C.

FREEZEmarker®—Freeze Indicators • Single-use indicators irreversibly change color from green to white to visually signal that a freeze event has occurred. • A range of indicators at –6°C, –1°C and 0°C.

Product Implementation Support— Seamless Integration Temptime reviews the packaging and shipping processes and procedures of our customers to develop a customized implementation plan that includes: • Packaging procedure review to support an optimal launch of the product • Process evaluation to integrate the application of the indicator • Work flow recommendations • Training of your sales and operations employees, and • Support in the design of user communication tools

Customized TransTracker Products 1. Branded: Integration of your logos, user instructions, and quality messages to include in shipments to your customers. 2. Temperature ranges: While we have a broad range of time and temperature monitoring capabilities, we can also work with you to develop custom indicators that meet your specific needs.

Corporate Profiles 2015

Special Advertising Section Specialty Pharmacy Continuum

Specialty Pharmacy Continuum • November/December 2015

POLICY

RETAIL PHARMACY continued from page 1

Commercial

Medicare Part D

Cash

Exchange Plans

Medicaid in Non-Expansion States

U.S. Retail Rx Growth

Medicaid in Non-Expansion States

8 6 4

Growth, %

by industry expert Adam Fein, PhD, the CEO of Drug Channels Institute, at the meeting’s opening plenary session that “the battle for the specialty pharmacy patient is getting tougher. Just hanging out your shingle and getting accredited won’t cut it anymore.” Nonetheless, the current climate includes plenty of “retail-friendly industry tailwinds,” said Michael Nameth, RPh, the CEO of Aureus Health Services and a member of the NASP board of directors. “Global trends in the industry translate to more patients, more drugs and more prescriptions.” The Affordable Care Act (ACA) means more patients are insured—and that’s particularly good for retail, Mr. Nameth said, pointing to an IMS Health PayerTrak report from January 2015, showing that Medicaid was the leading driver of retail prescription growth in the first year of expanded coverage under the ACA (Figure). “There are a lot of new patients in government programs, and many of these patients are already in community pharmacies. Combine that with the fact that life expectancy for many specialty patients is increasing, like people with HIV. They’re living a nice long life, but guess what—they’re contracting the traditional diseases we’re all subject to. Now the community pharmacist can take care of that total patient.”

2 0 –2 –4

Rolling Quarters –6 6

Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2013 2013 2013 2013 2013 2013 2013 2013 2013 2013 2014 2014 2014 2014 2014 2014 2014 2014 2014 2014 2014 2014

Figure. Contribution to retail prescription growth. Source: IMS Health, PayerTrak, Jan 2015.

heavy lifting compared with a few years ago when more products were [given via] infusion. There’s also less cold-chain management, and drugs are easier to handle and distribute.”

Roadblocks Remain Despite the favorable environment, as noted, it’s not a wide-open door for community retail pharmacies to plunge into specialty. The NASP experts focused on several key requirements and barriers for the eager community pharmacy: Data, data and more data. “You have

‘How many NASP meetings do you have to sit in and look at the trending slides and worry about missing the biggest change in pharmacy?’ —Mike Wysong

The panelists stressed, however, that community pharmacies face significant barriers to entering the specialty pharmacy market. Still, there are several factors favoring more of a communitybased approach—not the least of which is patient preference, noted Stephen Lagano, the founder of the biotech and pharma consultancy Altometrixs. “The patients offer an objective voice that needs to be heard more than ever before,” he said. Thus, if patients make it known that they want to get their specialty prescriptions from their local community pharmacy, that can have an effect over time, he noted. Another positive trend for community pharmacies eyeing specialty, Mr. Nameth said, is the growing “user-friendliness” of many specialty drugs and classes. “There are more self-injectables and orals, which are much easier to get the patient started on,” he explained. “There’s less

to be good at data and get better and better,” Mr. Lagano said. “Data requirements will only be increasing, especially as reimbursement moves more and more to outcomes.” This requires a scalable pharmacy platform to collect and report data—and the ability to either absorb the significant cost of such a system or get a partner to do it with you. Infrastructure. “You need comprehensive systems to manage prior authorization, the appeals process and patient assistance programs. It’s critical to have these ready to go from the start,” Mr. Nameth noted. Clinical services. “Patients really want to talk to someone who understands what they go through on a day-to-day basis,” Mr. Nameth stressed. “You need highly experienced staff that can connect with your patients and focus on outcomes and adherence.” Retail often gets dinged on adherence: Multiple studies have found

that mail-order and specialty pharmacy patients have significantly higher adherence rates than retail pharmacy patients. To overcome this challenge, community pharmacies aiming for specialty need system-driven clinical programs to demonstrate how they are positively affecting adherence rates. Community pharmacies that leap into specialty without careful planning, fearful of “missing out,” are making a mistake, the panel agreed. “You have to think long term,” Mr. Lagano said. “People think they need to start with accreditation and try to negotiate for all these contracts, but you have to have the foundation to execute first. It takes patience.”

Starting Small The virtues of starting small in specialty were described by Mike Wysong, the CEO of CARE Pharmacies Cooperative Inc., a growing independent retail chain of more than 80 pharmacies in the Northeast, California, Florida and Wisconsin. CARE started with an informal specialty pharmacy initiative about five years ago; since then, Mr. Wysong said, its specialty business has tripled. CARE is a long-time contract holder and administrator for an HIV drug program for an indigent population, and that formed its initial foothold in specialty. “That type of pharmacy really played naturally into the strengths of our organization. Our pharmacies are high-touch, community-based [sites of care] that can do the little things that matter. We have since been growing organically in highbranded specialty medications.” HIV is a good place to start for many community pharmacies, Mr. Wysong suggested. “Many of those drugs are open distribution, and those patients need a lot of attention. There are still many specialty drugs that are open access on the hepatitis C front as well, and those

are a great place to start before you begin thinking about how you go to Genentech or AbbVie to get drugs that even the largest specialty pharmacies are struggling to get access to.” He added that community pharmacies should think about their uniqueness as a business. What customers do you serve? What are you particularly good or passionate about? “Know what therapeutic spaces you want to start in, and don’t try to be everything to everybody. Be very good at one or two therapeutic areas, at least to start,” Mr. Lagano said. But what about gaining access to some of those limited distribution drugs? “There are thousands of ways to skin that cat,” Mr. Wysong said. In CARE’s case, they chose to partner with Aureus. “I’m not marketing services for drugs I don’t have access to, but if I’m partnered with an organization like Aureus and I’m the first fill option, with them on back end to supplement, then I can go out and market to physicians for those drugs.” Another option, he suggested, might be pulling together a small cohort of three to five local community retail pharmacies to achieve the needed volume for negotiations to get into a limited distribution network. The biggest barrier for community pharmacies entering the specialty space may be anxiety and uncertainty, Mr. Wysong observed. “It’s moving so fast, it’s a huge investment, you have to add people, and the drugs are 30 grand or more to buy. But you know it’s coming: How many NASP meetings do you have to sit in and look at the trending slides and worry about missing the biggest change in pharmacy? There’s a place for you in the changing landscape.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • November/December 2015

POLICY

As USP Chapter <800> looms (sort of ) ...

Specialty Gets Busy on Hazardous Drug Safety Specialty pharmacies face the same challenges as hospitals in establishing programs to meet the proposed U.S. Pharmacopeial Convention (USP) Chapter <800> regulations for hazardous drug safety. The burden, however, is likely to fall heaviest on smaller “mom-and-pop” specialty pharmacy operations that lack the financial means to meet the USP’s stringent environmental requirements for protecting pharmacists, technicians and others against long-term exposure to toxic chemotherapy and other hazardous drugs. “It’s definitely going to be a bigger hurdle for smaller compounders,” said Dustin Herring, PharmD, the director of laboratory operations at Avella Specialty Pharmacy. “Just to build the required negative-pressure room itself is pretty daunting,” he added. In contrast, like most other large specialty pharmacies, Avella is well positioned to meet the proposed regulations, according to Dr. Herring. In April, the company opened a new 503B-registered

Safety and Health (NIOSH; http://goo. gl/UKI150), Dr. Herring noted. They include tacrolimus, the immunosuppressant agent, and microdose versions of leuprolide, a commercially available drug often used to induce fertility.

A Waiting Game for USP Like most health systems and specialty pharmacies, Avella is waiting to see what the final USP Chapter <800> will look like before taking the next steps, Dr. Herring said. These could include building a negative-pressure room for its nonsterile compounding lab and a separate similar room for storing hazardous drugs. He noted that hazardous drugs are already stored in a separate location at Avella and labeled according to regulations from the National Institute for Occupational Safety and Health.

the placement of a biological safety cabinet in an unclassified ISO (International Organization for Standardization) room. “Right now,” he said, “Chapter <797> doesn’t permit any hazardous drugs to be compounded outside of an ISO class 7 space, unless you’re working in an isolator. So that low risk with 12-hour BUD [beyond-use date] is not applicable to hazardous drugs. And Chapter <800> creates a situation where people who don’t have a physical plant to generate enough air for an ISO-classified room can put a biological safety cabinet in that room as long as it’s exhausted and as long as it has 12 air changes an hour and 0.01inch negative water column pressure.” Some organizations have called for an even longer delay in implementing the new regulations, citing the costly facility retrofits and hefty investments in engineering controls and personal protective equipment outlined in the proposals. The American Society of HealthSystem Pharmacists’ Bona E. Benjamin, BSPharm, the director of medication-use quality improvement, in a June 22 letter

new information; it’s not,” said Patricia C. Kienle, MPA, BSPharm, FASHP, the director of accreditation and medication safety at Cardinal Health Innovative Delivery Solutions. “A large part is already in USP <797>. Other parts in it have been around in the pharmacy literature since 1985.”

‘Just to build the required negativepressure room itself is pretty daunting.’ —Dustin Herring, PharmD Like the USP chapters governing sterile and nonsterile compounding (<797> and <795>, respectively), the proposed new safety standards will be legally enforceable by the FDA and state boards of pharmacy. “We used to think that the FDA never went into pharmacies or other entities that handle hazardous drugs,” said Ms. Kienle, a member of the USP Compounding Expert Committee. “But since [the New England Compounding Center meningitis outbreak in 2012] and the 2013 Drug Quality and Security Act put some teeth to that, we have seen the FDA far more interested in compounding issues. And virtually every state board of pharmacy is looking at sterile compounding in particular, but compounding in general.”

A Proactive Approach

IIn A April, il A Avella ll S Specialty i lt Ph Pharmacy opened d a new 503B 503B-registered i t d outsourcing t i ffacility ilit th thatt complies li with ith FDA cGMP GMP guidelines. id li

outsourcing facility that complies with FDA current good manufacturing practice (cGMP) guidelines. The new outsourcing facility is located in the same Deer Valley, Ariz., complex as Avella’s two 503A traditional compounding laboratories: one for sterile and the other for nonsterile medications. Dr. Herring oversees a laboratory operation staffed by various teams which include pharmacists, technicians and a quality assurance department that compounds specialty medicines for shipment to individual patients and/ or bulk drug substances for health care providers nationally. Some of the drugs compounded by Avella are considered hazardous by the National Institute for Occupational

It might be several years before the new regulations become operational. Eric Kastango, MBA, BSPharm, the president and CEO of Clinical IQ and CriticalPoint, said it was his understanding that USP had been planning to publish the final version in January or February 2016, with a possible implementation date six months after publication in the USP’s Pharmacopeial Forum. However, the revised Chapter <797> that USP released in September has increased the chances of a longer interval before Chapter <800> comes into play. “Some harmonization has to occur because there are things in <800> that are in direct conflict with the current <797>,” Mr. Kastango pointed out. One such conflict, he noted, centers on

to USP’s CEO Ronald T. Piervincenzi, PhD, asserted that “implementing this chapter without an extended implementation timeline would cause an undue burden on a large number of health care facilities and practices, and could have a negative impact on patient care.” USP issued the proposed Chapter <800> in 2014 and has since revised it to reflect the comments of various stakeholders. The chapter updates are designed specifically to increase environmental safety in facilities that prepare and administer hazardous chemotherapy and other drugs and to protect health care personnel from the long-term cytotoxic, teratogenic and genotoxic risks of exposure to hazardous drugs. “A lot of people think this is brand-

That sense of urgency isn’t lost on Avella, which recently introduced several other measures to increase environmental safety in its compounding labs, Dr. Herring said. For one, it employs a Lighthouse cleanroom system that continuously tracks air pressure, velocity, particle counts and other environmental factors in its compounding facilities (http://goo.gl/nFUBAl). Avella also employs two full-time microbiologists who perform “all of our environmental monitoring,” Dr. Herring added. Their presence helps to meet the USP <800> requirement for a medical surveillance program designed to minimize adverse health effects in staff members exposed to hazardous drugs. “Safety has always been our No. 1 priority,” Dr. Herring said. “That’s kind of our cornerstone.” —Bruce Buckley None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

Specialty Pharmacy Continuum • November/December 2015

POLICY

CROSSHAIRS continued from page 1

Ms. Shanahan added that the mailorder pharmacies working with Horizon (the service is known as “Prescriptions Made Easy”) and other manufacturers recently implicated in steep price increases aren’t likely to provide the high-touch, patient-focused services that genuine specialty pharmacies deliver. “We manage access to therapy, and we educate patients about their therapy and the disease state and how they work together,” she said. “We help the patient manage side effects from therapy and drive compliance and persistence, and we give patients 24/7 access to a knowl-

‘Charging high prices for medications does not define a specialty pharmacy.’

—NASP statement

The National Association of Specialty Pharmacy (NASP) issued a public statement in the wake of the recent media coverage, declaring that “charging high prices for medications does not define a specialty pharmacy.” Part of the problem is that a precise definition of what constitutes specialty

‘As an industry, it’s our responsibility to do a better job of telling our story, and now is an even more important time to tell it.’ —Phil Hagerman, RPh edgeable clinical pharmacist, and collect and report outcomes data. True specialty pharmacies provide holistic patient support services that are wrapped around the therapy to make sure that the patient can be successful.”

Multiple Players If Horizon were an isolated case, the current controversy might not carry as much heat. But the company is not alone: On Oct. 30, perhaps stinging from public outcry and increasing government scrutiny, Valeant Pharmaceuticals announced it was severing ties with a mail-order pharmacy called Philidor. Valeant used Philidor exclusively to fulfill orders for dermatologic products that critics claim are wildly overpriced (sidebar).

A Refusal To Pay Several pharmacy benefit manufacturers, including Express Scripts and CVS Health, have refused to pay for drugs such as Duexis, citing “profiteering” by the involved companies. “We agree that the pharmacies propped up by these manufacturers deliver nothing like the service that a true specialty pharmacy does,” said David Whitrap, the senior director of Corporate Communications at Express Scripts. Some have suggested that a better term for these pharmacies would be “captive pharmacies”—including Express Scripts, which has announced that it’s reviewing all such relationships. Avella’s Ms. Shanahan characterizes them simply as mail order or fulfillment pharmacies. “They fulfill the script without any of the wrap-around services of a specialty pharmacy,” she said.

pharmacy still eludes the field—exemplified by the fact that sessions at this year’s Armada and NASP annual meetings included ongoing discussions on the scope and definition of specialty. Still, working definitions do exist, such as the one cited in the NASP statement: “A specialty pharmacy is a state-licensed pharmacy that solely

or largely provides only medications for people with serious health conditions such as cancer, hepatitis, rheumatoid arthritis, HIV/AIDS, multiple sclerosis, organ transplantation or bleeding disorders.” But as Mr. Hagerman noted, “the minute we try to put a precise definition around specialty pharmacy, a new drug will come out of pipeline that is compellingly important and needs to be a specialty drug, and will not fit that description.”

Accreditation a Key Differentiator One distinguishing factor for a true specialty pharmacy is that virtually all of them are accredited by an independent third party such as URAC or the Accreditation Commission for Health Care, Mr. Hagerman said. “I can’t imagine that the pharmacies involved in these schemes are accredited. The process is rigorous and takes almost a year.” (Horizon and Valeant did not respond to requests for comment on this story, including whether they were accredited by any of the recognized

accrediting groups.) Ultimately, Mr. Hagerman said, it’s up to those who do the real work of specialty pharmacy to ensure that the work is understood. “This [controversy] might precipitate those of us in the specialty space to be more thoughtful about getting the word out around what we do. Over the last several months, we’ve amassed a large collection of patient and caregiver testimonials, and we recently released those as part of our ‘Diplomat Difference’ campaign, which shows people who may not really understand specialty pharmacy some of the scope of [our practice]. As an industry, it’s our responsibility to do a better job of telling our story, and now is an even more important time to tell it.” —Gina Shaw

What’s Your View?

Has specialty pharmacy taken an unfair hit in the controversy over Horizon’s and Valeant’s “specialty” drug pricing and distribution model? How should the industry respond? Send your feedback to davidb@mcmahonmed.com.

Late breaker:

Valeant, Horizon and the ‘Captive Pharmacy’ Saga

small group of employees at Valeant Pharmaceuticals was instrumental in running the daily operations of the Pennsylvania pharmacy Philidor Rx Services, according to a Nov. 12 report from Reuters based on interviews with several former employees of the pharmacy. They claimed that the Valeant employees also worked with Philidor’s founders to set up the business in 2013. In one case, Reuters reported, two Valeant employees were copied on a November 2014 email with an attachment explaining how to keep resubmitting rejected claims at different price points in order to get the highest amount an insurance company would pay. The Valeant officials used pseudonyms for their contacts within Philidor, Reuters reported. Valeant has severed ties with Philidor—as have the nation’s largest pharmacy benefits managers (PBMs), including Express Scripts, CVS and OptumRx—and the pharmacy will shut down by January. But the saga of Valeant and Philidor has put a spotlight on socalled “captive” pharmacies—those that derive virtually all of their business from a single manufacturer and/or a single drug. Lawsuits and countersuits have been flying. During the week of Nov. 9, Express Scripts terminated its relationship with Linden Care in Woodbury, N.Y., a pharmacy that participates in “Prescriptions Made Easy,” a program designed to increase the sales of a high-priced pain relief combination drug dsold by Horizon Pharma, under a “flawed network” finding. Linden Care has filed suit seeking to force Express Scripts to reinstate the relationship. On Nov. 11, Horizon’s CEO, Timothy Walber, fired off a press statement accusing Express Scripts of profiteering, since its own specialty pharmacy, Accredo, holds a 28% market share. “Based on its Accredo ownership, it’s not surprising that Express Scripts would target small, competitive independent specialty pharmacies in order to force those pharmacies from its network, attempt to dominate the U.S. specialty pharmacy medicine distribution channel and further boost its own profits at the expense of patients,” the statement said. Meanwhile, OptumRx announced that it would sever contractual ties with Irmat, a New York City–based pharmacy that gets the lion’s share of its income from dispensing dermatology drugs made by two companies, Galderma and Aqua Pharmaceuticals. Irmat is suing OptumRx, claiming that the PBM is trying to eliminate all competition to its own mail-order business. “Optum has the incentive and the ability to eliminate pharmacies that provide competing mail-order pharmacy services by terminating them from Optum’s network,” they said in a complaint filed on Nov. 12 in New York’s State Supreme Court. Despite all the charges and countercharges, industry expert Mark Zitter of Zitter Health Insights told Specialty Pharmacy Continuum that the whole saga may be more smoke than fire. “Of course I’m concerned, as many in the industry are, that this issue gives true specialty pharmacy a bad name,” he said. “But I don’t hear pharmaceutical companies talking about using specialty pharmacies as a tool to get more of their products prescribed. That’s not how specialty is thought of by most manufacturers.” Most exclusive pharmacy network relationships, Mr. Zitter said, involve rare disease drugs and a manufacturer who wants to know every one of those 500 or 1,000 patients by name, so it drives them through their specialty pharmacy and hub—which is often internal. “But I haven’t seen much where the specialty pharmacy network is just a way to drive more business to the manufacturer. Narrowing the network can restrict business too, which doesn’t seem very smart or practical.” Mr. Zitter said he would like to see more thorough public vetting of the claims against Valeant and Horizon, and their countercharges against the PBMs. “Since people are suing each other, it’s going to come out in court at some point.” —G.S.

NO No Vented filters! No Micro leaks! No Contaminated plungers! No Assembly Fixtures! No Ergonomic Guides! No Syringe setups! No Push Turn Push! No Balloons! No Nonsenseâ&#x20AC;Ś

Just a flawlessly engineered CSTD. Just Plug & Play!

www.equashield.com 1-855-378-2744

Safe. Simple. Closed.

Specialty Pharmacy Continuum • November/December 2015

POLICY

New Payor Models: Emerging Trends W

hen the Academy of Managed Care Pharmacy (AMCP) Foundation, in partnership with Pfizer Inc., commissioned a major report on the top 10 emerging health care trends affecting managed care pharmacy, one issue quickly emerged as No. 1: migration from the fee-for-service (FFS) FS) model of care to alternative provider payment models—particularly those that encourage providers to provvide more value-based patient care. Part of that trend is due to reccent efforts by federal officials to incentivvize value-based care. In January 2015, the Department of Health & Human S Services (HHS) Secretary Sylvia Matheews Burwell announced the bold goal of tying 50% of traditional FFS Medicare payments to quality or value through alternative payment modeels, such as accountable care organizations (ACOs) or bundled payment arran ngements, by the end of 2016. This is the first time in the history of the Mediedicare program that HHS has set explicit goals for alternative payment models and value-based payments. During a webinar hosted by AMCP, titled, “The Role of Pharmacy in Alternative Payment Models,” held in July, panelists discussed the ways that these new payment models are already affecting the health care landscape. Webinar panelist Jeremy Nobel, MD, MPH, the medical director of the Northeast Business Group on Health, in New York City, noted that the move away from FFS models has been building for some time. “Economic

what likely” that at least 50% of hospital revenue will come from payment systems that penalize poor-quality care. Payors certainly have gotten the message, said Dr. Nobel, pointing to

Hospital

Clinic

they achieve that potential of using data to effectively shape quality care remains to be seen, but Dr. Nguyen said they will undoubtedly be looked on as a seminal development in the evolution of the

Long-Term Facility

New federal rules encourage health care providers to work together to treat an individual patient across multiple care settings— including physicians’ offices, hospitals and long-term care facilities—potentially achieving greater quality and value in the process. Source: www.virginiamason.org/delivery-models.

data from ICORE Healthcare showing that, from 2011 to 2012 alone, the percentage of payors experimenting with bundled payment models for large, in-network oncology groups jumped from 36% to 53%. Taken together, it’s clear that over the next decade or so, the U.S. health care system will be a hotbed for experimentation with risk-sharing models of care,

‘Payors and their ACO partners have the freedom and ability to negotiate every aspect of the ACO program. It’s the wild, wild West.’ —Thanh-Nghia Nguyen, MPH, MBA, DrPH risk for delivery of care and population health has shifted from payors to providers for the last 25 years,” he said. “Health care systems are very familiar with payment approaches like capitation and bundled payments.” Indeed, according to the American Society of Health-System Pharmacists Foundation 2014-2018 Pharmacy Forecast, 86% of survey respondents said that, by 2018, it is either “very” or “somewhat likely” that at least 50% of hospitals will have agreements with payors for bundled payments encompassing shortterm acute care, physician services and long-term postacute care for at least one medical condition. Moreover, 91% of the respondants said it was “very” or “some-

41% thought that they were just another trend that would soon be replaced. So far, the early ACOs have yielded mixed results, Dr. Nguyen noted. On the plus side, one survey found that ACOs

Dr. Nobel pointed out. A key area of speculation is the future of ACOs that, so far, have gotten the lion’s share at the right time to meet investment when it comes to value-based payment models. Leavitt Partners has reported a 61% growth in ACO-covered lives, said Thanh-Nghia Nguyen, MPH, MBA, DrPH, the director of customer marketing for Pfizer Global Innovative Products Division. The total number of ACOs in the United States jumped from about 450 in 2014 to 744 in the first quarter of 2015, he noted. When surveyed during the webinar, 59% of participants said ACOs are here to stay, based on sound medical and financial principles, whereas a not-insignificant

performed better than FFS models in 28 of 33 quality measures. And there have been well-documented instances of ACOs achieving major cost reductions. According to the Centers for Medicare & Medicaid Services (CMS), in 2014, 20 Pioneer and 333 Shared Savings Program ACOs generated more than $411 million in savings. However, “one development that is alarming is that one-third have dropped out of the program,” Dr. Nguyen said. “No dominant ACO model has emerged.” The latest of the original 32 Pioneers to drop out is Dartmouth-Hitchcock Medical Center, which announced the move on Nov. 3. The facility said it will join CMS’ new Next Generation ACO program, which begins Jan. 1, 2016. According to CMS, Next Generation will include many of the same shared risk and reward benchmarks as the Pioneer program, but will offer providers first-dollar shared savings for spending below the benchmark, and allow for post-hospitalization enhanced home health visits and telehealth.

CMS Adds a Wrinkle Although the rules for CMS-sponsored ACOs are rigid, and may be challenging, at least they are generally standardized across the country. “Payors and their ACO partners have the freedom and ability to negotiate every aspect of the ACO program. It’s the wild, wild West,” Dr. Nguyen said. Nonetheless, ACOs represent a tremendous opportunity, as a force putting cost and quality on the same plane. Whether

health care system. Now that the health care system has tasted the fruits of the combination of cost and quality, these will become core ingredients in the future. Consolidation is another key trend to watch. Impatient with the pace of organic growth, firms are looking to add capabilities and diversify sources of revenue through mergers and acquisitions. Some of the mergers may involve local entities, while other players may decide to partner closely with hospitals in other states, Dr. Nobel said. The recent merger between Catamaran and OptumRx is an example of a “megamerger” that points to a shifting balance of market power. “While [economies of scale] may bring certain cost efficiencies, fewer, larger entities may potentially control the marketplace in various ways, “ he said. Dr. Nguyen cautioned that having additional leverage and bargaining power in the hands of a few behemoths could result in higher prices for both patients and payors, with one study pointing to 20% higher costs overall for patient care ( (JAMA 2013;310[18]:1964-1970). Everyone is striving for a gaining power model, he said. “But then, they have to manage those lives and manage them effectively and efficiently.” And that will be the real test of any new payment model. —Gina Shaw None of the sources reported any relevant ﬁnancial relationships.

The perfect complement to your current worRÅow system.

Prior Authorization

Pharma/Biotech Programs

Clinical Consult

ArmadaOne is an integrated web-based software platform that optimizes specialty pharmacy operations, prescription worRÅÅow and overall patient management. Armada has developed this new platform to seamlessly integrate with pharmacy dispensing systems and worRÅÅows used by specialty pharmacies across the country. ArmadaOne features include on-boarding specialty patients, streamlined management for prior authorizations, connectivity

Prescription Transfers

Dynamic R Reporting

with co-pay and patient assistance programs and ongoing clinical consultation and compliance monitoring. Other beneÄÄts include real-time data reporting for Pharma/biotech manufacturers, health plans, prescribers and other industry partners. ArmadaOne’s robust business intelligence also provides prescription status information, operational insights and other essential pharmacy management and productivity reports.

To schedule a product demo, call us at 866-766-4002 or visit us at armadaonerx.com

Specialty Pharmacy Continuum • November/December 2015

POLICY

Biosimilars: What’s in a (Nonproprietary) Name? Filgrastim, filgrastim, wherefore art thou filgrastim? National Harbor, Md.—The FDA’s proposed naming convention for biosimilars was a major topic of debate in the final plenary session of the 2015 National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo in October. Under the FDA’s proposed rule, all biological product names, biosimilars and their reference products would include an unbranded core name and a designated suffix. “For originator products, the core name would be the name adopted by the United States Adopted Name (USAN) Council for the drug substance when available,” the rule states. “Related, biosimilar or interchangeable products would include the core name of the relevant, previously licensed product and a designated, four-letter suffix attached by a hyphen.” When the FDA approved the first biosimilar filgrastim (Zarxio, Sandoz) in March 2015, it was given the “placeholder nonproprietary name” (NPN) of “filgrastim-sndz.” This designation reflected the original USAN given to the reference product granulocyte colonystimulating factor (filgrastim), plus the four-letter suffix that is a nod to the manufacturer. r

Under the FDA’s proposed rule, issued in August, this interim name would change, as would the name for the reference product—the suffixes would be random and have no meaning. Under the rule, Sandoz’s Zarxio (filgrastimsndz) would be renamed “filgrastimbflm,” while Amgen’s originator Neupogen (filgrastim) would be changed to “filgrastim-jcwp.” (The FDA also said it is considering suffixes based on manufacturer name, in which case filgrastimsndz might be back in play.) With the comment period on the proposed naming rule closed as of Nov. 12, Avalere’s FDA and regulatory strategy expert Gillian Woollett, MA, DPhil, explained that, if it’s approved, “we’re anticipating a system in which we have to go back and rename all currently approved biologics with some sort of hyphenated suffix.” But not everyone agrees on the likely outcome of the naming discussion—

including Sandoz, which had not yet submitted its comments on the FDA A draft guidance as of the NASP meetting, said Alan Ryaan, RPh, MBA, the company’s director of U.S. advocacy and alliance developm ment. “The draft guidance is a lot to diggest.” Mr. Ryan indicated i d that h Sandoz S d previously took the position that the nonproprietary name should be the same as the reference product, noting that the American Pharmacists Association, America’s Health Insurance Plans, the California Public Employees Retirement System and Express Scripts also called for the FDA to forgo different names for biosimilars. “We don’t see a scientific reason for there to be differentiation in the nonproprietary name,” he said. “Memorizing product names is difficult, and a unique NPN in addition to the brand name is a lot to ask. In terms of patient safety, there’s an NDC number on each product, and if you need to track the product, you can use the NDC.” Pfizer, which recently acquired bio-

The goal: better data on biologics, improved policy compliance

AMCP Launches Two New Programs Orlando, Fla.—At the AMCP Nexus 2015 meeting, the Academy of Managed Care Pharmacy announced the formation of two new programs: One will collect and provide information about biologics and biosimilars and the other will offer a resource concerning state and federal regulations that affect managed care pharmacy. The programs will launch in early 2016. The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) will be an active monitoring system that will draw on large sets of de-identified pharmacy and medical data from 100 million lives to provide unbiased scientific information about the safety and efficacy of marketed biosimilars and their corresponding novel biologics. The consortium is the only research network dedicated to active monitoring of these biological products. The framework will apply the same scientific, analytic methods used by the FDA Sentinel initiative, a postmarketing surveillance system that tracks the safety of therapies once they reach the market. “The BBCIC initiative reflects our

continuing commitment to public safety and health by evaluating possible issues concerning biologics and biosimilars,” said AMCP CEO Edith A. Rosato, RPh, IOM. The initiative will “provide patients and insurers the reassurance they need to use these new therapies,” she said at a press conference held during the AMCP Nexus meeting. The new group will involve a collaboration of managed care organizations, integrated delivery systems, pharmacy benefit management firms, research institutions and pharmaceutical companies. The effort comes as the first biosimilar, Zarxio (filgrastim-sndz), from

Sandoz, enters the U.S. market. As more biosimilars come to market, physicians, p y patients and other stakeholdeers will have questions about ttheir safety and effectiveness, said Bernadette n Eichelberger, PharmD, E tthe program director of tthe BBCIC. Although Europeans have had a decade of experience with biosimilars, they w only have small registries collecting this type of data. Dr. Eichelberger expected the BBCIC (www. BBCIC.org) to enable U.S. providers to become aware of any safety and efficacy issues much faster due to the number of lives that are being surveyed, as well as the robustness of the data collected. One of the key features of the consortium is that all of the collected data parameters, such as laboratory results, will be standardized, and researchers will be comparing apples with apples. The consortium will regularly analyze and publish results of the surveillance, she said, adding that transparency is par-

similar i il d drugmaker k H Hospira, i boosting b i its biosimilar pipeline to some 16 candidates, takes a different view. “Our philosophy is that each biosimilar should have its own unique INN [identifiable nonproprietary name],” said Toral Shah, Pfizer’s senior director and therapeutic area team leader for biosimilars commercial development. “They are highly similar—they are not identical or exactly the same. They reflect different manufacturing processes and analytics. At the end of the day, from a patient safety perspective, it’s important that each one has its own uniquely identifiable nonproprietary name that you can track safety-wise.” Amgen, which has three biosimilars in Phase III trials, takes the same see BIOSIMILARS, page 36

amount to the success of the program. “AMCP believes that the public’s and health care community’s understanding of biosimilars will be enhanced by the BBCIC’s balanced scientific approach,” Ms. Rosato explained. “If biosimilars are actively monitored after their introduction for safety and effectiveness, this will answer questions and concerns, leading to their greater acceptance and adoption in the U.S.”

Subscription-Based Resource The second program is a beta rollout of the State and Federal Pharmacy Intelligence Resource (SAFPhIR), AMCP’s new subscription-based offering that combines intelligence on recently enacted laws and regulations affecting managed care pharmacy with expert policy analysis and high-level guidance. The new resource contains many features that set it apart from other legislative and regulatory databases. These include the ability to tailor the information a user receives based on his or her state and federal priorities, and the ability to access a wealth of expert policy analysis and guidance that will make the content actionable for the entire managed care operation. “Government affairs will certainly appreciate SAFPhIR’s highly tailored, see AMCP PROGRAMS, page 36

Specialty Pharmacy Continuum • November/December 2015

POLICY

BIOSIMILARS continued from page 34

position, said Duane Barnes, the vice president for specialty pharmacy and PBM strategy. “Distinguishable names are important in this space, especially from a patient safety standpoint. We need to be able to track and distinguish these drugs when we see adverse reactions.” The Pharmaceutical Research and Manufacturers of America, an industry group, said it supports the FDA’s naming convention, but believed that the suffixes

should be distinguishable and meaningful by designating the manufacturer, such as sndz for Sandoz. Similarly, on Nov. 12, the Biosimilars Forum, a group representing biosimilars developers, stated that any suffix used “should be meaningful (preferably based on the name of the license holder), rather than random, as currently proposed.” Other groups, such as the Generic Pharmaceutical Association and the Kaiser Foundation, said adding a suffix was unnecessary and would create confusion among prescribers and patients.

In an interesting objection, the FTC said the proposal would inhibit price competition and questioned whether the proposal will have any effect on pharmacovigilance or inadvertent substitution, which were among the goals of the new naming convention. Mr. Barnes said one needs to keep in mind what’s at stake if distinguishable names are not eventually adopted as the biosimilars naming model. “If another biologic comes out and something [adverse] happens, how are you to know if it’s your product or someone else’s?

Read Specialty Pharmacy Continuum Anywhere, Anytime!

Whatever we decide now could be what stands when all these new products enter [the marketplace].” Dr. Woollett said U.S. and European experience with biosimilars already has proved instructive. The FDA, she noted, has 77 biologics currently approved and licensed, with only 25 INNs. “We already share nonproprietary names,” she said. “I’m not aware that there’s been any real safety issues.” In Europe, she added, “there are 22 biosimilars, including nine filgrastims, with different brand names and the same nonproprietary name, and the systems have coped. Zarxio has nearly 10 million patient-days of treatment in Europe [marketed there as Zarzio] with the same nonproprietary name and no issues regarding adverse event reporting.”

Download the iPad App here.

—Gina Shaw None of the sources reported any relevant ﬁnancial relationships.

AMCP PROGRAMS continued from page 34

highly valuable content, but other parts of the business and industry operations also will benefit from understanding the practical implications of policy and regulatory changes,” Ms. Rosato said. “There is a need in the health care marketplace for timely information on the multitude of federal and state mandates affecting managed care pharmacy and industry each year. AMCP is pleased to fill that need with SAFPhIR.” As many as 500 bills affecting managed care pharmacy are introduced every year in state legislatures, about 150 of which are signed into law. The product’s Web- and tablet-friendly application features the capability of designing content feeds based on each user’s unique needs. For instance, some users may only be interested in new state and federal laws and regulations affecting opioid utilization, whereas others may be interested in laws affecting biosimilars. “SAFPhIR [www.safphir.com] will provide users information they need to make informed decisions about their business,” said Tom Donnelly, AMCP’s vice president of SAFPhIR. “If there is a new law in California that will impact pharmacy benefit management companies, for example, we will have that coupled with expert analysis to provide guidance on how to meet the letter of the law.” Mr. Donnelly is seeking beta test customers who will get exclusive early access to the tool and provide input on making improvements. Beta users also will receive valuable discounts on ongoing subscriptions. —Marie Rosenthal

Specialty Pharmacy Continuum • November/December 2015

TECHNOLOGY

Prescription Adherence Boosted Via Mobile App Can a mobile app boost medication adherence? Pharmacy benefits manager (PBM) MedImpact Healthcare Systems Inc. expects that it can, and is marketing a “gamified” medication adherence app to its managed care, employer group and health-system clients. The goal is to help these organizations help members comply with their medication regimens by engaging them through their smartphones long term, said Marty Mattei, PharmD, the vice president of clinical product innovation and strategy for the San Diego–based PBM. Sustaining patient interest with mobile apps in general and with health apps in particular is a challenge, Dr. Mattei said. Despite the convenience of mobile phones, usage levels for many products typically drop off significantly after only a few months. The company is hoping that this particular app’s use of incentives, which allow patients to earn points in a style akin to video games, will help keep individuals motivated and involved. The app allows users to program automatic dose reminders and refill alerts, and provides information on potential drug interactions and side effects. Userscan enter reminders and also browse information about over-the-counter medications and supplements.

Choosing a Mobile App Partner

ccording to Eric Sredzinski, PharmD, of Avella, specialty pharmacies interested in partnering with a mobile app developer to increase medication adherence among patients should consider the following: Transparency and systems integration. “The vendor we chose, mscripts, is directly tied into our pharmacy management system,” he said. Ease of access to compliance data and an analytics dashboard. That access allows the specialty pharmacy to drill down to understand patient performance and demographics. With the mobile app that Avella is currently using, “we can actually look at the data as we’re talking to patients, so we can encourage patients when they are compliant or offer verbal reminders and reinforcement as needed,” he said. A multimodal approach. This approach should incorporate the use of a mobile app as an aspect of increasing adherence along with educational and support services from the specialty pharmacy. “While not for every patient,” Dr. Sredzinski said, “a mobile app is another tool to assist in improving the adherence rate.”

—S.B.

Most important, according to Dr. Mattei, the app engages patients by enabling them to track and view their adherence, and by letting them work toward rewards when they take their prescriptions as directed. These rewards include gift cards to their favorite stores and donations to charities. MedImpact will offer the app for a fee as part of a package that includes analytics capabilities. This combination of data collection and analytics will allow clients to measure medication compliance in any populations they decide to target, and then use the data to help fine-tune services and interventions, Dr. Mattei said. Organizations that purchase this package can offer the app to all members or to selected populations with specific health concerns, such as cardiovascular disease, diabetes or asthma.

A Billion-Dollar Problem With an estimated annual cost of $300 billion, medication nonadherence remains a huge problem, according to the Council for Affordable Health Coverage (CAHC; http://goo.gl/r2yeL3). Half of all patients do not take their medications as prescribed, and 20% of all new prescriptions go unfilled, the CAHC has reported. Adherence is lowest among patients with chronic illness—the same patients who have the most to lose if they do not follow their medication regimens. There is considerable interest by the health care community in trying mobile apps as a tool to improve medicationrelated behaviors and habits. “Despite being untested, medication apps represent a possible strategy that pharmacists can recommend to nonadherent patients and incorporate into their practice,” concluded one review of 160 medication apps (J ( Am Pharm Assoc 2003;53[2]:172-181).

were 2.9 times more likely to disscontinue their medication regimen ns than patients who used the app, reported Eric Sredzinski, PharmD, the executive vice president of clinical affairs and qualityy assurance for Avella Specialty Pharm macy. He noted that 79% of Avella patients u using the app achieved 90% or greater adherrence, compared with 65.3% of patients wh ho did not use the platform. The study used d proportion of days covered to assess ad dherence rates in HIV patients taking single i l and multiple-source medications, including efavirenz-emtricitabine-tenofovir (Atripla, Bristol-Myers Squibb) and emtricitabine-tenofovir (Truvada, Gilead). “The No. 1 reason for not being adherent is forgetfulness,” Dr. Sredzinski told Specialty Pharmacy Continuum. “Having a tool that can provide reminders about your refills as well as when to take your medication provides an extra support system. Most of us are pretty well tethered to our cell phones, so having something that is always around has the ability to change patients’ behavior.” Dr. Sredzinski added that he is interested in seeing outcome data from MedImpact’s use of incentives and rewards in a mobile app as a technique for increasing compliance. MedImpact did its own extensive evaluation of products on the market

and felt that a mobile offeriing needed d d a blend bl d of user-friendliness, intuitive design, easily digestible presentation of information and incentives to keep patients interested, according to Dr. Mattei. Although MedImpact is not marketing the app directly to pharmacies, availability to this trade channel is within the realm of possibility, he said. “Specialty pharmacies would probably be the most important market segment because it’s so critical for these patients to complete their therapy regimens,” he said. “You don’t want to spend $100,000 on a therapy for 12 weeks to a year and not have the patient be as close to 100% adherent as possible.” —Susan Birk None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

Career Opportunities Education Financial & Legal Services Medical Equipment

HIV Patients Benefit Data on mobile apps as a tool for bolstering medication compliance are beginning to accumulate. A study presented at the 2015 Armada Specialty Pharmacy Summit revealed a significant improvement in medication adherence among patients with HIV who used a mobile app developed by mscripts, in San Francisco, for refill reminders, dosage reminders and other prescription information. Patients who did not use the app

For classiﬁed advertising, contact Craig Wilson 212-957-5300 x235 cwilson@mcmahonmed.com

Specialty Pharmacy Continuum • November/December 2015

TECHNOLOGY

Data integration streamlines operations

Using EHR To Support Specialty Pharmacy Denver—Experts from two major academic health systems shared practical insights on integrating specialty pharmacy into a broader systemwide electronic health record (EHR) at the American Society of Health-System Pharmacists 2015 Summer Meetings. “Building and implementing a specialty pharmacy clinical management service in a hospital’s existing EHR does not require a separate specialty pharmacy module or a large amount of custom programming,” said Jack Temple, PharmD, the manager of information technology (IT) and medication-use systems at the University of Wisconsin (UW) Hospital and Clinics, in Madison. “Modifications to existing EHR clinical tools to include a medication focus is a good foundational start,” noted Dr. Temple, whose facility recently went through an 18-month process of configuring a specialty pharmacy information system. Previously, UW had used a separate third-party retail pharmacy system to do the bulk of its drug dispensing, distribution and medication claims adjudication to third-party payors. As with many hospitals and health systems, UW was faced with the decision of whether to configure documentation of specialty pharmacy care within the system’s

EHR Components In UW Care Model

• Diagnosis • Prescribe Rx • Referral work

EHR Tools Used • • • •

Clinical encounters Standard episode of care Scripted patient care process Smart clinical documentation tools, with discrete data elements • Patient outreach • Patient portals • Reporting

larger EHR platform (in this case, Epic), or buying and using a third-party “offthe-shelf” system. After extensive talks with one such vendor, Dr. Temple and specialty services supervisor Andrew Pulvermacher, PharmD, and their team decided not to reinvent the wheel, and instead adapt the existing Epic platform to meet their needs. “The idea was to use the integrated EHR platform to build on other patient encounters that were occurring in our health care system, like laboratory or ED [emergency department] visits, or other clinical specialties and follow-up, to build a holistic picture of the patient in conjunction with tracking anything related to specialty pharmacy care,” Dr. Temple explained. Whenever possible, the specialty pharmacy informatics team worked to develop clinical pathways for disease states related to specialty pharmacy, with medication-specific components that could be layered on a standard underlying Epic build. “Things like

medication adherence and related questions are similar across disease states, but need to be configured and plugged into the clinical pathway for evaluation and documentation,” Dr. Temple said. The new specialty pharmacy component of UW’s Epic system officially rolled out in early 2015, with three initial disease states: oncology, hepatitis C and HIV infection. “We use a functionality within the system called an ‘episode of care,’” Dr. Temple explained. “For example, when a woman is pregnant, those nine to 10 months of her life is one episode of care, focused on that pregnancy. Certain disease states are similarly connected together. We are using that functionality to track a patient’s progress of care longitudinally so that we can show positive benefits and outcomes with our follow-up. The episodes of care give you the ability to track and trend information around things like lab values or side-effect profiles.” Future steps for UW, Dr. Temple said, will include documentation and tracking

• Follow-up care • Treatment outcome

Informatics Team Members •

Manager (1 FTE, RPh) 30% of time spent on IT

•

Team Supervisor (1 FTE, RPh) Informatics Pharmacists (3 FTE, RPh) 4 personnel

•

Analysts (6.5 FTE) One Shared Business Analyst (0.5 FTE)

•

New Positions in Recruitment Analyst for TAC (1.0 FTE) Business Analysts (1.0 FTE)

• Prior authorization program enrollment • Dispense Rx • Treatment follow-up • Document care and outcomes • Track and report outcomes data

PHARMACY INFORMATICS

Team Areas of Responsibility • All things medication related in the EHR: -Create clinically appropriate medication records (inpatient and ambulatory)

• Lab visits

-Implement safe medication prescribing/ordering and administration workflows across the EHR -Ensure accurate billing

of referral requests, an outpatient pharmacy build-out and integration, a patient episode-synopsis report, and patient portal questionnaires and follow-up. As for any health system that wants to leverage the power of EHRs in specialty pharmacy, Dr. Temple stressed that such an undertaking “does not require a specialty pharmacy module or large-scale custom programming,” he stressed. He added that if a hospital chooses to make modifications to existing EHRs, “a good foundational start” is to include a medication focus in such efforts.

Vanderbilt University’s Experience Meanwhile, Vanderbilt University Medical Center (VUMC) is going through the same process of decision-making about specialty pharmacy information management and integration that UW recently completed, said William Walker, PharmD, a pharmacy IT analyst with VUMC’s specialty pharmacy, in Nashville, Tenn. “Right now, the systems that we use for specialty pharmacy processes are separate,” he said. “We use three systems: an opportunity list identifies potential patients [who] can use our service, a system for our clinical assessments and refill management, and one for dispensing. “We’re trying to evaluate the most objective way to integrate the systems, so the business can accomplish their goals,” Dr. Walker said. “Since the data is in disparate systems, we need to integrate the data. Another challenge is the increasing amount of different data requests that come from manufacturers and payors. There is currently no standard for specialty drug reporting.” —Gina Shaw None of the sources reported any relevant ﬁnancial relationships.

® Unit Do se Bar Cod , in Pharma g, c Nursing y & Supp Experts ly !

• 64 Bit Compatible • Enhanced Printing, Fonts and Date Calculations • 1-D and 2-D Multi-Part Bar Codes • Include Tall Man Lettering, Shapes and Images • Scan Bottles to Import from Included NDC Database • Security Options to Ensure Your Work Flow • Group and Sort Your Formulary • Searchable Electronic Log • Easy Database Networking • Supports All Medi-Dose® and LiquiDose® Laser and Thermal Labels

MILT 4 is the newest version of Medi-Dose's industry M leeading labeling and bar coding software. Every feature oof this custom-written program was specifically ddesigned to accommodate the needs of healthcare pprofessionals. With our large variety of laser and direct thhermal labels, you can clearly identify and easily bar code all medications.

Download Demo at MediDose.com

•

800.523.8966

Please see us at Booth #1112 at the ASHP Show in New Orleans

CAREGIVER. PATIENT. SURVIVOR.

OUR SPECIALTY PHARMACY RESOURCES + A CARING TOUCH Brenda cared for her husband during his battle with cancer. She was there—offering support, going to every appointment and making sure he took his prescription on time. Later, when she was diagnosed with breast cancer, the caregiver became the patient. Her husband was there every step of the way, and so was her pharmacy team. Personal experiences like those would later inspire her to become a patient advocate with Diplomat. Diplomat is a different kind of specialty pharmacy. The patient is at the center of everything we do. We strive to give the high-touch care you would expect for someone you love. Our care team includes pharmacists that are some of the best in the Þeld. We are Diplomat, and we are here to serve. SEE BRENDA’S STORY AND LEARN MORE ABOUT OUR EFFORTS AT DIPLOMAT.IS/HERE HELP US CELEBRATE NATIONAL PHARMACY WEEK WITH #WEAREHERE @DIPLOMATRX

BRENDA BREAST CANCER SURVIVOR DIPLOMAT, MANAGER OF PATIENT ADVOCACY

DIPLOMAT CELEBRATES BREAST CANCER AWARENESS MONTH