May/June 2016 by McMahon Group

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Bridging the gap between the hospital and alternate-site care Volume 5 • Number 3 • May/June 2016 • specialtypharmacycontinuum.com

POLICY EMD Serono Digest 2016: the payor/provider disconnect ........................ USP Chapter <800> chemotherapy safety not just for hospitals .......

Your specialty pharmacy passed accreditation. Now what? .......................... 10

2015 approvals a record; 2016 pipeline strong

For cancer and HCV:

Specialty Drugs Remain A Robust Market Force

Are ‘Miracle Cures’ Sustainable, Given High Cost of Care?

San Francisco—Less than 1% of Americans use specialty drugs, yet the medications now account for 38% of the nation’s pharmacy drug spending. The figure is expected to rise further as more orphan and other specialty drugs pass through g the regulatory g yp pipeline, p , accordingg to speakers p at the Academy of Managed Care Pharmacy’s AMCP 2016 meeting.

San Francisco—About a decade ago, Steven G. Avey was diagnosed with mantle cell lymphoma. His doctors told him it was likely incurable. But then they prescribed a specialty medication, rituximab (Rituxan, Genentech) in combination with four other chemotherapy drugs. “Without it, I wouldn’t have made it,” said Mr. Avey, a vice president of the specialty clinical team with MedImpact Healthcare Systems, with headquarters in San Diego. As he noted to an audience at Specialty Pharmacy Connect, a special session of the Academy of Managed

OPERATIONS & MGMT Panel at MHA Summit tackles trends in specialty pharmacy ........

CLINICAL

see COST OF CURE, page 18

The shifting cost of factor therapy for hemophilia .................

Safety tips for at-home infliximab infusions ........

How much attention should be paid to cancer/psoriasis link?.....

TECHNOLOGY PATH Pro e-tool drives generic utilization— and savings .......................

ASK THE EXPERT Stacey Ness, PharmD, on MHA Inc. members’ inroads into specialty pharmacy ............................

Grass-Roots Effort Drives Advocacy For Home Infusion

“By 2018, we could see half of all pharmaceutical drug spending on specialty medications,” said Aimee Tharaldson, PharmD, the senior clinical consultant for emerging therapeutics at Express Scripts, and a conference presenter. “Over the last six years, the FDA has approved more specialty than traditional drugs, and that trend is expected to continue.” The FDA approved a record number of 56 drugs last year, of which 33 were specialty medications. Most were orphan drugs and almost half were oral medications. So far this year, the FDA has approved 10 additional specialty drugs. More specialty drugs means more medications for conditions previously difficult to treat or incurable, such as hepatitis C (HCV). It also means a whole lot of money exchanging hands. HCV treatment would cost the health care system $160 billion if all 3.2 million infected individuals in the United States were treated, noted Doug Long, BS, MBA, the vice president of industry relations at IMS Health, and another conference speaker.

Las Vegas—Advocacy for home infusion may seem complicated, but it’s really not; it comes down to developing relationships with legislators and their staffers and communicating a simple but precise message, a panel of experts said at the 13th Annual MHA Business Summit. There’s certainly a need for such advocacy, noted panelist Paul Mastrapa, the president and CEO of Option Care. “The understanding of what we do is borderline nonexistent,” he said. During one Capitol Hill meeting he had in 2008 with a young congressman, the legislator mistook the term home infusion for a call to start building homes.

see PIPELINE, page 5

see ADVOCACY, page 8

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Specialty Pharmacy Continuum • May/June 2016

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HOME INFUSION

Michele McMahon Velle, MAX Graphics/Creative Director

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Volume 5 • Number 3 • May/June 2016

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Specialty Pharmacy Continuum • May/June 2016

POLICY

EMD Serono Specialty Digest 2016

What’s Keeping Payors Up at Night? Las Vegas—Managing oncology drugs and services remains the top challenge faced by commercial health plans, according to highlights from the 2016 edition of EMD Serono Specialty Digest, a survey of 58 commercial health plans representing more than 140 million covered lives, presented at the 2016 Asembia Specialty Pharmacy Summit. Just as in 2015, 79% of respondents to the 2016 survey ranked oncology as one of their top five drug management hurdles. “Oncology is the No. 1 challenge for 285 respondents,” said Mike Lonergan, RPh, a senior vice president at Artemetrx Specialty Drug Solutions, who presented the new survey results at the 2016 Asembia Specialty Pharmacy Summit. That’s unlikely to change anytime soon. Oncology medicines comprised more than one-third (35%) of all new drugs launched in 2015, Doug Long, the vice president of industry relations for IMS Health, noted during a separate session on the U.S. specialty pharmacy market. “This is the most innovative period I’ve seen in the field,” Mr. Long said. “The good news is that oncology drugs are becoming more targeted,” which potentially boosts efficacy, he noted. “Between now and 2020, we expect that 91% of all the oncology launches will be targeted.”

Perhaps not surprisingly, oncology and SOC management also are perceived by payors as their least successful management tasks. Only 11% of respondents considered either one of these areas their most successful, while 41% said managing infusion SOC was their least successful front, and 30% said oncology was. Payors were more pleased with their response to the drug pipeline (22% most successful, 3% least successful), and particularly with their ability to ensure clinically appropriate use of medications (58% most successful, 3% least successful). “Improving or enhancing on a good base is clearly easier than addressing newer and more complex challenges,” Mr. Lonergan said. It shouldn’t be surprising, then, that payors identified SOC initiatives (19%) and new or enhanced utilization management and prior authorization programs (22%) as the most important activities

‘There is a clear gap between value and satisfaction, and between what payors need and what they are getting, when it comes to reporting.’ —Mike Lonergan, RPh To manage the growth of oncology, it appears that many more plans are employing clinical pathways. In 2014, about one in five plans (37% of covered lives) used oncology clinical pathways, while in 2015, that had grown to 38% of plans, representing 74% of lives, according to the Specialty Digest report. Another one in four plans (14% of lives) will implement at least one pathway this year. Beyond oncology, other concerns included simply determining the value of specialty drugs: 71% of the EMD Serono survey respondents ranked this a top five challenge, compared with 66% in last year’s survey. Ensuring clinically appropriate use was a top five concern for 69% of this year’s respondents, compared with 60% last year. But one of the areas that’s adding new gray hairs for commercial payors is managing site of care (SOC) for infusions, which became a top five problem for 64% of plans versus 53% last year.

their organization undertook to manage specialty medications during the previous year. With 46% of their specialty drug spending on the medical benefit side, and nearly one-third of that (29%) in the high-cost hospital setting, Mr. Lonergan noted, “this is a serious pain point. Payors are going to want to continue to push [SOC] to specialty pharmacies and home infusion providers, which are ranked as the most competitively priced sites of care.” At specialty pharmacies, 68% of respondents said they received competitive pricing; in outpatient hospital settings, 58% of respondents said the pricing was nott competitive. SOC programs took a big jump in 2015; 44% of plans reported that they had them in place, compared with just 31% in 2014, according to the Specialty Digest. Another 35% of plans said they were on track to implement such programs within the next 12 months, and only 21% said they had no current plans to put them in place.

Payors that had already implemented SOC programs were taking a fairly strict approach, with 68% requiring use of the preferred site with a limited allowance for medical exceptions. Less common were strategies such as contacting members to recommend the preferred site after initial treatment (44%) and providing cost-sharing incentives to use the preferred site (32%).

Payor–Provider Disconnect As in previous years, there is a disconnect between the specialty pharmacy services that payors place the most value on and the services they are most satisfied with from their specialty pharmacy partners. While dispensing rated high in value (88% of respondents ranked it high) and in satisfaction (81% said they were satisfied), this category was an outlier. Patient services such as help with financial assistance programs and education to promote adherence were ranked highly by 82% of respondents, but only 64% said they were satisfied with their specialty pharmacy’s efforts in these areas. Reporting on interventions and outcomes, expenditures and savings had an even bigger lag: It was important to 82% of respondents, but just 30% were satisfied. A new area of the survey this year focused on the sources payors have for specialty pharmacy data. It turns out that payors often must generate their own data: 61% said they produce their own internal reports on pharmacy benefit spending; 82% produce their own reports on medical benefit spending; and 67% produce their own SOC spending reports. “There is a clear gap between value and satisfaction, and between what payors need and what they are getting, when it comes to reporting,” Mr. Lonergan said. “This represents an opportunity for specialty pharmacy providers to improve their game and deliver value to differentiate themselves in an increasingly crowded marketplace.”

Payors Differ on PCSK9s Mr. Lonergan highlighted the differing coverage policies between proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, which had only been on the market for a few months before the latest survey, and the new directacting oral antivirals for hepatitis C virus (HCV), which have now been on the market for more than two years. In the 2015 survey, just 53% of payors had selected a preferred oral HCV agent, and only 29% excluded coverage of nonpreferred products. One year later, virtually all payors (93%) had a preferred agent, and 57% excluded the nonpreferred products.

More than two-thirds of plans require a specific fibrosis score for coverage of oral HCV medications, with the vast majority requiring a fibrosis score of 3 or higher. That’s likely a reflection of the fact that nearly 250,000 new patients received treatment for HCV in 2015, vs. about 170,000 in 2014, according to IMS Health data. Ledipasvir-sofosbuvir (Harvoni, Gilead) led U.S. drug sales last year, with a market share of 3.4% and triple-digit sales growth of 819.8%, Mr. Long reported.

Coverage Policies for Hepatitis p Treatment Percent, % 0

Select preferred oral agents

Exclude coverage of nonpreferred products

Follow FDA label for coverage

Require specific fibrosis score

80 100

* 68

Track viral load response

Limit treatment to responders

Require behavioral contract

66 31 25

2014

2015

*Not shown because question format was different for this item in 2014. Source: EMD Serono Specialty Digest, 12th Edition (2016)

PCSK9 policies, on the other hand, are still maturing. Only 14% of plans in the 2016 EMD Serono survey had designated a preferred agent among the two that were approved in this class at the time: alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen). In contrast, 84% of plans required a trial of a high-intensity statin before initiating PCSK9 treatment, and 75% limited the drugs to statin-intolerant patients. “The PCSK9s are the first high-cost specialty drugs indicated for long-term use in high-prevalence disease states,” Mr. Lonergan said. “We can expect with a more mature market that many more payors will designate a preferred PCSK9.” —Gina Shaw The sources reported no relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • May/June 2016

CLINICAL

PIPELINE continued from page 1

Overall, on an invoice price basis, specialty pharmaceuticals accounted for about $151 billion of the nearly $425 billion spent on prescription drugs in the United States in 2015, an increase of 21.5% over 2014, according to an April report from IMS Health. Still, although specialty medicine spending continues to grow, the rate of that growth appears to be declining from its 2014 peak, Mr. Long noted. He further predicted that 44% of pharmaceutical spending will be on specialty drugs through 2020. “We live in interesting times,” he said. “The dialogue at this meeting five years ago was around primary care blockbusters. Now we’re talking about specialty. In five years, we’ll be talking about specialty entering the primary care space.”

dence indicating a substantial improvement over existing therapies. So far, the FDA has granted 100 such designations, including drugs for HCV, cystic fibrosis and meningitis B. (Not all have yet been approved by the agency.) “This is the most innovative period in the history of the pharmaceutical marketplace because of specialty drugs,” Mr. Long said.

Products in the Pipeline Continuing to top the specialty market are drugs for inflammatory conditions,

‘We’ve barely scratched the surface in orphan drugs. This is not your father’s R&D.’ —Doug Long, BS, MBA multiple sclerosis (MS), cancer, HCV and HIV. Inflammatory conditions remain the leading specialty therapy class, with infliximab-dyyb (Inflectra, CelltrionPfizer) receiving the latest FDA approval on April 5; the drug is a biosimilar to

Janssen’s Remicade and is indicated for multiple inflammatory conditions. Dr. Tharaldson noted Inflectra could launch in early October, although litigation may delay the date. She also anticipates more see PIPELINE, page 6

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Tracking Trends Dr. Tharaldson advised keeping an eye on three specialty market trends in the years ahead: increased competition, orphan and cancer drug development and breakthrough therapies. Increased competition is already helping to fill niche markets. While there were no specialty FDA-approved targeted pharmaceuticals for idiopathic pulmonary fibrosis (IPF), hereditary angioedema (HAE) or melanoma as of 2005, for example, there are now two therapies for IPF, five for HAE and eight for melanoma. Meanwhile, orphan drugs are not so orphaned anymore. Twenty-nine percent of specialty pipeline drugs will have that indication, Dr. Tharaldson noted. Of those, about one-fourth are orphan cancer medications. This is no coincidence. “Thirty percent of orphan medicines become blockbusters,” she added. “It’s lucrative for manufacturers to develop orphan medicines.” What’s more, according to Mr. Long, the drugs require less time maneuvering through the FDA regulatory system. “We’ve barely scratched the surface in orphan drugs,” he said. “This is not your father’s R&D.” By 2020, more than 470 drugs will be available to treat some of the 7,000 conditions that each afflict fewer than 200,000 people. Approximately 25 million patients in this country have an orphan disease for which no or limited treatments are available, according to Mr. Long. While global medicine spending on orphan drugs is expected to be less than 2%, he added, it could grow to as much as 10% in developed markets such as the United States. Breakthrough therapies are also reaching the market faster. Established as a therapy designation in 2012 by the FDA, by definition they target serious or life-threatening conditions with evi-

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Specialty Pharmacy Continuum • May/June 2016

CLINICAL

PIPELINE continued from page 5

biosimilars, as well as injectable biologics and expanded indications for the class in the coming months and years. Notable products in the pipeline include a biosimilar of adalimumab (Humira, Abbvie) from Amgen and an expanded indication for ustekinumab (Stelara, Amgen) for the treatment of Crohn’s disease. Both drugs might be approved as early as September. Meanwhile, Valeant Pharmaceuticals’ brodalumab and Janssen’s guselkumab could change the psoriasis treatment landscape with approvals potentially coming in 2017. Trends for MS include new injectable biologics and drugs for progressive cases of the disease. Dr. Tharaldson highlighted a 40-mg glatiramer acetate generic of Teva’s Copaxone in development by Mylan/Sandoz/Synthon, which could be approved by the FDA in February 2017. Genentech’s ocrelizumab is expected to be approved in December 2016, a drug that targets both relapsing forms and primary progressive MS via CD20+ B cells. In oncology, Dr. Tharaldson noted that trends will include breakthrough and targeted therapies, immunotherapy development and competing oral drugs. There will likely be a host of new additions. Cancer drugs comprised one-third of drugs launched in 2015, according to Mr. Long. In the next five years, he suggested, cancer treatment will represent the largest category of the 225 new medications expected to be introduced. The FDA’s most recent specialty drug approval came on April 11 for a cancer therapy: venetoclax (Venclexta, AbbVie/Roche), a new oral treatment for chronic lymphocytic leukemia that works as a B-cell lymphoma-2 inhibitor. Among drugs next in line are rociletinib (Xegafri, Clovis Oncology), a twice-daily oral epidermal growth factor receptor inhibitor for non-small cell lung cancer (NSCLC) set for FDA approval in

‘If we do not avail ourselves of the value offered by biosimilars, we lose the most meaningful opportunity we will have in the near term to slow the rate of pharmaceutical pricing growth.’ —Steven Lucio, PharmD June, and atezolizumab (Genentech), an infusion that targets PD-L1+ urothelial carcinoma and NSCLC that could win approval in September. Mr. Long also recommended paying attention to PD-1 pathway inhibitors, not only to treat cancer but also for Alzheimer’s disease. “That could be huge,” he said. Meanwhile, the standard of care for HCV is rapidly evolving. Pangenotypic regimens and shorter treatment duration are the latest trends, Dr. Tharaldson noted. Four HCV drugs are now in the pipeline, with the next likely approval coming in June for Gilead’s sofosbuvir/velpatasvir combination. Currently, about 1 million people in the United States are living with HIV, and that population is expected to grow, Dr. Tharaldson pointed out. Trends in HIV treatment include a therapeutic vaccine and injectable therapies. All six drugs in the HIV pipeline could receive FDA approval in 2017, including Gilead’s oral integrase inhibitor, GS-9883;

Immune Response BioPharma’s vaccine, Remune; and Bristol-Myers Squibb/ViiV Healthcare’s oral attachment inhibitor, fostemsavir. Dr. Tharaldson also highlighted four drugs in development for asthma and allergy, as well as three for Duchenne muscular dystrophy, nine for non-alcoholic steatohepatitis (NASH) and three for primary immunodeficiency.

Cutting Costs With Biosimilars Given the rising prices associated with many of these drugs, experts emphasized a need to embrace biosimilars in the specialty pharmaceutical market. “We had a generic wave, now we need biosimilars,” Mr. Long said. “The market will need biosimilars to offset costs.” The less money spent on pharmaceuticals, the more money is available for other needs in the health care system, he added, noting that appropriate use of pharmaceuticals is part of that equation. A treatment-compliant patient is less prone to end up in the hospital, where

Spending on Specialty Medicines (US$ Billions)

additional dollars would be spent. Biosimilars act like competing brands, at a discount of 15% to 30%, Dr. Tharaldson pointed out. “But there are a lot of legal hurdles to get these products to market,” she said. Patent litigation will delay the availability of biosimilars as reference biologic manufacturers defend existing patents for as long as possible, she explained. Even after FDA approval, biosimilar products will not be available on the market for at least 180 days. (Court rulings stipulate that a 180-day notice of launch cannot be given until after FDA approval.) “For these drugs, it’s hard to say when they will get approved—and for those approved, when they will launch,” she added. Specialty generics represent about a $16 billion opportunity. Biosimilars may prove even more lucrative at a forecasted $43.8 billion, due in large part to 56 patent expirations through 2020, according to Dr. Tharaldson. So far, the FDA has approved two biosimilars: filgrastim-sndz (Zarxio, Sandoz) and infliximab-dyyb (Inflectra), which may be launched later this year. “Even though the introduction of biosimilars to the market has been slow, we must use the examples of the products that have been approved to educate ourselves, our fellow clinicians and patients about this new category of drugs and avoid any misperceptions that would inappropriately limit use,” said Steven Lucio, PharmD, a senior director of clinical solutions and pharmacy program development at Vizient, who did not present at the conference. “If we do not avail ourselves of the value offered by biosimilars,” he added, “we lose the most meaningful opportunity we will have in the near term to slow the rate of pharmaceutical pricing growth.” —Lynne Peeples Drs. Tharaldson and Lucio, and Mr. Long reported no relevant ﬁnancial relationships.

150.8 O Oncology

124.1 26.3

28.9 A Autoimmune 16.2

Viral hepatitis V

17.7

Multiple sclerosis M

18.8

HIV antivirals H

97.3 82 24.8 10.1 7.8

88 24.9

24.1 12.2 11.1 9.1

Other specialty O

12.2 30.2

11.9 23.5 18.3

13.1

15.2 25.6

28.1

33.1

39.1

24.1 2011

2012

2013

2014

2015

Spending on specialty medicines doubled in the past five years, contributing 70% of overall medicine spending growth between 2010 and 2015 Source: IMS Health, National Sales Perspectives, Jan. 2016

Specialty Pharmacy Continuum • May/June 2016

POLICY

USP <800> Tips Can Be Applied to Home Infusion New Orleans—The U.S. Pharmacopeial Convention (USP) General Chapter <800> provides a detailed road map for minimizing exposure to chemotherapy and other hazardous drugs in health care settings. Although it doesn’t specifically mention the home infusion setting, its requirements apply to all health care personnel who handle hazardous medications. So if home health care aides or other health care professionals go into the home, “they need to be compliant with USP <800>,” said Patricia C. Kienle, MPA, BSPharm, FASHP, the director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions, during a session at the 2016 annual meeting of the National Home Infusion Association (NHIA). That compliance covers all aspects of the home infusion delivery process, from how the drug is prepared, packaged and transported, to the use of personal protective equipment (PPE) during administration, to the proper disposal of contaminated drug paraphernalia and protective garb. It also covers the cleanup steps required after an infusion or if a disastrous spill occurs. Compliance for home care providers should begin, Ms. Kienle noted, with an awareness of the 182 antineoplastic and other drugs listed as hazardous by the National Institute for Occupational Safety and Health (NIOSH). “Those are the ones that need to follow all of the precautions in Chapter <800>,” she said. (For further information, visit www.cdc.gov/ niosh/docs/2014-138/pdfs/2014-138.pdf.) Ms. Kienle was joined in a discussion of the USP’s new standards at the NHIA meeting by Marc Stranz, PharmD, the vice president for compliance at Elwyn Pharmacy Group, a specialty drug and home infusion provider headquartered in Garnet Valley, Pa. Dr. Stranz agreed that awareness of the NIOSH list was paramount. That 2014 list has grown considerably since its first appearance in 2004, and it is expected to continue to expand as more targeted chemotherapy and specialty drugs are approved. “Not everyone understands that the NIOSH list is not just antineoplastic drugs; there are antibiotics, antivirals, anticonvulsants, hormones and fetal risk–category drugs as well,” Dr. Stranz said, adding that “chloramphenicol is on this list. It’s been around for nearly 70 years.” Newer agents such as telavancin (Vibativ, Theravance Biopharma) are also included, Dr. Stranz pointed out, adding that 60% of the drugs given at home are antibiotics. Pharmacies know, he said, that an

antiviral drug such as ganciclovir has to be compounded in a biological safety cabinet (BSC) and precautions taken, but he added that he wasn’t “sure that everyone is aware that drug is hazardous because it’s not a chemotherapy agent, and by that I

mean communicating that information to patients’ families.” For home infusion providers, hazardous drug precautions are hardly new. Hazardous drugs have long been considered a problem for home care, said Luci A. Power, MS, RPh, the senior pharmacy consultant for Power Enterprises in San Francisco. “Drugs are toxic regardless of the environment,” she said. Safe handling of hazardous drugs, she

added, has been addressed in a series of guidance documents, including the ASHP’s “Guidelines on Handling Hazardous Drugs” ((Am J Health Syst Pharm 2006;63[12]:1172-1191). Dr. Stranz noted that “conscientious” home care organizations “put these safety precautions in place a long time ago.” For more than three decades, he has served as an executive and compliance see USP <800>, page 9

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Specialty Pharmacy Continuum • May/June 2016

POLICY

ADVOCACY continued from page 1

Wayne Grau, the vice president of legislative affairs for Managed Health Care Associates Inc. (MHA), who moderated the discussion, agreed that such misconceptions are common. Home infusion providers “deliver services to patients in a very seamless manner,” Mr. Grau said. “While that’s great, it’s also invisible,” because legislators mostly only interact with retail pharmacies. Advocating with legislators at the local, state and national levels is therefore critical, he stressed. Start by targeting a legislator’s district director or health legislative aide, Mr. Grau said. Congressional and other rep-

sors in the Senate and 62 cosponsors in the House, he said. Mr. Wilson stressed the importance of patient stories in telling the home infusion story, including the impact the lack of coverage has on Medicare beneficiaries. NHIA works to gather these patient stories, which can be submitted through the association’s website.

‘Keep It Simple’ Because it’s difficult to get into all the nuances of home infusion, it’s “really critical to keep it simple,” Mr. Mastrapa said. “Walking through a patient example is the best way to bring it home to these legislative staff. They really are focused on … understanding what we do for peo-

‘Look at your advocacy efforts as an investment in your [home infusion] business and as part of a risk management strategy.’

Talking Points for Trips to Congress

he NHIA has home infusion resources such as talking points and data, forms to share your or your patients’ stories with members of Congress, and lists of which congresspeople serve on which government committees and representatives’ key staffers. For more information, see www.nhia.org/resource/legislative/index.cfm.

—Tyler Wilson resentatives have a lot going on and they frequently ask these staffers for their opinion. “They may be 23 or 24 years old, but they’re smart, they work hard and they also have the one thing we need—the ear of the congressman or congresswoman … and they need to be our advocate.” “Look at your advocacy efforts as an investment in your [home infusion] business and as part of a risk management strategy,” said Tyler Wilson, the president and CEO of the National Home Infusion Association (NHIA). NHIA is accessible to all home infusion pharmacies that join the association; the organization can follow up on local meetings with legislators by connecting with the lawmakers or their staff in Washington, Mr. Wilson noted.

ple and why it is relevant and important.” Eric Ho, PharmD, a vice president of specialty pharmacy and industry affairs for Paragon Healthcare Inc., agreed. “We are part of a very specialized and nuanced industry,” Dr. Ho said. When that story is told, he noted, it becomes a very compelling narrative that can help overcome “the ignorance and apathy of some legislators.” Logan Davis, PharmD, MBA, the director of franchise development for Vital Care Inc., which has 70 home infusion pharmacies in 23 states, said when he introduces himself as a pharmacist, the first thing a person thinks of is a retail pharmacy counter. He tries to make personal connections with legislators and staffers, and immediately shifts to the message of home infusion. “I like to say,

‘We’re ultimately the experts on [home infusion], and we do have a very compelling story to tell.” —Eric Ho, PharmD NHIA has been working in support of the Medicare Home Infusion Site of Care Act, which would provide comprehensive Medicare coverage for all facets of home infusion therapy in the Medicare fee-for-service program, similar to the practice by most private sector health insurers. The act “would allow Medicare beneficiaries to receive infusion treatments in their homes,” Mr. Wilson said. The bill was introduced in January 2015 by Sens. Johnny Isakson (R-Ga.) and Mark Warner (D-Va.), and by Reps. Eliot Engel (D-N.Y.) and Pat Tiberi (R-OH). There is now “good bipartisan support in the House and Senate,” with 24 cospon-

‘Imagine you have a loved one who needs four weeks of antibiotic therapy after being discharged from the hospital. We provide an option for IV meds in the home so they don’t have to go to a nursing home and can more quickly get back to work and family.’ That really opens their eyes. “It’s definitely something anybody can do; it doesn’t take a professional to tell our story,” he said. Bringing photos of your facility, or an elastomeric pump or other supplies to such meetings, or inviting legislators to home infusion facilities, can help demonstrate advances in care, the panelists said. “Even though we’re saying IVs, people are

‘Even though we’re saying IVs, people are envisioning someone dragging around an IV pole to the restroom or the kitchen. It’s just not reality anymore because the technology has come so far.’ —Logan Davis, PharmD envisioning someone dragging around an IV pole to the restroom or the kitchen,” Dr. Davis said. “It’s just not reality anymore because the technology has come so far and helps make home infusion so much more accessible to patients.” Some representatives have been “blown away” by visiting a home infusion pharmacy, Dr. Ho said: “To see it and have confidence that [home infusion is] a safe, effective therapy given to patients goes a long way.” Option Care is developing a video on a day in the life of a home infusion pharmacy, in part to help educate some of its own employees, Mr. Mastrapa said. It has brought a lobbyist to one branch to meet team members and hear patient stories from intake staff. “Anything we can do to help bring visibility to the patient has just tremendous impact,” he said. Lobbyists can provide access to people on the Hill, the panelists said, but they need to be managed and they’re not cheap. NHIA hired a lobbying firm to lend additional support to its efforts in advancing the Medicare Home Infusion Site of Care Act, for example, and Option Care

also has hired lobbyists to help out. Make sure to coordinate any advocacy efforts with associations like the NHIA, the panelists added. “If [legislators] sense there’s disagreement in the industry, things will freeze and not move forward,” Mr. Mastrapa said. “The more aligned we are, the more they hear from multiple providers, the more consistent the message is.” That type of consistency, he noted, “really helps move things along.” Overall, said Dr. Ho, don’t feel intimidated to call or visit legislators “because we’re ultimately the experts on this topic, and we do have a very compelling story to tell.” Don’t delegate the job to just anyone in your organization, he added: “It needs a real dedication to explain what we do and why it’s important.” Mr. Mastrapa concurred: “These folks are working for us; they like to hear from constituents. Meet with them, start a relationship, be open. We do noble work; we should be really proud of it.” —Karen Blum None of the sources reported any relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • May/June 2016

POLICY

USP <800> continued from page 7

officer for health care companies that provide specialty drugs and home infusion services. “In my 30 years of doing this,” Dr. Stranz told Specialty Pharmacy Continuum, “we’ve always very carefully communicated the need for personal protective equipment and administration techniques for chemotherapy as well as other drugs considered hazardous. “Patients receiving chemotherapy like 5-fluorouracil have always had warnings and precautions taken against exposure of the staff, the patients and patients’ family members in the home. That’s not new,” he said. What is new, he added, is Chapter <800>’s required use of closedsystem drug transfer devices during home infusions, just as they are in hospital outpatient clinics and oncologists’ infusion suites. For home health agencies and hospital-owned infusion services, compliance with USP Chapter <800> starts with preparation in the pharmacy. Ms. Kienle said pharmacies with cleanroom suites that conform to the sterile compounding requirements of USP Chapter <797> are already well on their way to meeting the Aug. 1, 2018, deadline for implementing the Chapter <800> standards. The chapter, she added, “does introduce another option that may be useful to some home care pharmacies,” and that is the use of a containmentsegregated compounding area (C-SCA) in place of a positive-pressure International Organization for Standardization (ISO) 7 anteroom opening into a negative-pressure ISO 7 buffer room containing a BSC or compounding aseptic containment isolator—all vented to the outside. A C-SCA needs to be enclosed within walls, Ms. Kienle said, but “it doesn’t have to be a cleanroom, so it is less expensive to make it compliant.” The catch, she added, is that it can only be used to compound sterile medications with a beyond-use time of 12 hours. “That means it has to be started within 12 hours, not completed,” she noted. That timing allowance, Ms. Kienle said, could be useful for home care, “for example, with 5-flourouracil, which is put in pumps that run for days.” The use of appropriate PPE is another key issue, Ms. Kienle said. “Most home health agencies have been providing that information to patients and their caregivers,” she added. “But what they may not have known is that there is a specific standard specified in USP <800> that gloves have to meet.” They have to be labeled ASTM D6978, she said, meaning they meet the American Society for Testing and Materials’ standard for chemotherapy permeation. Home cleanup is another challenge.

Studies have shown “that this stuff does not get cleaned up really well,” Ms. Power said. “Even if you’re in a controlled environment—in the pharmacy, in the hood—and all you’re doing is cleaning that piece of stainless steel, you may really not know that your effort is effective. And if you can’t be sure about cleaning a stainless steel pharmacy counter standing up, how effective will you be on a bathroom floor at home?” Ms. Power pointed out a Japanese study published last year in Oncology

Nursing Forum (2015;42[6]:665-671), showing the effects of indirect exposure of family members to cyclophosphamide following the drug’s administration to patients with breast cancer. A total of 243 urine samples were collected from family members, and cyclophosphamide was detected in the samples of five family members (17-252 ng per member). “Number one,” said Ms. Power, “we want to avoid generating that contamination as much as possible. So being aware of which activities generate the contamination, making sure that any time there

is waste, either of cleaning materials or tubing—anything that could be contaminated with chemo—that it’s well contained within double plastic bags and disposed of correctly.” —Bruce Buckley Ms. Kienle reported that she is an employee and stockholder of Cardinal Health, and that she is an elected member and vice chair of the USP Compounding Expert Committee, but her presentation was not endorsed by or afﬁliated with USP. Dr. Stranz and Ms. Power reported no relevant ﬁnancial relationships.

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Specialty Pharmacy Continuum • May/June 2016

POLICY

You’ve Got It, Now Flaunt It Having accreditation in specialty pharmacy means that the pharmacy has proven it operates at the highest level of professionalism, using verified standards, policies and procedures. A thorough, well-researched accreditation program provides external evidence of compliance with standards that are consensus-based and focused on highquality patient care delivery, according to Lynnae M. Mahaney, BSPharm, MBA, FASHP, the executive director of the Center for Pharmacy Practice Accreditation (CPPA). “Accreditation is a tool to push pharmacy practice forward,” Ms. Mahaney said.

accreditation that hold benefit for a pharmacy seeking to improve its own ability to be efficient and to operate at the highest level of professionalism.” Margherita Labson, RN, MSHSA, CPHQ, the executive director of the Home Care Program at the Joint Commission, pointed to an interesting duality inherent in becoming accredited. Even though the review process focuses on internal operations, “ideally

Using a seal of accreditation in your company’s marketing materials is one of the most powerful ways to leverage the benefits of successfully navigating the review process. Specialty pharmacy is one of the fastest-growing areas of medicine, so being accredited can distinguish you from other specialty pharmacies in your market, added Gracelyn McDermott, MBA, PMP, the vice president of accrediting and client services at URAC. “You’ve got large specialty pharmacy groups and you’ve got ‘mom and pop’ firms, so accreditation is a way of really evening out the playing field. It is a good starting point and is a manifestation of the level of quality that each of the organizations [provides].” After successfully navigating the review process, an organization should appreciate just how difficult a challenge it has met, according to J. Andrew Maddigan, MS, MBA, a marketing manager at the Accreditation Commission for Health Care. “An accreditation is an arduous and exhausting, and at the same time satisfying, process that an organization goes through. It’s more than getting the sticker on the window or a certificate to hang on the wall,” Mr. Maddigan said. “Accreditation defines a pharmacy’s commitment to quality, and there are a number of internal elements to

accreditation should serve as an external validation that [those] operations are in accordance with law and regulation—and your own expectations,” Ms. Labson explained. These standard operating procedures are critical in specialty pharmacy, according to Sandra C. Canally, RN, the president of The Compliance Team, because the specialty pharmacy cares for high-risk patients who frequently are undergoing complex treatments. That is why the high-touch clinical services that specialty offers are critical. “We believe that operational excellence leads to clinical excellence and obviously, good outcomes,” she said. So, once you’ve got it, flaunt it, the accreditors noted. Make sure all the stakeholders are aware that your pharmacy met the compliance standards that set it apart from the others. “Once you achieve that accreditation, there are a number of ways that you can make your [partners] know what you have attained,” Mr. Maddigan said. “You want to weave the message into your overall marketing strategy.” After taking up to a year to obtain the accreditation, the last thing the pharma-

cy might want to do is mark keting. Yet, it would be losing aan opportunity to increase business by not getting the word out, not only to pharmaceutical companies, thirdparty payors and pharmacy benefit managers, but also physicians and patients. Each has a stake in your pharmacy that can affectt your bottom line. “There iis no negative to marketing yo our accreditation to everyone,” Ms. Canally pointed out. The first way to marrket your accreditation status is tto use the accreditor’s seal of accreditation. All of the accreditors allow the specialty pharmacy to use the seal on their digital and printed materials, as long as they still hold the accreditation. (All accrediting agencies require pharmacies to undergo reaccreditation at regularly scheduled times. If the pharmacy decides not to seek reaccreditation, it must stop using the seal.) Send out a press release to your local newspapers and magazines, as well as business press, such as Specialty Pharmacy Continuum, the accreditors noted. If you have a printed or electronic newsletter, include an announcement when you are accredited or reaccredited, and occasionally write about a standard that helps you improve patient care or customer service. Use social media: Post your success on Facebook, Google+ and LinkedIn, and don’t forget to tweet. Tailor your message to each stakeholder. Pharmaceutical companies and the money folks are going to want to know that the pharmacy’s interventions increased adherence, reduced adverse events and hospital admissions, and that the pharmacy can provide the metrics to back up these claims, according to Ms. Mahaney. Physicians and patients want to know that the pharmacy is going to deliver good patient care and great customer service, so patient satisfaction scores will be important.

“The commitment to constant improvement is a really big factor,” Ms. Mahaney said. Talk with people. Be a source for local podcasts and radio and television broadcasts. Don’t forget your staff and their interactions with those outside the pharmacy. “You are not so much promoting accreditation as you are promoting quality,” Ms. McDermott said, so use your accreditation announcement as an opportunity to talk about what sets your pharmacy apart from another. In all these efforts, however, the experts said pharmacies cannot misrepresent the meaning of the accreditation. It is not an endorsement that one is better than another. The accreditation means the pharmacy operates to a high standard, not that the accreditor says it is the best pharmacy in the state, they said. Nor is accreditation any type of guarantee. “What you are able to present to them [your stakeholders] is, ‘my program is a credible program that has been subjected to rigorous evaluation,’” Ms. Labson said. Many of the accreditors will help pharmacies promote their accreditation, so make sure you contact them after you receive it and find out what type of promotional support they offer. There are kits, sample press releases, and other forms, and most will also send out their own announcements. —Marie Rosenthal

Next Issue: What Could Derail Your Accreditation? Our coverage of how accreditation is transforming the specialty pharmacy provider review process continues in the July/August issue of SPC. The focus will be on aspects of accreditation that most often trip up providers. If your organization had undergone an accreditation review and you’d like to share pitfalls and lessons learned, contact the editor at davidb@mcmahonmed.com.

Specialty Pharmacy Continuum • May/June 2016

POLICY

Joint Commission Adds Palliative Care Accreditation

he Joint Commission is launching the industry’s first certification for home health and hospices that provide palliative care services in a patient’s place of residence. Organizations were able to begin applying for the voluntary Community-Based Palliative Care (CBPC) certification on May 1, 2016, with on-site surveys to start on July 1. The CBPC certification option covers a three-year period. Key CBPC certification requirements include: • a robust interdisciplinary care team; • customized, comprehensive care plans; • after-hours care and services; • use of evidence-based clinical practice guidelines; and • a defined handoff communications process. p

Joint Commission–accredited home care organizations may seek CBPC certification at their upcoming resurvey or any time prior via an extension survey. Organizations not yet accredited by the Joint Commission may pursue the certification with an initial accreditation survey. During the on-site survey, home health or hospice nurses experienced in the delivery of palliative care services will evaluate an organization’s compliance with CBPC standards and requirements. Services must be available to patients 24 hours a day, seven days a week (with after-hours service availability). In addition, at least three patients must be actively receiving CBPC services at the time of the survey, and at least five total must have received palliative care services anytime in the prior 12 months. “This certification is long overdue,” Margherita Labson, RN, MSHSA, CPHQ, the executive director of the Joint Commission’s Home Care Program, told Specialty Pharmacy Continuum. “Palliative care comprises a significant amount of the care that needs to be able to be deliv-

ered in the community. Without it, people keep going back and forth to the hospital. Successfully managing serious symptoms in the home and community gives patients what they want—to be at home— and improves their quality of life. It also reduces the strain on acute care facilities, allowing them to redirect their services to patients who are acute and need them for curative services.” While most Joint Commission–

accredited specialty pharmacies are unlikely to have the service profile to pursue this accreditation themselves, Ms. Labson said it will be important to them. “Specialty pharmacy plays a key role in successful community-based palliative care services. Communitybased palliative care is for seriously ill patients who have no option for a ‘cure,’ but who can successfully manage long-term chronic care, which means

patients with neuromuscular disease, cancer, HIV and many other diseases that touch at the heart of specialty pharmacy. This is a good opportunity to start meaningfully addressing the needs of a large population of our patients.” For more information, sign up for a free interactive webinar on June 1 (http://pages. jointcommission.org/HC2016Webinars.html).

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Specialty Pharmacy Continuum • May/June 2016

OPERATIONS & MANAGEMENT

Part 2 of a Two-Part Series

Specialty Pharmacy Trends and Challenges Las Vegas—Defining fair market value (FMV) for specialty pharmacy services, managing the rising costs of specialty medications and dealing with the fragmented care that can occur as a result of limited drug distribution networks were some of the topics addressed during a wide-ranging panel discussion at the 13th Annual MHA Business Summit. Although the issues may not be new to all stakeholders, they nevertheless can be powerful determinants of success in this increasingly competitive trade channel, the panelists agreed. Burt Zweigenhaft, the president of the National Association of Specialty Pharmacy (NASP), who moderated the panel, said FMV is one of the more scrutinized and debated topics in this space. Key players, he noted, are still struggling to define FMV and determine its importance in placing a value—and price—on the many services that specialty pharmacies provide. “We build all of this infrastructure to support high-touch patient care,” Mr. Zweigenhaft said. “But nothing is free; there are significant costs associated with these programs.” So the questions he posed to the panel were this: How does one establish FMV for specialty pharmacy services? And having done so, can manufacturers and specialty pharmacies work those estimates into contracting and other strategic partnerships?

experience with what services should be considered bona fide,” Ms. DeLong said. “For many of them, however, specialty product distribution is a new concept; it’s foreign territory.” Thus, defining bona fide services in the latter setting remains a challenge, she noted. Part of that determination “will hinge on deciding what services are considered core versus enhanced,” Ms. DeLong

dispensing and purchasing.” In Ms. DeLong’s view, “we’re not there yet; there still isn’t agreement” among manufacturers and specialty pharmacy providers. That’s not to say, however, that future efforts won’t help to bring consistency, she stressed. “I think it will be a while, but certainly the industry could take a proactive view on this, and perhaps work toward a common understanding on which services are considered core or enhanced.” Tom Nusbickel, the head of U.S. Market Access, Biologics, at Hospira, now a Pfizer company, tackled FMV from a manufacturer’s perspective. There’s no doubt, the panelist noted, that “specialty pharmacy providers deliver meaningful services to patients.” However, “as manufacturers, we’re being asked to spell out very clearly why those services are necessary—why it’s not something that could be done by someone else, for

Performance-Based Contracting Weaving his own experience into the discussion, Mr. Zweigenhaft noted that performance-based contracting is becoming an increasingly more common tool for setting payments for specialty pharmacy services. “We’re starting to see manufacturer agreements with payors stating, ‘Well, if you don’t achieve the clinical or data reporting outcomes you promised, you’re not going to get full reimbursement. Or maybe we’ll ask for a refund.’” Mr. Zweigenhaft added a caveat, however: For performance-based contracting to work optimally, data aggregation and reporting need to be spot-on. “For some providers, that may be a challenge,” he said, “because we are not as transparent as an industry as we used to be.” New, smaller operators trying to break into specialty also may find data reporting to be a barrier to entry, he added.

Complex, High-Cost Care

Feds Driving Value Panel member Julie DeLong, CFA, CVA, a managing director in the valuation practice at Navigant Consulting Inc., a Chicago-based firm that works with companies to establish FMV for specialty pharmacy services, agreed that FMV may be one of the hottest topics in specialty pharmacy. That’s partly due, Ms. DeLong noted, to increased government scrutiny of arrangements between pharmaceutical manufacturers and providers. “This has put the spotlight on specialty pharmacy services [furnished] to pharmaceutical manufacturers and has increased the need for FMV analysis to support payments for these services,” she said. Ms. DeLong echoed Mr. Zweigenhaft’s point that there are currently no workable, standardized definitions for the type of services that would be considered “bona fide” in fee-for-service arrangements. (Although the term “bona fide” is defined in a federal regulation on fees paid by manufacturers known as 42 CFR 447.502, it does not provide any guidance on whether a specific service would be considered bona fide.) “Manufacturers have been in fee-for service arrangements for wholesale drug distribution for a long time and have

who feel they can really help us solve this puzzle.” Those interested can contact Mr. Zweigenhaft at burt_zweigenhaft@me.com.

explained. “Those decisions are certainly very integral to government pricing.” The problem is that not all specialty pharmacies provide the same services, whether they be clinical counseling, Risk Evaluation and Mitigation Strategy compliance, cold chain management, data track and reporting, adherence monitoring or any other component of the specialty pharmacy business model. Indeed, as many of the panelists noted, if you’ve seen one specialty pharmacy, you’ve seen one specialty pharmacy. Acknowledging those challenges, Mr. Zweigenhaft asked the panel to comment on “how we can get to a universal definition of fair market value” for specialty pharmacy, and in doing so, establish when the work component “rises above the core services we all provide in

example, potentially at a lower cost. So we have to apply a reasonable test and determine, with appropriate standards for evaluation, fair market value” in such settings, he said. Mr. Nusbickel said the debate over FMV is not going away. “These areas are under a lot of scrutiny,” he stressed. Mr. Zweigenhaft said the profession should encourage such scrutiny. “If we are willing to re-engineer the health care system for physicians so that reimbursement is not based on how much care is provided, but instead on the quality and value of that care, then we need to do that for specialty pharmacy as well. It’s time to get serious about this, and NASP is on it.” To that end, NASP has convened a task force to define FMV, he noted. “We are looking for bright minds and folks

One key area of performance for specialty pharmacy providers is to achieve high rates of medication adherence, Mr. Zweigenhaft noted—a point echoed by panelist member Dino Martino, RPh, the executive director and general manager of PerformSpecialty, an accredited provider based in Orlando, Fla. And that’s understandable, Mr. Martino said, given the high cost of specialty medications. He noted that one of the first spotlights on cost was shone on sofosbuvir (Sovaldi, Gilead), which was approved in 2013 for the treatment of chronic hepatitis C. The drug launched with the thenhefty price tag of about $84,000, but because it is potentially curative, sofosbuvir typically results in a one-time cost to the health system for a given patient, he noted. That’s in stark contrast to other, more recently approved specialty pharmacy drugs, such as those for hemophilia, cystic fibrosis and other chronic, complex diseases. For those disorders, treatment can cost hundreds of thousands of dollars per year—essentially for the lifetime of the patient. Given such cost pressures, Mr. Martino noted, it’s not surprising that manufacturers want proof from providers that patients are actually taking their medications. But beyond that, they also want to know that providers can ensure that the efficacy for specialty drugs cited in clinical trials “is actually being replicated in real-world clinical settings,” he said.

Specialty Pharmacy Continuum • May/June 2016

OPERATIONS & MANAGEMENT

In those trials, “you remove all of the variables we know can get in the way of achieving the best results,” he said. “That’s where we step in as providers; we help patients manage their complex diseases and treatments. That’s why specialty pharmacy as an industry still exists and will continue to exist—as long as we keep the patient foremost in our business models.”

‘If we are willing to re-engineer the health care system for physicians so that reimbursement is not based on how much care is provided, but instead on the quality and value of that care, then we need to do that for specialty pharmacy as well.’ —Burt Zweigenhaft

Debating Limited Distribution Audience members were invited to ask questions of the panel, and several focused on the burdens that can result when specialty drugs are placed in limited distribution networks. One long-term care (LTC) provider said “it is terrible” that operators in the LTC space often don’t have access to such networks. She cited fragmentation of care as one key downside. “These are extremely fragile patients we’re talking about,” she said, and it’s hard enough to manage their polypharmacy without having to add a different pharmacy provider into the care equation. Given those concerns, she asked, “is it possible that we might see some special dispensation going forth, to allow LTCs greater access to some of these limited

distribution drugs?” Several panel members cited the need for LTC providers to be accredited as a baseline condition of participation for joining a limited distribution network. Panelist Heather Bonome, PharmD, the director of pharmacy at URAC, one of the nation’s top pharmacy accreditors, stressed, however, that if an LTC entity decides to pursue specialty pharmacy accreditation as means of network entry, “that’s not a long-term care-focused review process; we’ll be looking at your overall ability to deliver specialty pharmacy services.” LTCs thus need to have a broad understanding of how their capabilities will be assessed, she stressed. Mr. Martino said he understands

from first-hand experience the frustrations providers feel when they are closed out of specialty drug networks. “It’s difficult when we know that we’re supplying the same—and sometimes even better—service than the bigger providers, and yet we aren’t granted access,” he said. In such scenarios, “you have to be ready to battle, to set yourselves apart, to be included.” Mr. Martino acknowledged, however, that limited distribution networks are limited for a reason. “Every time a manufacturer gives a provider access to their specialty product—particularly drugs that are highly complex, that have a high degree of sensitivity around their use and that require considerable clinical oversight—that’s

another provider they need to monitor for multiple levels of compliance.”

Get Involved Mr. Zweigenhaft said he recognizes there are no easy answers to solving the complex practice issues tackled by the stakeholder panel. But one thing is very clear, he noted: with the specialty drug spend continuing to rise at a recordsetting pace, and the pipeline for new specialty medications ever-widening, “we need to keep this debate going—and that’s a great opportunity for alll stakeholders to get involved and shape the future direction of our industry.” —David Bronstein

What’s Your View? The MHA panel tackled d several challenging issues facing specialty pharmacy. What’s your take on these issues? Send your comments to davidb@mcmahonmed.com med com for possible inclusion in a follow-up article or comments section in future issues.

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Specialty Pharmacy Continuum • May/June 2016

CLINICAL

The Shifting Cost of New Hemophilia Factors Las Vegas—It’s an exciting new world of prolonged half-life factor medication for people with hemophilia. However, specialty pharmacies face unprecedented challenges in helping their patients understand all the available options, and in assisting them with getting payors to pay for the medications, said Dan Dalton, MS, RPh, the pharmacy program manager for the Hemophilia Treatment Center Pharmacy at the University of North Carolina at Chapel Hill, at the 2016 Asembia Specialty Pharmacy Summit. “We have as many new drugs arriving within the last two years as we’ve seen in the past several decades,” Mr. Dalton noted in a separate interview with Specialty Pharmacy Continuum. For example: • Octapharma’s Nuwiq, the first fourthgeneration recombinant factor VIII produced in a human cell line without pegylation or protein fusion (which may reduce the development of inhibitors), hit the U.S. market for hemophilia A on May 1. • CSL Behring’s Idelvion is a novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B. The first such product to offer up to 14-day dosing, it was approved by the FDA in early March. • Alprolix (hemophilia A) and Eloctate (hemophilia B), both from Biogen and approved in spring 2014, were the first long-acting recombinant factor concentrates in their respective types of hemophilia. “But within the same time period, I’ve seen [our] patients go from good insurance coverage under their major medical plans, with low out-of-pocket deductibles or relatively minimal costs of $2,000 to $3,000 for the year, to 25% to 50% coinsurance as they were transitioned under pharmacy benefits at the beginning of 2016,” Mr. Dalton observed. He recalled a patient who had been put on one of the new prolonged halflife drugs in 2015. “It was being paid for appropriately, at rates that were allowable, all last year. In January, the patient suddenly had one copay exceeding $43,000 due to a 50% coinsurance under his pharmacy benefit. Thanks to collaborative efforts of the manufacturer and our pharmacy, we were able to offset some of his coinsurance through financial hardship waivers and get them compassionate product from the manufacturer for the remainder of this year, to await open enrollment for insurance. But the challenge for this family is to find appropriate insurance for next year.”

to $0.09, while the PMPM for rFVIIa prophylaxis ranges from $0.46 to $0.81, depending on the dose,” he said. “But this model only included costs associated with the bypassing agents, and not other direct and indirect costs of bleeding. Prophylaxis may result in a 69.5% reduction in new target joint bleeding formation, but this study was not powered to include that in their analysis.” Indeed, a 2011 modeling approach

robust pharmacy component.” Adherence can be particularly challenging in hemophilia for a number of reasons, Dr. Rich said. “We are typically talking about a younger age range of patient, with what can be a lifelong treatment. Fluctuation or disappearance of symptoms, forgetfulness and convenience issues and lack of time for treatment all have a big impact on adherence.” Beyond adherence, specialty pharma-

Patients with hemophilia are prone to joint bleeds (hemathrosis). A normal knee is shown far left; a knee with hemathrosis is shown right.

This situation is not unusual. “Most manufacturers of factor products offer up to $12,000 per year in copay assistance, but a case like this can exhaust it in a single order,” Mr. Dalton said. Payors may be thinking that the cost of treating a bleed is less than the cost of preventing one, and on the surface, it appears that they’re right, noted Mr. Dalton’s co-presenter, Sheldon Rich, RPh, PhD, the president of the Floridabased health care consulting firm SJR Associates. Dr. Rich pointed to a recent study in Journal of Managed Care & Specialty Pharmacy, which found that costs of prophylaxis with activated prothrombin complex (aPCC) for hemophilia patients with inhibitors were significantly lower than the costs of the recombinant factor VIIa (rFVIIa) on-demand dose of 786 mcg/kg per bleed, saving $573 per kilogram for each episode avoided. But prophylaxis with rFVIIa, on the other hand, cost $1,724 per kilogram for each bleeding episode avoided—an annual cost that was 78.4% higher than the on-demand dose of 695 mg/kg per bleed. “The estimated PMPM [per member per month] of adopting an aPCC prophylaxis regimen ranges from –$0.25

found that lifetime on-demand treatment would result in an average of 1,494 joint bleeds and consumption of 4.9 million IU of factor VIII concentrate, while lifetime intermediate-dose prophylaxis resulted in much higher factor consumption (8.3 million IU) but dramatically reduced joint bleeds—a mean of just 357. The direct and indirect costs of bleeding episodes can be extensive, Mr. Dalton noted, including hospitalizations and emergency department visits on the direct side, and rehabilitation and occupational therapy, home health care, and costs of treatment for side effects and adverse events on the indirect side. “Proper treatment of hemophilia is expensive, but the long-term economic impact of poorly managed hemophilia is even greater,” he said.

A Move Toward Specialty Payors and pharmacy benefit managers (PBMs) are increasingly moving hemophilia products to the pharmacy benefit, making specialty pharmacists much more important to the process. “In most hemophilia treatment centers, until recently the model was most commonly physician dispensing, without necessarily having a specialty pharmacist involved,” Mr. Dalton said. “With more and more PBMs converting hemophilia out of [the medical benefit] and into pharmacy, programs that dispense factor are realizing the value of having a

cies also can play an important role in helping their patients with hemophilia avoid or minimize the use of medications that can increase bleeding risk— not just anticoagulants but nonsteroidal anti-inflammatory drugs and anticoagulants. “Even things like stool softeners should be used with caution,” Dr. Rich advised. “Your patients should also be careful of things like automatic blood pressure cuffs, which can cause bleeding if they get too tight.” These issues may seem obvious to the specialty pharmacist who manages hemophilia regularly, but Mr. Dalton described what can happen when the ball gets dropped: the case of a 40-yearold patient with mild hemophilia A who underwent cardiac surgery at a community hospital. “Two weeks later, his chest incision continued to bleed heavily despite daily factor VIII infusions,” he said. The patient had developed an inhibitor; this is relatively rare among mild hemophilia A patients, occurring in only 5% to 10% of this population ( (Blood 2014;124[15]:2333-2336), and the treating physician had not considered the possibility. “The patient was transferred to a hemophilia treatment center,” Mr. Dalton said, “but despite aggressive treatment, he died 24 hours later.” —Gina Shaw Dr. Rich and Mr. Dalton reported no relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • May/June 2016

CLINICAL

Home Infusions of Infliximab May Be a Safe Option New Orleans—On the package insert for infliximab (Remicade, Janssen Biotech), you will find warnings of potential adverse effects including anaphylaxis. What you won’t find, however, are details regarding where the immunosuppressant should be administered. “Sometimes pharmacists think that [the prescribing information mandates] that a patient has to be in the hospital or a hospital-based infusion center to

In their retrospective study, Dr. Curry and her colleagues looked back at 1,866 infusions of infliximab—1,441 administered at home and 410 at

ambulatory treatment sites—for 291 Option Care patients between May 1, 2012, and May 31, 2014. A nurse stayed with patients throughout every infusion, monitoring vital signs and looking out for any signs or symptoms of an adverse drug event (ADE). None of the infusions resulted in a severe ADE and only 13 (0.7%) were associated with a fever, hives or other moderate ADE. Accounting for the

majority of the 4.2% overall ADE rate were 65 (3.48%) mild reactions, including nausea and headaches. Infliximab infusions have been administered in the home care setting for more than 15 years, yet the practice continues to be a topic of debate. The new findings, according to Dr. Curry, bolster the case for its safety. Her team’s data proved consistent with see INFLIXIMAB, page 17

Joint Commission Accreditation Helping specialty pharmacies demonstrate performance excellence

‘We wanted to make sure that infliximab in the home care setting would be safe for patients. Our data suggest that it is.’ —Kendra Curry, PharmD receive infliximab therapy,” said Kendra Curry, PharmD, the corporate director of Option Care specialty infusion programs. But that may not always be the case for patients needing the infusion for autoimmune disorders such as Crohn’s disease and rheumatoid arthritis, Dr. Curry noted. When given under the right conditions—with a properly trained staff and anaphylaxis protocols in place—home infusions of infliximab may be a safe, efficient and welcome option, according to research presented by Dr. Curry and her team at the 2016 National Home Infusion Association Annual Conference & Exposition. “As we’re seeing health care change, payors and providers are looking for more cost-effective, convenient care for patients,” Dr. Curry said. “We wanted to make sure that infliximab in the home care setting would be safe for patients. Our data suggest that it is.”

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Visit pages.jointcommission.org/SPinfo for more information on accreditation for specialty pharmacy providers. Or call us, we’d like to help you reach your quality goals. 630-792-5070

Specialty Pharmacy Continuum • May/June 2016

CLINICAL

ISMP Report Links Psoriasis Rx and Cancer Some biological products used to treat psoriasis may be associated with an increased risk for skin cancer and other malignancies, according to a recent report from the Institute for Safe Medication Practices (ISMP) publication, QuarterWatch. Although no definitive causal link is claimed, experts are urging increased vigilance for the cancer signal in patients taking certain psoriasis medications—a billion-dollar therapeutic category for specialty pharmacy, according to the latest industry figures from IMS Health. Analyzing 38,952 drug-related adverse events submitted to the FDA Adverse Event Reporting System about psoriasis medications from September 2014 to September 2015, the ISMP found 1,315 cases (3.4%) indicating a malignant or benign tumor. Skin cancer excluding melanoma were reported most often (254 cases), followed by breast (68 cases) and prostate cancer (51 cases). The review was published in the April 6 issue of QuarterWatch, which monitors all adverse drug event reports submitted to the FDA. Grouping the psoriasis drugs by mechanism of action, the investigators found the interleukin-12/23 inhibitor ustekinumab (Stelara, Janssen) had the strongest association with cancer. There were 296 cancer cases reported in relation to the drug, and the odds of cancer being reported when taking the drug were 15 times higher than with apremilast (Otezla, Celgene), a phosphodiesterase 4 inhibitor with no known immunosuppressive properties that was used as a reference drug. A strong association with cancer also was observed for biological products that block the tumor necrosis factor (antiTNF medications), including etanercept (Enbrel, Amgen), infliximab (Remicade, Janssen), adalimumab (Humira, AbbVie), certolizumab (Cimzia, UCB) and golimumab (Simponi, Janssen). There were a combined 882 cases of cancer reported in relation to these medications, and the odds of cancer being reported when taking an anti-TNF drug were five times higher than with apremilast. There was no correlation between the interleukin-17a inhibitor secukinumab (Cosentyx, Novartis) and cancer; but there were too few cases overall for this drug to draw a conclusive evaluation, the authors said. “This report is a wake-up call about what a poor job we are doing monitoring and how little we know about the cancer risks of these potent immunosuppressant drugs that are being increasingly used for an ever-wider group of medical disorders,” said Thomas J. Moore, QuarterWatch project director and senior scientist, drug safety and policy at ISMP, in

Horsham, Pa. “We have reason to believe there may be a substantial risk, but poor tools for understanding how big a risk is being taken and who’s vulnerable.” While the report doesn’t necessarily prove these drugs were the cause of the cancers observed, the findings are still significant “because once you get into hundreds and hundreds of cases, it seems unlikely that all the people were wrong about the link,” Mr. Moore said. “This is more than theoretical risk,” and clinicians should keep in mind the “substantial differences” seen among the drugs, he said. Looking back at preapproval data for ustekinumab, the ISMP authors noted that animal model studies suggested a cancer risk. Mice engineered to lack interleukin-12 or 23, for example, developed larger skin cancers more rapidly when exposed to ultraviolet (UV) radiation than normal mice.

Janssen Responds Janssen disagreed with the QuarterWatch findings, both to ISMP and to Specialty Pharmacy Continuum. A company-funded review of more than 12,000 patients enrolled in the Psoriasis Longitudinal Assessment and Registry (PSOLAR) identified no increased risk for malignancy, major adverse cardiovascular events, serious infections or mortality from ustekinumab (J ( Drugs Dermatol July 2015;14[7]:706-714). This report identified 60 malignancies in 4,364 patients taking the drug, for a rate of 0.48 per 100 patient-years. “The risk of cancer from the QuarterWatch report is notably inconsistent with the collective body of evidence derived from long-term clinical trial data, observational registry safety data and spontaneous post-marketing reporting information available to date,” said Megan Farina, a company spokeswoman. “In contrast to the QuarterWatch findings, these data do not show an increased risk for malignancy relative to other treatments for psoriasis.” Janssen performs a similar type of analysis of data in the FDA adverse event database and World Health Organization Vigibase on a quarterly basis and monthly within the company safety database to identify potential safety signals, Ms. Farina said: “A detailed evaluation is performed of all events where a potential association is identified. To date, these analyses have not yielded evidence to validate any malignancy signals for Stelara.”

Although such data may weaken the link between psoriasis drug therapy and cancer, the disease itself does carry an elevated risk for malignancy, according to a study by British investigators. The study included 198,366 patients with psoriasis who were prescribed ustekinumab, psoralen, methotrexate, cyclosporine, acitretin, adalimumab, etanercept, infliximab or phototherapy ((JAMA Dermatol 2016;152[3]:282290). The patients had no medical history of HIV, cancer, organ transplants or hereditary disease. An association between psoriasis and cancer, “albeit small,” was seen in the study, the investigators reported, with adjusted hazard ratios for any incident cancer excluding nonmelanoma skin cancer ranging from 1.06 (95% CI, 1.02-1.09) to 1.62 (95% CI,

neous cancers, he added. Moreover, TNF inhibitors frequently are used in combination with other drugs such as cyclophosphamide, which together can increase the risk for malignancies in these patients. Patients with a history of premalignant skin cancer, such as actinic keratosis, or those who had a basal cell or squamous cell carcinoma should not be prescribed these medications, Dr. Hulisz said, nor should anyone with a personal or family history of cancer or tuberculosis. Additionally, patients who take the drugs should be counseled to use sunscreen, have annual skin cancer screenings and watch for any new suspicious lesions or changes in existing moles. Patients taking biological drugs should also be screened for colon, breast and

Healthy Skin

Psoriasis scales

keratin layer epidermis

plaques inflamed skin

sweat gland hair follicle dermis subcutaneous layer

1.16-2.28), depending on disease severity and cancer type. (No drug-specific breakdowns were provided.)

Informed Patients Despite the divergent data, patients still need to be informed of the risks and benefits associated with psoriasis medications, stressed Darrell Hulisz, RPh, PharmD, a clinical pharmacy specialist with University Hospitals, Case Medical Center, in Cleveland. “On the hospital side [the association between psoriasis drugs and cancer] is pretty well known, especially if you’re on a P&T committee,” Dr. Hulisz said. He noted, however, that the ISMP report, while important, has to be “taken with a grain of salt,” because “it’s not a scientific study per se.” Determining causality for cancer in this population is difficult, he pointed out, because “a lot of people with psoriasis are already predisposed to developing skin cancer more often than [the] general population.” Many people with psoriasis also get ultraviolet radiation treatments, which can increase the risk for cuta-

other cancers if they are at the recommended ages for those screenings, said Cindy O’Bryant, PharmD, an associate professor at the University of Colorado Skaggs School of Pharmacy, in Aurora. “This phenomenon is not new,” she said, noting the increased association with cancer seen with organ transplant recipients taking immunosuppressants. “But these medications provide a new way of suppressing the immune system that is reaching many more patients with a variety of diseases. You don’t have to have cancer or an organ transplant any more to be immunosuppressed.” Because of emerging data like this, it’s important that providers be judicious in prescribing these medications, Dr. O’Bryant said. Efforts should be made to dissect out which patients are at risk for developing cancers to create guidelines that will determine who are the best candidates for them, she noted. —Karen Blum The sources reported no relevant ﬁnancial relationships.

Specialty Pharmacy Continuum • May/June 2016

CLINICAL

INFLIXIMAB continued from page 15

the range of ADE rates—2.5% to 5.6%— reported in previously published studies of infliximab infusion for patients treated in alternative sites of care, including the home (Can J Gastroenterol 2010;24[5]:307-311). Ellen Scherl, MD, the director of the Jill Roberts Center for Inflammatory Bowel Disease at NewYork-Presbyterian and Weill Cornell Medicine, in New York City, suggested that further

research is still warranted—specifically, studies investigating the risk–benefit and cost–benefit ratios for home and ambulatory site infusions. “When a patient has an anaphylactic reaction—to any IV biologic—it needs to be managed quickly and safely,” Dr. Scherl said. “Home infusion companies must ensure patient safety and manage infusions with a nurse on-site, appropriate oxygen and IV medications when indicated.” Still, she suggested that ambulatory care centers may be a more cost-effective

option than home care for such infusions. “We need to look at this from an economic viewpoint,” added Dr. Scherl. “What is the cost of having one nurse to one patient during home infusions? Is that going to be financially beneficial?” Dr. Curry, too, noted that home or ambulatory site infusions are not for everyone. “Patient selection is key,” she said. “There may be patients who are more comfortable in certain sites of care or would prefer a physician on hand. Maybe they’ve had reactions in the past.

Every patient is different and their needs may be different.” The same goes for injections beyond infliximab. “Labeling restrictions don’t necessarily have to restrict the site of care,” she added. “But each therapy needs to be looked at individually and patients selected on a case-by-case basis to identify the best site of care.” —Lynne Peeples Drs. Curry and Scherl reported no relevant ﬁnancial relationships.

NEW PRODUCT Innovatix Launches Accreditation Advisory Services

nnovatix, LLC, the nation’s leading non-acute care supply chain solutions company and group purchasing organization, has launched a new consulting service designed to support pharmacies in achieving recognition from various accrediting bodies. Named Innovatix Accreditation Advisory Services, the new fee-for-service program will leverage the company’s broad industry expertise to help improve the efficiency of this often complex, timeconsuming process. Innovatix Accreditation Advisory Services offers pharmacies three levels of support to best meet each client’s needs and available resources: • In a Level 1 engagement, Innovatix reviews the pharmacy’s standards and processes against accreditation measures, then helps refine the application prior to submission to the accrediting body. • A Level 2 engagement is more hands-on, with Innovatix experts helping to create the required standards and processes through a series of weekly calls and monthly on-site meetings. • Level 3 offers the most comprehensive support through a full-time consultant who prepares the pharmacy’s accreditation submission from start to finish. According to the press release, the program has proved to be a success for participants, generating new and positive experiences for members, such as Miller Drug, a family-owned, independent pharmacy in business since 1957 that recently expanded into the specialty market and wanted to achieve accreditation. “Innovatix has been a pivotal component in our accreditation journey,” said Vincent Mainella, the chief operating officer of Miller Drug. “Without their guidance, this process would have been daunting, time-intensive and difficult to complete ahead of the ninemonth time frame.” Pharmacies interested in learning more about Innovatix Accreditation Advisory Services should visit www.innovatix.com/IAAS.

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Specialty Pharmacy Continuum • May/June 2016

CLINICAL

COST OF CURE continued from page 1

Care Pharmacy’s AMCP 2016 meeting in April, stories like his are becoming increasingly common. In fact, Joan Lunden, the former co-host of ABC’s “Good Morning America,” opened the meeting with her story of beating breast cancer with the help of specialty drugs. “Specialty pharmaceuticals have completely changed the landscape of medicine over the last few years,” Mr. Avey said. “They will prolong life, save lives and improve the quality of life for people who have rare, debilitating diseases.” And the medicines will be costly. Although specialty drugs represent a tiny percentage of the total number of paid prescriptions—around 1% to 2%—they make up a growing proportion of the cost, Mr. Avey explained. Some experts anticipate specialty drugs will account for half of all pharmaceutical spending within a few years. “We’re going to see that more and more pharmaceutical products are going to cost $300,000 per year for small patient populations,” said Jeff Henderson, a vice president of managed markets for Intarcia Therapeutics, with headquarters in Boston, and another session speaker. In fact, the cost for a course of cancer treatment already hovers around $175,000. “Drugs are better, like we’ve never seen them before,” added Steve Miller, MD, a senior vice president and chief medical officer for Express Scripts, headquartered in St. Louis, and who also spoke at the session. “The trouble is, the price is like we’ve never seen before, too. This is truly not a sustainable situation. We not only need to find room in the bucket to pay for these drugs, but also to take care of patients.”

‘A Holistic Approach’ To that end, Dr. Miller suggested that specialty pharmacy must take a “holistic approach” to cutting costs and caring for patients. That may include figuring out how to better use data, and how to better predict which patients need which products. “We need to take bold actions,” he said. “We’re all going to have to be innovative.” He pointed to one example where such efforts might make a difference. Erlotinib (Tarceva, Genentech) is an FDA-approved treatment for non-small cell lung cancer. The drug’s efficacy is well documented, adding an average of more than five additional months of life. Tarceva also is approved for advanced-stage pancreatic cancer. Although the survival advantage for this indication is statistically significant, it amounts to an average of 12 additional days of life. But, as Dr. Miller noted, the cost of the drug for a lung cancer patient and pancreatic cancer patient is the same. Should patients who have dif-

Steven G. Avey, vice president of the specialty clinical team with MedImpact Healthcare Systems and a cancer survivor, speaks during an AMCP session on the cost of cancer care.

ferent diseases always bear the same cost for treatment? “Perhaps reimbursement should examine how a drug is used,” he said, suggesting this might be an opportunity to start looking at how to reimburse pharmaceutical companies differently based on disparate indications. Alan Lotvin, MD, the executive vice president of specialty pharmacy for CVS Health, in Woonsocket, R.I., agreed. The consideration of different costs for drugs when their effectiveness differs is an area of active investigation, according to Dr. Lotvin, who also participated in the session and underscored his own concerns regarding unsustainable trends in drug costs. “It seems that with every

new innovation, there’s another zero to the left of the decimal point,” he said. He noted two ways by which CVS Health is using the concept of value to better align drug costs and outcomes. The first is based on the fact that many specialty drugs have multiple indications and contracting according to condition rather than by drug molecule. In the examples of etanercept (Enbrel, Amgen) and adalimumab (Humira, AbbVie), both drugs have multiple indications, including varying forms of rheumatoid arthritis (RA), psoriasis and other immune-mediated skin disorders. (The indications do not entirely overlap.) In treating RA, 13 drugs including these two compete. However, only four drugs (including adalimumab)

‘It seems that with every new [specialty drug] iinnovation, in nova no vati va tion ti on,, there’s on ther th ere’ er e s another anot an othe ot herr zero he zero to to the the left l ft of le of the the decimal deci de cima ci mall point p in po intt [for [[ffor cost].’ cos o t]].’’ —Alan —Ala —A la an Lotvin, Lotv Lo ttv vin i , MD M

vie in Crohn’s disease. The more competition there is, the more power on the payor’s side of the negotiation, Dr. Lotvin explained. “This can be done within the current drug payment systems,” he said, “and we are incorporating these concepts into our formularies.” The second approach, according to Dr. Lotvin, is better alignment of incentives between physicians and payors. Tremendous variation exists among oncologists in costs of treating breast cancer, with prices ranging from a high of $300,000 down to $20,000 per episode. “When we investigated this variability, we found five potentially modifiable cost factors: regimen selection, use of generics, use of supportive agents, site of care and duration of therapy,” Dr. Lotvin said. “When there are equally effective drugs, the physicians often have financial incentives to use the more expensive agents.” But by changing how doctors are reimbursed, making the profitability of all drugs in a category the same, it may be possible to eliminate the unintended consequences of the current pricing structures, he suggested. CVS Health will be piloting such an approach with clients this year.

Putting Patients First Guaranteeing the proper use of these high-priced drugs can also go a long way in optimizing (and proving) a medication’s worth, experts said. “How do we ensure that a patient truly understands what the medicine is for, how it works and how to take it? And how do we ensure they stay adherent to the regimen?” Mr. Avey said. “Then how do we assess the effectiveness in terms of improving or maintaining their health status? These are challenges we grapple with every day.” Simply measuring adherence is a challenge, according to Mr. Henderson. Rates recorded in a clinical trial, for example, can be very different from the real world after a product is approved and on the market. The high cost itself is another critical variable and a common barrier to access for many patients. A pharmacist’s expertise can assist with these and other challenges. “As we heard from Joan Lunden, and from surveys, the No. 1 frustration of patients is their ability to get answers from their health insurer,” Mr. Henderson said, noting that specialty pharmacies can assist patients as they work through the process with their health insurer. “Patients become friends with their case managers. They are in a position to help the patient work through obstacles, and provide them education and counseling.” Dr. Miller shared another example of where keeping the patient central to decision making optimizes value for everyone. In December 2013, the FDA approved sofosbuvir (Sovaldi, Gilead Sci-

Specialty Pharmacy Continuum â&#x20AC;˘ May/June 2016

CLINICAL

ences), a breakthrough treatment to cure hepatitis C virus (HCV), a disease that affects an estimated 3.2 million Americans. But the manufacturer set the price for the medication at $1,000 per tablet in the U.S.â&#x20AC;&#x201D;totaling $84,000 per regimenâ&#x20AC;&#x201D; even though the manufacturer that originally developed the drug (and later sold it to Gilead) had planned to sell the product on the U.S. market for less than half as much. Meanwhile, Gilead charged $50,000 in Western Europe and as little as $900 in India for the same drug. (An analysis by the independent nonprofit Institute for Clinical and Economic Review [ICER] determined that a price for ledipasvir and sofosbuvir [Harvoni, Gileadâ&#x20AC;&#x2122;s second-generation HCV drug] ranged between $34,000 and $42,000 per regimen would deliver an appropriate amount of value and enable the treatment of all known HCV-infected patients in the United States.)

$23,000 a year to treat compensated cirrhosis, $60,000 a year to treat end-stage liver disease, $112,000 a year to treat hepatocellular carcinoma and $450,000 for a liver transplant.â&#x20AC;? Still, Dr. Miller became worried, even angry, about what he felt was an unfairly high price for HCV treatmentâ&#x20AC;&#x201D;a price tag that he suggested had led many payors to only cover treatment for their sickest patients. He decided that Express Scripts would contract for the drug at the launch price. Then in December 2014, the FDA approved another new HCV

medication, the combination drug ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets (Viekira Pak, AbbVie), which appeared to be at least clinically equivalent to Sovaldi as well as Harvoni, Gileadâ&#x20AC;&#x2122;s $94,000 successor. Express Scripts proceeded to negotiate a deal with AbbVie to significantly discount its Viekira Pak for their clients, making it affordable to â&#x20AC;&#x153;treat all patients, not just the sickest,â&#x20AC;? Dr. Miller noted. After this deal, other payors began to follow suit and negotiated arrangements with both AbbVie and Gilead. The price

of both therapies dropped. â&#x20AC;&#x153;Because of our initial action,â&#x20AC;? he said, â&#x20AC;&#x153;these follow-up negotiations will ultimately lower the national spend on hepatitis C drugs by more than $4 billion annually. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s your responsibility to do what Joan is looking for,â&#x20AC;? Dr. Miller told meeting attendees, â&#x20AC;&#x153;to take great care of these patients and help them afford the drugs.â&#x20AC;? â&#x20AC;&#x201D;Lynne Peeples Drs. Avey, Henderson, Miller and Lotvin reported no relevant ďŹ nancial relationships.

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Septem mber 26-28, 2016 Omni Shoreham Hotel Washin ngton, DC Whatâ&#x20AC;&#x2122;s more, he explained, because Sovaldi needs to be taken with other medications, the total treatment price actually approached $150,000, posing a threat to not only the wallet of patients, but also to the bottom lines of American health care payors, including employers. In a statement to Specialty Pharmacy Continuum, Gilead said it had â&#x20AC;&#x153;responsibly and thoughtfully priced Sovaldi and Harvoni,â&#x20AC;? and that the products were â&#x20AC;&#x153;initially priced in line with the previous standards of care.â&#x20AC;? In many cases, the company added, their drug was â&#x20AC;&#x153;less than previous standards of care at the time of approval, even though these products represented a significant improvement over the prior standard of care in terms of efficacy, safety, duration and tolerability.â&#x20AC;? The company added that â&#x20AC;&#x153;unlike treatment for other chronic diseases, Sovaldi and Harvoni offer a cure â&#x20AC;Ś at prices that significantly reduce HCV treatment costs and deliver significant savings to the health care system over the long term. The one-time cost of Harvoni or Sovaldi pales in comparison to the lifetime costs associated with treating HCV including

Specialty Pharmacy Continuum • May/June 2016

TECHNOLOGY

e-Tool Offers Speciﬁc Help for Generic Buying Until recently, it wasn’t unusual for McKesson Corp.’s independent long-term pharmacy customers to approach the company for help purchasing appropriate generics for their patients. “We heard a lot of questions about ‘Can you help me be more efficient and effective in purchasing generics? Can you get me a higher reimbursement or a lower cost?” said Rich McKeon, MBA, the vice president for McKesson Alternate Site Pharmacy. “What we realized quickly was there wasn’t really a standard way that our independent, long-term care pharmacies had to build a formulary or a preferred drug list.” Enter PATH Pro, McKesson’s new Post-Acute Therapeutics Formulary Management Program. The program, which is free for subscribers of McKesson Connect, the company’s online ordering system, contains information from Creighton University’s Center for Drug Information and Evidence-Based Practice about more than 250 generic drugs across over 20 therapeutic class-

es. PATH Pro, which can be accessed directly from the ordering platform, indicates which of the generics are considered preferred and nonpreferred for geriatric patients. For every generic drug reviewed, there are individual drug monographs with references to support the preferred or nonpreferred designation. The program also allows for financial analysis, featuring information about the drugs’ Maximum Allowable Cost, Average Wholesale Price and Wholesale Acquisition Cost. “The idea is it helps give a clinically vetted list pharmacists can use to talk to nursing homes, and ideally reduce adverse events and complications,” Mr. McKeon said. The program will be updated quarterly and monographs will be revised as needed, he said.

“Many pharmacies have a formulary they’ve already developed but maybe they don’t invest in keeping it up-to-

to see what was already on the market, what others were doing, and then go and select the drugs,” said James R.

‘[PATH Pro] definitely sounds interesting. It looks like they are doing something to help ... long-term care pharmacies get a competitive advantage in the market.’ —Joseph Marek, RPh date, or maybe it isn’t as comprehensive as they’d hoped,” he added. “We’re able to free up some of their time and some of their dollars from investing in that.”

Successful Beta Launch The program is working well for a pharmacy service in Tennessee that first beta tested the product and has had it installed since November 2015. “To research therapeutic substitutions before, we’d have to spend some time

Dunham, RPh, MBA, the senior vice president of Americare Pharmacy Services and Pegasus Express Pharmacy, in Cookeville, Tenn. “Now we can go right from Connect to this program and say really, for this facility, we want to select this line of generic interchanges. ... It’s very much a turnkey product.” Mr. Dunham’s staff of four full-time and four part-time pharmacists process more than 50,000 prescriptions a month for 136 long-term care facilities. Pharmacies are

Avella Launches New Oncology, Hep C Apps Avella Specialty Pharmacy recently launched two new mobile apps designed to help clinicians select the most appropriate specialty drug options for hepatitis C (HCV) and oncology patients, apps the company said were the first of their kind in the specialty pharmacy industry. The HCV app encompasses all current therapies for the disease. Providers begin the treatment selection process by choosing the patient’s genotype, and then entering the patient’s treatment experience and other considerations. The resulting screen suggests medication, dose, duration, virologic response rate and clinical study data. The app also provides access to the American Liver Foundation’s Non-Alcoholic Fatty Liver Disease Fibrosis score calculator. The oncology app uses a similar decision-support process to help providers determine appropriate medications for many types of cancer. Providers can search by medication or disease state to get information for 70-plus medications, including each drug’s FDA indication, formulation, dosing, monitoring parameters and key counseling points. Both apps offer links to industry news and resources along with copay and financial assistance programs, and make it easy to connect with an Avella account manager and download prescription referral forms. The apps were developed in response

to feedback from health care providers about challenges in keeping up with the pace of drug development in these areas, noted Todd Speranzo, Avella’s vice president of marketing. In 2015 alone, 19 new oncology medications and two new therapies for HCV were approved by the FDA. “Pharmaceutical manufacturer representatives are a great resource, but they can only represent their own products,” Mr. Speranzo told Specialty Pharmacy Continuum. “As a specialty pharmacy, we’re in a unique position in that we can educate health care providers about a broad spectrum of medications. These apps will help pro-

viders stay informed of any changes to this information in close to real time. We’ve built the apps so that many updates to the content can be made without having to refresh the entire app, so we will make ongoing content updates every two to three weeks. “Hepatitis C and oncology were chosen because of the rapid pace of

change in those two disease states,” Mr. Speranzo said. “That’s where we see the most emergent products and changes in indications.” The two apps were downloaded about 2,600 times since launch. According to Mr. Speranzo, “We expect to start receiving requests for additional functionalities and disease states over the coming weeks, and we would certainly consider launching additional apps based on that feedback.” —Gina Shaw

Specialty Pharmacy Continuum • May/June 2016

TECHNOLOGY

incentivized to save costs by comparing drugs, saving time or cutting acquisition costs, he said. Moreover, it helps to “have a consistent purchasing plan that we can get those drugs day in and day out without having to worry about making a huge purchase that at some point doesn’t make sense for cash flow.” Having the program recently helped his pharmacy win a contract over a competitor, Mr. Dunham noted. “The advantage for an independent pharmacy like ours is now we can go and compete against larger long-term care pharmacies that have dozens of people looking over therapeutic substitutions. All of this is at a touch of our fingers, and it does make a nice differentiator in business.”

LTC Provider’s Take Joseph Marek, RPh, the director of pharmacy services for CommuniCare, a network of 53 nursing homes, a longterm acute care hospital and two small geriatric psychiatric hospitals in Ohio, Pennsylvania, Missouri and Maryland, manages his company’s formularies. He said PATH Pro “definitely sounds

interesting. It looks like they are doing something to help these long-term care pharmacies get a competitive advantage in the market.” At CommuniCare, the pharmacy and therapeutics committee meets regularly to review drugs and their potential substitutes, to evaluate their clinical performance and cost. If one drug is clinically superior they will prefer

that one, Mr. Marek said, but if the drugs are clinically equal they will look at the cost and select the less expensive option. About 75% to 80% of drugs taken by the geriatric population now are available as generics, Mr. Marek said. In working with three pharmacy vendors, “we have it set up so that if there’s a generic available, they auto-

matically dispense it.” For more information, see http:// mckessonalternatesiterx.com/solutions-meet-needs/path-pro. —Karen Blum None of the sources reported any relevant ﬁnancial relationships other than their stated places of business.

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Specialty Pharmacy Continuum • May/June 2016

ASK THE EXPERT

Q&A: Stacey Ness, PharmD Managed Health Care Associates Inc. (MHA), one of the country’s leading health care services and technology companies and largest alternate-site group purchasing organizations, recently held its 13th Annual Business Summit in Las Vegas, which focused on a wide range of issues affecting the long-term care (LTC), home infusion and specialty pharmacy markets. During the meeting, Specialty Pharmacy Continuum sat down with Stacey Ness, PharmD, RPh, CSP, MSCS, AAHIVP, MHA’s Stacey Ness, PharmD senior director of specialty clinical services, to gain insights into some of these issues, as well as the group’s efforts to advocate on behalf of its members. SPC: Recognizing that MHA Specialty Pharmacy Solutions offers pharmacy members support through all classes of trade, one of the noteworthy developments at the meeting was the release of the MHA LTC Member Study. What did the report say about this segment of your membership’s interest in, and involvement with, specialty pharmacy? Dr. Ness: We found significant growth over the previous year in the provision of specialty medications by our LTC members into senior care settings. That included a 37% increase in medications for inflammatory conditions, a 25% increase in hepatitis C virus (HCV) medications, a 13% increase in the use of drugs for multiple sclerosis, 13% more use of HIV drugs and a 71% increase in immune globulin therapy. So specialty is clearly a strong growth area in LTC. SPC: But isn’t specialty pharmacy still a relatively new area for many LTC providers? And as such, do some of them face barriers to entry, such as access to limited distribution contracts for specialty drugs? Dr. Ness: Certainly, network access remains a challenge; manufacturers and in some cases payors are imposing limitations on distribution and dispensing, so that only a few specialty pharmacies are allowed to participate, or an exclusive specialty pharmacy is allowed to participate for that particular payor. That’s a huge challenge that continues to put pressure on specialty pharmacies, and frankly this is occurring across multiple trade channels, not just LTC. However, limited distribution proves especially challenging in the LTC space. It is common business practice in the LTC industry for one pharmacy to service the entire LTC facility. LTC pharmacies have the expertise and understanding of the regulations and nuances that accompany servicing nursing home patients. If that LTC dispensing pharmacy is not given access to the specialty drug needed to fulfill an order, significant barriers are created to getting the facility resident the specialty medication in a timely manner and to meeting all the regulations that are set forth by the federal government. In addition, this creates fragmented care that is difficult to manage for the dispensing pharmacy, the attending physician, the consultant pharmacist and the nurses who are responsible for storage and administration of the medication. SPC: Does MHA advocate on members’ behalf to gain access to those networks? Dr. Ness: We are working very hard on that score, in part by educating manufacturers on the challenges that it presents to patients and caregivers when they can’t use their preferred provider because of closed net-

Dr. Ness: First, just to be clear, the desire to enter into specialty pharmacy isn’t limited to LTC; we definitely are seeing significant growth in the specialty space overall. As for why LTC providers are interested, of course, the aging population is driving part of it. And many of those patients are living longer with chronic disease and aging into LTC facilities as needed. But on top of that, many of these patients are presenting with HIV, HCV or other chronic conditions that require high-touch clinical care and specialty drug therapy management, in addition to skilled nursing services. And in the case of HCV, this trend is only going to gain strength, because the Medicare-age population is one of the most underdiagnosed for HCV as a whole. SPC: Do you offer care pathways for HCV and these other chronic conditions of an aging population? Dr. Ness: From a clinical services standpoint, we do a lot of education: We produce clinical spotlights that look at products in that particular therapeutic category; we do disease state overviews; we publish therapeutic comparison charts; and we provide resources with guidelines and best practices to help position the pharmacy providers to provide excellent care. Through our Clinical Therapy Management (CTM) software application developed by MHA Specialty Pharmacy Solutions, we also have pathways built in for HCV and HIV that are available to both specialty and LTC pharmacies.

works. That type of drug distribution model can fragment patient care, which is not optimal for our pharmacy members orr their patients. MHA is also looking into strategic partnerships to help ensure there’s connected care between specialty pharmacies that have access to the drug and the LTC facility and other pharmacies that are taking care of the patient. SPC: Data reporting is another challenge that providers face when trying to break into specialty pharmacy. I imagine all MHA members have to grapple with that. Dr. Ness: Absolutely; those reporting requirements can be very burdensome for pharmacies, no matter what the trade channel. Think of it: In some cases, you have pharmacies with upwards of 50 different payor agreements, and you need to create 50 different data reports because there’s no industry-wide, standardized means of collecting and formatting those reports. And then you have some manufacturers that are increasingly asking for not just quarterly, monthly or weekly reports, but daily reports on many of the drugs in this space. It’s a huge resource and time investment for a pharmacy. SPC: Does MHA offer any help to members that are considering a move into specialty? Dr. Ness: Yes, we do some level-set analysis on the specialty landscape as a whole, and then set forth some concrete next steps for how to evaluate the market opportunity. So we have a checklist of the things that our members will need to look at and evaluate in terms of pursuing this as a new or expanded business model. SPC: Why has specialty pharmacy caught the eye of LTC providers?

SPC: When you’re talking to prospective members, what’s the core value that you tell them MHA brings to the table? Dr. Ness: MHA’s goal is to help the member succeed in their core business, whether it be LTC, home infusion, specialty, retail, etc. We do that through clinical education, as noted, as well as education of the marketplace in general, manufacturer-based agreements, and services and solutions such as our CTM modules. With CTM, the idea is to provide our members with a turnkey technology system that they can use to document patient interventions and track and report outcomes, without having to invest in their own clinical software build out. Members also benefit from our legislative advocacy (see related story, page 1). We’re able to provide those back-end clinical services as well as the contracting piece to help pharmacies with their bottom line, along with the education and legislative services. SPC: Are there any new initiatives we should know about? Dr. Ness: Yes, we recently announced that MHA has formed an enhanced partnership with Evaluate Pharma to provide some really great in-depth drug pipeline reporting about what’s coming in the market through Phase II and III clinical trials within each of the different specialty therapeutic categories. The reports also take a look at these research developments from a business perspective, noting future trends such as projected sales and what the pharmaceutical industry is focused on in terms of research. The reports include comprehensive clinical information about these drugs, the mechanism of action, etc. We are really excited about offering this new information resource to MHA members. —Reported by David Bronstein

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1 Massoomi, Fred, “Assessment of Testing Method for Closed System Transfer Devices across Vapor Release” www.regulations.gov, Comment ID: CDC-2015-0075-0027. 18 February 2016. 2 Bar Ilan, Igal, “Comparative Study of Vapor Containment Efﬁciency of Hazardous Drug Transfer Devices” Migal Analytical Chemistry Laboratory, 12 January 2009. 3 Bar-Ilan, Igal and Hadar, Edna, “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination Alcohol Vapors Detection” Milouda & Migal Laboratories, 13 April 2014. 4 Massoomi, Fred, “Assessment of Closed System Transfer Devices 5FU Drug Leakage” www.regulations.gov, Comment ID: CDC-2015-0075-0027. 17 February 2016. 5 Bar-Ilan, Igal, “Fluorescent Evaluation of Dry Connections in the EQUASHIELD™, Phaseal® and Tevadaptor®/ Onguard™ Closed System Drug Transfer Devices” Migal Analytical Chemistry Laboratory, 5 February 2009. 6 Fouzia, Berdi, et al. “Assessing the Efﬁciency of CSTDs for Compounding” — Pharmacy Purchasing & Products. Vol. 12 No. 7. July 2015. 7 Nelson Laboratories, “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the EQUASHIELD® Closed System Drug Transfer Device.” 2014.