Fall 2012 - Specialty Pharmacy Continuum by McMahon Group

sa th Pu ry Ye bl is a h in

Bridging the gap between the hospital and alternate-site care

Volume 1 • Number 4 • Fall 2012

specialtypharmacycontinuum.com

In This Issue Clinical

Latest findings on hepatitis C treatment from The Liver Meeting

New studies support use of alemtuzumab in patients with MS

Disease State Spotlight

Diplomat pharmacist shares her expertise on managing hereditary angioedema

Shows Raising the Evidence Bar Sandy Profession Can In Specialty Pharmacy Take a Punch I H n mid-September, Aetna announced that it would cease reimbursing for most uses of repository corticotropin injection (H.P. Acthar gel), a highly purified preparation of adrenocorticotropic h hormone designed d i d for f extended d d release. l The drug’s manufacturer, Questcor, markets it for a number of indications, including

drug’s use in a given indication. “Specialty drugs already represent 20%-plus in terms of medication spending, and the pipeline is close to 50% specialty drugs,” said David Calabrese, RPh, MPH vice MPH, i presii dent of clinical services and chief pharmacy officer for pharmacy benefit manager Catamaran (formerly SXC

Ask the Expert

16 19

Specialized HIV pharmacies may improve care

Policy

•

N. Lois Adams, RPh, MBA speaks out on the meningitis outbreak.

Operations & Mgmt

Bosutinib approved as new second-line option for CML

Corporate Spotlight Cigna see page 7

Connexus see page 13

urricane Sandy slammed into the heavily populated New York-New Jersey metropolitan area on Monday night, Oct. 29, flooding or destroying countless homes, plunging millions into darkness and severely testing the preparedness of hospitals and health care providers across the region. To prepare for the storm, the nurses, pharmacists and drivers who staff the Walgreens Infusion Services branch in Eatontown, N.J., began to draw up contingency plans on the previous Friday for what was looking more and more like a major assault on the New Jersey shore. Their attention focused on the center’s

infantile spasms, multiple sclerosis, neuromuscular conditions and nephrotic syndrome—but Aetna declared that the clinical evidence of the drug’s g supep riority to less costly steroids was insufficient to justify reimbursement for any indications beyond infantile spasms. Moves like these are likely to become more common in specialty pharmacy, as payers set higher bars for the quality of the evidence supporting a particular

see SANDY, Y page 4

Payers Rank Value of Key Pharm Services Specialty gets high marks on core services, lower ones in clinical areas

Health Solutions). “Therapies in general are becomingg more complex p and more targeted, and that means you will need mechanisms to ensure appropriate use. There’s no doubt in my mind that we’ll see even tighter scrutiny around the use of [specialty] products.” Questcor may be able to convince Aetna to reconsider its decision on

pecialty pharmacies are hitting the mark with payers on core functions, such as direct distribution and performance guarantees for accuracy, but they are falling short on what might be considered “cognitive” services, such as enforcing preferred product selection, tracking patient interventions and managing drug waste, misuse and abuse. Those are some key findings based on survey responses from 102 payers,

see EVIDENCE, page 22

see PERFORMANCE, page 18

•

FDA Approval Pfizer’s new oral RA treatment, Xeljanz, approved

•

The Book Page Handbook on Injectable Drugs: 17th Edition Lawrence A. Trissel, FASHP

See page 26.

See page 27.

Evidence based. Patient proven.

Product Features FDA approved indications1 : s Chronic inﬂammatory demyelinating polyneuropathy (CIDP) s Primary immunodeﬁciency (PI) for both IV and SC administration s Idiopathic thrombocytopenic purpura (ITP)

Product properties1 : s No sugar s Optimal pH of: (4.0-4.5) s IgA content: average of 46μg/mL s Only trace amounts of sodium s Close to physiologic osmolality: (258 mOsm/kg)

Easy to use1 : s Latex-free packaging s Tamper-evident vials (cap overwrap) s Vials available in 1, 2.5, 5, 10, and 20 g s Long 3-year shelf life; room temperature storage* * Up to 6 months at any time during 36-month shelf life.

Important Safety Information Gamunex-C, Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified, is indicated for the treatment of primary humoral immunodeficiency disease (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP). Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, 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 deficient 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 Acute 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 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). Please see adjacent page for brief summary of Gamunex-C full prescribing information. 1. GAMUNEX-C package insert. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2010.

For more information: Grifols, Inc. Customer Service: 888 325 8579 Fax: 323 441 7968

Grifols, Inc. 5555 Valley Boulevard, Los Angeles, 90032 CA - USA Tel. 888-GRIFOLS (888 474 3657) www.grifolsusa.com

Printed in USA.

September 2012

GX116-0912

GAMUNEX® X®-C

• 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 Immune Globulin Injection (Human) 10% those at risk of hyperviscosity.

Caprylate/Chromatography Puriﬁed

• 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) To report SUSPECTED ADVERSE REACTIONS, contact Talecris • Idiopathic Thrombocytopenic Purpura (ITP) Biotherapeutics, Inc. at 1-800-520-2807 or FDA at • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 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 • Fall 2012

DISASTER PREPAREDNESS

SANDY continued from page 1

more than 400 homebound patients spread out from Cape May at the state’s southern tip to Bergen County in the north. These patients rely on regular visits from Walgreens home infusion nurses and prompt specialty medication deliveries to stay out of hospitals and, for many, to survive. The nurses manage the needs of patients requiring a whole range of medications and nutrition support, including anti-infectives, biologic response modifiers, chemotherapy, enzyme replacement therapy, IV immunoglobulin and pain management treatments. The Walgreens’ team in Eatontown prioritized patients one by one, based on the severity of their conditions. Those who would suffer harm without infusions, such as stage IV heart failure patients on inotropic agents, moved to the head of the list, whereas others whose medications were deemed less critical became potential wait-list candidates. “We had major triage going on,” said Beverly Greatorex, RN, general manager of the services’ Eatontown office, which lies about five miles from the shore and less than 20 miles from where Sandy made landfall in Ocean County. The staff also considered other critical “what-if” scenarios: How would the center’s four pharmacists and pharmacy manager prepare and label compounded medications and parenteral nutrition

solutions if power shut down? What would they do if they lost connection to the Internet and pharmacy computer system? How could lab values be taken and evaluated quickly enough to make necessary medication or nutrition support adjustments? What’s more, how would patients without power refrigerate fragile IV preparations or recharge the battery packs powering infusion pumps? And what if downed trees and power lines blocked roads? How would nurses and drivers get to patients?

Tactical Plan Put in Place By 11:30 a.m. Sunday, a tactical plan had been developed and was set to go into operation. For the next 8.5 hours, and then again the following day, the entire staff of nurses, along with pharmacists and drivers, worked feverishly to beat the hurricane’s anticipated Monday midafternoon arrival. Critical medications that normally would have gone out later in the week were delivered on Sunday. Patients on specialty medications delivered by battery-powered infusion pumps received back-up 9-volt battery packs. Patients on medications and parenteral nutrition solutions requiring refrigeration were urged to get ice blocks to maintain product stability. “On Monday,” Ms. Greatorex said, “I wanted everyone back by 2 o’clock, so they could get safely back in their homes by the time the storm hit.” It stuck with fury. The whole of Mon-

mouth County, where the center is located, lost power on Monday night along with most neighboring counties. On Tuesday, the center was closed. It lacked the electricity needed to power its systems. “Walgreens was wonderful,” Ms. Greatorex said. “They shipped us a huge generator, and by Tuesday night we were back on generator power.” The center still had no telephone or Internet access. “We managed with cell phones,” Ms. Greatorex said. Reimbursement and other clerical staff were put to work calling patients on mobile phones to let them know when medication deliveries would arrive. A manual system was put in place to make medication delivery tickets and pharmacy board–required labels. By Thursday the center got access to a WiFi hot spot, “and we were able to get back into our pharmacy system,” she said. “We had all of our pharmacists huddled in the conference room working off laptops. It was almost like a MASH [Mobile Army Surgical Hospital] unit.” Reaching patients after the storm became a logistical nightmare. Uprooted trees and downed power lines blocked access to many roads, and drivers and nurses calling on patients to perform routine management services had to find alternate routes, often lengthening their trips by three or four times. The gasoline shortage that developed after the storm magnified the pressures. “It was very tough,” Ms. Greatorex said. “We tried to prioritize and map out our

EDITORIAL BOARD

routes very efficiently. We were lucky in that I do have a core of nurses who live close to the office, so they took deliveries with them whenever they called on patients, and if we could use UPS for any of the deliveries, we did.” One nurse who was visiting a young enzyme-replacement patient in Jersey City experienced firsthand the kind of devastation that had befallen people all over the region. As she was administering the infusion, the flood-weakened ceiling in the patient’s home started to drip and then collapsed under the weight of snow delivered by a Nor’easter that hit the week after Sandy. The fire department showed up, along with agents from the New Jersey Office of FEMA. The family had to be evacuated. On the phone, the nurse told Ms. Greatorex that she was staying with the family. “He’s a special needs kid,” she said. “I have to be here. Someone has to speak for this family and navigate them through this system. I’m not leaving until everything is taken care of.” After the storm, Ms. Greatorex reflected on the harrowing events of the previous two weeks. She had not had more than four hours sleep a night during the entire time, she said. “I think we came through very well. We have a tremendous staff here. The nurses, pharmacists and drivers … no one was more important than the other. Everyone pulled together just incredibly.” —Bruce Buckley and Joan Buckley, RN

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Volume 1 • Number 4 • Fall 2012

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SPECIALTY PHARMACY

Dan Radebaugh, Director of Production and Technical Operations Marty Barbieri, Production Manager Brandy Wilson, Circulation Coordinator

N. Lois Adams, MBA, RPh Chairman, President and CEO Freedom Pharmacy Orlando, FL

Michael Sicilian President, Managed Health Care Associates, Inc. Florham Park, NJ

Randy Falkenrath Senior Vice President CVS Caremark Woonsocket, RI

HEALTH-SYSTEM PHARMACY Ernest R. Anderson Jr, MS, RPh System Vice President of Pharmacy Steward Health Care System Boston, MA

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

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Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Tool Helps Predict Chemotherapy Side Effects Using a predictive tool called OnPART (Oncology Preferences and Risk of Toxicity), researchers have identified single-nucleotide polymorphism (SNP) networks that predict an individual patient’s risk for six common side effects of combination chemotherapy regimens with greater than 90% accuracy, according to a recent study. “OnPART will allow clinicians to know prior to the first cycle of chemotherapy what the patients’ risks are for side effects,” said Ed Rubenstein, MD, the president & CEO of Boston-based Inform Genomics, OnPART’s developer. The company’s oncology advisory board predicted that, once available, “this new product would be a game changer,” Dr. Rubenstein told Specialty Pharmacy Continuum.

‘This is the first personalized medicine product to take a very broad look at 2.5 million SNPs, to look at combination chemotherapy and to then develop a robust and actionable product.’ —Ed Rubenstein, MD According to an Oct. 1 press release from Inform Genomics, the single-center observational study, conducted at The West Clinic, in Memphis, Tenn., enrolled 384 patients with breast, colorectal, lung, and ovarian cancers in late January 2012. The patients were treated with standard chemotherapy regimens as prescribed by their physicians, including dose-dense doxorubicin, cyclophosphamide and paclitaxel for breast cancer; oxaliplatinbased regimens (such as FOLFOX, which includes oxaliplatin plus leucovorin and 5-fluorouracil) for colorectal cancer; and carboplatin plus paclitaxel-based regimens for lung and ovarian cancer. Patients were followed for a minimum of two chemotherapy cycles. Saliva was collected from each patient with an FDA-approved kit for DNA samples. When the samples were analyzed, 2.5 million SNPs per patient could be identified. The researchers studied six side effects: nausea and vomiting, diarrhea, oral mucositis, fatigue, neuropathy and cognitive dysfunction. For the regimens analyzed in the completed study, OnPART predicted all six side effects with greater than 90% accuracy. “This has never been done before,” said Dr. Rubenstein. “There’s lots of evi-

dence that variations in genes or SNPs are associated with side effects, but it has been done with single-agent chemotherapy using a limited number of genes or SNPs and looking at single

side effects. Single-gene variant tests are available but not widely adopted. This is the first personalized medicine product to take a very broad look at 2.5 million SNPs, to look at combination chemo-

therapy and to then develop a robust and actionable product.” Lee Schwartzberg, MD, the senior partner and medical director of The West Clinic, and principal investigator of the study, noted that with this tool, “we can now identify patients at risk for these side effects before they ever receive chemotherapy. This allows us to customize our chemotherapy regimens

•

see CHEMO TOOL, page 26

Specialty Pharmacy Continuum • Fall 2012

Cigna Specialty Pharmacy Management

CORPORATE SPOTLIGHT

Affordable care. Maximized outcomes. Superior experience.

t Cigna, we’re committed to putting our customers’ needs first—working every day to make their health journey more affordable, more effective and more satisfying. And in doing so, we’re also able to deliver superior value to the companies our customers turn to for benefit coverage. That’s particularly true when it comes to conditions that require specialty medications. The drugs for these complex conditions alone have an annual trend of nearly 20%1 making specialty pharmacy drugs one of the fastest growing drivers of rising costs in a company’s benefit plan today. While only 3% of customers use these medications, they account for 26% of total health care costs.2

We Do What Others Can’t As a fully integrated health services company, Cigna can do what most specialty pharmacy benefit managers can’t: lower TOTAL health care costs—not just drug costs. We do it by utilizing proven and innovative solutions, holistic strategies designed to align incentives and connect key stakeholders with information to encourage and reward the best outcomes, and deliver the best value—regardless of where specialty drugs are covered, dispensed or administered. Better cost management. Cigna manages the total cost of care—not just the drug costs. We go beyond unit discounts, coordinating care across both the medical and pharmacy benefits to find the most appropriate solutions. Our medical and pharmacy sites of service (doctor’s office, home health, infusion suite, specialty and retail pharmacy), cost-effective network, contractual relationships and alignment of incentives allow us to create more efficient plan designs. Designs that encourage and reward—both our customers and their doctors—to make the most cost-effective and clinically appropriate choices to lower total health care costs. Better health outcomes. Our clinical review of medications, therapy management and health advocacy programs have a total patient-health focus—integrating our medical, pharmacy, behavioral and disability plans to ensure customers get the right drug, the right dose and that they take it as prescribed. TheraCare® provides additional support services to customers with specialty conditions, leading to better drug therapy management and individual productivity. In addition, direct access to health care professionals lets us align incentives directly to outcomes to ensure that doctors work in tandem with us to deliver therapy management that reduces gaps in care and unnecessary complications for better overall health outcomes. Better customer experience. 80% of customers on specialty medications have at least one other chronic condition, which makes their overall health needs even more complex. At Cigna, we take a holistic approach to helping our customers with their total health needs. One ID card, one contact number and one support coach make it easier for them to access our services and get the support they need to better manage their medications—and their health. Cigna Home Delivery Pharmacy offers them convenient home delivery, automatic refill reminders, special handling and 24/7 service. Through education, coaching and plan design incentives, we not only make working with us simple, easy and enjoyable— we also are able to help customers lower costs, and improve their health and productivity, so they are more satisfied with their total health experience. The specialty pharmacy market has evolved significantly over the past decade and its rapid growth is expected to continue. Cigna is poised to respond to the dramatic changes of the specialty pharmacy market by continuing to provide its customers and clients: • Lower costs—overall health care costs, not just drug costs • Superior cost and trend management • Improved outcomes through continuity of care and adherence • Holistic and personalized customer care

References 1. Cigna FY Projected Book of Business. January-August 2012 2. Cigna Analytics 2010-2011.

“Cigna,” and “TheraCare,” are registered service marks and the “Tree of Life” logo,” “GO YOU,” and “Cigna Home Delivery Pharmacy” and “Cigna Specialty Pharmacy Management” are service marks of Cigna Intellectual Property, Inc., licensed for use by Cigna Corporation and its operating subsidiaries. All products and services are provided exclusively by such operating subsidiaries and not by Cigna Corporation. Such operating subsidiaries include Connecticut General Life Insurance Company, Cigna Health and Life Insurance Company, Tel-Drug, Inc. and Tel-Drug of Pennsylvania, L.L.C. © 2012 Cigna

TO LEARN MORE visit Cigna.com or contact Claire. Burchill2@cigna.com

Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Liver Meeting Roundup Boston—The Liver Meeting 2012 featured the latest in research, treatment guidelines and advances in the field of hepatology. Here, we highlight some the most compelling presentations related to treatment for patients infected with the hepatitis C virus (HCV) and HIV. A Shortfall in Statin Use. A study from the University of North Carolina at Chapel Hill suggests that providers are hesitant to prescribe statins to patients with dyslipidemia and chronic liver disease, despite data and guidelines supporting the safe use of the drugs in this patient population. The cross-sectional study identified 1,198,221 patients with dyslipidemia. Statin use was compared in patients with HCV without cirrhosis, patients with compensated cirrhosis of any etiology and a group of controls without liver disease. The investigators found that statins were prescribed to 1,055 (28.7%) of the HCV-infected patients, 1,092 (34.1%) of the patients with compensated cirrhosis and 710,564 (59.6%) of control patients. Patients with HCV or compensated cirrhosis thus were significantly less likely than controls to receive statins (odds ratio, 0.31; 95% confidence interval, 0.29-0.32). The authors recommended increased education to change providers’ perceptions of statin hepatoxicity risk among patients with chronic liver disease. “This study confirms that statins are underused in the HCV population and those with liver cirrhosis. As pharmacists, we can and should do a better job in

educating patients and physicianss about the safety o of statins in this population,” said speecialty pharmacist Janet Nguyen, PharmD, BCPS, vice president of network strategy att ModernHEALTH in Monrovia, Calif. “We should h ld b be doing d i a review of their medication profile and identifying opportunities to provide interventions for patients who should be put on a statin for their cardiovascular benefits.” Response-Guided Therapy. Current guidelines state that patients who are coinfected with HCV and HIV should be treated for 48 weeks, especially if polymerase chain reaction (PCR) tests for HCV remain positive at four weeks. But Canadian researchers presented data suggesting that response-guided therapy (RGT)—usually with pegylated interferon plus ribavirin (PR)—can significantly shorten the duration of therapy. In the study, researchers at Toronto General Hospital used electronic medical records to identify all patients with HCV genotype 2 or 3 with HIV coinfection. PCR tests for HCV were performed every four weeks of drug therapy until

a negative result (<50 IU/ mL) was achieved. m In the intent-to-treat analysis, 23 of 35 patients were treated with the w RGT protocol, and 20 R patients completed their p treeatment. According to the researchers, only one patient needed the full 48 weeks of therapy to achieve a sustained virologic response (SVR)—a finding that was especially striking, considering the fact that less than half of the patients (nine) had a negative PCR HCV test at four weeks. Based on the results, “the use of response-guided therapy allows [treatment] to be shortened in the majority of individuals” with HIV and HCV coinfection, the researchers concluded. Positive Telaprevir Data. Researchers from the University of Milan in Italy presented a study on the use of telaprevir (Incivek, Vertex) for patients with HCV genotype 1 with severe fibrosis or compensated cirrhosis. In the openlabel, early-access program spanning 16 countries, patients were treated for 12 weeks with telaprevir and PR, followed by PR. At four weeks, 54% of patients had undetectable HCV RNA and at 12

weeks, 79% had undetectable viral loads. Serious adverse events occurred in 14% of patients, which is similar to rates from Phase III registration trials. “The study results are consistent with what we have seen with other telaprevir studies,” commented Dr. Nguyen. “There is still a misnomer out in the community with what telaprevir can do for patients. It is a potential cure for HCV and people still don’t realize that. In this study, and other studies, even patients who had partial or null response to therapy in the past have hope with this therapy.” Impact on Quality of Life. Another study presented at The Liver Meeting evaluated the quality of life (QoL) in patients with chronic HCV who achieved SVR versus non-SVR after IFN-based HCV treatment. German researchers found that SVR had a significant effect on liver-related morbidity, and improved QoL and productivity. Specifically, 759 of 1,355 patients achieved SVR after first therapy and only three of those developed a liver-related clinical event compared with 31 non-SVR patients. Increased QoL (scored on the Short Form-36 Health Survey) and productivity (measured by higher frequency of employment, higher number of working hours and lower number of outpatient and inpatient visits after HCV treatment) also were significantly associated with patients who achieved SVR. —Megan Block, MPH

New Guidelines for HBV-Infected Health Care Workers The Centers for Disease Control and Prevention (CDC) has issued revised guidelines for managing health care providers and medical students who are infected with hepatitis B virus (HBV) to reduce the risk for transmission to patients. The new guidelines ((MMWR Recomm Rep 2012;61:1-12) echo the 1991 CDC recommendations (MMWR ( Recomm Rep 1991;40:1-9) that HBV infection should not disqualify infected individuals from practicing surgery, dentistry or medicine while also updating the recommendations in several key ways. Most notably, the CDC no longer advocates that providers or students with HBV inform patients of their HBV status, because disclosing this information “might actually be counterproductive to public health.” “In general, I think these recommendations are a first step toward preventing discrimination against HBVinfected health care workers while still protecting patient safety,” said Robert S. Brown Jr., MD, MPH, Frank Car-

dile Professor of Medicine, chief, Center for Liver Disease and Transplantation, Columbia University College of Physicians and Surgeons, NewYork-Presbyterian Hospital/Columbia University Medical Center, in New York City. “It is clear that HBV-infected health care providers should not be restricted in their ability to practice medicine and surgery, and this is now clearly stated,” said Dr. Brown, who was not involved in creating the new guidelines. The new guidelines discuss advances in the management of chronic HBV infection, notably that HBV DNA serum levels should be used to monitor infectivity instead of hepatitis B e-antigen status. They also recommend a threshold serum HBV DNA value of less than 1,000 IU/mL as safe for practice.

Three main situations in which health care providers would pose a risk to patients are addressed in the guidelines: • Providers with an infectious virus circulating in the bloodstream; • Providers with an injury (a puncture wound) or a condition that permits exposure to infectious fluids; and • Providers whose infectious fluid comes into direct contact with a patient’s wound or exposed tissue. Most HBV-infected health care workers do not meet these criteria and pose no risk to patients, but those who might meet the criteria (notably providers performing exposure-prone procedures) should be monitored by an expert review panel, according to the report. “The importance and efficacy of standard precautions and other measures are critical as highlighted in this piece; however, I am concerned that the creation of local expert panels may lead to variability across facilities and ongoing discrimination in some institutions which is not based on data or clear risk

to the patients,” Dr. Brown said. Specifically, the new guidelines state that this expert panel would evaluate the provider’s HBV status, assess practices and adherence to recommended surgical and dental techniques, and would investigate providers for suspected and documented breaches resulting in patient exposure. The panel also would reinforce the practice of standard precautions, including double gloving, regular glove changes and avoiding the use of blunt surgical needles. Based on these guidelines, the authors encourage institutions to develop their own policies for identifying and managing HBV-infected health care providers and students. To view the recommendations, visit www.cdc.gov/mmwr/preview/ mmwrhtml/rr6103a1.htm. —Victoria Stern Dr. Brown reported no relevant conﬂicts of interest.

Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Anti-Leukemia Agent Shows Promise for MS in Trial The leukemia drug alemtuzumab was more effective than interferon (IFN) beta-1a in reducing clinical relapses and slowing disability and loss of brain volume in patients with multiple sclerosis (MS) during recent multinational trials. Alemtuzumab, an anti-CD52 antibody originally developed as a treatment for B-cell chronic lymphocytic leukemia under the trade name Campath (Genzyme), was the first drug shown to be superior to IFN beta-1a (Rebif, EMD Serono/Pfizer) for improving disability outcomes, according to the investigators of the Phase III CARE-MS (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis) I and II trials. The drug is being developed as a therapy for MS under the name Lemtrada. Although Campath remains available free of charge to leukemia patients, it was removed from the market in September to prevent its unauthorized use for MS. In an editorial accompanying the studies, which were published online in The Lancett on Nov. 1, The Lancet expressed concern about the company’s decision to remarket the drug and its potential effects on the cost of the drug. “There is concern that with a licence for multiple sclerosis, the cost of alemtuzumab could rise and might become too expensive for many patients (and health systems).” They also noted that discontinuation could prevent MS patients who have already started treatments from getting “their vital second course.” Amid this backdrop, these Genzymesupported trials yielded positive results in support of the drug’s use in patients with MS. During the studies, the investigators evaluated adult patients with relapsingremitting MS who were treatment-naive (CARE-MS I) or who experienced at least one relapse while taking IFN-beta-1a or glatiramer (CARE-MS II). Compared with IFN beta-1a, alemtuzumab reduced the relapse rate and the risk for cumulative disability in both trials. In CARE-MS I, patients were randomized to receive IFN beta-1a (44 mcg three times per week; n=195), or alemtuzumab (12 mg; n=386) daily for five days at baseline and again for three days at 12 months. Of the 187 patients randomized to IFN beta-1a included in the primary analyses, 75 (40%) relapsed compared with 82 of the 376 alemtuzumab-treated patients (22%) included in the primary analyses (rate ratio, 0.45; 95% confidence interval [CI], 0.32-0.63; P<0.0001). In CARE-MS II, patients were randomized to receive IFN beta-1a (44 mcg three times per week; n=231), or one of two doses of alemtuzumab (12 mg; n=436) or 24 mg; n=173) daily for five days at baseline and again for three days at 12 months. (The investigators later closed enroll-

ment into the alemtuzumab 24-mg arm, and their primary analyses compared the 12-mg dose of alemtuzumab with IFN.) Of the 202 patients randomized to IFN and included in the primary analyses of

CARE-MS II, 104 (53%) relapsed compared with 147 of the 426 patients (35%) given 12 mg of alemtuzumab. The rate ratio in the alemtuzumab group was 0.51, a significant decrease (95% CI, 0.39-0.65; P<0.0001). Additionally, in CARE-MS II, alemtuzumab reduced the risk for sustained accumulation of disability by 42% relative to the IFN beta-1a (P ( =0.0084). According to a press release from Genzyme, this sug-

gests “a reversal of pre-existing disability in some patients.” The incidence of serious adverse events did not differ between the treatment groups in both trials. Genzyme noted that an early monitoring program was in place to detect alemtuzumab-related autoimmune disorders, which were then managed using conventional therapies. —Sarah Tilyou

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Specialty Pharmacy Continuum • Fall 2012

CLINICAL DISEASE STATE SPOTLIGHT

Specialty Pharmacy’s Role in Managing Patients With Hereditary Angioedema Hetty A. Lima, RPh, FASHP Vice President, Specialty Infusion & Rare Diseases Diplomat Specialty Pharmacy Flint, Michigan

Hereditary angioedema (HAE) is a rare but serious autosomal dominant genetic disease that is characterized by episodes of swelling that may involve the face or extremities, gastrointestinal (GI) tract, or, less commonly, the larynx (which can lead to asphyxiation).

termed Quincke’s Edema. Dr. Quincke reported the condition as “angioneurotic edema” because at that time the underlying pathophysiology was thought to include a link between mental stress, anxiety, and episodes of angioedema. Several years later, however, Dr. William Osler recognized the “familial nature” of the disease and first published a description of a hereditary form of angioedema in 1888.1 In 1963, HAE was linked to the absence of C1 inhibitor.4 As an inherited autosomal dominant

disease, HAE can span many generations. Half of an individual’s offspring are at risk for developing the disease, even when only one parent is affected. However, up to 25% of HAE cases are caused by a spontaneous genetic mutation.3 HAE is not more prevalent in patients of a given sex or race, although women tend to present with this condition more frequently than men.5 A greater percentage of women report having more severe symptoms of HAE at puberty and while taking estrogen-

containing oral contraceptives.5 First attacks of HAE tend to occur in childhood (mean age, 7.8 years),1 but onset may occur later in life. The mean age at diagnosis is 16.8 years (range, 1-42 years).1 Approximately 50% of patients with HAE will be symptomatic by the age of 10 years.3 Although prompt diagnosis of HAE is critical to reduce morbidity and mortality, it may take as long as 10 to 22 years after the first attack for a diagnosis of HAE to be made.1 Undiagnosed

This rare orphan disease, which affects between 4,000 and 10,000 individuals in the United States,1 is largely misdiagnosed. Insufficient awareness of HAE among physicians can contribute to a substantial lag time in diagnosis.

Disease Mechanism HAE is caused by mutations in the C1 inhibitor (C1INH) H gene that results in a deficiency or dysfunction of the plasma protein C1 inhibitor (C1-INH). The C1-INH enzyme inhibits the protein kallikrein, which, in turn, releases bradykinin. Excessive or unregulated amounts of bradykinin cause blood vessels to widen and open spaces between the cells in the blood vessel walls, allowing fluids to leak out into the extracellular spaces and surrounding tissues. This reaction is different from a classical histamine reaction involving the local inflammation pathways and consequently, the disease does not respond to standard anti-anaphylactic or antihistaminergic treatment (antihistamines, ephinephrine, or corticosteroids).2 These recurrent episodes (or attacks) of non-pitting edema are associated with significant pain and discomfort, and also can be life-threatening. These attacks of swelling occur in the skin, GI tract, extremities (hands and feet), and upper respiratory tract.2 As many as 30% of untreated HAE patients who experience a laryngeal attack may asphyxiate.3 An example of a patient experiencing an HAE attack is shown in Figure 1.

Inherited Disease First described in the medical literature in 1882 by German physician Dr. Heinrich Quincke, HAE was initially

July 4, 2008

Day 1, Sept. 1, 2008, 11:30 AM

Day 1, Sept. 1, 2008, 2:00 PM

Day 2, Sept. 2, 2008

Day 7, Sept. 7, 2008

Day 12, Sept. 12, 2008

Figure 1. Patient experiencing an HAE attack. HAE, hereditary angioedema Source: Roles C. Sarasota. Anything Arts.com. Blogs. January 26, 2009. http://sarasota.anythingarts.com/profiles/blogs/cliff-roles-newsletter-week-8. Accessed October 4, 2012.

Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Table 1. Prodromal Signs Of an Acute HAE Attack Edema without urticaria (hallmark sign of HAE) Erythema marginatum-like, nonpruritic rash Paresthesias (tingling, itching, tightness, or pain) Flu-like symptoms Headache Abdominal discomfort Urticaria Fatigue Malaise

Mucosal HAE attacks also can occur in the upper respiratory tract; these attacks can present as laryngeal swelling, either alone or in conjunction with swelling of the face, lips, tongue, soft palate, and uvula. Although laryngeal attacks account for less than 1% of all HAE attacks, they result in approximately 30% of all HAE fatalities.6 As many as 50% of HAE patients will experience an upper respiratory tract attack during their lifetime; although laryngeal attacks can be life-threatening, most attacks resolve before airway obstruction occurs.2

Irritability Mood changes Hyperactivity Thirst Nausea HAE, hereditary angioedema Based on reference 1.

HAE patients are at risk for frequent attacks that result in 15,000 to 30,000 emergency department visits per year. If left untreated, HAE can result in a mortality rate as high as 30%, primarily due to airway obstruction. Patients who experience the most severe types of HAE attacks can be incapacitated for as many as 100 to 150 days annually.3

Types of HAE Attacks HAE attacks manifest as recurrent episodes of angioedema without pruritus or urticaria. HAE attacks can be cutaneous, affecting the extremities, face, and/or genitals, or mucosal, affecting the GI tract and/or upper airway. Attacks of the extremities, which are frequent and affect up to 96% of HAE patients,3 can cause temporary disfigurement but rarely are life-threatening or require emergency treatment. Most HAE attacks will involve a primary site, but multiple sites can be involved. Cutaneous attacks are the most common type and they present as nonpitting, swelling of the face, extremities, or genitals that can be temporarily disfiguring.2 Mucosal attacks affecting the abdomen may be mild to severe and are the second most frequent type of HAE attack. These attacks present with varying degrees of pain, nausea, vomiting, and constipation and often are misdiagnosed as bowel obstructions or appendicitis, leading to unnecessary surgery. Additionally, patients with abdominal symptoms who present with hypotension due to fluid loss from the abdomen are at risk for hypovolemic shock.3

HAE Clinical Features HAE attacks tend to increase in severity during the first 24 to 48 hours and then tend to gradually subside during the next 48 to 72 hours. Attack length varies, but some attacks can last for as long as 5 days. The frequency of HAE attacks varies from patient to patient. They may occur weekly to yearly and appear to increase in frequency after puberty. HAE also is associated with an increased incidence of other autoimmune diseases including inflamma-

tory bowel disease, juvenile rheumatoid arthritis with immunoglobulin A deficiency, glomerulonephritis, pernicious anemia, thyroiditis, Sjogren’s syndrome, drug-induced lupus, and systemic lupus erythematosus.2 The majority of HAE patients will have attacks without any warning, and onset is quite sudden (<1 hour) in abdominal and airway attacks. However, some patients with HAE will experience prodromal signs of an acute attack that may signal the need for treatment. Typical prodromal signs of an HAE attack are listed in Table 1.1 Approximately one-third of HAE patients will have erythema marginatum, a serpiginous, non-pruritic rash on their trunk and extremities before or during an attack.1,7 Many patients report various “triggers” for angioedema attacks, the most common appear to be physical trauma, dental procedures and extractions, or manual repetitive tasks such as gardening and construction work. Medications such as angiotensin-converting enzyme inhibitors also can trigger an HAE attack.2,3

HAE Resources http://www.haea.org/ 2010 International Consensus Algorithm for the Diagnosis, Therapy, and Management of Hereditary Angioedema

http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC2921362/

Canadian HAE Network

http://www.haecanada.com

HAE, hereditary angioedema

Case Study A.S. is a 58-year-old woman who has experienced HAE attacks for the past 32 years. A.S. has no family history of HAE, but both her son and daughter were tested and are carriers. Her son has experienced 2 upper lip attacks but her daughter has had no episodes. Although her primary care physician also has HAE, this physician never prescribed any of the newer agents for HAE because of their “high cost.” Last December, A.S. experienced her worst HAE attack to date. She had a laryngeal attack, and was intubated and put on life support. After discharge, she was referred to an allergist who prescribed danazol and icatibant (Firazyr, Shire). A.S. began experiencing an increase in the frequency of her HAE attacks and in August she had an acute abdominal attack. She came to Diplomat Specialty Pharmacy with a referral for icatibant. Despite having an increase in the frequency of HAE attacks, A.S. was reluctant to get her icatibant prescription filled due to the agent’s high cost. Our HAE patient care coordinator worked diligently with the patient, her insurer, the pharmaceutical manufacturer’s patient support group, and her prescribing physician, facilitating initiation of therapy for A.S. The patient was given injection training and can successfully self-administer icatibant at home. This case illustrates the need for further general and primary care physician education regarding HAE awareness and available treatment options. Additionally, practitioners should realize that cost should not be a barrier to prescribing lifesaving medications used to treat HAE. A dedicated specialty pharmacy HAE care team and primary care model can serve as a valuable extension to the prescribing physician in providing a normal and attack-free lifestyle for patients living with HAE.

Types of HAE HAE has 3 distinct phenotypes, and diagnosis is confirmed by measuring the individual’s serum level of the proteins C4, C1q, and C1-INH.2 Most people with HAE have C1-INH levels that are 5% to 30% less than normal.3 Lower levels of C1-INH affect an individual’s ability to regulate the inflammation cascade, allowing large amounts of bradykinin production to occur. Approximately 85% of patients with HAE have type 1, which is a quantitative deficiency or abnormally low levels of C1-INH; 15% of patients with HAE have type 2, a qualitative deficiency with normal or slightly higher-thannormal levels of misshapen, dysfunctional C1-INH protein.1 Type 3 HAE is the rarest of the 3 phenotypes and predominantly affects women.8 It is estrogen-dependent, characterized by fully functional, normal levels of C1-INH. Some physicians classify type 3 HAE as an entirely separate disease that possibly is the result of a factor XII mutation seen in patients with this HAE type.3,6,7

HAE Treatment Approaches HAE treatment centers on 2 approaches: management of acute HAE attacks and prophylactic therapy. The 2010 International Consensus Algorithm for the Diagnosis, Therapy and Management of Hereditary Angioedema summarizes recommendations for treating acute attacks of HAE based on the anatomic area that is involved.9 A summary of FDA-approved treatments for HAE appears in Table 2.9-14 Figure 2 summarizes the mechanism of action of current and potential HAE treatments.11,13-16 Pharmacologic treatment of HAE consists of 3 treatment modalities: rescue treatment during acute HAE attacks; short-term prophylaxis prior to a patient’s exposure to a known HAE trigger, such as a dental procedure; and longterm routine prophylaxis for patients who experience frequent and/or severe attacks. It is important to note that standard anti-inflammatory therapies such as antihistamines, corticosteroids, and epinephrine are ineffective in individuals with HAE.1 The following products are approved therapies for HAE: The C1 esterase inhibitor [human] products Cinryze (ViroPharma) and Berinert (CSL Behring); ecallantide (Kalbitor, Dyax), and icatibant (Firazyr, Shire). The goal of acute HAE therapy is to terminate or alleviate an attack that is already in progress and to further minimize the associated morbidity and

•

see ANGIOEDEMA, page 14

Specialty Pharmacy Continuum • Fall 2012

Solving Specialty Pharmacy’s Data Dilemma

CORPORATE SPOTLIGHT

A new breed of information management systems has emerged to streamline operations and reduce costs.

or many specialty pharmacies, the difficulty of unlocking and leveraging the true value of data negatively impacts operations, regulatory compliance, and even patient outcomes. Forward-looking specialty pharmacies seeking to optimize operations and ensure better outcomes need data management solutions designed for flexibility so they can deliver superior patient-centric solutions and streamline reporting processes. There are many specialty pharmacy tools on the market today, all of which perform valuable functions. But, none of them address the core overarching issues—making sense of specialty pharmacies’ disparate systems and making specialty pharmacy data meaningful and useful. Existing retail Pharmacy Management Systems (PMS) are hobbled by rigid and static reporting capabilities that require cumbersome “workLawrence James, President and CEO. arounds” and retrofitting to address specialty pharmacies’ requirements. Today, however, a new class of data management tools—designed specifically for specialty pharmacy—is emerging. Coupled with specialty pharmacy expertise and consulting, these tools represent a breakthrough in how these organizations use data. This new class of tools, pioneered by Connexus Technology, connects to leading PMS systems and allows flexible reporting to govern disease management, regulatory compliance, operational efficiency and better patient outcomes.

Specialty Pharmacy’s Unique Hurdles Specialty pharmacies typically dispense drugs that require ongoing monitoring, and interaction with physicians, pharmacists and patients. Retail tools are not built to handle these interactions and associated reporting, and are used primarily for financial analysis or to look at the high-level health of the business; they are not able to look at the clinical side of the business. Workarounds to compensate for legacy PMS shortcomings are inefficient and costly, and ultimately have a negative impact on patient care. Regulations implemented by the Department of Health and Human Services, such as HIPAA, and those issued by other governmental bodies continually impact specialty pharmacy. Due to the ever-changing nature of compliance, and the need to monitor new drugs, specialty pharmacies need information systems that are flexible so that it is easier to remain compliant. Factor in the separate sets of regulations and disease-specific data requirements governing specialty pharmacies, and the need for specialty pharmacy data management tools becomes clear. In a typical specialty pharmacy scenario, day-to-day information often is recorded on paper forms, which are passed between departments to expedite orders, or recorded on spreadsheets for tracking. There is no way to monitor what is happening with the business or even to keep track of the therapies. For more advanced specialty pharmacies that have systems in place, merging siloed data between systems is problematic and prevents them from looking across the business and pulling transactional or clinical data for comparison.

Facilitating Access and Analysis of Disparate Data Sources The Connexus Technology tools pull all of these disparate, siloed data sources together, enabling specialty pharmacies to extend the functionality and realize benefits of reporting and leveraging data across all facets of their operations. Connexus tools connect to the data source of any pharmacy management system being used. Connexus consultants then employ the proprietary Touchpointt methodology and work with the specialty pharmacy to walk through the organization’s workflows, identify problems, determine which reports are needed and implement the solution. Connexus integrates readily with multiple data sources, including existing PMS systems, empowering the pharmacy to automate reporting processes, create queries and remove bottlenecks throughout the organization. Connexus tools are rapidly deployed and easily customized to operate as a standalone system or can be integrated with an existing PMS. Information from multiple data sources can be viewed from a dashboard and combined to generate reports for better clinical management as well as a more comprehensive look at the health of the business. Connexus’ customization also extends to the clinical side of the business, handling all lab values and drugs for improved therapy management and reporting to payers, manufacturers, pharmacy benefit networks and regulatory bodies. Specialty pharmaceutical companies have a unique set of opportunities to optimize their businesses within their existing information management systems by providing greater clarity between pharmacists, physicians and payers, and streamlining reporting processes. By unlocking the potential of their data through leading-edge software and integration, specialty pharmacy can emerge as leaders in health care data management, while optimizing operations and—most importantly—patient outcomes. Written by Lawrence James, President and CEO, Connexus Technology, an innovator of data management tools for the health care industry. Headquartered in Philadelphia, the company focuses on designing and implementing dynamic information management and reporting tools for large health care organizations. Connexus Technology is the recent recipient of the Philadelphia Business Journal’s “Health Care Innovation Award–Consultant of the Year 2012.”

ADDRESS: 1341 N. Delaware Ave. Office #507 Philadelphia, Pa 19125

PHONE AND FAX: 1.866.237.5542 (Phone And Fax)

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Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Table 2. Current Treatments for HAE

ANGIOEDEMA

Trade Name

Generic Name

Class/Indication

Route of Administration

Various

Danazol

Attenuated androgen indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females

Oral

Cinryze

C1-esterase inhibitor (human)

C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE

Berinert

C1-esterase inhibitor (human)

Plasma-derived C1-esterase inhibitor indicated for the treatment of acute abdominal or facial attacks of HAE in adult and adolescent patients

Kalbitor

Ecallantide

Plasma kallikrein inhibitor indicated for treatment of acute attacks of HAE in patients aged 16 years or older

Subcutaneous

Firazyr

Icatibant

Bradykinin receptor 2 antagonist indicated for treatment (self-administration) of acute attacks of HAE (I, II, III) in patients aged 18 years or older

Subcutaneous

continued from page 11

mortality of an attack. The paramount concern during an acute attack is to halt the progression of the edema and alleviate symptoms, particularly those involving the larynx. Berinert, Kalbitor, and Firazyr are FDA-approved for the treatment of acute HAE attacks. Many individuals with HAE have known triggers for an attack, such as dental procedures or other planned or emergent invasive surgery or procedures. Using short-term prophylaxis prior to a known precipitating event may prevent the attack from occurring. Berinert is used 1 to 6 hours prior to an event. Fresh frozen plasma (FFP) also has been used, 2 units 1 to 12 hours prior to the event.7 Kalbitor is used subcutaneously when the patient experiences an acute or sudden HAE attack and Firazyr also is approved for the treatment of an acute HAE attack. Both Kalbitor and Firazyr are administered once a patient starts to experience the signs and symptoms of an acute attack.2 The goal of long-term prophylactic therapy is to prevent future HAE episodes while minimizing the frequency and severity of attacks. Prophylactic therapy prevents hospitalizations and emergency room visits and can be further subclassified as long- or shortterm. As the name implies, long-term prophylaxis minimizes the frequency and severity of HAE attacks and may be appropriate for patients who have more than 1 attack per month, are disabled for more than 5 days per month due to HAE attacks, or have a history of airway obstruction.7 The FDAapproved therapies for long-term HAE prophylaxis are steroids such as danazol and Cinryze. Danazol treatment is 200 mg 2 to 3 times daily titrated downward by less than 50% every 1 to 3 months until a suitable level is reached based on the patient’s clinical response. Prophylaxis with Cinryze is 1,000 IU every 3 to 4 days.7 Anabolic Steroids

For years, oral, attenuated anabolic steroids such as danazol or stanozolol were the only treatment options available for patients with HAE. Attenuated steroids increase the concentration of plasma C1-INH by increasing hepatic production of C1-INH and are used for longterm prophylaxis in adults. A dose of 600 to 800 mg of danazol given orally can reduce the number of HAE attacks by 90%.2,5 Although they are the lowest cost option for treatment and they can reduce the number of attacks a patient will

HAE, hereditary angioedema Based on references 9-14.

experience, nearly 80% of patients taking androgens report significant adverse events (AEs), including female virilization, headache, weight gain, depression, acne, and more serious side effects such as myocardial infarction and stroke.17 These AEs can be particularly problematic for female HAE patients, and these agents are contraindicated in patients who are pregnant or breastfeeding.2 C1-Esterase Inhibitors

C1-esterase inhibitor concentrates derived from pooled human plasma have been available in Europe for many years and have become first-line therapy for HAE in many countries. In 2008, the FDA approved Cinryze as an alternative to androgens for routine prophylaxis against HAE attacks in adolescents and adults.11 Cinryze is available as a lyophilized solution, is administered intravenously, and is approved for self-infusion in the home. The usual dose is two 500-IU vials (for a total of 1,000 units) given IV at a rate of 1 mL per minute over 10 minutes every 3 to 4 days. In randomized trials, patients receiving C1-esterase inhibitors reported having half the number of attacks compared with placebo.3 Because Cinryze is derived from donated human plasma, there is a theoretical risk for viral transmission of infectious agents or viruses, but no cases have been reported in the literature. Surveillance for blood-borne pathogens should include testing for hepatitis B and C and HIV. Hepatitis B vaccination of patients also is recommended. AEs include sinusitis, rash, headache, and upper respiratory tract infection. In contrast to attenuated androgens, Cinryze is highly affective and has fixed dosing. This therapy, however, is very expensive, often costing $300,000 or more per year, and health insurers have rigor-

ous prior authorization processes in place. Cinryze is a limited-distribution product and is available through the CINRYZESolutions Support Program (patient intake hub), Caremark Specialty Pharmacy, and CuraScript Specialty Distribution. Additionally, ViroPharma provides for home nursing support through an affiliation with the Specialty Pharmacy Nursing Network. In October 2009, a second C1-esterase inhibitor, Berinert (CSL Behring), was approved. Berinert is the only C1-esterase inhibitor approved for the on-demand treatment of ongoing acute facial, laryngeal, and abdominal HAE attacks in adolescents and adults.12 It should be noted that Berinert also is derived from pooled human plasma and carries the same potential risk for viral transmission as Cinryze. Berinert, which is not approved for prophylaxis, is a lyophilized concentrate (500 units per vial) that requires reconstitution with 10 mL of sterile water (included). The lyophilized vials may be stored at room temperature. The recommended dose of Berinert is 20 units/kg body weight, infused at a recommended infusion rate of 4 mL per minute. For example, a 70-kg patient would require 1,400 units infused over 7 minutes.12 Patients using Berinert report a median onset of attack relief in 48 minutes. In an extension study, patients experiencing laryngeal attacks had a median onset of relief in 15 minutes. In January 2012, Berinert received a label expansion as the only “on-demand” therapy for selfadministration. Like Cinryze, Berinert is a limited-distribution specialty pharmaceutical; it is available from Accredo, Biofusion, BioRx, BioScrip, Caremark, Coram, Crescent, CuraScript, and Walgreens/OptionCare.18

Other HAE Therapies In December 2009, the FDA approved

a third agent, Kalbitor, a plasma kallikrein inhibitor. Kalbitor is a genetically engineered recombinant protein that reduces production of bradykinin by inhibiting kallikrein and is approved for the treatment of acute HAE attacks in patients aged 16 years or older. The safety and efficacy of Kalbitor for prophylactic therapy has not been established. Unlike the C1-esterase inhibitors, Kalbitor is administered subcutaneously. Kalbitor is available as a single-use glass vial containing 10 mg/mL of solution. The usual dose is 30 mg (3 mL), administered subcutaneously in three 10-mg (1 mL) injections. If an HAE attack persists, an additional 30-mg dose may be administered within a 24-hour period.13 Kalbitor’s product labeling carries a black box warning for anaphylaxis, which has been reported after administration of this agent. The warning states that due to the risk for anaphylaxis, Kalbitor should only be administered by a health care professional with appropriate medical support to manage anaphylaxis and HAE. Health care professionals should be aware of the similarity of symptoms between hypersensitivity reactions and HAE, and patients should be monitored closely. Allergic reactions and anaphylaxis to Kalbitor manifest as rhinitis, chest discomfort, wheezing, flushing, pharyngeal edema, pruritus, urticaria, and/or hypotension.2,19 Due to the high potential for anaphylaxis, Dyax, the manufacturer of Kalbitor is required by the FDA to participate in a Risk Evaluation and Mitigation Strategy program.13 Dyax also provides for home infusion nursing services for Kalbitor via a specialty pharmacy arrangement with Walgreens Infusion Services. Like the other products for HAE, Kalbitor is a limited-distribution drug that is available through 2 wholly owned sub-

Specialty Pharmacy Continuum • Fall 2012

CLINICAL

Fresh frozen plasma16

Antifibrinolytics15

Androgens16

C1-INH dysfunction

C1-INH (concentrate or recombinant)11 7. Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.

Active FXIIa

Replaces/increases Inhibits

Active kallikrein

Kallikrein inhibitors13

BK BK B2R antagonist (icatibant)14

BK B2R

Vasodilation and increase in vascular permeability16

Figure 2. Targets of HAE treatment: current and potential therapies. BK, bradykinin; BK B2R, bradykinin B2 receptor; C1-INH, C1 inhibitor; HAE, hereditary angioedema Based on references 11,13-16.

sidiaries of AmerisourceBergen Specialty Group. US Bioservices Corporation serves as the specialty pharmacy distributor and also administers “Kalbitor Access,” a comprehensive call and service center for patients and health care providers seeking information and access to Kalbitor. ASD Specialty Healthcare serves as the wholesale distributor for Kalbitor to teaching hospitals in the United States.20 In August 2011, the FDA approved the fourth drug to treat HAE, Firazyr. Firazyr is a second-generation, synthetic bradykinin B2 receptor (B2R) antagonist approved for treating acute HAE attacks in patients aged 18 years or older. It is administered as a subcutaneous injection and is approved for self-administration.14 It is the first acute treatment for HAE that patients can administer without the assistance of a health care professional. Firazyr often is used for breakthrough attacks that may occur while an HAE patient is on other prophylactic therapies. The antagonism of the bradykinin B2R can decrease coronary blood flow, and caution should be used when using Firazyr in patients with acute ischemic heart disease or unstable angina.2 Firazyr is available as a prefilled, single-use, self-injectable syringe. Each syringe delivers 30 mg of Firazyr; the drug is given by slow subcutaneous injection, over at least 30 seconds, right under the skin in the abdomen. If a patient’s symptoms continue or come back, additional doses of Firazyr may be given, but the doses must be separated by at least 6 hours and no more than 3 doses of Firazyr can be given in a 24-hour period. Firazyr should be

stored at 36°F to 77°F (2°C-25°C). Common AEs of Firazyr include injection-site reactions such as redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site, fever, increased levels of plasma transaminase, dizziness, nausea, headache, and rash. Shire has an arrangement with inVentiv Health to provide subcutaneous injection training and administration of Firazyr via its OnePath program, and the drug is available through several specialty pharmacies. In addition to these 4 drugs used in the treatment of HAE, at least 2 more are in the pipeline. Cetor, made by Sanquin, is another C1-INH concentrate and Rhucin/Ruconest by Pharming, NV is a recombinant C1-INH concentrate derived from the milk of genetically altered female rabbits.21

Specialty Pharmacy’s Role in HAE Drugs used in the treatment for HAE are distributed through specialty pharmacies. Specialty pharmacies play a significant role in educating HAE patients about their disease state as well as teaching patients to administer these drugs. Patient considerations for self-administration of HAE therapy at home include: • Motivation to comply with home therapy • Demonstrated understanding of the risks for pathogen transmission from blood-based products • Presence of a willing care partner who is present during infusions • Good peripheral access Additionally, specialty pharmacies help patients access HAE therapies and

reduce delays in all payer segments and all practice sites by advocating for HAE patients and obtaining reimbursement for HAE therapies. At Diplomat Specialty Pharmacy, we use a multidisciplinary HAE care team to assess the HAE patient’s ability to self-infuse at home. Moreover, patients undergo a comprehensive initial assessment by a nurse and a pharmacist who both have therapy management expertise in HAE. Team members obtain a thorough “attack history,” identify known attack triggers, and develop individualized care plans for HAE patients. These plans are shared with the individual’s prescribing physician to facilitate coordination of care.

References 1. Jacobs J, Johnston DT. Applying recent evidence in hereditary angioedema–optimizing patient care. Pharmacy Practice News. 2011;38(10 suppl):1-8. 2. Fox T. Quality-of-life implications for patients with hereditary angioedema who self-administer C1 inhibitor. Pharm Prac News. 2011;38(5):32-33. 3. Kaplan AP, Riedl MA. Hereditary angioedema: viewpoints from the experts. Medscape Education. http://medscape.org/viewarticle/716395. Accessed October 3, 2012. 4. Donaldson V, Evans R. A biochemical abnormality in hereditary angioneurotic edema: absence of serum inhibitor of C1-esterase. Am J Med Sci. 1963;35:37-44. 5. Johnson DT. Diagnosis and management of hereditary angioedema. J Am Osteopath Assoc. 2011;111(1):28-36. 6. Smith L. Key companies and products in the market to treat the orphan disease hereditary angioedema. Seeking Alpha. http://seekingalpha.com/article/292535-key-companies-andproducts-in-the-market-to-treat-the-orphandisease-hereditary-angioedema. Accessed October 3, 2012.

8. HAEI. HAE disease. What causes HAE? http://www.haei.org/node/25. Accessed October 3, 2012. 9. Bowen T, Cicardi M, Farkas H, et al. 2010 International consensus algorithm for the diagnosis, therapy and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010;6(1):24. 10. Danocrine (danazol) prescribing information. Sanofi-Synthelabo, Inc.; 2008. 11. Cinryze (C1 Esterase Inhibitor [human]) prescribing information. ViroPharma Inc., 2011. http://www.viropharma.com/~/media/Files/ CINRYZE%20PI_July2012.ashx. Accessed October 3, 2012. 12. Berinert (C1 Esterase Inhibitor [human]) prescribing information. CSL Behring. http:// labeling.cslbehring.com/PI/US/Berinert/ EN/Berinert-Prescribing-Information.pdf. Accessed October 3, 2012. 13. Kalbitor (ecallantide) injection, for subcutaneous use. Dyax Corp. February 2012. http:// www.kalbitor.com/hcp/rems/pdf/KalbitorFullPrescribingInformation.pdf. Accessed October 4, 2012. 14. Firazyr (icatibant) Injection, for subcutaneous use prescribing information. Shire Orphan Therapies, Inc. August 2011. http:// pi.shirecontent.com/PI/PDFs/Firazyr_USA_ ENG.pdf. Accessed October 4, 2012. 15. Levy JH, O’Donnell PS. The therapeutic potential of a kallikrein inhibitor for treating hereditary angioedema. Expert Opin Investig Drugs. 2006;15(9):1077-1090. 16. Zuraw BL. Novel therapies for hereditary angioedema. Immunol Allergy Clin North Am. 2006;26(4):691-708. 17. Bork K, Bygum A, Hardt J. Benefits and risks of danazol in hereditary angioedema: a long-term survey of 118 patients. Ann Allergy Asthma Immunol. 2008;100(2):153-161. 18. CSL Behring Berinert referral form. http:// www.berinert.com/docs/ben_referral.pdf. Accessed October 4, 2012. 19. U.S. Food and Drug Administration. FDA approves Kalbitor for treating potentially lifethreatening attacks of hereditary angioedema. December 2, 2009. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/2009/ucm192687.htm. Accessed October 4, 2012. 20. Dyax Corp. Form 10-Q for DYAX CORP, 2 May 2012. Quarterly report. http://biz.yahoo. com/e/120502/dyax10-q.html. Accessed October 4, 2012. 21. Pharming Group N.V. New data published on RUCONEST’s protective effects after severe blood loss. July 2, 2012. Marketwire. http:// www.marketwire.com/press-release/pharming-group-nv-new-data-published-on-ruconests-protective-effects-after-severe-bloodpinksheets-phguf-1675738.htm. Accessed October 4, 2012. Ms. Lima reports no relevant ﬁnancial conﬂicts of interest. Penny Erickson, HAE patient care coordinator at Diplomat Specialty Pharmacy, assisted in the development of the patient case study.

Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

Ask the Expert

A Compounder and d Specialty Pharmacy Provider Speaks Out on NECC N. Lois Adams, MBA, RPh, is in a unique position to offer insights into the meningitis outbreak that has been tied to contaminated methylprednisolone injections prepared by the New England Compounding Center (NECC). Ms. Adams is chairman, president and chief executive officer of Freedom Pharmacy, an Orlando, Fla.-based company that compounds a variety of products, some of which are sterile drugs for injection. The company also has been providing specialty retail pharmacy services since 1984, with a focus on cystic fibrosis. Specialty Pharmacy Continuum recently spoke with Ms. Adams on a wide range of issues raised by the outbreak, including the degree to which state boards of pharmacy are able to police the practice of compounding, and whether increased federal oversight and/or new legislation is required to ensure product integrity and patient safety. Q. State boards of pharmacy have been given the lion’s share of regulatory and enforcement authority over compounding pharmacies, albeit with some FDA involvement in cases of clear-cut patient harm. Do you think those mechanisms are enough, given the breadth of the current outbreak? A. What happened at NECC was a clear and flagrant violation of state pharmacy laws, which resulted in the deaths of more than 30 people. Those deaths are tragic, and our hearts go out to the families and loved ones who have been affected. But this is not an issue of a lack of regulation by the FDA. I know there has been a call from many quarters that the FDA get more involved—including the agency itself, which asked for more policing power during this week’s Congressional hearings. But our view is that the agency should nott be given authority over the practice of pharmacy. The officers and owners of NECC are really at issue; they are the people who need to be dealt with properly. Those people were manufacturing. When we compound, in contrast, it’s in response to an individual prescription that is sent to us; NECC had a ton of product on their shelves just sitting there waiting for mass shipments. That’s not what responsible compounders do. Now, the fact that the Massachu-

BY THE NUMBERS 438 | Meningitis cases 19 | States affected 32 | Deaths

setts Board of Pharmacy apparently let this situation persist is a serious problem, and so I was not surprised to see that actions have been taken to address that. [James Coffey, director of the state’s Board of Pharmacy, was dismissed in early November]. Q. And yet the safety problems at NECC are not an isolated occurrence. In 2002, five people in North Carolina treated with the same steroid implicated in the current outbreak con-

in place that are sufficient to ensure the sterility and safety of compounded medications. In my judgment, NECC— and its parent company, Ameridose, based on recent developments—was a flagrant violator and they are in no way representative of compounding pharmacies currently operating. [On Nov. 12, the FDA announced that it had found several serious flaws in Ameridose’s manufacturing processes, including a leaking ceiling in a supposed clean room and a bird flying

‘It’s our view that the state boards of pharmacy have rules and regulations in place that are sufficient to ensure the sterility and safety of compounded medications.’ —N. Lois Adams, MBA, RPh tracted fungal infections; one of the patients died ((MMWR 2002;51:11091112). And this isn’t even the first time that NECC has been cited for safety violations. So isn’t that justification for a more aggressive approach to regulation and enforcement that goes beyond state boards of pharmacy? A. It’s our view that the state boards of pharmacy have rules and regulations

through a room where sterile drugs are packed. Other potentially serious threats to patient safety included reports of patients being over-sedated on the induction agent oxytocin made by the company, or the drug having no anesthetic effect even after a maximum dose was administered.] I have been in this industry for 50 years. When I went to pharmacy school,

we compounded; it was a core skill, and it is again—the pharmacy schools are teaching students how to do it the right way. The idea of sterility is so important; it’s a core tenet of what we do. If you’re going to manufacture an injectable compound, there are two sets of rules from USP [United States Pharmacopeia]: Chapter <795> for external preparations and Chapter <797> for infusions, etc. It’s a very exhaustive, comprehensive set of guidelines that obviously NECC and now Ameridose didn’t feel was important enough to follow. To me, this is a cautionary tale of what happens when you flout existing rules and regulations—not a call for new, potentially onerous regulations that may hurt legitimate compounding pharmacies and get in the way of our delivering timely, highquality patient care. Q. Drug shortages have been cited as one reason why some compounding pharmacies with checkered records of compliance are able to continue to attract customers. Do you think that’s a contributing factor? A. Sure. And there are many causes of drug shortages. But one in particular, in my view, has contributed to some of the problems we’re seeing. The FDA has temporarily shuttered several generic drug manufacturers over the years when the agency has evidence of manufacturing problems. Of course that is a legitimate role for the agency to play. But in some cases, the government has not done enough to ensure that adequate supplies of the affected medications are available from alternate manufacturers during the shutdowns. To fill the resulting shortfall, some pain clinics, health systems and other end-users have to then turn to suppliers whose track record for safety is hard to determine. In our case, the issue has been periodic shortages of the raw materials we use to compound Amikacin, an aminoglycoside that we compound into an aerosol for our cystic fibrosis patients as a topical antibacterial. The last time

Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

this critical drug was absolutely not available from our usual supplier, rather than go to some company for the basic ingredients who I did not have 100% confidence in, we approached the FDA with our problem. I talked to their people who are in charge of surveying and monitoring overseas plants, and they went through the process of getting the drug for me from a reputable alternative supplier. So I think sometimes the federal agencies are not used to the degree that they could be. Instead of partnering with a supplier who may or may not be following good manufacturing practices, use the agencies that can help you get product from reputable suppliers. They certainly did that for me. Bottom line, although we don’t want to see the FDA step in and regulate what we as compounders do on a daily basis, we certainly don’t think they are the enemy. Far from it—as in the case of the Amikacin shortage, the FDA can be an effective partner in helping us to pro-

vide safe compounded medications for our patients. Q. Do you compound any products that are in any way similar to the injectable methylprednisolone that caused NECC so many problems, and if so, what specific processes and procedures do you follow to ensure safety and sterility? A. First, we don’t compound methylprednisolone; that’s just not the business we want to be in. But we do prepare some sterile drugs for injection, morphine being a good example. We prepare the drug as a syringe for injection into intrathecal pumps that are then used in patients with severe chronic pain, including quadriplegics and patients with cancer. We obtain

the raw material from PCCA [Professional Compounding Centers of America], a very respected supplier with a strong history of sound manufacturing practices. In fact, we have attended training sessions by PCCA, and we adhere to their standards. Of course, the main standard we follow are those set forth in USP Chapters <795> and <797>. Our environmental controls, for example, are very robust, and are based on USP tenets. We start every morning by cleaning the IV hoods, compounding room floors and surfaces, as well as the anteroom, alternating with bleach and ammonia. That’s done daily. We do a second wipe down before anything is placed in the hood, and when we do the actual compounding, we use 100% aseptic techniques. We also undergo periodic inspections by the state board of phar-

macy, and we also are accredited by the ACHC [Accreditation Commission for Health Care]. Those are just a few of the measures we take or undergo to ensure sterility and safety. Q. So it sounds like you’re of a mind that current regulations and guidelines suffice, as long as enforcement is where it is needed to be. Does that leave any room for change? A. Of course—as long as it comes from people who are familiar with what we do as pharmacy compounders. The NABP [National Association of Boards of Pharmacy] is pushing for a national board that would somehow be involved in the regulation of pharmacy practice, which would include compounding. I am confident that the NAPB understands what it is that we do, so I would welcome their adding more consistency to how compounding and other aspects of pharmacy practice are regulated. —Reported by David Bronstein

Specialty Pharmacy Unfairly Maligned?

everal leading specialty pharmacy providers who were contacted by this newspaper for comment on the meningitis outbreak either did not respond or asked to remain anonymous, citing legal constraints. One source, a pharmacist in charge of infusion services at a top-five specialty pharmacy, said corporate counsel was “very nervous about our going on record.” But given the option to speak without attribution, the source quickly cited a major concern about the outbreak. “It’s very upsetting to see media reports referring to NECC [New England Compounding Center] as a specialty pharmacy,” the source said. “They are decidedly not a specialty pharmacy; they’re a compounding pharmacy, and a very bad one at that, based on the results of investigations I’ve seen. So it’s unfortunate that reputable companies in our industry are being painted with such a broad brush.” The source commented on several additional issues raised by the meningitis outbreak: Who Should Regulate Compounding Pharmacies? The source said that state boards of pharmacy “are in the best position” to police pharmacy compounders, including inspecting pharmacy operations, developing appropriate regulations and responding in cases where safety problems or manufacturing violations occur. However, that process is not infallible, in part because of state-by-state variations in enforcement, the source noted. “I think the state boards need to be better educated in terms of what [safety checks] need to be in place for pharmacy compounders. Some boards are very progressive and they have incorporated these measures into pharmacy law. Others clearly do not have that level of understanding.” Given that lack of consistent oversight, patient safety advocates such as Public Citizen have urged the FDA to step up its monitoring of compounding pharmacies. On Nov. 14, during Congressional hearings, FDA commissioner Margaret Hamburg showed her support for such a move by asking that the agency be given a clear mandate to test products made by compounding pharmacies. The source agreed that some added oversight by the FDA is called for, especially given the history of repeated safety violations by compounders and the agency’s track record of responding to some of the past transgressions. At the least, “the [agency] should be taking steps to ensure that the ingredients used in compounding are safe and are manufactured by FDA-registered and inspected facilities.” However, “Do I think that it is the federal government’s job to patrol every state? No, I don’t think that’s possible, nor probably desirable. But they can implement basic quality-control standards, perhaps via legislation, that the states would have to adopt.” The source cited, as an example, a bill that was introduced in early November, called the Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 6584). The bill includes several safety provisions, including a requirement that a compounded drug must be prepared in response to a prescription for an individual

patient, which echoes many state laws that distinguish between compounding and large-scale manufacturing. (It is interesting to note, however, that the VALID bill grants a waiver to the prescription requirement in the event of drug shortages—a provision that could be problematic, given the fact that many health systems and pain clinics said they had turned to NECC for methylprednisolone after ongoing shortages of the steroid.) Are USP Guidelines on Sterile Compounding Sufficient To Ensure Safety? Some industry experts maintain that although United States Pharmacopeia (USP) Chapter <797> can be an effective tool for compounding pharmacies to ensure sterility and safety, tweaks may be needed. Tom Van Hassel, RPh, MPA, vice president of the Arizona Board of Pharmacy, told Specialty Pharmacy Continuum that his state has chosen to create its own set of rules for pharmacy compounders that include selected components of USP <797>. Such an approach “is more targeted and raises far fewer compliance issues” than trying to implement the full USP guidelines, he noted.

‘If one of your family members needed a sterile IV solution, which would you prefer—a company that adheres 100% to USP sterile compounding guidelines, or one that doesn’t?’ The specialty pharmacy infusion executive took exception to that piecemeal approach. “I was on the USP committee that drafted these guidelines,” the source said. “In my mind, you can’t pick and choose which provisions of <797> suit you. If one of your family members needed a sterile IV solution, which would you prefer—a company that adheres 100% to USP sterile compounding guidelines, or one that doesn’t?” Pointing to the emerging details of the NECC case, the source added, “This is what happens when USP sterile compounding regulations are not followed.” Is Accreditation an Important Safety Tool? The source said that accreditation should be on the agenda of any company that takes quality control and patient safety seriously. “There are several accrediting bodies that have developed national standards to accredit pharmacies; we’ve obtained ACHC [Accreditation Commission for Health Care] and URAC [formerly known as the Utilization Review Accreditation Commission] accreditation for disease management, and we’re in the final stages of seeking URAC accreditation for Specialty Pharmacy and VAWD [Verified-Accredited Wholesale Distributors] accreditation.” —David Bronstein

Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

PERFORMANCE continued from page 1

including commercial health plans, Medicare Advantage Prescription Drug Plans and managed Medicaid plans across the United States, that were published in EMD Serono’s Specialty Digest, 8th Edition: Managed Care Strategies for Specialty Pharmaceuticals. Payers were asked to rank both the importance of services provided by their specialty pharmacy and their level of satisfaction with their contracted pharmacy’s performance on a scale of 1 to 5. Performance guarantees of accuracy and direct distribution to a patient’s home or business were the two highest-ranked services with respect to importance (ranking for both, 4.6); these services also were tops among those for which payers were satisfied with specialty pharmacy providers’ (SPPs) performance (rankings, 4.0 and 4.1). Payers considered enforcing preferred product selection to be nearly as important (ranking, 4.5), but they were not nearly as satisfied with SPPs’ performance in this area (ranking, 3.5). Tracking outcomes of patient interventions rated a 4.4 on the importance scale but only 3.2 on the satisfaction scale. Services ranked as less important—less than 4.0— included seeking financial assistance for patients, performing prior authorization review and contracting for rebates. Debbie Stern, the president of the managed care consulting firm Rxperts, Inc., who authored the report and presented excerpts of it at the ARMADA Specialty Pharmacy meeting in May, told Specialty Pharmacy Continuum, “More and more specialty pharmacies are putting in performance guarantees for accuracy and delivery. That’s where they’re doing the right thing.” However, she added that “there are big gaps in payer perceptions of clinical management—what the pharmacists are actually doing as pharmacists to manage the patient from a clinical perspective.” Ms. Stern has worked with several specialty pharmacies to help develop programs geared toward payer needs. “They are challenged by the idea that they need to be documenting what they do,” she said. “Every intervention you make on a specialty drug—tracking waste and abuse, making sure the patient is taking the right drug and that it matches their diagnosis—could potentially save the patient and the payer money and result in better patient management. Specialty pharmacies all say they do wonderful things, but how many are actually tracking and proving it?” Ms. Stern suggested that specialty pharmacies need to see themselves more as partners of payers, providing valueadded services above and beyond what might be available in a retail environment. “What are you doing to help the

‘A specialty pharmacy could really differentiate itself with a crackerjack drug waste and abuse management program.’ —Mark Zitter health plan realize its goals? If you’re tracking adherence and looking at reasons why patients don’t stay adherent, and you identify side effects or intolerability of route of administration as a problem, do you then contact the doctor, do follow-up and document getting the patient back on therapy?” That sounds like a lot of work, noted Ms. Stern, but it can be done. “A specialty pharmacy that does this, and does it well, would stand out from the crowd.” But this does not necessarily apply for all payers, argued managed care expert Mark Zitter, the founder and CEO of the

patient out of the hospital, but, given the cost of the drugs, only a subset of payers is willing to pay specialty pharmacies more to persuade patients to do something they should already be doing.” Mr. Zitter sees waste and abuse as an area in which specialty pharmacies truly can make their mark. “For example, when a 30-day supply of an oral oncology drug is delivered and the patient dies, or goes into hospice or develops intolerable toxicities during that first week, can the rest of the dose be salvaged? g If you y u half a vial of a $2,000 drug, is there use any way to distribute [it]

so that the other half can be reused? Or if it’s not reused, at least the payer isn’t charged twice? A specialty pharmacy could really differentiate itself with a crackerjack drug waste and abuse management program.” The survey makes clear that pharmacies will need to start documenting their value to payers. “It’s not that difficult, but it’s just not necessarily built into the processes they’ve set up or in their mindset,” Ms. Stern said. She pointed to some smaller pharmacies that have documented the results they’ve achieved by employing new hepatitis C treatment algorithms. These pharmacies have reported being able, for example, to stop a patient’s therapy and save money or to keep a patient on therapy and improve successful outcomes, she said. “That stuff is what payers would just gobble up.” —Gina Shaw Ms. Stern reports that she is a consultant to EMD Serono. Mr. Zitter reports no relevant ﬁnancial conﬂict of interest.

‘Specialty pharmacies all say they do wonderful things, but how many are actually tracking and proving it?’ —Debbie Stern Zitter Group. “Payers are heterogeneous. They all want low costs but are more diverse in their willingness to pay for cognitive services,” he said. “For example, if a specialty pharmacy enhances adherence to [a multiple sclerosis] drug, that’s a good thing. But for most biologics, adherence actually costs more money than it saves. All payers want to keep the

To Boost Specialty Pharmacy Value, Tech’s Not King

f specialty pharmacies really want to set themselves apart from the pack on matters of high priority to payers—such as adherence—more and better technology may not be the only way to go. Jay Bryant-Wimp, PharmD, owner and CEO of AccurateRX, suggests that auto-refills, data monitoring and computerized alert systems to oversee adherence are less important than “the personal touch.” Mr. Bryant-Wimp told Specialty Pharmacy Continuum, “that face-to-face, personalized interaction” between the specialty pharmacy and the patient “makes all the difference in the world. But,” he noted, “currently, most specialty pharmacies farm out their nursing.” In an outcomes study he conducted during his tenure at OptionCare/Walgreens, Mr. Bryant-Wimp showed the benefits of keeping that direct connection between the specialty pharmacy and its patients. During the study, hospitalization rates for patients with bleeding disorders decreased by more than 600% when nurses directly employed by the pharmacy, rather than nurses from contracted agencies, provided patient care. The cost savings? More than $2 million (ASHP Midyear Clinical Meeting, 2007; abstract P269D). Insurance companies often segregate their pharmacy and health benefits into silos, making it harder to detect such a benefit, however. “This could be the model for disease-specific care, but often there is no sharing of outcomes across the company,” noted Mr. Bryant-Wimp. “And specialty pharmacies don’t always offer hospital or emergency room avoidance as part of their coverage.” He suggested that specialty pharmacies propose to their payers a baseline project in a smaller, key target area of their patient population. “Do an intervention where you not only use your own nurses, but give them the tools to be able to teach and impact behavior,” he said. “For many patients, it all comes down to what they do when they’re having a problem or pain at 7 p.m. on a Friday night. Do they go to the ER, or are they comfortable enough with the people they talk to at their specialty pharmacy that they’ll call and let them know? If the patient doesn’t have the relationship to call you and know there’s someone who’s paying attention, all the technology in the world won’t matter.” —G.S.

Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

HIV-Specialized Pharmacies May Improve Adherence Community pharmacies that offer specialized services for HIV/AIDS patieents may be more effective than traditional community pharmacies in improving adherence and persistence with antiretroviral therapy, according to a study in AIDS Patient Care and STDs (2012;26:526-531). Limited to one pharmacy chain, Walgreens, which also funded the research, the study included 95 specialized pharmacies and 1,462 traditional pharmacies, with 7,064 patients in each group. The services of the specialized pharmacies, located in nine cities in seven states, included medication review, adherence assessment, refill synchronization and continual availability of HIV/ AIDS medications. The researchers analyzed pharmacy claims for Sept. 1, 2010 through Aug. 31, 2011. Medication adherence was measured via a modified proportion of days covered (PDC) calculation, based on prescription refill data. PDC was calculated as the total days a patient possessed an adequate regimen (three or more antiretroviral medications) divided by days between the patient’s first fill date and last fill date plus days supply remaining from the last fill. Persistence was measured as the number of days from when a patient possessed an adequate regimen to discontinuation of the regimen. Specialized pharmacy patients had a significantly greater mean (74.1% vs. 69.2%; P<0.0001) and median (90.3% vs. 86.3%; P<0.0001) PDC than traditional pharmacy patients. Additionally, a greater percentage of patients in the specialized group had a PDC of 95% or better than the traditional group (39.3% vs. 35.5%). Patients in the specialized group also were significantly more persistent with therapy ((P=0.0117). When the study period ended, 1,448 specialized pharmacy patients remained on an adequate regimen compared with 1,402 traditional pharmacy patients. Asked whether the differences in PDC between the specialized and traditional groups were clinically significant, study co-author Glen Pietrandoni, RPh, AAHIVP, told Specialty Pharmacy Continuum, “We are not measuring viral load and CD4—we as community pharmacists don’t always have access to the laboratory data. Success in our study is tied to adherence, and there is a significant difference there.” Mr. Pietrandoni, the senior manager for HIV and Hepatitis Services, at Walgreens, in Deerfield, Ill., also said,

•

see ADHERENCE, page 26

Table. Adherence Measurements T Study Population

Mean PDC, %

Median PDC, %

Patients on Regimen at End of Study

Specialized pharmacy patients

74.1

90.3

1,448

Traditional pharmacy patients

69.2

86.3

1,402

PDC, proportion of days covered

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Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

‘Good Results’ program:

Preventing Adverse Drug Events in Patients Cheryl Graziose, RPh Assistant Director of Clinical Services AHF Pharmacy AIDS Healthcare Foundation Tampa Bay, Florida

Potential ADE

Other

ADE

No problems

Sarah Butler O’Rourke, PharmD Staff Pharmacist AHF Pharmacy AIDS Healthcare Foundation Tampa Bay, Florida

64%

Laura Middleton Fields

11%

PharmD Candidate University of Florida, College of Pharmacy St. Petersburg, Florida

21% 4%

Figure 1. Medication-related issues identified during follow-up calls. ADE, adverse drug event

birth, medication, and date written— is entered on the Good Results Data Collection Form (a Microsoft Excel spreadsheet). Additionally, patient comments or reported ADEs are docu-

Number of ADEs

critical “new transitions of care”: when new medications were prescribed and when medications were changed. The program was designed to track initial and follow-up consultations for patients prescribed new medications or those with changes to their current regimens. During the initial consultation, patients are counseled regarding proper medication dosing and instructions, auxiliary warnings or directions (food), potential ADEs, how to prevent ADEs, and when to contact the medical provider. Pharmacists or pharmacy students provide follow-up telephone consultation to these patients to address their concerns and ensure safe and appropriate medication use. By contacting patients in the comfort of their homes, AHF is better able to reinforce important dosing information and address their questions or concerns about their medications. Because most patients do not visit their medical provider for 3 to 6 months after a new medication is prescribed, pharmacists play a crucial role by reinforcing the proper use, answering questions about the medication, and preventing ADEs related to the new medication. Data collection is completed by using the pharmacy computer system to print the “New Prescription” tracking report that identifies new prescriptions or dosage changes. Data are collected only for patients prescribed new medications for chronic conditions; short-term or one-time prescriptions are excluded. Relevant information—including patient name, date of

12 10

No harm, medication ineffective Patient self-management Temporary, requiring intervention Event occurred, temporary harm

8 6 4 2 0

Types of ADEs

Figure 2. Types and occurrences of ADEs. ADE, adverse drug event

Number of ADEs

IDS Healthcare Foundation (AHF) Pharmacy implemented the Good Results Program as a medication safety initiative to provide and document safe medication use and prevent adverse drug events (ADEs) in a complex HIV/ AIDS patient population with adherence issues, multiple chronic conditions, and complex medication regimens. The AHF Pharmacy-Tampa Bay is a specialty community pharmacy practice site attached to the AHF Tampa Bay Healthcare Center. In addition to pharmacists specially trained in the care of patients with HIV/AIDS, the Tampa site employs pharmacy interns and is an Advanced Pharmacy Practice Experience rotation site for third- and fourth-year pharmacy students. AHF’s American Academy of HIV Medicine–certified physician provides primary and specialty care for the clinic patients. The foundation’s patients are prescribed complex, highly active antiretroviral therapy with multiple drug interactions, as well as medications for chronic medical conditions and adjunctive therapy. Patients frequently feel overwhelmed with the vast amount of new medical or prescription information given during an office visit, and some may not comprehend or remember what was communicated to them by the medical provider and the clinical pharmacist. It also is common that patients do not initiate communication with their health care providers because they feel they are intruding on time that could be used for a more difficult patient. Thus, AHF pharmacists play an especially important role in ensuring that patients understand the dosing, indication, and side effects associated with their antiretroviral regimens and other chronic medications. The Good Results Program began when the community-based clinical pharmacists identified 2 points as being

mented on the form. The data collection form automatically populates callback dates for 7 and 30 days after the initial date written. A pharmacist or a pharmacy student contacts patients within 7 to 14 days of the start date of the medication, and again at 30 days if indicated by comments and feedback entered on the data collection form (after the initial or follow-up contact). Potential or reported ADEs are documented and classified on the “Medication Therapy Intervention and Safety Documentation Program” form.¹ (This form, developed by Steven Chen, PharmD, an associate professor of clinical pharmacy at USC School of Pharmacy in Los Angeles, was shared with pharmacy teams participating in the Health Resource and Service Administration’s Patient Safety and Clinical Pharmacy Services Collaborative.) The AHF Pharmacy-Tampa Bay team collected data over a 6-month period. The team counseled 138 patients regarding the safe and appropriate use of their medications. Of these patients, 29 (21%) experienced an ADE in one of the following categories: no harm because medication was ineffective, patient self-

Dose discrepancy

5 4 3

Treatment not optimal Underuse or misuse ADE concerns Perceived ineffectiveness

2 1 0

Types of ADEs

Figure 3. Types and occurrences of potential ADEs. ADE, adverse drug event

Specialty Pharmacy Continuum • Fall 2012

OPERATIONS & MANAGEMENT

regarding the effectiveness of therapy. Many patient concerns were alleviated regarding optimal treatment for their conditions, and potential ADEs were prevented with pharmacist intervention. The patients who did not have any issues to report were appreciative of the additional attention and relationship with their pharmacist that the program fostered. Pharmacist involvement in the safe and proper use of medication is important because “an estimated one-third to one-half of all patients in the United

managed the ADE, the ADE was temporary and was modified by pharmacist intervention, and the ADE resulted in temporary harm (Figures 1 and 2). Additionally, 15 (11%) patients experienced a potential ADE categorized by dose and administration discrepancy, treatment not optimal based on current evidence/guidelines, medication underuse or misuse, concerns about an ADE, and perceived ineffectiveness of medication therapy (Figure 3). Other documented interventions and issues reported during the follow-up calls involved an additional 4% of patients. Most patients were highly responsive to the follow-up consultation regarding the safe and proper use of their medication. Pharmacist counseling rectified problems in the early stage of this “new” transition of care and treatment by correcting/clarifying dosing instructions, identifying medication underuse or misuse, and educating patients

We Want Your Pearls Do you have an interesting practice pearl you’d like to share? If so, send it to smtilyou@mcmahonmed.com. Pearls should: • Focus on a clinical or operational problem at your institution, with tips (“tricks of the trade”) on how to manage the problem via an innovative system or strategy

States do not take their medications as prescribed.”² The AHF Good Results Program provides a format to document pharmacist counseling and follow-up communication when new medications are initiated or therapy changes. Additionally, AHF interventions allowed patients to voice other concerns about their health and helped foster important pharmacist–patient relationships. This program supports AHF’s safe medication use initiative and provides another tool to improve medication adherence in a complex disease state population.

References 1. Chen S. Medication Therapy Intervention and Safety Documentation Form. http://www. acumentra.org/downloads/medicare/ADE/ USC-ADE-pADE-tool-manual-4-6-2012.pdf. Accessed July 17, 2012. 2.

Wettergreen S. Pharmacy Times. October 10, 2011. http://www.pharmacytimes.com/ news/A-Script-for-Change-Improving-Medication-Adherence/. Accessed July 17, 2012.

Presented as a poster (29-T) at the 2012 ASHP Summer Meeting.

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OPERATIONS & MANAGEMENT

EVIDENCE continued from page 1

the nephrotic syndrome indication, with positive new data presented at the American Society of Nephrology’s “Kidney Week” meeting at the end of October (abstracts FR-OR125 and THPO1140). And that’s what other drug manufacturers will have to be able to do if they expect to continue to market expensive specialty drugs for multiple indications, experts predicted. “This is already starting with oral oncologics, such as those for renal cell carcinoma, and with the injectables for rheumatoid arthritis—where there are multiple agents and payers don’t perceive a big distinction regarding efficacy,” noted managed care expert Mark Zitter, of the health care consultancy The Zitter Group, in an interview. “If payers see three, four or five products that they believe are all clinically equivalent, they may say that they

won’t cover some of them at all if you can’t make a case for their superiority—or they may ask for rebates” from manufacturers.

A Growing Trend At present, this trend is mostly limited to what Helen Sherman, PharmD, the vice president of Solid Benefit Guidance, a benefit consultancy, called “sophisticated payers”—those with a significant investment in technology for evidence assessment—but it’s progressively spreading. “Advanced payers are progressively demanding more evidence of certainty of performance, especially around clinical end points that are meaningful,” Dr. Sherman told Specialty Pharmacy Continuum. “The most sophisticated of these are trying to sort out whether intermediate end points, such as progression-free survival, are actually meaningful in a given indication—in some cases they are and in some cases they are not.”

‘There’s no doubt in my mind that we’ll see even tighter scrutiny around the use of [specialty] products.’ —David Calabrese, RPh, MPH

‘Advanced payers are progressively demanding more evidence of certainty of performance, especially around end points that are meaningful.’ —Helen Sherman, PharmD

These sophisticated payers probably control less than 10% to 15% of covered lives, but they cast a long shadow. “There are payers with millions of covered lives watching these sophisticated payers and utilizing their knowledge and conclusions,” Dr. Sherman said. She predicted that specialty oncology drugs, in particular, soon will be at a crossroads. “I have self-insured employer groups in our consulting practice that just want to exclude coverage for high-cost cancer medications simply because of the expense,” she said. “That’s probably not realistic under today’s member benefit contracts, but as more and more of the high-cost drugs come onto the market with soft data, we’re going to see a wide array of reactions. Many of these new agents are coming in for fourthor fifth-line use, which is difficult in terms of study design and results in a lot of uncertainty. Pharma will need to provide compelling information when surrogate end points and uncontrolled study designs are used.” Payers also are upping the ante with regard to monitoring responses and outcomes for drugs that they do cover, noted Mr. Calabrese. “They want quality metrics, clinical effectiveness metrics and safety metrics to ensure that they aren’t continuing to pay for a product without appropriate assessment of its continued benefit with time.” Mr. Calabrese said that Catamaran is trying to leverage technology to make such assessments less burdensome to payers and providers. “We’re developing tools that can screen medical and pharmacy claims data in a real-time fashion that might avoid the need for a fax or a phone call by the physician to get prior authorization. If we can

glean information from medical claims, warehouse it and tie it into the pharmacy claims adjudication system, and then tap into further information like lab data and ICD-9 [International Classification of Diseases, Ninth Revision] codes at the point of care, we can make this much smoother.”

Great Opportunity For Specialty Pharmacy In light of these trends, forwardlooking specialty pharmacies have a tremendous opportunity to differentiate themselves from the pack. “There’s a gap in this space right now, in terms of truly making a difference, both in monitoring and adherence,” Dr. Sherman said. (See pp. 1 and 19 for additional takes on this.) “All of them have programs, but there’s still a long way to go to take it to a sophisticated level of care, making sure the patient is really adherent, troubleshooting side effects and finding solutions. It’s difficult to prove a supportive service is better than the norm, but there is an opportunity and it’s doable.” Specialty pharmacy today requires a very high-touch model that demands consistent communication with the patient, said Mr. Calabrese. “There’s a much higher level of interaction and monitoring that has to go on with these therapies,” he said. “And the obligation is to ensure that only the most appropriate patients are receiving these drugs … and that they’re properly educated and equipped to get the most benefit from them.” —Gina Shaw Mr. Zitter, Mr. Sherman and Mr. Calabrese reported no relevant ﬁnancial conﬂicts of interest.

Specialty Pharmacy Continuum • Fall 2012

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Specialty Pharmacy Continuum • Fall 2012

POLICY

FDA Approves New Second-Line Option for CML On Sept. 4, the FDA approved the oral tyrosine kinase inhibitor bosutinib (Bosulif, Pfizer) to treat chronic myelogenous leukemia (CML). Indicated for adult patients with chronic, accelerated, or blast-phase Philadelphia chromosome-positive CML who are resistant or intolerant to first-line therapy, bosutinib is being distributed through both specialty and retail pharmacies. Bosutinib was evaluated in a clinical trial in patients with chronic, accelerated, or blast-phase CML (N=546), according to a press release from the FDA. The patients had disease that progressed after treatment with imatinib (Gleevec, Novartis) or imatinib followed by dasatinib (Sprycel, Bristol-Myers Squibb) and/or nilotinib (Tasigna, Novartis), or they could not tolerate adverse events (AEs) of previous therapy. Among patients with chronic-phase CML previously treated with imatinib, 34% achieved major cytogenetic response (MCyR) after 24 weeks, with 52.8% of these responses lasting at least 18 months. Among patients with chronic-phase CML previously treated with imatinib followed by dasatinib and/or nilotinib, 27% achieved MCyR within the first 24 weeks of treatment, with 51.4% of the responses lasting at least nine months. Among patients with accelerated CML who had been treated with at least imatinib, 33% had complete hematologic response and 55% achieved overall hematologic response within the first 48 weeks of treatment. Among patients with blastphase CML previously treated with at least imatinib, 15% and 28% achieved complete hematologic response and

overall hematologic response, respectively, within the first 48 weeks of treatment.

him or her from complying with the prescribed regimen. For example, the patient might simply forget to take the

Reimbursement specialists at Accredo ‘assist patients receiving costly medicines to make sure they access the benefits for which they are eligible.’ —Milayna Subar, MD The most common AEs in patients receiving bosutinib were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, fever and fatigue. Accredo Health Group, a subsidiary of Express Scripts, is a specialty pharmacy carrying bosutinib. Milayna Subar, MD, the vice president and national practice leader for oncology at Express Scripts, told Specialty Pharmacy Continuum some of the strategies Accredo uses for their patients taking oncology drugs such as bosutinib. For a medication to be effective, the patient has to take it, Dr. Subar stressed. To help foster adherence, she noted, Accredo’s team works with the patient to address issues that may prevent

drug, there may be tolerability issues with the medication, or the patient might be on an extensive regimen with many medications that he or she has to remember to take. “In our clinical program, clinicians get on the phone with patients and talk with them and answer questions,” Dr. Subar said. “They make sure the patients know how to take the medications—what time of day, with or without food.” Additionally, reimbursement specialists at Accredo “assist patients receiving costly medicines to make sure they access the benefits for which they are eligible,” she said. The company also provides related services such as verification of coverage, help with prior authorization if it is required (some-

Chronic myeloid leukemia.

times involving a call from a clinician to the physician) and help seeking copay assistance if it is needed. Asked why a specialty pharmacy would be more useful than a retail pharmacy for patients with CML, Dr. Subar said, “In a specialty pharmacy, clinicians are really focused on the cancer patient and medications used by cancer patients. Retail pharmacists don’t dispense these very often. The pharmacist needs to understand the nuances of the drug and have the necessary expertise.” —George Ochoa

Humira Receives Indication for Ulcerative Colitis n September, the FDA expanded its approval of adalimumab (Humira, Abbott) to include the treatment of moderate to severe ulcerative colitis (UC) in adults. Combined with its 2007 approval for Crohn’s disease, adalimubab is now positioned to treat the two primary forms of inflammatory bowel disease. Classified as a tumor necrosis factor (TNF) blocker, adalimumab may be used to control UC in the event that immunosuppressant medications such as corticosteroids, azathioprine and 6-mercaptopurine have not been effective. “Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” according to Donna Griebel, MD, the director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “[This]

Photo courtesy of Abbott Laboratories

approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.” Two clinical trials were conducted

to establish adalimumab as a treatment for UC. In both trials, investigators used the Mayo scoring system to determine participants’ degree of UC by measuring stool frequency, rectal bleeding and endoscopy. The studies aimed to determine the number of patients whose Mayo score decreased to a value of 2 or lower after an eightweek treatment period. The study included 908 patients who had never been treated with a TNF blocker or who had lost response to or were intolerant of TNF blockers. At the start of the trial, all of the patients had a Mayo score of 6 to 12, with an endoscopy subscore of 2 to 3. Patients were assigned to take adalimumab or a placebo based on a random selection. Results from both studies showed that a far greater percentage of patients treated with adalimumab achieved clin-

ical remission (16.5%-18.5%) compared with those on placebo (9.2%-9.3%); one of the studies also showed that the number of patients who sustained remission was twice as high in patients taking adalimumab as in the group on placebo (8.4% vs. 4.1%). The studies were unable to establish the effectiveness of adalimumab in treating patients who had become intolerant of, or lost response to, TNF blockers. No new side effects were established apart from those already identified, which included infections, headache and rash. For the treatment of UC, adalimumab is approved for an initial dose of 160 mg, a second dose of 80 mg two weeks after the initial dose and a 40-mg maintenance dose every other week thereafter. —Based on a press release from the FDA and Abbott Laboratories

Specialty Pharmacy Continuum • Fall 2012

POLICY

Enzalutamide To Be Distributed Via Specialty Pharmacies 20

Months

Approved on Aug. 31, enzalutamide (Xtandi, Medivation/Astellas Pharma) is an oral agent for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. But patients will not find it in retail drugstores, or even in all specialty pharmacies. Enzalutamide is being distributed through a network of selected specialty pharmacies and specialty distributors.

18.4 13.6

John Liu, senior director of reimbursement and market access strategy at Astellas, in Northbrook, Ill., explained why specialty pharmacy was chosen as a distribution method for the once-daily androgen receptor inhibitor. “We wanted to make sure patients had optimal access to Xtandi. We also wanted control over the product, to try and prevent counterfeiting and diversion. We also wanted to ensure control of inventory, and the integrity of data we’d be getting.” He also said that “competition was a consideration—we were second to market after Johnson & Johnson’s Zytiga [abiraterone acetate], and had a chance to observe their experience. Given our current FDA-approved indication … it made sense to exclude the retail setting.” Mr. Liu explained that the initial indication, which is similar to that of abiraterone acetate, is post-docetaxel castration-resistant prostate cancer, rather than the entire prostate cancer treatment continuum. Currently, 17 specialty pharmacies, including Accredo, CuraScript,

CVS Caremark and Walgreens, are in the enzalutamide network, along with six specialtyy distributors. The distributors are included, said Mr. Liu, “to accommodate communityy physicians who self-dispense out of their own office-based pharmacies [and] hospitals.” The network was selected to provide 100% market coverage of the top 50 managed care organizations and top 10 pharmacy benefit managers (PBMs), said Mr. Liu. He added, “The patient-support side of these specialty pharmacies is well known. They work with physicians and nurses in keeping patients compliant, and work with health plans and PBMs. What the specialty pharmacies do varies. But you’ll see more patients on therapy staying on course, with a higher and more consistent level of service.” Enzalutamide must be prescribed in accordance with a comprehensive patient access program, Xtandi Access Services, said Mr. Liu. “It includes a

virtual copay card program, in which commercially covered patients pay $20 per month for up to 12 monthly refills. … If a health care plan doesn’t provide a coverage decision within seven business days, Astellas will provide a one-time 14-day supply free of charge and overnight the gratis fill to the patient.” Additionally, he said, “Medicare and Medicaid patients can get a referral to two independent copay foundations if they need assistance with their outof-pocket expenses. The ‘uninsured and those patients deemed to be functionally uninsured’ can participate in the Astellas Access Program, so long as they meet other eligibility requirements.”

Clinical Data The efficacy and safety of enzalutamide were assessed in a Phase III clinical trial of 1,199 patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, according to press releases from the FDA and Medivation. The primary end

Enzalutamide

Placebo

Figure. Median overall survivala a

P<0.0001

point of the trial was overall survival. The median overall survival for patients who received enzalutamide was 18.4 months, compared with 13.6 months for patients who received placebo ( <0.0001). Seizures occurred in 0.9% (P of patients on enzalutamide and 0% of patients on placebo. The most common adverse reactions (≥5% of patients) were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety and hypertension. —George Ochoa

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POLICY

New Oral Therapy Approved for RA The FDA has approved tofacitinib (Xeljanz, Pfizer)—the first oral biologic agent for the treatment of rheumatoid arthritis (RA)—for use in patients with moderate to severe RA who have had inadequate response or intolerance to methotrexate. The drug may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). It should not be used with other biologic DMARDs or with potent immunosuppressant drugs, such as azathioprine and cyclosporine. Pfizer sought approval of two twicedaily doses for tofacitinib, 5 and 10 mg, but only the 5-mg twice-daily dose was approved. The company plans to con-

tinue to evaluate the 10-mg dose for RA and also is studying the drug for other indications such as ulcerative colitis, psoriasis and Crohn’s disease. The FDA approved tofacitinib, a Janus kinase inhibitor, with a Risk Evaluation and Mitigation Strategy that requires dissemination of safety information,

including details about the risks for serious infections, tuberculosis, cancers and lymphoma. The agency also is requiring Pfizer to conduct postmarketing studies to evaluate tofacitinib’s potential long-term effects on heart disease, cancer and serious infections. Although as an oral therapy, tofacitinib has an advantage over injectable RA agents, such as adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen) and infliximab (Remicade, Johnson & Johnson), an analysis from GlobalData indicates that Pfizer’s “high

hopes” for this new drug “may not be fully realized until safety and efficacy is proven to that of current biologics.” Based on their analysis and feedback from clinicians, Dina S. Rufo, MS, a therapy area analysis for GlobalData, predicted that tofacitinib “will play a third-line therapy role” until such time as that comparable safety and efficacy is established. Tim Anderson, an analyst at Sanford Bernstein, further noted that “it is understandable why (new) patients might prefer an oral therapy versus one that requires needle-based delivery,” but he predicted that patients currently benefiting from other agents would be unlikely to switch. —Sarah Tilyou

OPERATIONS & MANAGEMENT

ADHERENCE continued from page 19

“Pharmacists can make a big difference [to adherence]. With the potent new therapies for HIV in the past 15 years, HIV can be considered a chronic disease. Patients may not see their physician more than once or twice a year. As pharmacists, we see the patient every month. We can answer questions about

care and understand the complexities. Because of this, we become an important part of their health care team.” Patricia Fulco, PharmD, BCPS, FASHP, AAHIVE, a clinical pharmacy specialist in internal medicine and HIV at Virginia Commonwealth University Medical Center, in Richmond, described Walgreens’ approach as a “unique … way of demonstrating adherence level based on going to a specialty pharmacy.”

The study’s limitations include potential bias from the “healthy adherer effect,” acknowledged Mr. Pietrandoni. “Patients who choose to use HIV-specialized pharmacies may have more positive health behaviors at the onset and, therefore, may be more adherent to their medication regimens.” An additional limitation, Dr. Fulco said, is that “PDC is insurance data [and] not an exact mea-

sure of adherence. They can’t measure patients taking medications, just filling them. They don’t know virologic outcomes.” However, she said, “to get such large numbers in the study—huge numbers in this type of setting—you can’t do better than that.” —George Ochoa Dr. Fulco reported no relevant ﬁnancial conﬂicts of interest.

CLINICAL

CHEMO TOOL continued from page 5

and side-effect control interventions in a patient-centered care paradigm. These side effects can impair function, create inefficiencies in medical practice and are costly to patients and payers.” OnPART includes a differentiating factor in personalized medicine—a validated method that quantifies patients’ concerns for the different side effects of chemotherapy, according to Dr. Rubenstein. He gave the example of a flight attendant with breast cancer who might be particularly concerned about diarrhea because it could interfere with her ability to perform her job during international flights. If, using OnPART, her physician determined that one chemotherapy regimen put her at high risk for diarrhea, he could switch her to an equally effective regimen that entailed

With this tool, ‘we can now identify patients at risk for these side effects before they ever receive chemotherapy. This allows us to customize our chemotherapy regimens and side-effect control interventions in a patient-centered care paradigm.’ —Lee Schwartzberg, MD

lower risk for diarrhea. If all regimens put her at high risk, he could pretreat her for diarrhea. The goal of OnPART development, said Dr. Rubenstein, would be a commercial product such as a custom chip microarray including approximately 500 SNPs, which would generate a display of risk of side effects across relevant chemotherapy regimens within five to seven days. Because it would be a laboratorydeveloped test, FDA approval would not be needed, said Dr. Rubenstein. Clinical Laboratory Improvement Amendments (CLIA) certification would allow OnPART to be brought to market. According to the press release, the company intends to present final study data at major oncology meetings. Commercial launch of OnPART is expected in the third quarter of 2014. —George Ochoa

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Robert M. Fulcher; Eugenia M. Fulcher March 26, 2012 This book helps you learn to calculate drug dosages safely and accurately. A practical worktext format covers everything from basic math skills to reading and interpreting labels and physicians’ orders, introducing key calculation and conversion concepts and then providing hundreds of problems so you can practice and master the material.

Pharmacy Management, Third Edition

Shane Desselle; David Zgarrick; Greg Alston June 12, 2012 The book is filled with advice from the field’s top experts who take you through the principles applicable to all aspects of pharmacy practice, from managing money to managing personal stress. Long after you’ve completed your last course, you’ll turn to this book for answers to make your practice more professionally rewarding and personally enriching.

Understanding Pharmacology for Pharmacy Technicians

Mary Ann Stuhan August 6, 2012 Throughout this textbook, anatomy and physiology are discussed in rela-tion to various disorders and associated pharmacotherapies to give the p a acy technician pharmacy tec c a students stude ts a context co te t for o how o drugs d ugs work. o SPC1112

TALYST IS DEDICATED TO PROVIDING ENTERPRISE-WIDE MEDICATION MANAGEMENT ACROSS YOUR HEALTH SYSTEM. Carla Corkern, CEO Talyst

For 10 years, we at Talyst have been improving pharmacy operations across your health system. As an executive, I understand the challenges of running a successful business and am dedicated to delivering technology that offers greater inventory control, enhanced workflow efficiency and improved patient safety—ensuring your success. Talyst is a leader in pharmacy automation and your expert partner in pharmacy operations. We work with you to create the right solution for your health system and offer a powerful software platform with a suite of hardware components to meet your specific needs.

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