Summer 2012 - Specialty Pharmacy Continuum by McMahon Group

sa th r –2 y 01 Y ea 2

Bridging the gap between the hospital and alternate-site care

Volume 1 • Number 3 • Summer 2012

specialtypharmacycontinuum.com

In This Issue Ask the Expert

The benefits of URAC accreditation.

Operations & Mgmt

New global drug registry may boost supply-chain safety.

Tips for weathering specialty drug recalls and shortages.

Policy

Proper coding, patient intake key to infusion reimbursement.

340B drug discount program a $6 billion market force.

Clinical

Walgreens Specialty Pharmacy’s approach to multiple sclerosis management.

New data support tadalafil for pediatric pulmonary arterial hypertension.

BUYER’S GUIDE See insert after page 6.

Carving a Specialty Niche Within the ACO Model Las Vegas V —Specialtty pharmacies can play a central rolee in improving health outcomes and reducing costs as the health care syystem continues to shift to an acco ountable care model, Diplomat Speccialty Pharmacy CEO Philip Haggerman, RPh, told attendees off the annual Armada Speciaalty Pharmacy Summit. Mr. Hagerman urged specialty pharmacies to provide value-added services and invest in technological infrastructure and up-to-date edu-cation and training to t position themselves as key players in an acccountable care environment.. “The new paradigm w will be challenging but will also prresent many opportunities,” said M Mr. Hagerman, who delivered a state-of-thes industry address at th he Summit. “We are crossing over from what used to be a siloed approach to patient care and, as we do d this, we want to make sure we meet our o partners’ needs by optimizing outcomes and costs.” The Accountable Caare Act provides the conceptual framework for an accountable care model, with the imperative to work collectively, but Mr. Hagerman said it does not spell out a “formula to achieve the efficiencies that it’s aiming for.” The onus to demonstrate these efficiencies and to provide outcomes data is on the individual pharmacy, said Stephanie S. Holliday, PharmD, the director of clinical program development at Prosperity Specialty Pharmacy, an AcariaHealth Company, in Falls Church, Virginia. “To maintain our position in a provider network, we need to show that our services and treatments are leading to both optimal therapeutic and financial outcomes,” Dr. Holliday told Specialty Pharmacy Continuum. “This means analyzing factors such as staff time spent on patients,

•

see ACO MODEL, page 13

FDA Approval

Costs Driving Specialty Drug Pharm’s Future Scottsdale, Ariz.—A fast-growing number of Americans with cancer, multiple sclerosis (MS), HIV/AIDS and dozens of other illnesses are living longer, healthier lives thanks to specialty pharmaceuticals. It’s no surprise, however, that the significant benefits of these sophisticated medications come at a high price. Specialty pharmacists, pharmacy benefit management companies (PBMs) and payers are wrestling with the best way to provide these medications to patients who need them without breaking the bank. “The most important thing we need

•

see DRIVING FORCE, page 5

Interferon Takes Hit in MS Study; Patient Fallout?

nterferon-β therapy did not produce a long-term reduction in the progression of disability among patients with relapsing-remitting multiple sclerosis (MS), according to a study in the Journal of the American Medical Association ( (2012;308:247-256 ). Based on the results, specialty pharmacists may need to manage patients’ expectations about interferon-β’s impact on the disease, experts suggest. Patients who are concerned by the widely publicized study findings also must be told not to stop complying with interferon-β

•

see EFFICACY, Y page 21

The Book Page

Rayos approved for rheumatoid arthritis, other inflammatory conditions.

Pharmacy Management, Third Edition

See page 11.

See page 27.

By Shane Desselle, David Zgarrick, and Greg Alston

The PROOF is everywhere you look GAMUNEX- C has proven efﬁcacy and patient outcomes in CIDP, PI, and ITP*1

Important Safety Information for GAMUNEX-C Gamunex-C, Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified, fi is indicated for the treatment of primary humoral immunodefi ficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic infl flammatory demyelinating polyneuropathy (CIDP). Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) productss in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insuffi ficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gamunex-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer Gamunex-C at the minimum concentration available and the minimum infusion rate practicable. Gamunex-C is contraindicated in individuals with acute severe hypersensitivity reactions to Immune Globulin (Human). It is contraindicated in IgA defi ficient patients with antibodies against IgA and history of hypersensitivity. Gamunex-C is not approved for subcutaneous use in patients with ITP or CIDP. Due to the potential risk of hematoma formation, Gamunex-C should not be administered subcutaneously in patients with ITP. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy. Thrombotic events have been reported in association with IGIV. Patients at risk for thrombotic events may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization and/or known or suspected hyperviscosity. There have been reports of noncardiogenic pulmonary edema [Transfusion-Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid fl volumes or where fluid volume may be a concern. Gamunex-C is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. In clinical studies, the most common adverse reactions with Gamunex-C were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP). *CIDP=Chronic infl flammatory demyelinating polyneuropathy; PI=Primary immunodefi ficiency; ITP=Idiopathic thrombocytopenic purpura. Reference: 1. Data on fi file, Grifols. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see adjacent page for brief summary of GAMUNEX X- C full Prescribing Information.

To get GAMUNEX-C call 1-888-MY GAMUNEX (694-2686) USA Customer Service: 1-800-243-4153 www.gamunex-c.com

GAMUNEX® X®-C

Immune Globulin Injection (Human) 10% Caprylate/Chromatography Puriﬁed

• Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. • Aseptic Meningitis Syndrome (AMS) has been reported with GAMUNEX-C and other IGIV treatments, especially with high doses or rapid infusion.

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to • Hemolytic anemia can develop subsequent to IGIV therapy due use GAMUNEX®-C safely and effectively. See full prescribing to enhanced RBC sequestration. Monitor patients for hemolysis information for GAMUNEX-C. and hemolytic anemia. GAMUNEX-C, [Immune Globulin Injection (Human) 10% • Monitor patients for pulmonary adverse reactions (transfusionCaprylate/Chromatography Puriﬁed] related acute lung injury [TRALI]). Initial U.S. Approval: 2003 • Volume overload WARNING: ACUTE RENAL DYSFUNCTION and FAILURE See full prescribing information for complete boxed warning. • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C does not contain sucrose. • For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.

• GAMUNEX-C is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. • Passive transfer of antibodies may confound serologic testing. ----------------------------ADVERSE REACTIONS---------------------------• PI – The most common adverse reactions (ⱖ5%) with intravenous use of GAMUNEX-C were headache, cough, injection site reaction, nausea, pharyngitis and urticaria. The most common adverse reactions (ⱖ5%) with subcutaneous use of GAMUNEX-C were infusion site reactions, headache, fatigue, arthralgia and pyrexia.

• ITP – The most common adverse reactions during clinical trials (reported in ⱖ5% of subjects) were headache, vomiting, fever, -------------------------INDICATIONS AND USAGE------------------------nausea, back pain and rash. GAMUNEX-C is an immune globulin injection (human) 10% liquid • CIDP – The most common adverse reactions during clinical indicated for treatment of: trials (reported in ⱖ5% of subjects) were headache, fever, chills, hypertension, rash, nausea and asthenia. • Primary Humoral Immunodeﬁciency (PI) • Idiopathic Thrombocytopenic Purpura (ITP) • Chronic Inﬂammatory Demyelinating Polyneuropathy (CIDP)

To report SUSPECTED ADVERSE REACTIONS, contact Talecris Biotherapeutics, Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

----------------------------CONTRAINDICATIONS-------------------------------------------------------DRUG INTERACTIONS---------------------------• Anaphylactic or severe systemic reactions to human • The passive transfer of antibodies may transiently interfere with immunoglobulin the response to live viral vaccines, such as measles, mumps • IgA deﬁcient patients with antibodies against IgA and a history and rubella. Passive transfer of antibodies may confound of hypersensitivity serologic testing. ---------------------WARNINGS AND PRECAUTIONS--------------------• IgA deﬁcient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure. • GAMUNEX-C is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMUNEX-C subcutaneously in patients with ITP. • Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.

--------------------USE IN SPECIFIC POPULATIONS -------------------• Pregnancy: no human or animal data. Use only if clearly needed. • Geriatric: In patients over 65 years of age do not exceed the recommended dose, and infuse GAMUNEX-C at the minimum infusion rate practicable.

Talecris Biotherapeutics, Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1716

08939771/08939782-BS Revised: October 2010

Specialty Pharmacy Continuum • Summer 2012

INDUSTRY NEWS

‘The Apothecary Shops’ To Launch Company Rebrand in August In 1996, John D. Musil, PharmD, opened the first Apothecary Shop, in Scottsdale, Ariz. Since then, the company has expanded from a regional compounding pharmacy to a national specialty pharmacy operation, with 17 locations in seven states and a national distribution center that services all 50 states. To reflect this growth, the company plans to launch a new corporate identity in August. “We have made a transition from a strong regional specialty pharmacy to a national player in specialty pharmacy, and the rebranding is the culmination of those efforts,” company president Keith Cook told

Specialty Pharmacy Continuum. Pointing to the “huge shift in the pipeline to more specialty products,” Mr. Cook noted that the company is well positioned to fulfill “the unique requirements it takes to properly dispense” these products. ‘Avella,’ the new company name, is

Ask the Expert

shows our clients, physicians, members, and others in the marketplace that CVS Caremark has organization-wide dedication to delivering high-quality health care and providing exceptional customer service to help people on their path to better health.

Maribeth Bettarelli, director, Quality and Acrreditation, CVS Caremark

: A growing number of specialty pharmacies are becoming accredited through URAC. What are the major benefits of accreditation—why do it?

: What competitive advantages does it confer, from a business/ operational/marketing perspective?

: Earning and maintaining accreditation demonstrates our compliance with national standards for delivering quality health care services and supporting patient safety. Ultimately, it

: Accreditation can give us an edge over competitors who may not have it. Again, it demonstrates our commitment to delivering high-quality health care, customer service and patient programs. It can be an influential factor for

intended to creaate brand consistency and stream mline communication with partn ners and customers on a natio onal level, according to the company. The letters within Avella are selected from key words in the company’s mission statement; Health, Devotion, and Excellence, according to a company press release. The firm’s infinity logo “further illustrates the continuous and uninterrupted commitment to

clients when they are deciding which organization they want to contract with. A commitment to quality requires resource investment, and the accreditation process can be quite rigorous, so going through that exercise and obtaining accreditation really shows the industry that CVS Caremark is quality focused in how we manage our business and service our clients.

Q A

: Are there clinical/patient care benefits?

: Accredited organizations can provide both clinical and patient-care benefits. The standards are in place to help ensure we understand, implement

patients and providers,” the press p release statted. To datee, The Apothecary Shops (TAS) is not the only name under which the company has operated; for instance, the Greater Sacramento Pharmacy, a TAS take-over, still operates under its own name, while another acquisition was renamed ‘TAS Specialty.’ “’The Apothecary Shops’ is a generic term– like ‘The Paper Shop,’” said Todd Speranzo, vice president of marketing. “We

and maintain a consistently high quality standard in our service and support model. For example, some standards focus on delivery and oversight of utilization management programs. These programs are in place to ensure the right patients receive the right medications through the right delivery (i.e., medications should be used in a safe, effective and appropriate manner for patients to get the full benefit).

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Volume 1 • Number 3 • Summer 2012

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SPECIALTY PHARMACY Cindy Kunzendorf, PharmD General Manager Accredo/CCS Locations Elmhurst, IL

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Stephanie Holliday, PharmD Clinical Pharmacy Specialist Prosperity Specialty Pharmacy Falls Church, PA

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Specialty Pharmacy Continuum • Summer 2012

OPERATIONS & MANAGEMENT

DRIVING FORCE continued from page 1

to do is get a grip on the costs of these very effective products that are draining the health care system,” said Randell “RJ” Correia, PharmD, senior vice president of pharmacy services at OptumRx, a San Diego-based PBM that serves more than 13.5 million ccustomers through mail service pharrmacies and more than 67,000 commu unity pharmacies. In a session at the Pharmacy BenB efit Management Institute’s 2012 ann nual Drug Benefit Conference, Dr. Corrreia pointed to statistics illustrating the stags gering costs associated with the speccialty pharmacy industry. Specialty pharmacy spending accounts for one-th hird of the nation’s total drug costs, an nd is rising twice as fast as conventional drug d spending. The average price of a specialty medication is $22,800 annu ually per patient, according to data from OptO umRx. In one large health plan, thee top five areas under the specialty pharm macy medical benefit account for more tthan $1 billion per year in spending: oncology injectables, rheumatoid arthritis drugs, immunoglobulin, agents to combat neun tropenia, and hemophilia treatmentts. These figures, along with patien nt demand for the advanced medicaations, are expected to rise rapidly, saaid Dr. Correia, because there are more tthan 900 biotech medications in the pipelline, according to a 2011 report by the Pharmaceutical Research and Manufactu urers of America. He also noted that indu ustry insiders believe that by 2030—or so ooner—specialty medications will account ount for up to 44% of a plan’s total expenditure (http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC2706163/).

Specialty Designated Programs As part of the solution to accelerating costs, Dr. Correia said payers are turning to specialty designated network programs to reduce the financial burden and to improve the health of patients. In such programs, the patient

cannot trademark or claim exclusivity to the name.” The company remains steadfast to its mission—“to optimize patient health through a relentless devotion to clinical excellence.” This is achieved through the devotion of its staff, according to Mr. Cook. “We believe that people still value exceptional customer service and our team is focused on exceeding [customers’] expectations,” he said. Avella will continue to acquire and open pharmacies in strategic mar-

typically gains around-the-clock access to pharmacists and receives greater health plan and pharmacy benefit guidance. This results in higher numbers of patients taking their drugs appropriately, as well as increased satisfaction levels with the medications. For example, in one oral oncology program conducted by OptumRx, medication adherence was improved by 50%. The total spending reduction per patient the first year was $19,606, due primarily to indirect health care cost savings such as fewer emergency room visits, less hospitalization and reduced drug waste, said Dr. Correia. The spending reduction per patient the second year—$9,700— was lower, as expected, but

still substantial. In another example, Prescription Solutions, a PBM owned by OptumRx, OptumRx conduct conducted a study of patients with MS who were enrolled in a seven-month disease therapy management program. These patients demonstrated a significantly longer duration of therapy, greater medication persistence and a lower discontinuation rate, resulting in a 33.6% decrease in relapses, said Dr. Correia. Such programs require individualization, with specific resources and systems for each specialty therapeutic

category, according to Dr. Correia. For the MS program, specialty pharmacists monitor patients monthly until their condition is stable. Then, as needed, they screen patients for depression, exacerbations of their condition and response to therapy. They track emergency room or hospital admissions, manage drug side effects, monitor the

‘The most important thing we need to do is get a grip on the costs of these very effective products that are draining the health care system.’ —Randell ‘RJ’ Correia, PharmD

vaccination status and a assess any lifestyle issu ues, nutrition and exerciise. For an oncology prograam, specialty pharmacists do all of the above, but the calls are biweekly. They also monitor lab biweekly laboratory results, contact the prescribing physician as appropriate and focus on managing the patient’s pain. “The key is making sure your program is smartly developed, monitored and adjusted over time as new data come in,” he said. “As the complexity of these drugs evolves, and as new drugs become available, organizations have to be fairly nimble so they can respond to changes. You also need to

‘We believe that people still value exceptional customer service and our team is focused on exceeding [those] expectations.’ —Keith Cook

kets, the company noted. Future plans also include expanding their nation-

invest in these programs early on to get the full benefits.” More programs are implementing patient registries, which provide another way to share information to improve medication adherence and patient outcomes. Dr. Correia said PBMs generally emphasize outreach, communication and data, which result in a higher lev-

al distribution center, creating a web portal that will allow the tracking of

el of adherence. But some critics of PBMs believe these groups are adding to health care costs, and are questioning how long the current system can survive. “PBMs are trying to hold onto specialty profits in a commodity market. But health plans are concerned with the high cost of specialty and want solutions to reduce cost,” said Craig S. Stern, RPh, PharmD, MBA, president of Pro Pharma Pharmaceutical Consultants, Inc., based in Northridge, Calif. “But the good old days are rapidly going away. Purchasers won’t continue to pay huge prices for these specialty drugs without significant price oversight and utilization management.” One thing players in the specialty pharmaceutical industry seem to agree on is that there’s no “one-size-fits-all” strategy to solve the skyrocketing cost problems. “Our job is to ensure that specialty pharma drugs are used properly, that the patient understands the side effects and can manage them to gain the full benefit,” said Jody L. Miller, MBA, CEO of Reliance Rx, a specialty pharmacy based in Amherst, N.Y. “If you can do that, and prove your value to payers, that’s how you’ll survive.” —Dana Hawkins-Simons

prescriptions and the channeling of more resources into the areas of rheumatology and dermatology. The specialty pharmacy industry is experiencing rapid growth in recent years. “By 2014, revenue for specialty pharmaceuticals is forecasted to exceed all other drug categories and surpass the $100 billion spent in 2010,” according to Xcenda, a consultancy group and managed market agency. —Maureen Sullivan

Specialty Pharmacy Continuum • Summer 2012

OPERATIONS & MANAGEMENT

Drug Tracking Registry Offers Safety, Benefits A new global drug safety registry due to launch this summer will elevate “track-and-trace” capabilities over radiofrequency identification (RFID) and bar coding in several ways, according to its developers Leavitt Partners and Park City Group. The registry, with the working name ReposiTrak, is designed to pinpoint exact locations of every batch of pharmaceutical products in the supply-chain pipeline, from manufacturers to pharmacies. This would bring three practical benefits to specialty, hospital and retail pharmacies and their prescription drug suppliers. First, it could expedite recalls by reducing tracking times from weeks to minutes, so affected products could be identified quickly and removed from distribution. Second, the registry could “help mitigate” critical drug shortages— which multiplied from 61 in 2005 to more than 250 in 2011, according to FDA figures—by “giving a virtual view of where product is anywhere in the U.S.,” Kristina Lunner, a senior advisor to Leavitt Partners told Specialty Pharmacy Continuum. Third, ReposiTrak could make it tougher to push counterfeit medications through the supply chain because “it has the capacity to examine inventories and know when irregularities come into the system,” noted Rich McKeown, president and CEO of Leavitt Partners, who served as chief of staff to former Health and Human Services Secretary Michael O. Leavitt, the firm’s founder. “The ability to help manage all these areas of need is a major step forward,” said Mr. McKeown. Global counterfeit drug sales were estimated to be a $75 billion problem in 2010, up 92% from 2005, according to the Center for Medicines in the Public Interest. At press time, Mr. McKeown said that pilot trials under way at pharmacies indicate that the registry will monitor the supply chain efficiently, effectively and economically, using the following features: • The ability to create an e-pedigree with complete backward and forward visibility; this includes foreign imports entered into the system by manufacturers (when permitted by FDA to help alleviate a drug shortage). FDA defines pedigree as “a statement of origin that identifies each prior sale, purchase or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.” • ReposiTrak’s Universal Translator—a key simplifier for users of the registry, especially pharmacies dealing with multiple sources. “Think of it as the United Nations,” said Ms. Lunner. It has standard identifiers for products and synchronizes information technology communications for all parties

in the pipeline, regardless of the language or technology used. It accepts data in any format. • The ability to function with specialty, hospital and retail pharmacies’ existing technology. By contrast, RFID and bar coding could potentially require hardware. • No start-up or connect fees for pharmacies, just a $10 monthly maintenance fee. Pharmaceutical tracking is a sister application to food tracking by the registry. Both build on the viaLink technology used to synchronize retailers with

authorized. The registry also compares distributed quantities with quantities received by lot number, and issues alerts when information doesn’t match, is missing or isn’t authenticated. Commenting on the ReposiTrak system, Bruce Kneeland, a pharmacy industry consultant based in Royersford, Pa., said that based on the information from Leavitt, it appears that they “have created a way to accomplish what has eluded the industry for years—a simple, comprehensive and practical way to keep track of pharmaceuticals from the [active pharmaceutical ingredient] stage to the will-call bin of the pharmacy.” Mr. Kneeland predicted, “If the system finds traction … it could help immensely in preventing drug diversion and simplifying the drug recall process.” However, he added, “Unfortunately,

registry will arrive on the market as Congress discusses two bills to reauthorize the Prescription Drug User Fee Act. At press time, the House and Senate were in negotiations about how to reconcile their respective approaches (Senate bill S.3187 and House bill H.R. 5651) to requiring tighter tracking of the drug pipeline and notifications by manufacturers of potential drug shortages, said Ms. Lunner, a former vice president of government affairs for the American Pharmacists Association. “With so much FDA funding tied to the legislation, most consider this a must-pass piece of legislation. Add industry support of the bill [to] … bipartisan Congressional support, and it’s very likely the bill will pass,” she predicted. “Assuming the final bill includes a national standard, it would be beneficial because stakeholders feel the patchwork of state regulations [presents] an operational challenge,” according to Ms. Lunner. “FDA and Congress have tried before to establish track-and-trace and pedigree requirements but faced various barriers to implementation.” According to the Healthcare Distribution Management Association, 20 states had no pedigree legislation or regulation, whereas 18 had adopted final rules as of June 2012 (map). Moreover, two states had proposed legislation, eight had enacted it, and another two had enacted it and were developing final rules.

‘If the system finds traction ... it could help immensely in preventing drug diversion and simplifying the drug recall process.’ —Bruce Kneeland

suppliers. Supply chain participants register products with the ReposiTrak engine at every point in the shipping process; ReposiTrak can validate each lot as it is received into a location. Valid lots are certified, security signed and

good technology is not always the answer. Too often we find that political issues affect the market. … It is all too rare for the best technology to win over those that have the connections.” A year-and-a-half in development, the

20 No legislation or regulations Enacted legislation; rules pending

—Al Heller

Proposed legislation

Enacted legislation

Final rules adopted

Legislation vetoed

Rules pending; no legislation

WA ME MT

OR MN ID

MI NE

IA IL

UT CA

IN WV

KY TN

CT NJ

AR MS

MA RI

NC AZ

DE MD

AK FL

Figure. Distributor licensing and pedigree requirements by state.a a

Current as of June 21, 2012.

Source: Healthcare Distribution Management Association.

Specialty Pharmacy Continuum • Summer 2012

OPERATIONS & MANAGEMENT

Plan Ahead To Manage Recalls and Shortages Phoenix—The best ways to survive specialty and home infusion drug shortages safely are to plan as much as possible and to think creatively to manage your product supply, said experts presenting at the National Home Infusion Association’s annual conference. Although branded products used by specialty pharmacies are less likely to be in short supply, you never know when a shortage might hit because of unforeseen problems such as an ingredient shortage or manufacturing plant fire, said Donald Filibeck, PharmD, MBA, director of pharmacy process and training for Accredo Health Group, Inc., an Express Scripts subsidiary, in Dublin, Ohio. “If you are doing any home infusion at all, you have been significantly touched by multiple drug shortages,” said Dr. Filibeck, noting that some pharmacists spend at least half their time managing inventory related to drug shortages, such as vials of sterile water or sodium chloride used to reconstitute some injectable pulmonary arterial hypertension drugs. Shortages of amino acids, trace elements, vitamins and macro ingredients such as electrolytes have affected other infusion groups. Many of the drug shortages that occurred in 2010 and 2011 significantly affected specialty pharmacy providers: 80% were injectable drugs, 28% were oncology drugs, 13% were anti-infective agents and 11% were electrolyte/infusion drugs, Dr. Filibeck noted. A difficulty for one company can cause a big problem. According to findings from the FDA Center for Drug Evaluation and Research’s Drug Shortage Program, 40% of the 127 shortages they studied from January 2010 to August 2011 were caused by just three companies. One company was involved in 27 shortages. “If one [manufacturer] goes down, there’s no way the others can gear up to make up the demand,” Dr. Filibeck said. Most companies use ‘just-in-time’ manufacturing processes, and don’t stockpile product, he said, and they can’t quickly make more or add or change production lines because of regulatory issues. To minimize the effect of shortages, Dr. Filibeck advised pharmacists to communicate regularly with major vendors and monitor Web sites for drug shortage information. As soon as there are hints of a potential shortage, he said, pharmacists should put the drug on a list of products to watch, purchase the full amount of product possible without hoarding and start planning how to handle things three, six or even nine months down the line because it may not be clear when a drug will become available again. He also recommended that pharmacists talk to physicians if needed about using alternate dosages or products if there are substitutions and

consider alternate suppliers if possible. Dr. Filibeck urged pharmacists to “think outside the box” to stretch prod-

ucts as long as possible. For example, pharmacists can offer oral pediatric vitamins to some patients to preserve infu-

‘Think outside the box’ to stretch products for as long as possible. —Donald Filibeck, PharmD, MBA

Table. Resources for Managing Drug Shortages American Society of Health-System Pharmacists

http://www.ashp.org/menu/ PracticePolicy/ResourceCenters/ DrugShortages.aspx

American Society for Parenteral and Enteral Nutrition

http://www.nutritioncare.org

FDA

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

Institute for Safe Medication Practices

http://www.ismp.org/

National Home Infusion Association

http://www.nhia.org/

sion vitamins for patients who need them more, or administer the vitamins less often. For generic products such as selenium, which has only one manufacturer and therefore no substitute, pharmacists could analyze their patients to see if some could take it less often. Because shortages affect multiple roles in pharmacy, including pharmacists, purchasing and billing staff, everyone from entry-level staff to the director or manager should be concerned with shortage management, said Jamie Tharp, PharmD, inventory and distribution manager for the University of Michigan HomeMed infusion pharmacy, in Ann Arbor. Each shortage is unique, Dr. Tharp said. There may be equivalent products available, but changes in presentation (liquid vs. dry) and changes in concentration can pose risks for errors, so pharmacists need to be vigilant when making such substitutions. At the University of Michigan HomeMed infusion pharmacy, a pharmacy manager is available to purchasing staff, and all buyers are pharmacy–tech certified and have attended training sessions on selecting alternate products. Education and communication are key to safe administration of medicines during a shortage, Dr. Tharp said, so she recommended that pharmacists do not rely on just email. Emails describing how to handle shortages “may be one and a half pages long, and people don’t have time to read that,” she told Specialty Pharmacy Continuum. Plus, juggling several shortages can lead to staff fatigue: “People are tired of seeing email from me about anotherr national shortage.” When shortages hit, Dr. Tharp reviews on-hand inventory, product and alternative availability, and then develops a management plan. Complicated or severe shortages may require an impromptu staff meeting to discuss the plan of action or let the staff see and handle the product in cases in which a look-alike or sound-alike drug will be substituted. She also has set up an internal Web site with drug shortage and management information that staff can refer to as needed. The table lists some resources for managing shortages. Additional tips from Dr. Tharp to ensure safety during shortages include updating compounding references and prescription forms to accommodate a substitute drug, arranging the pharmacy setup so the substitute drug is available on a fast-moving shelf, physically separating look-alike/sound-alike drugs, and communicating clearly with patients about any shortage-related issues. —Karen Blum

Specialty Pharmacy Continuum • Summer 2012

OPERATIONS & MANAGEMENT

CCS, Coram and Walgreens part of a small but growing learning experience

Residencies for Home Infusion Pharmacists During her last year of pharmacy school at the University of Oklahoma, Stephanie Manning, PharmD, did a clinical rotation at the Oklahoma City branch of a specialty infusion provider. “I had never heard about home infusion before, and my preceptor there introduced me to all the basics of how it works and the pharmacist’s role in home infusion.” Prior to that, Dr. Manning had already decided that she wanted to do a pharmacy residency after completing her degree, but she had been undecided about her focus. Her experience with home infusion during her clinical rotation made her wonder whether such a thing as a home infusion residency even existed. “I was looking through residency programs on the ASHP [American Society of Health-System Pharmacists] Web site and found that Critical Care Systems [CCS] had a home infusion residency,” Dr. Manning said. After speaking with some of CCS’ previous residents at the ASHP Midyear meeting, she settled on CCS as her first choice for a residency. Dr. Manning had stumbled on what was, at the time, the only active pharmacy residency specifically devoted to home infusion pharmacy. Since then, Coram Specialty Infusion Services, where she pursued the clinical rotation that sparked her interest in the field, also has launched a similar residency, and

Walgreens has reinstated a postgraduate year (PGY)-1 residency program in home infusion that was on hiatus when Dr. Manning was looking for a program. CCS’ home infusion residency first

‘Our residents experience the continuum of care with the patients as they come out of the hospital ... and [they] learn to respond to all facets of patient care.’

Specialty Pharmacy: A Pharmacy School Unknown?

got its start in 2007, when three of the organization’s pharmacists—Barbara Prosser, RPh, Caryn Dellamorte Bing, RPh, MS, and Donald Filibeck, PharmD, MBA—began discussing the growth of

CS’ home infusion pharmacy resident Stephanie Manning, PharmD, said she got virtually no exposure to specialty pharmacy issues—such as the extended stability that is so important in home infusion—during her pharmacy school training. She’s not alone, said Diplomat Specialty Pharmacy’s President and CEO Phil Hagerman, RPh. “There is no college of pharmacy with a reputation for any focus on specialty pharmacy. And with more and more drugs, such as oncology and rheumatoid arthritis medications, being channeled through specialty pharmacy, we have to start challenging academia to aggressively instill this specialty coursework,” stressed Mr. Hagerman. The Accreditation Council for Pharmacy Education (ACPE) does not keep track of specialty pharmacy coursework at colleges of pharmacy, according to Lindsay M. Antikainen, MS, accreditation facilitator for professional degree program accreditation. “The ACPE’s standards are really focused on developing a generalist curriculum, so the curricular content required by our standards is aimed at that,” she said. “Specialty coursework is really up to the individual programs to develop, both in terms of didactic and experiential curricula. That’s not something we track, as it varies widely from institution to institution.” Jennifer Hagerman, PharmD, who was an associate professor of pharmacy at Ferris State University College of Pharmacy, in Big Rapids, Mich., before becoming Diplomat’s director of education, said that students taking electives in specialty pharmacy or managed care will get basic introductions to the field. “But if you want to truly delve

—Caryn Dellamorte Bing, RPh, MS

pharmacy residency programs in the wake of ASHP’s new pharmacy residency accreditation standards. “We were all acutely aware of the number of residencies out there; they were all primarily hospital and academic-type residencies,” said Ms. Bing. “But more and more schools were starting to recognize that there were other sites of practice besides hospital or community settings. We had a wealth of experience with home infusion and saw the opportunity to build on that with a residency.” Dr. Filibeck noted, “We struggle for pharmacists, just like every other major segment of pharmacy. The schools don’t seem to be educating people for nonhospital, nonambulatory-type positions, and the move by ASHP and other professional associations to push for residency as a requirement for direct patient care gave us an opportunity to structure a residency and groom future pharmacists for our locations.”

Building Momentum

into specialty pharmacy, you have to do a residency.” Currently, there are only three ASHP categories for accrediting PGY-1 pharmacy residencies: communitybased, managed care and pharmacy practice. Specialty pharmacy residencies, like CCS’ home infusion program, are accredited under the pharmacy practice section, but Mr. Hagerman said that he thinks specialty pharmacy needs its own PGY-1 accreditation category. But that’s unlikely to happen, according to Janet Teeters, RPh, MS, ASHP’s director of accreditation services, because the group is aiming for fewer PGY-1 categories, not more. “We’re trying to merge community, managed care and pharmacy practice so that instead of three sets of standards for a residency you just have one,” she said. “Regardless of where your setting is, your residency should give all pharmacists these basic skills.” Other efforts to address the learning opportunities in specialty pharmacy also are moving forward. A new specialty pharmacy certification program, offered through the Specialty Pharma Education Center, will begin offering courses in September. To achieve certification as a certified specialty pharmacist, participants will be required to complete 30 hours of educational programs within a 12-month period. For its part, Diplomat has established an internal training program, called Diplomat University. “We partner with Ferris State University to provide specialty pharmacy continuing education programs for both our pharmacists and our technicians,” noted Dr. Hagerman. “This is in an effort to address the lack of time devoted to specialty pharmacy in the pharmacy school curriculum and in educational CE [continuing education] opportunities as a whole and to keep our pharmacists and technicians current in this rapidly growing industry.” —G.S.

In August 2007, CCS launched its PGY-1 home infusion residency program at five of its locations: Chicago; Houston; Philadelphia; Boston; and Tempe, Ariz. “At the time, the company was structured in five regions, and the company leadership supported putting a residency training program in each of our regions,” said Ms. Bing. During that first year, they were able to recruit only two residents—one in Philadelphia and one in Boston. During that year, both sites successfully went through ASHP’s accreditation process for PGY-1 pharmacy residencies, and the following year, CCS was able to recruit home infusion pharmacy residents for all five sites. By the program’s third and fourth years, they were able to fill the five residencies through the ASHP’s Residency Matching program. “We’ve gone from just a handful of applicants to having the high-class headache of being selective in screening potential applicants,” Dr. Filibeck said. The residency is set up as a hub-andspoke model, with central management of program design, standardized learning and policies. In addition to a primary corporate preceptor, there is at least one preceptor, and preferably more, working at each branch location where the resident is located. Pointing to some of the benefits of the program, Ms. Bing said that the home infusion residency offers pharmacy residents unique learning experiences. “We have an on-call component with 24/7 services to our patients, involving more ongoing clinical monitoring, I believe,

Specialty Pharmacy Continuum • Summer 2012

OPERATIONS & MANAGEMENT than what you would see in many hospital rotations. That experience is very acute—a patient is there for a couple of days and then discharged,” she noted. In contrast, she added, “our residents experience the continuum of care with the patients as they come out of hospital. We have the highest-intensity, highest-acuity patients, and the residents in our program learn how to respond to all facets of patient care.” On a typical day, CCS home infusion residents do many of the same activities CCS pharmacists do, such as taking referrals and managing patients through the care process. “The rest of the learning experiences are geared to give them exposure to things that they might not see in other programs, such as the opportunity to provide drug information and clinical information support, not just at their own location but across our entire network of home infusion branches,” said Cindy Kunzendorf, RPh, MBA, general manager of Accredo’s CCS locations. Residents can specialize in individual areas of home infusion, such as heart failure or nutrition. “My resident [Dr. Manning] is currently doing an extra rotation in nutrition, so that she can be more confident as a practicing clinician in managing home parenteral nutrition patients,” said Ms. Kunzendorf. Noting that the residency has exposed her to areas of pharmacy practice she had never experienced in school, Dr. Manning said, “I never learned about extended stability issues during my education. We’re dispensing a week’s worth of parenteral medication at a time and have to make sure it’s safe and will be effective for that patient in their home. Pharmacy school’s focus is either on the retail aspect or on the clinical aspect of hospital pharmacy. But in the hospital, you’re monitoring labs on a daily or every-other-day basis; with home infusion, it’s weekly, if that.”

At this year’s Armada summit, I spoke quite a bit about the need for specialty pharmacy to get involved in education and training of residents.” That’s not easy, conceded Jennifer Hagerman, PharmD, Diplomat’s director of education. “Your curriculum needs to be well defined, with clear goals and objectives and qualified preceptors. Residents need to be able to rotate through a number of different areas, such as operations, business development and managed care.” But the rewards can be substantial. Of

the four residents Diplomat has had so far (three in its prior community pharmacy residency and one in its new specialty pharmacy residency), three have been hired long-term, two in management roles. “It’s always about trying to find talented people to take your company to the next level,” Mr. Hagerman said. Given the lack of a stand-alone specialty pharmacy residency (sidebar), Mr. Hagerman thinks specialty pharmacy needs its own accreditation category. “Specialty pharmacy is a $100 billion segment of our industry,” he said. “It needs

its own specific, accredited program.” Dr. Filibeck wouldn’t argue with that. “There has been a true lack of good, experienced home infusion pharmacists, and creating a residency has empowered all of us to share our experience as the industry is growing and changing, and impart our knowledge to future leaders. When I look at these people, I know they will do something incredible with their careers, because they had such a good start.” —Gina Shaw

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Invaluable Guidance Dr. Manning praises CCS’ willingness to give residents the freedom to pursue their areas of interest. “They’ve let me take over the TPN [total parenteral nutrition] patients and work closely with one of the dietitians,” she said. “I have guidance from both Caryn [Bing] and Don [Filibeck], who are my corporate preceptors, and then I also have the branch preceptors. I think I’m being molded into a good, solid clinical pharmacist in home infusion.” “It’s so exciting to see that CCS has done this,” said Phil Hagerman, RPh, president and CEO of Diplomat Specialty Pharmacy, in Flint, Mich., the nation’s largest privately owned specialty pharmacy. “I think every small to mid-sized specialty pharmacy should be figuring out how to hire a resident.

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Specialty Pharmacy Continuum • Summer 2012

POLICY

Specialty Drug Market Share Set for Solid Growth Las V Vegas—The market share of specialty pharmaceuticals is set to grow in upcoming years, according to Douglas Long, vice president of industry relations for the health care industry research company IMS Health, Inc. In a presentation at the Annual Armada Specialty Pharmacy Summit, Mr. Long forecasted that “specialty categories will have better growth than traditional pharmaceuticals” and that “eight out of the top 10 drugs in 2015 might be specialty products.” Mr. Long pointed to recent increased spending on drugs for cancer, autoimmune diseases, HIV and hepatitis C as examples of some of the categories of specialty pharmaceuticals that will increasingly dominate the drug marketplace. Market research conducted by IMS, which is based in Parsippany, N.J., showed that overall prescription spending has grown inconsistently over the past five years, with a 3.7% spending increase in 2011 compared with 2010. Some reasons for the modest growth include the compounded effects of patients taking on a larger cost burden and overall decreases in spending due to the economic downturn, as well as a “drought” in innovation, medication safety concerns, conversions of prescription drugs to over-the-counter products and ongoing introductions of generics, Mr. Long explained. “The market share of generics is reaching an all-time high as many of the top-selling branded products are losing patent protection,” he said, noting that ggenerics accounted for 54% of market volume growth in 2011. Although overshadowed by spending on generics, spe-

cialty pharmaceuticals did account for 8.8% of overall growth in expenditures last year, he noted. Ten new branded specialty drugs are slated for approval by the end of 2013, including four drugs for the treatment of diabetes and three drugs for multiple

Table. FDA Approval Highlights of 2011 35 new drugs approved Second-highest total of last decade Two new drugs for hepatitis C One new drug for late-stage prostate cancer First new drug for Hodgkin’s lymphoma in 30 years First new drug for lupus in 50 years Seven new drugs that provide major advances in cancer treatment Two drugs (one for melanoma and one for lung cancer) represent breakthroughs in individualized medicine Ten indications for orphan diseases, which frequently lack any therapy

sclerosis, said Mr. Long. He also predicted that as an increasing number of biologic drug patents expire in 2013, some generic manufacturers might switch to investment in biosimilars creation. The shift will expand the product list for specialty pharmacies as expensive drugs in this class become more affordable and demand increases. “We believe biosimilars will succeed because payers will increasingly see bio-

‘We believe biosimilars will succeed because payers will increasingly see biologics as their main cost driver. However, biosimilars is not a short-term game.’ —Douglas Long

logics as their main cost driver,” he said. “However,” he added, “biosimilars is not a short-term game.” IMS has forecasted a 7.7% growth in spending on drugs in this class by 2015, with a further increase of 4.8% by 2020. The pace of biosimilar development and spending growth in coming years will largely depend on the balance between barriers and drivers to production and approvals, Mr. Long said. The FDA will require manufacturers to demonstrate equivalency to the

branded biologics they mimic, particularly during the next two to three years. Similarly, clinician safety concerns will need to be allayed. Furthermore, evolving regulatory manufacturing requirements and patent litigation also likely will serve as barriers. Counterbalancing these roadblocks will be p pressures from p patients and health insurers eager to access afford-

able versions of biologics, as well as from large companies such as Pfizer and Merck, both of which, he said, are planning to enter the biosimilars market. The hope is that these counterforces will expedite the formation of regulatory requirements, facilitating earlier adoption of good manufacturing processes, Mr. Long suggested. If the 35 new drug approvals issued in 2011 are indicative of things to come, there also will be more branded specialty pharmaceuticals entering the marketplace in the near future, Mr. Long said (Table). “Last year saw more new medicines launched than any other year in the past decade,” he noted. He pointed out that among the batch of new approvals were 10 specialty medications introduced for the treatment of orphan indications including Hodgkin’s lymphoma, systemic anaplastic large cell lymphoma, inoperable metastatic medullary thyroid cancer, congenital Factor XII deficiency, hereditary angioedema, late-stage nonsmall cell lung cancer, metastatic melanoma, kidney transplant anti-rejection, delayed-type hypersensitivity to Coccidioides immitis and clinical signs of scorpion envenomation. “If there’s a subtrend in specialty pharmaceuticals, it’s orphan drugs.” Commenting on the biosimilars trend in an interview, John Aforismo, RPh, the CEO and founder of RJ Health Systems, in Rocky Hill, Conn., predicted that the availability of more affordable biosimilars might result in more patients being treated with biologics. However, the parallel increase in the number of patients switching from branded biologics to biosimilars likely will affect the bottom line of specialty pharmacies. “Since payers will be significantly reducing their costs as they turn to biosimilars, pharmacies may want to negotiate compromise arrangements that incentivize the use of the biosimilar over the brand,” Mr. Aforismo said. Mr. Aforismo added that, despite greater access to biosimilars, “before a specialty medication is utilized, all other avenues should be exhausted. Remember, the right drug is needed for the right patient in order to have a successful therapeutic outcome,” he said. Furthermore, he noted, “We need to determine whether patients are adhering to their medication schedules, and if they are experiencing side effects, these should be addressed prior to making the decision to switch to a specialty pharmaceutical.” —David Wild Mr. Long and Mr. Aforismo reported no relevant financial conflicts of interest.

Specialty Pharmacy Continuum • Summer 2012

POLICY

Rayos Approved for Rheumatoid Arthritis, Other Indications

n July 26, the FDA approved Rayos, a delayed-release formulation of low-dose prednisone (Horizon Pharma), to treat rheumatoid arthritis (RA) and other diseases and conditions, including polymyalgia rheumatica, psoriatric arthritis, chronic obstructive pulmonary disease, and asthma. Rayos is available in 1-mg, 2-mg and 5- mg tablets. Known as Lodotra in Europe, Rayos has a four-hour time lag in its pharmacokinetic profile compared with immediaterelease prednisone formulations, according to a company press release. “Rayos, as studied in its clinical trials with ten p.m. dosing, reduces the overnight rise of inflammatory mediators, which results in less pain and stiffness for patients as they begin their day,” Michael Schiff, MD, a clinical professor of medicine in the Division of Rheumatology at the University of Colorado School of Medicine, in Aurora, stated in the press release. The effectiveness of Rayos was assessed in the CAPRA-2 (Circadian Administration of Prednisone in Rheumatoid Arthritis) trial, a 12-week, randomized, controlled study in patients with active RA (N=350). The patients had

been receiving non-biologic disease-modifying antirheumatic drug (DMARD) therapy for at least six months, with an incomplete response. Patients were randomized to Rayos 5 mg (n=231) or placebo (n=119) administered at 10 p.m. in addition to DMARD therapy. Patients treated with Rayos showed significant improvement in the primary endpoint of American College of Rheumatology 20 response criteria compared

with the placebo group (47% vs. 29%, P=0.001). Additionally, as a secondary endpoint, the CAPRA-2 investigators measured the relative change from baseline in duration of morningg stiffness at 12 weeks. The Rayos group had a median decrease in duration of morning stiffness of 55 minutes compared with 33 minutes for

placebo ((P=0.001). According to the Rayos prescribing information, common adverse reactions for corticosteroids such as Rayos in clinical trials include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changb es and increased appetite and weight gain. —George Ochoa

NSAIDs Tied To Nonadherence In Patients With RA

heumatoid arthritis (RA) patients who take a nonsteroidal anti-inflammatory drug (NSAID) are less likely to adhere to their prescribed drug regimen than patients who take a disease-modifying anti-rheumatic drug (DMARD), according to the latest National Health and Wellness Survey. The survey’s results, detailed in a press release from Kantar Media, showed that 32% of NSAID users are intentionally nonadherent compared with 13% of non-biologic DMARD users and 15% of biologic DMARD users. NSAID users are more likely to be uninsured compared with both categories of DMARD users. Compared to patients taking biologic DMARDs, NSAID users are more likely to have lower incomes (14% vs. 32% with income above $75,000) and they have a 13% higher rate of obesity. Compared with patients taking non-biologic DMARDs, NSAID users have lower mental quality-of-life scores (43 vs. 48 on a 100-point scale) and physical quality-oflife scores (35 vs. 38 on a 100-point scale). The survey used the Morisky Medication Adherence Scale (MMAS-4) to measure adherence and the Short Form (SF)-12v2 to measure health status. “The differences in adherence, and therefore health outcomes, between NSAID and DMARD users suggest that NSAID users are trying to manage their RA symptoms occasionally, rather than viewing RA as a condition that needs to be managed on an ongoing basis,” said Amir Goren, PhD, of Kantar Health, who conducted the survey. “Helping RA patients who use NSAIDs gain access to disease-modifying therapies may help increase their adherence and [improve] health outcomes.” —SPC Staff

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Specialty Pharmacy Continuum • Summer 2012

POLICY

A Step-Wise Plan Can Boost Reimbursement Phoenix—Gathering complete information, including patient credit card numbers, during intake and paying strong attention to proper coding are crucial when it comes to getting reimbursed for infusion services, according to presentations at the National Home Infusion Association’s annual conference. “Reimbursement is not an act, it’s a series of processes,” said David Franklin, the president and CEO of Advanced Care Consulting Services, in Shelby Township, Mich., who discussed the fundamentals of getting paid. There are four payers when it comes to health care, he said: government, commercial insurers, patients and, if payment isn’t made, providers. In that case, Mr. Franklin said, “you just became the provider and the payer at the same time, which is a really lousy business model.” Part of what makes reimbursement tricky is there’s no standardization, he said. You could take five patients with identical symptoms and have five reimbursement outcomes, depending on who is paying the bills. Two of the most common reasons infusion claims are rejected are incorrect diagnosis codes and incorrect service dates. “These are completely avoidable, because someone is entering the wrong data in the claim,” according to Marianne Swank, EDI reimbursement manager for Walgreens Infusion in Deerfield, Ill. Incorrect diagnosis codes usually result from someone not pulling them correctly from a drop-down computerized list in practice management systems or because a digit is missing from a referral source, Ms. Swank told Specialty Pharmacy Continuum. In that case, she said to call back the referral source for clarification. A common Medicaid rejection is code 165 (authorization needed). It could be that someone got the authorization, but it either was not documented on the claim form or not documented in the correct place. Invalid service dates result when a medication is dispensed one day, but the service doesn’t happen until the next day and you try to bill for it the day it’s dispensed. What’s concerning is that infusion providers’ claims are rejected much more often than other health care providers,’ according to Ms. Swank, and the proposed switch from International Statistical Classification of Diseases and Related Health Problems (ICD)-9 to ICD-10 codes in October will make it even more of a challenge to make sure billing is accurate. “Of all provider types, [infusion] rejections are almost twice as high as anyone else’s,” she said.

About 8.7% of all infusion claims that went through the claims management company Emdeon within a year’s time were rejected compared with 4.2% of other provider claims. Ms. Swank discussed the most common reasons claims were rejected for infusion services, based on information from Emdeon and two other claims management companies. Emdeon’s top reasons for rejections were factors including invalid service dates, diagnosis codes or payer information. Another company, RemitDATA, reported that during the last quarter of 2011, half of rejected Medicare claims were coded 204, an expected rejection; 8% were rejected because they were duplicate claims and 7% because they were noncovered services, deemed not a “medical necessity” by the payer. For Medicaid claims rejected during that same time period, 22% were refused because of a missing referral, 11% had submission or billing errors, 10% of claims were rejected for excessive charges and 10% because the services were not provided or authorized by the designated providers. And when it comes to commercial claims, 23% of rejected claims were refused for being duplicates, whereas 12% were considered noncovered charges. ZirMed, another claims management company, said in the first

two months of 2012 that its top rejection codes were for incorrect procedure descriptions, duplicate claims, no medical coverage effective for the date of service and invalid service dates. Ensuring reimbursement relies on several steps, including gathering complete information during intake, Mr. Franklin said. Often it’s the billing department that gets blamed for unpaid claims, he said, but those employees are really like janitors, trying to clean up “an ugly intake process.” It’s important to put a well-spoken, articulate person, not just any clerk, in an intake role. He recommended that the intake clerk take the following steps for a complete claim: gather patient demographic information including address,

‘Of all provider types, [infusion] rejections are almost twice as high as anyone else’s.’ —Marianne Swank emergency contact and employer information; obtain a patient’s credit card number and permission to use it when necessary; verify everything—physician information, medical orders, primary and secondary diagnosis (and making sure they support the order), insurance information and hospital information; check if hospice or other providers will be involved; and check any contracts with payers to make sure services will be covered. It is also imperative to ensure that customers have a clear understanding of their financial obligations because it makes them more likely to pay later,

Private payers make up 20% of patients. ‘These dollars are all of your profit and probably some of your overhead. You have to collect them. You simply have to.’ —David Franklin

Mr. Franklin said. Several years ago, private payers made up 2% to 3% of patients, and unpaid bills were regularly written off as bad debt. Now private payers make up 20% of patients, Mr. Franklin said: “These dollars are all of your profit and probably some of your overhead. You have to collect them. You simply have to.” Additionally, someone will need to check revenue qualifications with payers on a frequent basis, noted Mr. Franklin. Medicare patients’ cards can be scanned to verify coverage status and region to ensure the region is correct. Coding and other information should be checked monthly. Because Medicaid programs can vary by state, reimbursement staff will need to call or

check the Web site for updated information monthly. With more than 5,000 commercial payers, reimbursement is largely contract-driven, so contracts and documentation requirements should be checked quarterly. When it comes to documentation, dispensing orders are fairly simple— including a description of the product or service, the patient’s name and order date—but remuneration orders are more complex. They must list the full name of the patient, be personally signed and dated by a physician and include a detailed description of the product or service. If proof of delivery

Specialty Pharmacy Continuum • Summer 2012

POLICY

ACO MODEL continued from page 1

medication waste and any other variables that might save money for the payer and for the health care system as a whole, while preserving therapeutic outcomes.” Carrying out these analyses depends on the ability of individual pharmacies to procure data and requires significant investment into “enterprise data warehouses,” both Dr. Holliday and Mr. Hagerman emphasized. These warehouses can be used to collect and analyze data from a network of health care providers, adding value to the specialty pharmacy’s function in a provider network, Mr. Hagerman added. “Right now, we have labs, physicians and pharmacies all working with separate databases,” Mr. Hagerman explained in an interview. “However, in the new paradigm, which is built on a team-based approach, collection and analysis of data through centralized enterprise data warehouses will be key.” Providers can use the processed data to refine clinical practices, reduce inefficient spending and, by doing so, steer themselves towards optimal outcomes–cost ratios. As robust national and regional outcomes and cost data emerge, clinicians will be able to compare their warehoused data to “best-inclass” data from their region and across the country, Mr. Hagerman said. There also is an opportunity for specialty pharmacies to carve out a niche as part of the clinical delivery team in the accountable care environment by coordinating and delivering medication-related case management services, Mr. Hagerman added. “By guiding a team of nurses and pharmacists in reviewing a patient’s treatment, we can assess a medication’s side effects and provide palliative treatment when nec-

is required, delivery slips or trracking slips should be kept on file. If items are delivered to a nursing facility, it’s important to show that the supplies were received and used by a speecific patient. Physician notes, laboraatory results and anything else need ded to justify medical necessity allso should be filed. Coding correctly also is a mustt, Mr. Franklin said. Infusion providers may use a variety of codes—Healthcare Common Procedures Coding System (HCPCS), ICD-9, Current Procedural Terminology, Version 4 (CPT-4) and National Drug Codes (NDCs). Different

‘To maintain our position in a provider network, we need to show that our services and treatments are leading to both optimal therapeutic and financial outcomes.’ —Stephanie S. Holliday, PharmD

essary,” he said. “Rather than taking one set of health issues and creating others, we can help p shift patient care to a holistic case management approach and move from a reactive process to health problems to a more proactive approach to align with the ACO model.” Specialty pharmacies also can help biopharmaceutical companies disseminate novel medications, including biologics, which will gain market share over the next five years, according to Mr. Hagerman. “There are new and wonderful products in the pipeline, but the challenge is getting these often expensive drugs to people—to get the right patient on the right drug at the right time,” said Mr. Hagerman. “There are many things we can do to achieve this. For example, we can help reduce wasted product and, therefore, minimize costs for both patients and providers. This may mean beginning treatment with a short supply of medication until that treatment proves effective.” Specialty pharmacists also can help improve outcomes and reduce costs by offering companion diagnostic tests to determine the likelihood that a patient will respond to a specific medication, Mr. Hagerman said. Drug concentra-

tion assays, already available, can help fine-tune treatment and achieve appropriate serum drug doses, potentially reducing side effects while ensuring that treatment remains effective. Mr. Hagerman’s Flint, Michigan-based company, which is the largest independent specialty pharmacy in the country, provides a good example of the entrepreneurial approach specialty pharmacies might consider embracing in coming years. Their “Diplomat University” is an employee-training program that ensures staff members are familiar with the latest technologies and the current demands of health care delivery.

“We have seen improvements of more than 10% in numerous areas of our patient and physician satisfaction surveys since opening Diplomat University 18 months ago,” noted Mr. Hagerman. “Based on our experience, I believe all health care delivery companies should look seriously at internal educational initiatives as a key area to raise the bar in quality of care.” —David Wild

payers will require the use of different codes for reimbursement. If patients do not pay for portions

that aree not covered, it’s time to collect. Teelephone collections are more effectiive than repeat bills, according to o Mr. Franklin. When making a collections call, it is important to h have the following information n: nature of the debt, includin ng billing dates for thirdp arty payers; the reasons cclaims were rejected; and the dates the customer was billed. The correct person must be contacted—either the patient or the patient’s guarantor or spouse. If the debt is mentioned to anyone else, collection rights could be forfeited.

Mr. Franklin recommended that calls be made between the hours of 8 a.m. and 9 p.m. “Be polite but firm, do not let the customer control the call, state the facts slowly and respectfully, and give the customer a reason to pay, such as to stay honest or maintain a good credit rating,” he said. “Thoroughly document the date and time of the call, the party spoken to and the outcome. If a bill is not paid by a given cutoff date, write it off as bad debt and turn it over to a collections agency.” At that point, he said, any follow-up calls from a patient should be referred directly to the collections agency. —Karen Blum

‘Right now, we have labs, physicians and pharmacies all working with separate databases. However, in the new paradigm, which is built on a team-based approach, collection and analysis of data through centralized enterprise data warehouses will be key.’ —Philip Hagerman, RPh

Mr. Hagerman and Dr. Holliday reported no relevant financial conflicts of interest.

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340B Program a $6 Billion Market Force Deeply discounted drugs sold by manufacturers under the federal 340B drug pricing program provide billions of dollars a year in financial relief to more than 17,000 disproportion-share hospitals, clinics and other safety net providers covered under the program. The margin between buy-in costs and billing claims gives the 340B-covered entities the means to enhance clinical services and dispense more low-cost or free outpatient medications to uninsured and indigent patients. It also is critical to survival for some hardpressed 340B organizations. But for certain specialty products the discounts are not always available, particularly if manufacturers distribute the products solely through restricted networks. If these often costly drugs are obtainable at all, 340B providers frequently have to pay full price, reducing their ability to extend patient services. They also may be faced with deciding whether to administer specialty drugs that patients receive by mail from the exclusive networks and bring to their clinics for dosing—the so-called “brown-bagging” dilemma. Patientprovided drugs can increase uncompensated pharmacy costs, but more important they raise serious productintegrity questions. William von Oehsen, counsel to the Safety Net Hospitals for Pharmaceutical Access (SNHPA; pronounced SNAPA), said many of the organization’s more than 800 members “often find themselves excluded from those [limited] distribution networks,” and thus shut out from any possibility of discounts, which are not available through the networks. Mr. von Oehsen’s SNHPA co-counsel, Greg Doggett, said it was “really hard to gauge” how prevalent the lack of access is, but “based on the number of members that contact us about the challenges they experience trying to get the drugs at all or trying to get them at 340B prices, it is a common frustration among covered entities, particularly hospitals, which we represent.” Mr. Doggett acknowledged that there were legitimate reasons for manufacturers to restrict access to some of these often complex specialty treatments, including FDA-required Risk Evaluation and Mitigation Strategies (REMS). Others have noted at least one additional reason that prompts manufacturers to distribute their specialty products through large, limited-access networks: the ability to collect reliable national patient outcomes data. Mr. Doggett said, however, “there is concern among 340B providers that some manufacturers may be using these limited distribution systems to avoid selling the drugs at 340B prices.”

Mr. von Oehsen noted that the use of restricted networks could become even more widespread as “more and more specialty drugs are developed. So I think there is also trepidation about the future of this trend.” Indeed, the move in April by a group of health systems to form a nation-

al specialty pharmacy network called Excelera was primarily prompted by the challenge that restricted distribution networks posed to specialty drug access, as well as the retention of specialty pharmacy patients with complex health conditions (Specialty ( Pharmacy Continuum, Spring Issue). For the

‘The [340b] savings we can extract, and specifically from larger-cost specialty drugs, help offset … uncompensated care for the entire health system.’ —Daniel P. Kus, RPh

340B hospitals in the Excelera group, such as Henry Ford Health System and Fairview Health System, the lack of access to 340B pricing also meant being locked out of potential price discounts ranging from 25% to 50% that could be funneled into offsetting uncompensated care and extending patient services.

A Drug-Savings Juggernaut The stakes are great for 340B providers. In 2011, they spent roughly $6 billion for covered outpatient drugs, said Krista Pedley, PharmD, MS, director, Office of Pharmacy Affairs (OPA) at the Health Resources and Services Administration (HRSA), the unit that oversees the program. How much of that amount went for specialty drugs is unknown. Additionally, OPA doesn’t track pharmacy acquisition costs avoided by the program, but a backof-the envelope calculation based on the estimated discount range would put last year’s total 340B savings at between $2 billion and $6 billion. “The program is really important. It’s been tremendously successful, and it’s growing,” Dr. Pedley told Specialty Pharmacy Continuum. In 2005, there were 2,650 hospital sites in the program. HRSA’s most recent survey in April found that more than 5,000 hospital sites had become eligible, according to Dr. Pedley. The rapid growth has partly been fueled by the 2010 Accountable Care Act (ACA), which expanded eligibility to some 3,000 additional providers, including rural referral centers, critical access hospitals, freestanding cancer hospitals and sole community hospitals. Childrens hospitals, previously eligible under the Deficit Reduction Act of 2005, were also added under the ACA. So far, Dr. Pedley said, more than 1,600 of the newly eligible hospitals have registered for the program. Some of the 340B savings have gone to help disproportionate-share hospitals and others defray the cost of uncompensated care. Last year, for example, Henry Ford Health System in Detroit provided about $220 million worth of unpaid care to its indigent patients, said Daniel P. Kus, RPh, vice president of ambulatory pharmacy services. “The savings we can extract, and specifically from larger-cost specialty drugs, help offset that uncompensated care for the entire health system,” Mr. Kus said, adding, “the value to our system is about one-fifth of our total uncompensated care in any given year. “If we have a patient in the hospital who needs to be discharged but can’t be because they have no money to get their meds, our ambulatory pharmacies and

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Hennepin County Medical Center Benefits from 340B

he 340B discount program has given a welcome lift to Hennepin County Medical Center’s outpatient clinical programs, including a specialty pharmacy serving HIV patients on complex antiviral treatments. Behind a door marked only with the letters EPS (enhanced pharmacy services), HIV patients receive an extra measure of privacy when they arrive to pick up their medications. “The pharmacy also makes sure that they monitor the patients, so if they haven’t picked up their refills in a timely manner, there’s a feedback call to them,” Bruce Thompson, RPh, MS, director of health-system pharmacy services. “We certainly would not be able to provide those services if we didn’t have the 340B.” Using 340B fund benefits, Hennepin also recently launched a free mail-service program to make the delivery of specialty medications even more convenient and private. —B.B.

‘There is concern among 340B providers that some manufacturers may be using … limited distribution systems [for specialty pharmacy drugs] to avoid selling the drugs at 340B prices.’ —Greg Doggett our specialty pharmacy will absorb those costs,” he said, allowing the patient to be discharged with the assurance that “we can maximize their clinical outcomes. That’s one benefit of a specialty pharmacy being in an integrated network.”

A Boost to Clinical Care The 340B prices also have helped safety net hospitals expand and improve outpatient clinical services. At Minneapolis’s Hennepin County Medical Center, for instance, Bruce Thompson, MS, RPh, director of health system pharmacy services, said the $20 million a year spent for 340B-covered drugs “drives a positive margin” that allows our health system to expand services “both in pharmacy directly and in other patient-care areas.” Mr. Thompson said 340B savings helped increase the roster of pharmacists that provide medication therapy management services in community settings as well as in its clinics. Hennepin is in the midst of an expansion brought about by its status as an Accountable Care Organization (ACO). At the start of this year, he said, Hennepin and its physician group joined to become an integrated health care network and as a result, Mr. Thompson said, 44 clinics are now part of Hennepin’s ACO umbrella. “We’re looking to expand to more locations in the next couple of years,” he said. However, Michael Pitzl, RPh, director of community services, noted that without the cushion provided by 340B prices, Hennepin would not be able to provide additional pharmacists’ ser-

vices in those locations. “It’s not even an option,” he said. Mark Holtan, PharmD, manager of specialty services for the community pharmacy at Hennepin, added that “from the perspective of a front-line pharmacist at the pharmacy window, the ability to provide lifesaving medications to a patient who can’t pay” is one of the best benefits of the program.

IVIG Programs Benefit The 340B price discounts have also been crucial to programs that provide comprehensive care to patients needing costly specialty products for their survival, such as hemophiliacs and those requiring IV immunoglobulin (IVIG). In the United States, an estimated 20,000 or more people lack the clotting factors that normal individuals have to prevent uncontrolled bleeding episodes. These patients, many of them children, depend on the more than 140 federally supported hemophilia treatment centers (HTCs) to provide the clotting factor products that avert life-threatening hemorrhagic events. Most of the centers provide not just factor products but also the comprehensive care needed to reduce the risk for other chronic conditions that hemophiliacs are more likely to develop, such as heart and kidney disease. Joe Pugliese, president of the Hemophilia Alliance, said the treatment centers’ ability to provide these comprehensive services relies heavily on the savings that 340B program provides for clotting factor purchases, which can

cost as much as $250,000 a year for the average person with hemophilia. Mr. Pugliese also noted that the average discount on the “overwhelming majority” of factor products was not the 25% to 50% realized on most other products, but 17.1%. He added that the only time the average discount exceeded this percentage was when the average manufacturer price, or AMP, rose above the consumer price index. The 340B program “is absolutely critical to the sustainability of the comprehensive hemophilia treatment centers,” Mr. Pugliese said. It helps to cover “the annual visit to the HTC,” he added, “plus the ongoing uncompensated care that takes place between the visits.” He said, however, that Although HTCs have had few problems in obtaining access to factor products from manufacturers, they have sometimes been locked out of access to hemophilia patients because of patient assignment to exclusive provider networks. That was the case, he said, with Tricare, the huge U.S. Department of Defense health care program for military personnel and their families. Additionally, he said, five major Florida HTCs lost the chance provide care to Medicaid hemophiliacs in that state because they were not set up to respond to a statewide Request for Proposal issued by state health authorities. The contracts went to CVS Caremark and Coram Hemophilia Services. “Our position is that the HTC should always be the network for clinical care as well as for the pharmacy benefit,” Mr. Pugliese said. “There is an inherent benefit to the coordination of care between the clinical pharmacy and clinical care services that patients get at a treatment center. And we’re always going to be price competitive.” The 340B prices also are important to disproportionate share hospitals that provide IVIG treatments, but “the biggest concern with IVIG is always availability,” said Jerry Siegel, PharmD, FASHP, clinical associate professor at the Ohio State University College of Pharmacy, particularly of products that patients have been stabilized on and clinicians who have familiarity with the product profiles. “Formulary selection of all products, including IVIG, should always be driven by safety, efficacy and then cost,” Dr. Siegel said. “The availability of 340B pricing may not be the same for all IVIG products. For disproportionateshare hospitals this may be an important consideration.” Dr. Siegel noted, however, that “if economic considerations drive a change in IVIG product [selection], it may not be able to be used in all patient populations. Transplant and pediatric populations may be more

sensitive to adverse reactions and product tolerability.” He added, “while it might be desirable to have only one ‘workhorse’ IVIG product, it might be more practical to have a second product that is well tolerated in certain populations. Switching patients from one IVIG product requires caution, as each product has unique pharmaceutical differences and each patient may also have unique comorbid conditions. Matching the right product to the right patient is the ultimate goal. While access to 340B pricing is desirable to improve patient access and relieve disproportion-share hospitals from providing uncompensated care, it should not be the only reason for switching IVIG products.”

Profits or Patient Care the Real Driver? The size of the 340B percentage discounts have led some to question if the margins are being fully used to extend scarce patient-care resources or to bolster the bottom lines of disproportionate-share providers. Some Congressional lawmakers also have questioned whether 340B products are sometimes diverted to patients that don’t qualify under the program. However, a 2011 report by the General Accountability Office (GAO) found that among the organizations interviewed by investigators, 340B revenues were being used “in ways consistent” with the program’s purpose. The GAO also recommended that HRSA “take steps to strengthen oversight regarding program participation and compliance with program requirements.” In response, HRSA began a series of audits in February, the results of which Dr. Pedley said would soon be available on the HRSA Web site. —Bruce Buckley

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Carfilzomib Approval a Practice Changer? I

n late July, the FDA approved carfilzomib as a monotherapy for patients with relapsed and refractory multiple myeloma. Interviews with several hematology/oncology experts suggest that the drug, which will be distributed via specialty pharmacy networks, will have a significant impact on the treatment of this challenging malignancy. Onyx Pharmaceuticals, which will market the drug as Kyprolis, had asked that carfilzomib be approved for patients with multiple myeloma (MM) who are refractory to their most recent treatment and who had received at least two prior lines of therapy that included the proteasome inhibitor bortezomib (Velcade, Millennium) and an immunomodulatory agent—either thalidomide or lenalidomide (Revlimid, Celgene). The FDA granted that indication—a decision that followed an 11-0 recommendation for approval by the agency’s Oncologic Drugs Advisory Committee (ODAC). A single-arm, Phase II study (003A1) in 266 patients with relapsed and refractory multiple myeloma was the central trial in carfilzomib’s new drug application. The overall response rate (ORR) was 22.9%, with a median response duration of 7.8 months. Additionally, 62% of responding patients maintained response for at least six months and 27% for at least 12 months. Response did not differ by baseline demographics, disease-related or treatment-related characteristics, including whether patients were refractory to both bortezomib and lenalidomide. These results compare favorably to reports of single-agent therapies in patients with relapsed and refractory MM. The drug was well tolerated. Prior to the ODAC meeting, the FDA distributed a briefing document suggesting the drug’s benefit might not outweigh the risks, especially cardiac risks. In the 0031A1 study, according to the briefing document, seven deaths that occurred in the carfilzomib arm most likely were caused by cardiac toxicities. At the ODAC meeting, however, a non-voting participant from the FDA downplayed this data, saying the life-threatening heart-lungand liver-related adverse events (AEs) documented in the clinical trial were seen in only 4% of patients. The FDA participant pointed out that the singlearm design of the carfilzomib study made it difficult to correlate the deaths directly to the drug therapy, adding that it was not clear what the disease, previous therapy or the study drug itself might have played in the AEs documented in the study. Moreover, Onyx presented data that cardiac toxicities were common in patients with heavily pretreated MM. “It was really unclear whether there was any cause and effect between the carfil-

‘It was really unclear whether there was any cause and effect between the carfilzomib [study arm] and cardiac toxicity.’ —Wyndham Wilson, MD, PhD

Table. Discontinuations in Multiple Myeloma Patients Due to Adverse Events Adverse Event

Incidence (N=526) (%)a,b,c

Dyspnea

10 (2)

Pneumonia

10 (2)

Cardiac failure (congestive)

9 (2)

Renal failure (acute)

9 (2)

Blood creatinine increased

7 (1)

Pyrexia

6 (1)

Cardiac arrest

5 (1)

Thrombocytopenia

5 (1)

Excludes adverse events attributed to progressive multiple myeloma disease (e.g., disease progression, hypercalcemia, spinal cord compression).

Patients may be counted in more than one adverse event category

Data culled from several Phase II studies; not limited to the 003A1 trial.

zomib [study arm] and cardiac toxicity,” said Wyndham Wilson, MD, PhD, ODAC chairman and chief of Lymphoma Therapeutics at the National Cancer Institute. He said he had no hesitation voting yes.

Option for Refractory Patients Shaji Kumar, MD, an MM expert at Mayo Clinic, in Rochester, Minn., said that carfilzomib “adds one more option for patients who have exhausted currently available therapies” and carries an added benefit: “It causes very little neuropathy.” This AE can range from tingling and numbness in the fingers and toes, to painful neuropathy and to auto-

nomic neuropathy. The condition is a common dose-limiting toxicity of several MM therapies, including bortezomib, thalidomide and vincristine. In the case of IV bortezomib, the drug is associated with a 53% rate of peripheral neuropathy, 16% of which is grade 3/4, according to the drug’s Prescribing Information. In the carfilzomib study, 12.4% of patients had treatment-emergent peripheral neuropathy, with only 1.1% being grade 3, and grade 4 neuropathy was nonexistent. No patients discontinued treatment because of neuropathy. (See Table for other AEs linked to discontinued treatment.)

“Neuropathy is a problem that, although not life-threatening, is very vexing,” said Ravi Vij, MD, an associate professor of medicine in the Division of Oncology at Washington University School of Medicine, in St. Louis, who was involved with the carfilzomib trials. Lenalidomide, in contrast, is rarely associated with mild neuropathy, he added. If neuropathy does set in, Dr. Vij said, it often takes weeks or months to resolve and good supportivecare treatments do not exist. Dr. Vij added that pharmacists also should keep an eye out for dyspnea associated with carfilzomib therapy; 33.8% of patients in the 003A1 study experienced dyspnea of any grade; 3% experienced grade 3 and 0.04% experienced grade 4. “When people use carfilzomib in the community, they will need to be a little vigilant about dyspnea,” he stressed. Prior to the drug’s approval, some analysts speculated that the FDA might impose a postmarketing program to help ensure the safe and effective use of carfilzomib. Something of the sort did occur; as a condition of carfilzomib’s accelerated FDA approval, Onyx Pharmaceuticals is required to provide additional clinical data about the drug. According to the manufacturer, such studies are now underway.

Strength in Numbers Both Drs. Kumar and Vij said that carfilzomib is likely to be used in combination with at least dexamethasone or even with lenalidomide and dexamethasone. Twoand three-drug combinations are common in MM, they noted. Their views, stated just prior to the drug’s approval, proved to be partly prescient; the FDAapproved drug label recommends that patients should be premedicated with dexamethasone before each infusion to lower the risk for infusion reactions. Dr. Kumar added that he also sees a role for carfilzomib in up-front therapy, “but obviously there are no Phase III trials that have been done, so there is not going to be an approval in that setting,” he said. “It is something that needs to be studied.” A recent Phase I/II study suggested that up-front combination therapy might indeed be a viable option. The study evaluated carfilzomib in tandem with lowdose dexamethasone and lenalidomide. Of 36 patients newly diagnosed with MM completing eight or more cycles of therapy, 42% reached stringent complete responses. The 24-month progression-free survival estimate was 92%, the investigators reported (Blood ( d 2012 June 4 [Epub ahead of print]. The results were first presented at the 2011 annual meeting of the American Society of Hematology, in San Diego; abstract 631.)

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How the drug will be used also will depend on whether insurers will pay for it, which is dependent on the FDA label and compendia listing, Dr. Kumar noted. The cost of the drug and schedule also will influence use. Convenience also may play into treatment decisions. “With carfilzomib you have to come back two days every week, whereas Velcade, depending on what schedule you are using, can be two days per week or one day per week,” Dr. Kumar said. “I don’t think there is going to be one answer that fits all in how this drug will be used.”

Oncology Pharmacist’s View Ali McBride, PharmD, MS, a clinical pharmacy specialist at the Arthur G. James Hospital, The Ohio State University, in Columbus, said he agreed that several questions remain as to how the drug will be used in clinical practice, including whether the drug has potential for up-front therapy. The proper sequencing of carfilzomib also remains to be determined, he noted. “If you give bortezomib first, can you then use carfilzomib if the patient fails to respond? Or do you use carfilzomib as initial therapy followed by bortezomib?” All of these various clinical scenarios “may be in the mix in terms of potential ways to maximize patient response,” he noted. Dr. McBride pointed to a recent study ( (Blood d 2012;119:5661-5670) as evidence that using carfilzomib first may be the preferred strategy. In the multicenter, open-label Phase II trial, 129 bortezomib-naive patients with relapsed/refractory MM were treated with IV carfilzomib in two cohorts. Patients in cohort 1 were given 20 mg/m2 of the drug for all treatment cycles; cohort 2 received 20 mg/m2 for cycle 1 and then 27 mg/ m2 for all subsequent cycles. The clinical benefit response (overall response rate plus minimal response) was 59.3% in cohort 1 (95% CI, 45.7-71.9) and 64.2% in cohort 2 (95% CI, 51.5-75.5), according to the study, which included Dr. Vij as a co-investigator. Consistent with the FDA trial data, carfilzomib elicited a relatively low incidence of peripheral neuropathy (17.1% overall, with one grade 3 and no grade 4), the investigators reported. The lower rate of peripheral neuropathy seen in clinical trials of carfilzomib is significant, Dr. McBride stressed. Indeed, “It may prove to be one of the guiding points in choosing this drug over bortezomib,” he said. He noted, however, that there are now data suggesting that a subcutaneous (SQ) formulation of bortezomib also causes very low rates of peripheral neuropathy. In one study ((Lancet Oncol 2011;12:431-440), peripheral neuropathy of any grade occurred in 38% of patients given SQ bortezomib vs. 53% treated with an IV formulation ((P=0.044). “It will be interesting to

see what the head-to-head numbers on peripheral neuropathy are for these two drugs in patients with multiple myeloma,” Dr. McBride said. As far as reimbursement—always a key consideration with newly approved agents—Dr. McBride said it is a bit too soon to speculate on any issues that may arise. “As usual it will be a payer-driven decision,” he said. “The big issue, at least initially, is to remember that you will only be able to use the drug in the relapsed/refractory setting. Payers will most likely be very firm in

paying only for that indication.” Dr. McBride added a final note of caution based on the data from the 266-patient carfilzomib study: the trial did not establish whether the drug prolongs patients’ lives or increases progression-free survival, both of which are considered to be important markers of clinical response. Still, carfilzomib’s approval “is an important addition to our armamentarium for multiple myeloma—especially given its role in patients who are running out of other treatment options.” During a conference call, a spokesper-

son with Onyx said that carfilzomib’s specialty pharmacy distribution would begin by August 1. —Kate O’Rourke, with additional reporting by David Bronstein Dr. Vij is on the advisory board of Onyx and Celgene and has received grant funding from the companies. Dr. Kumar is the principal investigator on clinical trials supported by Celgene, Cephalon, Genzyme, Millennium and Novartis. Drs. Wyndham and McBride reported no relevant financial conflicts of interest.

Specialty Pharmacy Continuum • Summer 2012

CLINICAL D IS EASE ST A T E S P O T L I GH T

Managing the MS Patient: The Pharmacist’s Role Richard T. Miller, RPh, MBA Director of Clinical Services Walgreens Specialty Pharmacy Pittsburgh, Pennsylvania

Multiple sclerosis (MS) affects roughly 400,000 Americans and more than 2 million people worldwide, making it one of the most common neurologic disabilities.1 In the United States, someone is diagnosed with MS every hour. Due to factors ranging from the high cost of medication to the need for support—such as assistive devices and nursing care—MS management costs in the United States are estimated to be more than $16 billion annually.2 This chronic and progressive autoimmune disorder can be difficult to manage, causing a wide variety of symptoms, ranging from balance and cognitive problems to fatigue and depression. Given the range of symptoms and progressive nature of the disease, management of this patient population can be challenging, requiring a unique approach that can be provided through specialty pharmacy. Although there is no cure for MS, there are a number of treatments available that can slow disease progression or modify

its course. Without treatment, the disease may continue to progress and lead to further, irreversible damage, making adherence crucial. Remaining adherent to treatment regimens can be difficult for patients because most of these medications are complex, requiring injection or infusion, and they sometimes have debilitating side effects. Specialty pharmacists, therefore, can play a key role in helping patients with MS manage their treatment.

A Progressive Disease MS is more common in women and most often is diagnosed between ages 20 and 50.1 The cause of MS is unknown. Although MS has a genetic component, researchers believe other factors may be involved, including infection, geographic location, and environmental causes.3 In a patient with MS, the body’s immune system mistakenly attacks the myelin sheath that protects nerve fibers, damaging the central nervous system (CNS)—including the brain, spinal cord, and optic nerves. The resulting demyelination, or scarring, interferes with the ability of the CNS to transmit signals along the nerves. Nerves throughout the body can be affected, and symptoms can vary widely, and most commonly include numbness, balance and coordination problems, bowel and bladder dysfunction, vision problems, dizziness and vertigo,

sexual dysfunction, pain, cognitive dysfunction, emotional changes, and spasticity. Depression and fatigue also are common and can interfere significantly with quality of life (QoL).4 There are 4 types, or courses, of MS progression—relapsing-remitting, primary progressive, secondary progressive, and progressive relapsing. Each course can be mild, moderate, or severe. Most

Managing Multiple Sclerosis Patients in the Retail Setting

aving direct and consistent contact with a specialty pharmacist can be more important for patients with MS than for those with many other conditions. For this reason, Walgreens has piloted a number of specialty pharmacy programs at retail pharmacies that look at how well MS patients are managed when they receive their medications from a Walgreens community pharmacy. Traditionally, specialty pharmaceuticals are dispensed through a central fulfillment center that sends the medications to a patient’s home via the mail or delivers them directly to a doctor’s office for treatment. Within this model, specialty pharmacists and patient care coordinators handle most of their work with a patient over the phone. This is a highly effective way to manage patients with conditions such as MS. This model also provides an extra opportunity for pharmacy professionals to connect with patients that can make all the difference for medication adherence, which is especially complicated because of the severe fatigue and depression symptoms commonly associated with MS. However, when MS management is shifted to a community pharmacy, some of the important services provided by specialty pharmacists—including prior authorizations, access to limited-distribution drugs, and third-party coordination—can become more challenging. For this reason, Walgreens developed the Specialty Retail Support Center, which includes a full team of specialty pharmacists and patient care coordinators who are dedicated to supporting retail pharmacists as they work with patients who take specialty medications. Instead of spending time on prior authorizations and other time-consuming paperwork, these operations have been shifted to the team at the Specialty Retail Support Center, so retail pharmacists can continue to focus on patient care. With this resource in place, Walgreens Specialty Pharmacy launched an MS clinical program in December 2010. The program was designed to be more patient-centric than the retail pharmacy programs available at the time, and included enhanced levels of monitoring and care, such as regular assessments with patients, screenings for fatigue and depression, and medication side-effect management. An assessment of this program is under way to measure the benefits of the added screenings and high-touch care from a pharmacist. The MS clinical program and Specialty Retail Support Center model is an important case study in providing specialty pharmacy resources in the community through retail pharmacies. Although a community-based retail pharmacy often may provide more convenience for patients and more opportunities for high-touch care, it is essential that resources be in place to reduce the amount of time spent by retail pharmacists on administrative procedures, allowing more opportunity to focus on direct patient care.

people (85%) initially are diagnosed with relapsing-remitting MS; during this course of the disease, they suffer flare-ups of symptoms alternating with complete or partial remission during which no disease progression occurs.5 In the secondary-progressive course, the disease worsens steadily, with fewer or shorter periods of remission. Historically, about 50% of people diagnosed with the relapsing-remitting form developed secondary progressive MS within 10 years. Long-term data are not yet available to determine if treatment with the disease-modifying therapies, which became available starting in the 1990s, significantly delays this transition.5

MS Therapy and Challenges Because there is no cure for MS, the goal of therapy is to decrease the scale of disability, slow progression of the disease, treat individual symptoms, and enable the highest QoL possible. Management of MS patients is multipronged and can include diseasemodifying agents, corticosteroids to treat severe flare-ups, and symptom management medications to address specific symptoms. Additionally, most MS patients benefit from various forms of rehabilitation, such as physical therapy, occupational therapy, speech and swallowing therapy, cognitive rehabilitation, and vocational rehabilitation. Approximately three-fourths of MS patients find benefit in complementary therapies, such as acupuncture and biofeedback.6

Specialty Pharmacy Continuum • Summer 2012

CLINICAL

There are 8 FDA-approved diseasemodifying agents that are considered primary therapy for MS: interferon beta (IFNβ)-1a (Avonex, Biogen Idec; Rebif, EMD Serono), IFNβ-1b (Betaseron, Bayer; Extavia, Novartis), glatiramer (Copaxone, Teva), mitoxantrone, natalizumab (Tysabri, BiogenIdec/Elan), and fingolimod (Gilenya, Novartis). Of these, 5 are administered by injection, 2 are infused and the newest, fingolimod, is oral (Table). These agents are effective for many patients.7 However, medication adherence is a major concern due to the complex administration of most of the agents (infusion and self-injection) and their debilitating side effects, most notably flulike symptoms and headache. In a multicenter study of MS patients prescribed injection disease-modifying agents, nonadherence rates (patients missed 1 or more injections) ranged from 36% to 39%.8 The most common reason for nonadherence was forgetting to administer the injection (58%). Other reasons included injection-site reactions, diminished QoL, unfavorable perceptions of injectable medications, depression, and lack of support. Although the move toward oral medications removes some of those factors, adherence issues are not completely resolved because patients may forget to take their medications and side effects remain problematic. Side effects such as fatigue and depression are major challenges in the management of patients with MS, and their effects are multifactorial. They are not only difficult for patients to deal with, but they also can negatively affect medication adherence. Patients with MS have a 25% to 50% lifetime risk for developing depression,9 with symptoms ranging from a general state of sadness to decreased energy and even thoughts of suicide. Patients with MS who have depression are more likely to have a worse prognosis and more rapid disease progression.10 More than 80% of people who have

Myelin sheath

Normal

MS suffer from fatigue, and most say it is the worst symptom.11,12 Fatigue tends to worsen later in the day and can significantly interfere with a patient’s ability to function, at home and at work. Fatigue may last less than a month to 6 months or longer.

Walgreens Specialty Pharmacy Solutions Walgreens Specialty Pharmacy employs an approach that promotes the patient’s self-efficacy in managing specific MS symptoms. Walgreens keeps in mind that each individual has his or her own unique experience of medication side effects and MS symptoms. This patient-centric support is driven by scheduled assessments and screenings, not only for medication-specific side effects but also for depression and fatigue. These assessments are the cornerstone of Walgreens’ MS patient care. All of the disease-modifying agents are available to MS patients through

Damaged myelin

Multiple Sclerosis

Walgreens Specialty Pharmacy and are delivered to the patient’s door via fulfillment centers nationwide. In some cases, patients also may be able to receive their MS medications at a Walgreens community pharmacy. No matter the method of delivery, Walgreens Specialty Pharmacy provides quality care through extensive support services that include assisting patients in obtaining medications, coordinating insurance benefits, assisting with financial aid, and providing individualized therapy management and clinical support. Specialty pharmacist support of patients with MS is wide-ranging, and includes educating them about disease progression, ensuring appropriate medication dosing and administration, managing side effects, providing adherence support and assistance, providing recommendations regarding supportive care, and offering advice about overall health and wellness. The specific services and interventions provided

to ensure optimal care include initial health assessments, monthly follow-up assessments, and quarterly depression and fatigue screening. During the initial assessment, a Walgreens patient care coordinator asks the patient a series of questions to glean information on the patient’s experience with MS, the patient’s medication history, how the disease is affecting the patient’s life, and current medication regimen and concerns. The initial assessment also includes questions designed to determine whether the patient is experiencing symptoms of depression. If further assistance is needed—for instance, if the patient indicates that he or she has difficulty taking medications—the patient is referred to a Walgreens specialty pharmacist who provides follow-up guidance. All patients receive a variety of educational information, including a Wellness Planner that includes informative booklets on MS-related clinical issues (such as coping with depression or dealing with walking problems) and what to expect from MS medications. Follow-up assessment calls occur monthly and also involve a series of questions designed to provide patientcentric responses focusing on the patient’s compliance with medications, related concerns, and QoL. Walgreens may provide other support, such as following up with the care provider or helping the patient with financial assistance support. Specialty pharmacists can help answer a wide range of questions and address concerns related to side effects, allergic reactions, exacerbation of symptoms, medication efficacy, and injection-site reactions. The specialty pharmacists then may follow up with the patient’s physician if needed, such as when the patient is noncompliant. Additionally, Walgreens contacts every MS patient quarterly to screen for possible fatigue and depression, employing 2 standardized assessment see MANAGING MS, page 20

Patient Case

K is a 36-year-old man who was diagnosed with MS in 2008. He was started on subcutaneous glatiramer (Copaxone, Teva) and receives his medication and equipment from Walgreens Specialty Pharmacy monthly by mail. JK has struggled with several MS-related issues that have affected medication compliance, including quality-of-life concerns surrounding the medication, financial issues, and side effects. He has received extensive support from Walgreens to facilitate his compliance. Since starting therapy, JK has been counseled by a specialty pharmacist 4 times regarding issues that were raised by a Walgreens patient care coordinator, has completed 28 clinical assessments, and has received 6 letters reminding him to refill medications when no response was received from phone calls. In addition to these interventions, when JK reported a rash over his entire body in April 2009 and an injection-site reaction in September 2009, the specialty pharmacist intervened and communicated with JK’s physician.

Despite these efforts, like many MS patients, JK continued to struggle with medication-compliance issues. In November 2010, he stopped ordering his medications, stating that he was simply tired of taking them. A Walgreens specialty pharmacist intervened and, with the support of his physician, JK was able to return to therapy. In February 2012, JK experienced financial obstacles to obtaining his medication as he waited for funds to be deposited in his health savings account. Walgreens patient care coordinators worked with him to return him to therapy as soon as possible when funds were restored, and a Walgreens specialty pharmacist counseled him on medication compliance after he had missed a few weeks’ worth of therapy. Since this most recent intervention, JK has reported adherence to his medication regimen and has not missed a refill. This case study shows the issues faced by many MS patients and underscores the importance of regular contact and intervention by a specialty pharmacist.

Specialty Pharmacy Continuum • Summer 2012

CLINICAL

MANAGING MS continued from page 19

tools: the Modified Fatigue Severity Scale and the Whooley Depression Screen. If results are positive, the patient’s physician is alerted to ensure that these self-reported issues are addressed. Management of depression in MS patients is key to ensuring wellbeing and medication adherence.13

Improved Outcomes, Lower Costs The goal of the Walgreens MS clinical program is to provide excellent patient care resulting in reduction or delay of disease progression, improved outcomes, enhanced QoL, and decreased health care costs. Close contact, as provided by Walgreens, is particularly important to help patients with MS understand the importance of taking their medications and to manage their not-inconsequential side effects. The medication possession ratio of Walgreens-managed MS patients is 94%,13 which is significantly higher than the 63% reported in one study of patients treated at 17 neurology clinics.8 Through the quarterly screening program, specialty pharmacists play an important role in early identification of patients who may be suffering from

depression and fatigue and ensure these issues are addressed by the patient’s physician. Research has shown that managed MS patients whose depression symptoms were addressed were significantly more compliant in taking their MS medications than those whose depression was not managed: 86% versus 38%, respectively.2 Additionally, studies have shown that overall health care costs are lower for patients who are medication-adherent compared with those who are not.14-18 Although research is limited regarding the relationship between adherence and cost of MS medications, preliminary Walgreens research suggests that although drug costs are lower for patients who are noncompliant, medical costs are significantly higher, including costs for inpatient admissions and MS-related medical service costs.19 Furthermore, patient nonadherence is costly from a health aspect, resulting in poorer health care status.

Conclusion Specialty pharmacists play a crucial role in the continuity of care for MS patients. A system of pharmacy-provided support that includes regular contact, expert guidance, and excellent care is the cornerstone of specialty pharmacists’ ability to improve medication adherence and increase QoL for MS patients.

References 1. National Multiple Sclerosis Society. About MS. http://www.nationalmssociety.org/aboutmultiple-sclerosis/index.aspx. Accessed July 9, 2012. 2. Edlin M, Sonnenreich P. Trends in managing multiple sclerosis. PT. 2008;33(10):611-614. 3. Ziemssen T. Multiple sclerosis beyond EDSS: depression and fatigue. J Neurol Sci. 2009;277(suppl 1):s37-s41. 4. National Multiple Sclerosis Society. What causes MS. http://www.nationalmssociety. org/about-multiple-sclerosis/what-weknow-about-ms/what-causes-ms/index.aspx. Accessed July 9, 2012. 5. National Multiple Sclerosis Society. What is multiple sclerosis? http://www.nationalmssociety.org/about-multiple-sclerosis/whatwe-know-about-ms/what-is-ms/index.aspx. Accessed July 9, 2012. 6. National Multiple Sclerosis Society. Complementary & alternative medicine. http://www. nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/ complementary—alternative-medicine/index. aspx. Accessed July 9, 2012. 7. National Multiple Sclerosis Society. Treatments. http://www.nationalmssociety.org/ about-multiple-sclerosis/what-we-knowabout-ms/treatments/index.aspx. Accessed July 9, 2012. 8. Treadaway K, Cutter G, Salter A, et al. Factors that influence adherence with disease-modifying therapy in MS. J Neurol. 2009;256(4):568-576. 9. Chwastiak L, Ehde DM, Gibbons LE, Sullivan M, Bowen JD, Kraft GH. Depressive symptoms and severity of illness in multiple sclerosis: epidemiologic study of a

large community sample. Am J Psychiatry. 2002;159(11):1862-1868. 10. Joffe RT. Depression and multiple sclerosis: a potential way to understand the biology of major depressive illness. J Psychiatry Neurosci. 2005;30(1):9-10. 11. Zifko UA. Management of fatigue in patients with multiple sclerosis. Drugs. 2004;64(12):1295-1304. 12. Zifko UA. [Therapy of day time fatigue in patients with multiple sclerosis]. Wien Med Wochenschr. 2003;153(3-4):65-72. 13. Walgreens data on file. 14. Horne R. Compliance, adherence, and concordance: implications for asthma treatment. Chest. 2006;130(1 suppl):s65-s72. 15. Osterberg B, Blaschke T. Adherence to medication. N Engl J Med. 2005:353(5):487-497. 16. Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005;43(6):521-530. 17. Svarstad BL, Shireman TI, Sweeney JK. Using drug claims data to assess the relationship of medication adherence with hospitalization and costs. Psychiatr Serv. 2001;52(6):805-811. 18. Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004;4(3):191-195. 19. Khandelwal N, Jiang J, Moyer S, et al. Relationship between adherence to multiple sclerosis medications and total healthcare costs. Presented at the International Society for Pharmacoeconomics and Outcomes Research 13th Annual International Meeting; May 3-7, 2008; Toronto, Ontario.

Table. Characteristics of Multiple Sclerosis Medications Drug

Indication

Dosage

Storage

Interferon-beta-1a (Avonex, Biogen Idec)

Relapsing forms of MS

30 mcg intramuscularly 1 time per week

Refrigerate and protect from light. Vials may be stored at room temperature for up to 30 days, syringes for up to 7 days.

Interferon-beta-1a (Rebif, EMD Serono)

Relapsing forms of MS

22 or 44 mcg subcutaneously 3 times per week; titration required

IFNβ-1b (Betaseron, Bayer)

Relapsing forms of MS

250 mcg subcutaneously every other day

Store at room temperature, but refrigerate after reconstitution and use within 3 hours. Do not freeze.

Fingolimod (Gilenya, Novartis)

Relapsing forms of MS

0.5 g orally daily

Store at room temperature.

Glatiramer (Copaxone, Teva)

Relapsing-remitting MS

20 mg subcutaneously daily

Refrigerate; may be stored at room temperature for up to 30 days.

Natalizumab (Tysabri, Biogen Idec/Elan)

Relapsing forms of MS

300 mg IV every 4 weeks

Refrigerate and protect from light. After dilution, solution should be infused immediately. If not used immediately, refrigerate solution at 2°-8°C, and use within 8 hours (warm to room temperature prior to administration). Do not freeze.

Mitoxantrone

Secondary progressive MS, progressiverelapsing MS, worsening relapsing-remitting MS

12 mg/m2 IV every 3 months (lifetime max: 140 mg/m2)

Store at room temperature. After penetration of the stopper, store remaining undiluted concentrate no longer than 7 days between 59° and 77°F or 14 days under refrigeration. Do not freeze.

IFNβ-1b (Extavia, Novartis)

Look for our next Disease State Spotlight on pulmonary arterial hypertension in the fall issue.

Specialty Pharmacy Continuum • Summer 2012

CLINICAL

EFFICACY continued from page 1

therapy—a counseling message stressed by a coauthor of the new study. “We certainly are not suggesting that patients stop their medication,” Helen Tremlett, PhD, of the University of British Columbia in Vancouver, said in an interview with Specialty Pharmacy Continuum. “We knew before we started this study that these drugs are effective in terms of reducing relapse rates by about a third, and they also have a beneficial impact on the brain lesion load as measured by MRI. Those outcomes are still valid. This study asks a different question that couldn’t be addressed by short-term clinical trials.”

Study Details The study compared data on 868 drugtreated patients with untreated contemporary (n=829) and historical (n=959) cohorts. The main finding: Interferonβ therapy was not associated with a significantly lower hazard of reaching a disability score of 6 on the Expanded Disability Status Scale (EDSS), Dr. Tremlett and her colleagues reported. That disability is defined as the need for a cane to walk 100 m, confirmed at more than 150 days from baseline with no measurable improvement. Drilling a bit deeper, rates of reaching an EDSS score of 6 were 10.8%, 5.3% and 23.1% in the interferon, untreated contemporary and historical cohorts, respectively, with median active follow-

‘[Patients in the study] may not have had adequate treatment time to affect their progression to disability. . . [They] should continue to use interferon beta products as the medical community continues to search for even more effective ways to treat MS.” —Melody Ryan, PharmD, MPH up times (first to last EDSS measurement) of 5.1, 4.0 and 10.8 years. Adjustment for potential confounding variables did not yield statistically significant differences between the treated group and the contemporary cohort (hazard ratio [HR], 1.30; 95% confidence interval [CI], 0.92-1.83; P=0.14) or the historical cohort (HR, 0.77; 95% CI, 0.58-1.02; P=0.07). The results did not change with further adjustment for comorbidities, socioeconomic status and propensity scores. Patients were taking one of four preparations: interferon β-1b (Betaseron 250 mcg subcutaneously on alternate days) and interferon β-1a (Avonex, 30 mcg intramuscularly once weekly; and Rebif 22 mcg and 44 mcg subcutaneously thrice weekly). Switches between products and breaks of less than three months between consecutive prescriptions were not considered changes in treatment status. Alhough evidence about differences in therapeutic effectiveness among these drugs is lacking, “we were assuming they all had the same impact,” Dr. Tremlett said.

Patients in the control groups were not on any disease-modifying drugs for MS. Despite the adjustment for propensity scores, “the data hint that indication bias may still be present in the data in the contemporary analysis, which makes the historical control group [for whom interferon-β therapy was not yet available] a real bonus to the study,” said Dr. Tremlett, an epidemiologist who originally trained as a pharmacist in the United Kingdom. Dr. Tremlett said she hopes pharmacists and other health professionals will counsel MS patients to have more realistic expectations about interferon-β therapy. However, the data suggest there may be subgroups of patients who experience long-term benefits. “That is where we’re going next—trying to see if we can tease out who those responders might be” to support more effective, personalized treatment, she said.

Putting Results in Perspective Jacci Bainbridge, PharmD, professor of clinical pharmacy at the Skaggs School of Pharmacy and Pharmaceuti-

cal Sciences of the University of Colorado Denver, said that nonadherence to therapy, a major problem among MS patients, could have influenced the results. “We don’t really know if that was accounted for in that patient population,” said Dr. Bainbridge, a clinical pharmacy specialist in the neurology clinic. She urged pharmacists to encourage their patients to remain on therapy and to follow their neurologists’ instructions. “When patients have relapses, often they don’t come back to baseline, so to have them not relapse is very important,” she said. Melody Ryan, PharmD, MPH, an associate professor in the Department of Neurology at the University of Kentucky College of Medicine, in Lexington, said that known adherence problems among MS patients suggest the possibility that these patients “may not have had adequate treatment time to affect their progression to disability. . . Patients should continue to use interferon-β products as the medical community continues to search for even more effective ways to treat MS.” —Susan Birk Dr. Tremlett has received speaker honoraria and/or travel expenses to speak at conferences from the Consortium of MS Centres, US National MS Society, Swiss Multiple Sclerosis Society, University of British Columbia Multiple Sclerosis Research Program, Bayer Pharmaceuticals (invited speaker, honoraria declined), and Teva Pharmaceuticals (invited speaker). Dr. Ryan had no disclosures.

Study Supports Tadalafil Use In Children With PAH

new study has shown that tadalafil can be a safe and effective treatment for pulmonary arterial hypertension (PAH) in children. And in a separate study, investigators have offered a detailed account of how to prepare an oral suspension of the medication. Lesley D’Albini, PharmD, BCPS, the manager of Clinical Protocols and Therapy Management at Accredo Health Group, Inc., said she was excited to see both reports because she and her colleagues had been asked to provide

tadalafil to pediatric PAH patients but didn’t have guidelines on how to dose. The new findings are “a good resource and will really help physicians treat children with PAH with the correct dosing,” Dr. D’Albini told Specialty Pharmacy Continuum. “This is a big deal.” There are only a handful of therapies for PAH, an extremely rare condition marked by abnormally high blood pressure in the arteries of the lungs that can lead to right ventricular overload and failure. Current treatments include

prostanoids, endothelin receptor antagonists and phosphodiesterase type 5 inhibitors (PDE-5i). Two oral PDE-5i agents, sildenafil and tadalafil (Adcirca, Eli Lilly)—used for the treatment of erectile dysfunction in men—were recently approved by the FDA for the treatment of PAH in adults; these agents improve exercise capacity by relaxing blood vessels in the lungs. Tadalafil’s effects on children, however, had not yet been formally studied, according to the authors of a new study published online

Procedure for Compounding Tadalafil Suspension, 5 mg/mL 1.

Count out 15 tadalafil 20-mg tablets.

Triturate the tablets in a glass mortar to produce a fine powder.

Mix 30 mL of Ora-Plus with 30 mL of Ora-Sweet; stir vigorously.

Levigate 30 mL of diluent into the tadalafil powder from step 2 via geometric dilution until a smooth suspension is formed.

Transfer the mixture into a 2-oz, child-resistant, amber plastic prescription bottle.

Rinse the contents of the mortar into the bottle with enough of the diluent to bring the final volume to the 60-mL mark as predetermined with a graduated cylinder. Label the bottle “Shake Well Before Use” with an expiration date of 91 days after preparation.

in Pediatric Cardiology (2012;683-688. doi:10.1007/s00246-012-0180-4). The investigators, from the Children’s Hospital Colorado, in Aurora, retrospectively evaluated 33 pediatric PAH patients aged 4 to 18 years who started treatment with tadalafil between March 2008 and December 2010 and were followed until March 2011. Four patients were treated with tadalafil as a firstline therapy or as initial PDE-5i therapy in combination with another targeted therapy; 29 were switched from sildenafil to tadalafil, primarily because tadalafil can be taken once daily instead of three times per day. The average dose of sildenafil was 3.4 mg/kg per day (±1.1 mg/kg per day), and of tadalafil was 1.0 mg/kg per day (±0.4 mg/kg per day). Children weighing 40 kg or more were given the adult dose of tadalafil; children weighing 20 to 39 kg were treated with one-half of the adult dose, and children weighing 19 kg or less were treated with one-fourth of the adult dose. Researchers measured the clinical

•

see TADALAFIL, page 22

Specialty Pharmacy Continuum • Summer 2012

PATIENT EDUCATION

Practice Pearl

Facilitating Adherence for Tapering Schedules Linda Wessel, RPh Staff Pharmacist Trinity Retail Pharmacy Moline, Illinois

hen I began my career as a pharmacist, I found there were many things about a trip to the pharmacy that left customers feeling confused, annoyed, and/or overwhelmed. But of all the problems that my customers faced, decreasing medication schedules was the one I knew I could make easier for them. The prescription label on the medication bottle is just the right size for “take 1 tablet daily” or “apply to affected areas 2 times a day,” but when directions take more than a few words to be clear and easy to understand, as they so often do, a regular-sized drug label just doesn't cut it. So what’s the solution to this problem? To help patients understand their decreasing medication schedules, I just needed a little more space. I typed “see attached schedule” on the label. Then, just like I keep my own life in order with a personal calendar I hang on my home refrigerator, I made a calendar for the patient that clearly lays out the details of exactly when and how much medication to take each day. This way the patient can take the calendar home and follow it by hanging it on the refrigerator or carrying it. My calendar turned the “decreasing medication schedule” from a confusing and abstract concept into a clear and usable chart with all the details needed laid out in writing (Figure and Table). This tool can be used for many medications, such as prednisone, dexa-

TADALAFIL continued from page 21

effects of tadalafil through plasma brain natriuretic peptide levels, echocardiography, exercise capacity, cardiac catheterization and World Health Organization (WHO) functional class before and after initiating therapy. The investigators observed statistically significant improvements in pulmonary arterial pressure (53.2±18.3 vs. 47.4±13.7 mm Hg; P<0.05) and pulmonary vascular resistance index (12.2±7.0 vs 10.6±7.2 units/m2; P<0.05) in about half of the 29 patients undergoing repeat cat catheterizaete a tion, after switching to tadalaafil. Among the patients treated with tadalafil as initial therapyy, two WHO class 3 patients impro oved to class 1 or 2, and the remainiing class 2 patients did not deteeriorate. None of the patientts

methasone and psychiatric medications that the prescribing physician wants the patient to taper on or off slowly. Not only does this chart help the patient feel confident that he or she is taking the right dose at the right time, it also helps prevent medication errors and hopefully increases patient compliance. With all the talk about reducing readmissions to the hospital, this “trick of the trade” can help make the patients’ lives easier and may help them recover more quickly. This trick of the trade might be helpful to facilitate patient understanding of other complicated medication instructions as well.

Table. Sample Tapering Schedule Date

Friday February 3

2 tablets

Saturday February 4

2 tablets

1 1/2 tablets

Sunday February 5

1 1/2 tablets

Monday February 6

1 1/2 tablets

1 tablet

Tuesday February 7

1 tablet

Wednesday February 8

1 tablet

1/2 tablet

Thursday February 9

1/2 tablet

Friday February 10

1/2 tablet

—

Send Us Your Pearls! Have a clinical or operational pearl you’d like to share with SPC readers? Send manuscripts/ideas to

smtilyou@mcmahonmed.com

April 2012 Sunday

Monday 1

Tuesday 2

Wednesday 3

Thursday 4

Friday 5

Saturday 6

3 tabs 8 3 tabs

9 2 tabs

2 tabs

11 2 tabs

12 1 tab

7 3 tabs

13 1 tab

14 1 tab

STOP!

Figure.

added new vasodilator therapies after starting tadalafil. The side effects of tadalafil included headache, nausea, myalgia, nasal congestion, flushing and allergic reaction. Two patients discontinued the drug due to migraine or allergic reaction.

Pharmacokinetics a Next Step “We’re certainly excited about the preliminary results,” although the pharmacokinetics still have to be studied, a pediatric cardiologist David Dunbar Ivy, MD, the senior author of the study and the director of the pulmonary hyperten-

sion program at the hospital, told Specialty Pharmacy Continuum. Eli Lilly is planning a multisite study to investigate the drug’s pharmacokinetics in children aged 6 months to 17 years, he said. Dr. Ivy said that he and his colleagues continue to use the drug as a first-line therapy in some patients, but he noted that, although it appears safe in older children, it has not yet been tested in neonates or infants: “The doses we used [for the study] are very empiric.” Dr. Ivy cautioned pharmacists and other health professionals treating children with PAH to be sure of the correct diagnosis and treat any underlying medical issues. Patients given tadalafil should be carefully monitored for side effects, he added. An unrelated article published April 1 in the American Journal of Health-System Pharmacy (2012;69:592-594) provides instructions for preparing an oral sus-

pension of tadalafil for children or adults with PAH (box, page 21). Pharmacists from Riley Hospital for Children in Indianapolis and the University of Michigan Hospitals and Health Centers, who developed the solution, found it to be stable for at least 91 days when stored in amber plastic bottles at room temperature. Dr. D’Albini underscored the practical benefits of the new studies. “We get asked to try a lot of things off-label because [PAH] is so rare, and even more rare in children,” she said. “We have been instructing caregivers on splitting, double-splitting or triple-splitting [tadalafil] tablets.” To now have more formalized dosing instructions, she noted, should help improve patient care. —Karen Blum Dr. Ivy disclosed that he and the University of Colorado are paid a consulting fee by United Therapeutics and Pfizer.

Specialty Pharmacy Continuum • Summer 2012

INDUSTRY NEWS

A Partnership for Enhanced Discharge Planning As part of a four-week pilot program at St. John’s Hospital, in Springfield, Ill., a new retail outpatient pharmacy that concentrates on specialty medications delivered prescriptions to the bedsides of orthopedic patients who were about to be discharged. As part of the initiative, anticoagulants and pain relievers arrive with a hefty dose of patient education about how to take the drugs and recognize the signs of adverse effects, as well as other tips for ensuring optimal outcomes. Ginger J. Ertel, PharmD, St. John’s director of pharmacy, said that she expects this personalized bedside delivery program to roll out to all health care units throughout the 450-bed hospital by this fall—and, in the process, stamp the new specialty pharmacy site as more than a convenient stop on the patient’s way home. The plan is to integrate use of this pharmacy into routine discharge planning that begins 24 hours or more before a patient leaves the hospital, Dr. Ertel told Specialty Pharmacy Continuum. “I know what patients have to go through [when] getting prior authorizations and medication changes completed. When a [typical hospital-discharge] patient gets to the pharmacy, it’s too late because they’re on the way home,” she said. “By starting the process while the patient is still in the hospital, we’re able to work through all those hurdles.”

operator, is leasing 2,000 square feet of space in the hospital’s pavilion facility to run the chain’s first full-service stand-alone specialty pharmacy in Illinois (most of its retail pharmacies are located within supermarkets). Schnucks totally owns and operates this specialty pharmacy at St. John’s. By relocating the established Schnucks specialty practice from a retail store elsewhere to St. John’s Hospital, the Schnucks specialty pharmacy team, managed by Vallery Huston, PharmD, is “closer to patients,” said Dr. Ertel. Their existing patient base includes HIV, hepatitis C and organ transplant patients, some of whom the Schnucks specialty pharmacists treat at different clinics around Springfield; the immediate area has no specialty pharmacy competitors, although there is a compounding pharmacy nearby, she added.

Build It or Buy It? From left to right, Tina Nerland, RPh, Ginger Ertel, PharmD, and Vallery Huston, PharmD, at the Schnucks Specialty Pharmacy at St. John’s Hospital.

This specialty pharmacy is distinctive for two reasons—its early, “high-touch” involvement with inpatients about to

We’re in a

position

be discharged, and its outside ownership and operations. Schnuck Markets, a regional supermarket and pharmacy

Hospitals that want to retain a piece of the specialty pharmacy market have a common dilemma when it comes to adding any new service or capability: do they build it or buy it? For Dr. Ertel, outsourcing the new bedside medication

•

see PARTNERSHIP, page 24

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Specialty Pharmacy Continuum • Summer 2012

INDUSTRY NEWS

PARTNERSHIP continued from page 23

delivery program for specialty medications was the most logical solution. “Our own focus is inpatient pharmacy. It makes sense for us to partner with an outpatient pharmacy that has the retail computer systems and insurer relationships,” Dr. Ertel explained. She said that she got the idea to bring in an outside specialty pharmacy provider as a way to improve patient care, and went as high as the hospital’s CEO and COO for approval. The arrangements to do so took nearly a year.

Better Care Transitions Dr. Ertel described a process designed to help make the transition to home recovery and maintenance as seamless as possible. “We ask patients about to be discharged if they want the service. If they say ‘yes,’ we bring the medications to bedside, so pharmacy has the time to explain to them and [to their]

Tina Nerland, RPh, filling a prescription at the Schnucks Specialty Pharmacy at St. John’s Hospital.

time it could prove to help lower the hospital’s rates of 30-day readmissions, which Dr. Ertel said are already favorable: 21% for congestive heart failure (vs. 24.8% national average), 18.4% for pneumonia and 19.8% for heart attacks (both

where but come to see physicians in Springfield. Two full-time pharmacists, plus two residents and a support team staff the pharmacy. St. John’s, which is the flagship hospital of Hospital Sisters Health System (HSHS), includes a cancer institute and a level 1 trauma center. Dr. Ertel said its inpatient pharmacy already services a St. John’s chemotherapy infusion clinic and a congestive heart failure clinic. One looming question for a single specialty pharmacy such as the Schnucks unit at St. John’s Hospital is whether it could supply insurers and pharmaceutical manufacturers with the drug utilization and health outcomes data they seek for research and marketing. Ms. Williams of Value said it “can indeed

‘Our own focus is inpatient pharmacy. It makes sense for us to partner with an outpatient pharmacy that [handles specialty medications and] has the retail computer systems and insurer relationships.’ —Ginger J. Ertel, PharmD

Vallery Huston, PharmD, Schnucks specialty pharmacy manager, counsels a patient.

caregivers what each medication is for and how to take them safely,” she said. “Most patients really just want to go home. They feel tired and may not remember, so we re-emphasize again right before discharge to help make sure they understand.” Before dispensing, the hospital’s inpatient pharmacy confirms the accuracy of the medication list and shares allergy information with the specialty pharmacy. “We share whatever is in the patient’s best interest while conforming to [patient privacy regulations],” Dr. Ertel said. “We’re working through the possibility of the specialty pharmacy having access to patient’s electronic health records. That’s a new area to look into.” This high-touch bedside delivery approach helps the hospital reconcile medications for discharged patients—a practice pushed by both the Joint Commission and the Centers for Medicare & Medicaid Services. It is also designed to keep St. John’s directly involved in patients’ continuum of care. And over

matching the national averages posted on the U.S. Department of Health & Human Services Hospital Compare Web site).

Multiple Benefits Envisioned Dr. Ertel sees the specialty pharmacy helping St. John’s to sustain or improve these readmission rates, contribute to Hospital Consumer Assessment of Healthcare Providers and Systems scores and potentially create

better patient experiences that translate to better reimbursement rates for the Medicare services the hospital provides. She anticipates that 25% to 50% of discharge patients will choose to use the specialty pharmacy, noting, “The more we reach, the better outcomes will be.” Dr. Ertel added that any hospital with more than 100 beds could probably sustain a model like this, as long as there is ample public traffic. The pharmacy, which is co-branded as Schnucks Specialty Pharmacy at St. John’s Hospital, is next to the main building on campus. Open five days a week until 5:30 p.m., its hours are expected to expand this summer. “The hours aren’t an issue for discharge patients, since the process begins a day or more in advance,” Dr. Ertel added. The new specialty pharmacy serves not just the hospital’s discharge patients, but also the hospital staff as well as the general public. It delivers free to patients in Springfield, and mail-orders medications to patients who live else-

The Schnucks Specialty Pharmacy at St. John’s Hospital is open five days a week until 5:30 pm but is expected to expand its hours this summer.

provide the necessary metrics [using] a number of pharmacy software programs that were built specifically for specialty pharmacy. Reporting capabilities are included in these programs. Likewise, there are a few [companies] that service specialty pharmacy and include metric reporting as a service to the SPP that contracts with them.” Three software programs available are CPR+, ScriptMed and MHA, and one company that provides this type of reporting is Armada Health Care, a group contracting organization that markets a wide range of channel management solutions to specialty pharmacy providers.

Another SPP’s Perspective Can this partnership work from a clinical and business perspective, and serve as an effective model for other hospitals and health systems? Vicki Williams, RPh, a manager at Value Specialty Pharmacy in Duncansville, Pa., said the operational strategy is an “ideal model for specialty pharmacy.” The approach has several advantages, aaccording to Ms. Williams. First and fforemost, she noted, “the pharmacy has direct access to any specialist in the hosd pital—a major benefit, because specialty p pharmacy’s intent is to maximize the p rrelationship between physician, patient aand pharmacist.” Ms. Williams also pointed out that the bolstered patient contact and counseling b tthat occurs as a result of the partnership sshould boost post-discharge compliance with the prescribed treatment regimens. w —Al Heller

Specialty Pharmacy Continuum • Summer 2012

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Specialty Pharmacy Continuum • Summer 2012

IN BRIEF

CDC Expresses ‘Concern’ Over Rise of Emboli During Hospitalization

he rate of venous thromboembolism (VTE) in hospitalized patients is “an important and growing health concern,” according to a report released by the Centers for Disease Control and Prevention. Researchers found that each year, roughly 550,000 hospitalized patients aged 18 years and older had a diagnosis of VTE. Of those, nearly 29,000 per year died during their stay in the hospital. However, the survey was unable to determine whether deep vein thrombosis (DVT) or pulmonary embolism (PE) were present on admission, or if onset occurred during the hospital stay. Hospitalization is a major risk factor for the onset of VTE, which can manifest either as DVT, PE or both. Major surgery, immobility or comorbid conditions are some of the contributing factors for these largely

Cefepime Labeling Change Highlights Seizure Risk

n June, the FDA issued a safety alert announcing a labeling change for cefepime. According to the alert, cases of non-convulsive status epilepticus, a type of seizure, have been associated with the use of this antibiotic. According to the agency, the side effect occurred prim marily in patients with rrenal impairment who did not receive appropria atte dosage adjjustments off the h drug, although some cases occurred in patients who did receive these adjustments. A related FDA safety announcement stated that the “Warnings and Precautions” and “Adverse Reactions” sections of the cefepime labeling are being altered to highlight this risk. To minimize seizure risk, health care professionals should adjust the cefepime dosage in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with cefepime occur, the clinician should consider discontinuing the drug or making appropriate dosage adjustments in patients with renal impairment. In most cases, the seizures have been found to be reversible and resolved after discontinuing cefepime or after hemodialysis. Cases of non-convulsive status epilepticus linked to cefepime are documented in the medical literature and in the FDA’s Adverse Event Reporting System (AERS) database. An AERS search from the 1996 approval of cefepime through February 2012 found 59 cases of non-convulsive status epilepticus during cefepime administration. Of the 59 patients, 58 had renal dysfunction, with renal status unknown in the remaining case. In 56 of the 59 patients, cefepime dosing was not appropriately adjusted for renal impairment as recommended in

preventable conditions. The Centers for Medicare & Medicaid Services considers DVT and PE non-reimbursable complications of knee and hip replacement surgery. The survey covered a sample of discharges for short stays (less than 30 days, on average) from hospitals throughout the 50 states between 2007 and 2009. Researchers analyzed discharge data from the National Hospital Discharge Survey. Approximately 348,000 hospitalized adults were diagnosed with DVT each year; 277,549 had a diagnosis of PE and 78,511 a diagnosis of both DVT and PE. (Patients who were diagnosed with DVT were diagnosed as such, whether or not they also had PE, and vice versa.) Rates of hospitalizations were comparable between the sexes, with men comprising 46% and women 54%

the drug labeling. In 43 patients, the seizures resolved; 16 patients died, although most of these deaths (13) were known to be caused by another illness that developed simultaneously. Of the remaining three deaths, two may have involved causes other than cefepime; in the third, there were insufficient data to determine the cause of death. —George Ochoa

Crizotinib Shows Activity in Some Pediatric Cancers

rizotinib (Xalkori, Pfizer), indicated for the treatment of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive, has shown evidence of activity against three pediatric cancers also driven by ALK gene abnormalities. The cancers are anaplastic large cell lymphoma (ALCL), inflammatory myofibroblastic tumor and neuroblastoma. The results of the Phase I study by Yael P.

of cases. The survey also found that the incidence of VTE increased with patient age, rising from 9% for people aged 18 to 39 years to 64% for those aged 60 years and older. “These findings underscore the need to promote implementation of evidence-based strategies to reduce the number of preventable cases of VTE among hospitalized patients,” according to the researchers, who published their research in the June 8, 2012 edition of the Morbidity and Mortality Weekly Report. Many cases of VTE could be prevented through “appropriate administration of prophylaxis, which might include pharmacologic agents (e.g., antithrombotic agents) or mechanical devices,” they noted. The health agency plans to develop a Web-based VTE surveillance system for hospitals and other health care facilities.

Mosse, MD, an assistant professor of pediatrics at Children’s Hospital of Philadelphia at the University of Pennsylvania, were presented at the American Society of Clinical Oncology (abstract 9500). Seventy pediatric patients (median age 9.9 years; range 1.1-21.3 years) with refractory solid tumors and ALCL were enrolled in the study. Crizotinib, an oral targeted drug, was administered twice daily, with six dose levels evaluated. When possible, patients’ cancers were tested for ALK abnormalities, although this was not a requirement for enrollment. Of patients with ALCL, seven of eight (88%) had a complete response (CR). Of patients with neuroblastoma, two of 27 had a CR, and eight had no disease progression. Of neuroblastoma patients with a proven ALK K abnormality, two of eight had a CR. One patient with an inflammatory myofibroblastic tumor had a partial response, as did one with NSCLC.

—Maureen Sullivan

Dose-limiting toxicity included grade 3 dizziness, grade 5 intra-tumoral hemorrhage, grade 4 liver enzyme elevation and grade 4 neutropenia. In their abstract, the researchers concluded: “Inhibition of ALK in pediatric [patients] with ALK-driven tumors occurs with minimal toxicity and is associated with objective antitumor activity.” In an email to Pharmacy Practice News, lead researcher Dr. Mosse said: “In many ways, this trial is setting a new paradigm of treating pathways rather than tumors, and [of] allowing collaborations across tumor types. Cancer is an assortment of diseases with distinct genetic profiles, and this study allows us to leverage the genetics across pediatric and adult tumors.” —George Ochoa Dr. Mosse reported research funding from Pfizer.

SSIs After Joint Surgery Cost Hospitals Millions

significant percentage of patients who develop surgical site infections after undergoing hip or knee replacement surgery, will be readmitted to the hospital for further complications related to wound infections, new research shows. Preventing such readmissions could save the U.S. health care system as much as $65 million a year, according to research led by Keith Kaye, MD, of Detroit Medical Center/Wayne State University. Dr. Kaye’s group presented its findings at the 2012 annual meeting of the Association of Professionals in Infection Control and Epidemiology (APIC). The research team analyzed data from health insurance claims for about 40 million insured individuals covered by employer-based health plans. Their goal was to uncover the rate of readmission and the financial effects of surgical site infections (SSIs) beyond the initial treatment of the complications. “The prosthetic joint population was important to study because these patients are particularly vulnerable to adverse events following [SSIs], leading to unnecessary

pain, suffering and medical costs,” Dr. Kaye said in a statement. “Given the government’s focus on reducing readmission rates, such complications could likely be a future target for decreased reimbursement.” Of the 174,425 patients in the database who underwent hip or knee replacement in 2007, 1.2% were hospitalized for an SSI within one year of their procedure. Of those, more than 12% were readmitted in the following year due to SSI-related issues. The average hospital stay for the readmission was 8.6 days, at a cost of approximately $7,000 per patient. The data also showed that more than 40% of patients with SSIs were hospitalized for other reasons in the year following their diagnosis. For these patients, the average hospital stay was 6.2 days, at a cost of $31,000 In a statement, APIC president Michelle Farber, RN, CIC, said, “Infection preventionists need to be familiar with health care quality incentive programs to demonstrate the value of the infection prevention program to the financial health of their organizations and patient experience.” —Maureen Sullivan

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