At the heart of specialty pharmacy is pharmacy. We most often think of patients as being the centerpiece of the profession—and they are. Another significant truth, however, is that even the most successful patient-focused specialty pharmacies must have great businesspeople supporting them, driving the enterprise. Specialty pharmacy is both a profession and a business and one cannot fully exist in the absence of the other. The most entrepreneurial of businesses require this best of both worlds. In this month’s edition of 

, we take a more holistic approach and touch on a broad spectrum of topics.

	Our cover feature article gets to the core of the operation—the education and training of the pharmacist and other health care professionals. Our schools today are producing strong candidates as generalists in the profession, but will they be prepared for the rigors of specialty pharmacy? Will they have the expertise and training to be impactful with the emerging therapies upon graduation? What should a specialty pharmacy curriculum look like? We profile what is going on in academia and offer a challenge to specialty pharmacies to serve as a training ground to further the interests of our profession. Colleges of pharmacy must do their part, but so must industry on several fronts.

	Following up on our special oncology edition (

) is the second part of “Oncology Drug Management,” where we look at significant trends in patient care. Payers are taking a closer look at oncology on several fronts, including:

		Implementing preferred agent strategies

		Ensuring that oral oncology drugs are managed through specialty pharmacy

	Dave Suchanek, our world-class expert on the topic, gives us keen insight into “Fair Market Value, Part 2—Embracing the Practice,” with ideas on how our specialty pharmacy business can rationalize charges for specific services offered to industry, and on the other side, how industry can assess the value of those bona fide services offered by specialty. He offers some strong suggestions and a long list of questions that must be asked to validate the process and the necessary analytics for a comprehensive host of services. Dave’s suggestions have proved to be very successful and are viewed by many as the new standard for specialty pharmacy services. A number of contracting strategies emerge from his piece that our readers can put into practice today.

	Following up on the theme of entrepreneurialism and bringing specialty pharmacy back to its roots at the local level, Nick Calla offers a number of keen insights into how community pharmacy can participate more in the space. Many of his suggestions center on how, by working closely with managed care, community pharmacies can create networks of specialty providers. Specialty pharmacy started in the community and his plan looks to bring it back.

 and is responsible for commercial operations, trade-supply chain strategy development including 3PL selection, regulatory oversight, and “operationalizing” organizations. Mr. Steiber has served in several senior positions in pharmacy, distribution, and industry over the course of his 35-year career. Mr. Steiber is a licensed pharmacist in Texas, Washington, California, and Pennsylvania. He is affiliated with several professional associations and publications and is a frequent speaker on behalf of many professional organizations. Mr. Steiber graduated from Washington State University College of Pharmacy. He has participated in a variety of postgraduate programs in law and business development/ marketing at Harvard University and Northwestern University. Mr. Steiber currently resides in Plano, Texas, with his wife and 2 sons. Specialty pharmacy is both a profession and a business, and one cannot fully exist in the absence of the other.

Articles

Editorial

A Little Bit of Everything?

REMS programs in acute and chronic pain management continue to evolve to reduce risk associated with pain medications.

	The REMS landscape has continuously evolved over the last three and a half years. One of the fastest changing categories for REMS is within the pain management market, specifically the transmucosal immediate release fentanyl (TIRF) class and the long-acting/extended release opioid (L-aOA) classes. Brand and generic manufacturers within these 2 classes of products are deep in FDA negotiation on the final structure, implementation, measurement, and design of a shared system REMS for each class. In the meantime, individual pharmaceutical and generic companies have been requested by the FDA to develop and implement individual REMS to support their products.

	FDA has been working with the pharmaceutical and biotech industry for more than 2 years on a class-wide REMS for L-aOAs. On January 7, 2011, the FDA announced that it would require all TIRF companies to work together to create a shared system for implementation of a class REMS.

	Shared implementation systems for REMS are intended to reduce the burden on the health care system for implementation, making it easier for physicians and pharmacists, as well as any other stakeholders, to participate and comply. This has been a major obstacle for REMS in the L-aOA space, since the scale of use is so vast. The FDA’s Office of New Drugs director, John Jenkins, MD, called the shared implementation system for TIRF “A significant step toward reducing the burden on the health care system of implementing REMS programs.”

	To move to a shared system means there will be shifts in some products’ REMS to less restrictive for some and more stringent for others. Finding a compromise position that makes it easier for prescribers and pharmacies to operate in compliance is essential to ensuring access to these critical medications. Under the Abstral REMS, retail pharmacies are eligible to dispense if they complete program education, enroll in the REMS, and pass a system verification test demonstrating their pharmacy management system is configured to “interrogate” each Abstral prescription. This process uses the pharmacy switching technology to route the prescription data to the REMS program administrator’s database of enrolled pharmacies, prescribers, and patients.

	If the prescription meets all the rules for safe use, then the prescription can be dispensed. If not, messaging will appear to the pharmacist regarding the actions to take instead of dispensing. The “interrogation” of the Abstral prescription occurs in sub-seconds and is completely within the existing work flow of the pharmacy. Onsolis has similar controls and enrollment requirements, but it is only distributed by a single specialty pharmacy that must then connect to the Onsolis REMS program administrator to determine prescription eligibility in order to dispense.

	The current L-aOA REMS design calls for voluntary education of providers, which will be funded by industry but administered through accredited medical education providers. The L-aOA REMS program design does not have controlled or restricted distribution requirements associated with it.

	Pain management will continue to be a major public health focus for years to come. The Institutes of Medicine recently released a prepublication version of its study entitled “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.”1 In this important new study, the committee makes specific recommendations that will lead to a “cultural transformation in the way pain is understood, assessed, and treated.” While implementation of many of these transformative recommendations may be in the distant future, REMS programs in acute and chronic pain management continue to evolve to reduce the risks associated and improve the safe use of these vital medications. 

Heather Morel, MBA is vice president and general manager of reimbursement & access services for McKesson Reimbursement, Access and Safety Services in Scottsdale, Arizona. Morel leads the development and execution of reimbursement strategies and support services, patient assistance programs, risk evaluation and mitigation strategies programs, and other patient and physician-focused initiatives. She is a nationally recognized expert in health care reimbursement and marketing. Ms. Morel is a member of the 

Focus on REMS

REMS in Pain Management

The specialty pharmacy community should be prepared for legislation that could alter the supply and distribution of specialty pharmaceuticals.

	What has long been a pressure point on specialty pharmacies has finally found itself within Congress’ crosshairs—a nationwide shortage of life-saving medications, in particular generic sterile injectables, has recently become the subject of several key Congressional hearings and an FDA public workshop. To stem this crisis, the last few months have seen a number of House and Senate bills introduced to address the growing number of drug shortages and the resulting impact on distributors, pharmacies, and patients. While no piece of legislation has yet emerged as the front-runner, the specialty pharmacy community should be prepared for legislation that could alter the supply and distribution chains of specialty pharmaceuticals.

	According to the University of Utah Drug Information Service, which tracks drug supply and distribution, drug shortages reached a record high in 2010 and are on pace to exceed that level in 2011, with 210 shortages of different drugs being reported as of September 15, 2011. In addition to limited patient access for vital medications, an emerging market of pharmaceuticals coming from an unofficial supply channel (known as the “gray market”) has resulted in steep price increases and safety and quality issues for pharmaceuticals in short supply. A report conducted by Premiere in the beginning of 2011 recorded 1745 gray market offers to its health care alliance providers, with an average markup on these drugs of 650%.

	The impact of the drug shortage crisis is felt across the distribution stream— research institutions are citing detrimental effects on clinical trials; pharmacies are reporting gross markups and the emergence of unauthorized distribution chains; and providers are being forced to seek alternative treatment options for their patients when the recommended medication is unavailable.

	The vast majority of drugs in short supply are generic sterile injectables, including vital drugs needed for sedation and chemotherapy. The causes for these shortages are numerous: industry and the FDA both cite aging production facilities, consolidation of market share, small profit margins on generic drugs, and compromised raw materials overseas. Solutions are less clear.

	At both the Senate HELP and House Energy & Commerce hearings in September, legislators and industry alike debated a number of solutions designed to ensure patients are not denied access to vital therapies. While no single proposal has unanimous support, several key features of the major proposals in Congress are worthy of review.

	Proposals are wide-ranging and include establishing a national pharmaceutical tracking system (known as a “pedigree” system) and the creation of an early notification system to mandate that firms communicate with the FDA in advance of a drug shortage. Legislators and industry are also examining changes to drug reimportation regulations and different approaches to facility reinspections. Generic manufacturers recently agreed to help fund inspections of their facilities as part of a generic drug user fee program.

 would allow the FDA to monitor individual drugs as they move through the supply and distribution chain. A drug pedigree is the record of transactions from the manufacturer of origin through to the dispensing pharmacy (pedigrees generally include dates, names and addresses of all parties involved in a transaction, and specifics about the drug being transferred, including lot number). The adoption of a nationwide pedigree system would place new requirements on specialty pharmacy to confirm that a pedigree will be supplied prior to purchase from the distributor, and that each transaction is authentic.

would mandate that drug firms notify the FDA about any discontinuance or interruption in prescription drug manufacturing in advance, or in the case of an unplanned supply shortage, as soon as possible. While an earlier Senate version of this proposal did not include certain biologic products, the Preserving Access to Life-Saving Medications Act, introduced by Rep Diana DeGette (D-CO), includes all biologics in the mandate. While the legislation as currently written only places reporting requirements on manufacturers, it is possible that a final piece of legislation might include reporting requirements on all parts of the supply and distribution chain, including pharmacists.

	Congressional action on drug shortages is a long time coming. The specialty pharmacy community has been at the front lines of this national public health crisis for years—and will probably be required to be part of the solution. Current Congressional proposals to shore up communication lines between manufacturers, distributors, pharmacists, providers, and patients, as well as the FDA, are a likely step in the right direction. However, the underlying problems will likely still remain.

	Generic sterile injectables, which comprise the vast majority of these shortages, have extremely low profit margins and are manufactured at facilities in dire need of modernization and repair. Until the proper incentives for these medications are provided, manufacturers will have no incentive to devote additional resources to their production.

	In the meantime, specialty pharmacy must remain vigilant in the selection of suppliers, ensuring that products provided to patients are genuine, safe, and handled appropriately. Hopefully, in the near future and with additional Congressional action, this crisis will be a thing of the past. 

Ross Margulies is a health policy specialist at Foley Hoag LLP with expertise in federal and state health law and policy issues including Medicare and Medicaid, community health, and the impact of health care reform.

Jayson Slotnik focuses on health regulatory issues in his current practice at Foley Hoag LLP. He was formerly the director of Medicare reimbursement and economic policy at the Biotechnology Industry Organization in Washington, DC.  

Washington Insights

Drug Shortages Grab Congress' Attention 

Specialty drug manufacturers are under pressure to reduce costs associated with patient access solutions and FDA-mandated REMS programs.

	Specialty pharmaceuticals, and the supporting patient and physician ancillary services, have emerged as a focal point for the majority of manufacturers. The increasing number of specialty drugs available in the United States, coupled with the heightened research and development focus of major pharmaceutical manufacturers on biotech therapies, has resulted in an unprecedented shift in dynamics across the prescription drug industry. In fact, by 2014, specialty drug spend is estimated to comprise 40% of US drug spend (source: 

Express Scripts’ 2010 Drug Trend Report: A Market and Behavioral Analysis, April 2011

	This market shift from oral solid to specialty medications comes with 2 notable dynamics impacting manufacturers. First, it is increasingly important to provide patient and physician support services, such as reimbursement and patient assistance programs. Second, the FDA has imposed more stringent mandates on manufacturers to ensure the safety of approved products, primarily consisting of risk evaluation and mitigation strategies (REMS) and other post-launch surveillance requirements. Frequently, these safety and support programs require significant investments in dollars and total resources. Manufacturers now find themselves in the position of having to devise innovative ways to control costs.

	In the past, no expense was spared to ensure the successful launch of a product into the market. However, there has recently been a subtle but significant shift toward austerity in the manufacturer approach to launching and supporting new products.

	Perhaps the most significant driver of the austerity movement in specialty drug commercialization is the pressure to reduce costs associated with patient access solutions and FDA-mandated safety programs, such as REMS. A frequent catalyst for this cost sensitivity is the dynamic mergers and acquisitions environment. When companies merge or acquire a competitor, they strive to maximize all potential synergies, typically resulting in increased scrutiny of all buying decisions. This translates into more informed and effective purchasing decisions overall.

	Traditionally, specialty pharmacy support services have been awarded to numerous vendors, often resulting in inefficient and isolated efforts. For example, REMS program vendors would be selected by epidemiology groups or risk management departments. Procurement or reimbursement services were the responsibility of trade relations groups or brand teams. Adherence programs and nursing services often operated outside of REMS or reimbursement services. This practice of multiple vendors managing the support services for a single drug became the norm, but it did not take manufacturers long to realize the significant flaws in this fragmented approach.

	REMS programs perhaps play the most significant role in exposing the problems associated with fragmented support services management. These FDA-mandated programs must potentially be applied to all physicians, patients, and pharmacies involved in prescribing, administering, and fulfilling a drug with REMS requirements. Because REMS are applied across all prescriptions and potentially all stakeholders, they often must be coordinated with other programs.

	For example, a specialty drug may have a REMS requirement that a physician complete mandatory training prior to writing a valid prescription. Before a specialty pharmacy can dispense the drug it must verify that the REMS requirement for physician training has been satisfied. This typically would happen through a telephone call or electronic communication to the REMS program administrator. If the physician is not properly trained, the prescription is held until the physician complies with the training requirement and is entered into the REMS database as a validated prescriber. In addition to validating REMS requirements, prior to dispensing the drug the specialty pharmacy must also verify through the reimbursement hub administrator—and often through its own benefits investigation&mdash;that the prescription will be paid for by the patient’s insurance or other means. This reimbursement process requires the cooperation of the patient and the physician’s office.

Both REMS and reimbursement programs require intense coordination with patients and physicians and the compliance monitoring services of the specialty pharmacy. Frequently, the requirements of REMS programs overlap with other services and thus, a savvy manufacturer will consider how to best coordinate programs likely to be managed by separate vendors. Both support and safety programs are built on a foundation of communicating with patients, physicians, and pharmacies via telephone, fax, e-mail, US mail, or Internet. For individual drugs that have multiple safety and support programs run by multiple vendors, these communications often are confusing and may ultimately result in delayed patient therapy and increased rates of patients discontinuing therapy (Table).

	Additionally, multiple vendors frequently contact physicians’ offices with requests for action—all for the same patient and the same drug. Often the physician and the office staff believe these calls are about the same issue and that once they have satisfied a request for action, any subsequent requests are simply redundant and can be ignored. The assumption that resolving 1 issue will ensure a patient’s access to therapy is a common misconception within offices. The single-vendor solution may minimize this confusion and facilitate faster initiation of therapy.

	Physicians’ offices are not the only stakeholders impacted by the myriad of telephone calls and other communications surrounding a specific therapy. Patients, many of them profoundly ill, are often unable to navigate some of the complex requirements for medication access. Patients might master the process of verifying that their drugs are covered by their health plans and then navigate a separate process to obtain copayment assistance, only to be stalled in their attempts to enroll in a patient database for a REMS program. In the interim, their disease progresses and the medicine they so badly need—the medicine their physician has chosen as the best treatment&mdash;is delayed. All too often the patient complains to the physician and the physician responds by writing a different prescription that may not have as many requirements, but that is also not likely to be the best treatment available to that patient.

	While coordinating REMS requirements across numerous programs exposed the flaws in the multiple vendor model, there exists today a template for the effective application of multiple program requirements. A small handful of ultra-orphan specialty drugs are managed through an exclusive pharmacy system. In this system there is only 1 pharmacy with access to the drug and that pharmacy manages all the safety and support programs within 1 integrated program. While an exclusive pharmacy model is not viable for most drug programs, a single point of contact for integrated communications is preferred.

	An integrated solution allows a suite of services to function as a unified offering to meet manufacturer needs and requirements through the life cycle of a drug. This provides patients, pharmacists, and physicians’ offices with a seamless path that facilitates access to the appropriate therapy. Manufacturers are able to create customized programs around individual therapies that support the specific needs of patients and physicians as well as satisfy potential regulatory requirements. These programs are typically developed from a pool of services including third party logistics, specialty pharmacy, specialty distribution reimbursement services, REMS, patient assistance programs, customized adherence programs, and nursing services. The program elements vary, but true resource synergies are realized when all points of contact come in a coordinated manner from 1 vendor focused on the patient and physician experience.

	The appetite for integrated programs for specialty medications has increased dramatically over the past 12 months. Manufacturers are quickly adapting to the need to control costs while providing best-in-class service and adhering to regulatory requirements. Integrated programs deliver key results including cost synergies, clean data, insightful reporting, enhanced patient and physician experience, and the increase in the initiation and ongoing usage of a prescribed therapy. These results have been embraced by manufacturers and are rapidly driving a new standard in delivery of specialty medications. 

Kevin Cast utilizes more than 20 years of demonstrated experience and amassed expertise in the pharmaceutical and biotech industries to develop business solutions to support successful product commercialization. As Express Scripts’ vice president of strategy & contracting, pharma & biotech, he currently directs the business development team responsible for contracting with manufacturers. 

Viewpoints: The Last Word

Specialty pharmaceuticals, and the supporting patient and physician ancillary services, have emerged as a focal point for the majority of manufacturers. The increasing number of specialty drugs available in the United States, coupled with the heightened research and development focus of major pharmaceutical manufacturers on biotech therapies, has resulted in an unprecedented shift in dynamics across the prescription drug industry.

Vendor Integration: Focus on Customer and Cost Leads Manufacturers to Novel Approach 

	Within the past few years, the FDA has been approving an increasing number of specialty medications. Fourteen specialty medications were approved in the first three quarters of 2011, which matches the total number of specialty drugs approved in 2010. This is up from 10 specialty drug approvals in 2009 and 8 in 2008.

	Based on an analysis of the specialty pipeline, 2012 is shaping up to be a significant year for specialty drug approvals. By the end of next year, it is possible that 3 new oral, disease-modifying drugs for multiple sclerosis (MS) will be available. It is also anticipated that the FDA will approve the first oral alternative to injectable therapies for rheumatoid arthritis (RA). In addition, several new cancer drugs are expected to gain FDA approval and new drugs for cystic fibrosis (CF) may hit the market. More information about selected specialty pipeline medications can be found in this article.

 is an oral, disease-modifying medication in development for the treatment of MS. BG-12 is effective in reducing relapse rates in patients with relapsing remitting MS. According to a clinical study, BG-12 reduced annualized relapse rates by 53%. Key side effects associated with BG-12 use include gastrointestinal intolerance and flushing. Results from a pivotal trial comparing BG-12 to Copaxone (glatiramer acetate, Teva) are expected in the fourth quarter of 2011. Beginning next year, BG-12 will likely compete with Gilenya (fingolimod, Novartis)—the first oral disease-modifying drug approved for MS&mdash;as well as injectable therapies currently on the market for MS.

 is a novel immunosuppressant known as a JAK (or Janus-Associated Kinase) inhibitor that primarily inhibits the JAK-3 pathway, which is responsible for causing an inflammatory response. It is in development to treat moderately-to-severely active RA. Tofacitinib is an oral tablet taken twice daily. Its efficacy for RA is on par with the tumor necrosis factor (TNF) inhibitors (eg, Enbrel [etanercept, Amgen/Pfizer], Humira [adalimumab, Abbott]) so there is a potential for use in the first-line setting. Safety concerns associated with the use of tofacitinib include increases in cholesterol and liver enzymes and decreases in white blood cells counts that can potentially lead to infection. Pfizer is expected to file for approval of tofacitinib by the end of 2011, with approval likely in mid-2012.

 is an example of another JAK inhibitor that primarily inhibits the JAK-2 pathway that is involved with the formation and development of blood cells. It is being developed to treat myelofibrosis, which is an uncommon, life-threatening blood cancer characterized by bone marrow failure, enlarged spleen, poor quality of life, and shortened survival. Approximately 30,000 patients in the United States have myleofibrosis. Other than allogenic stem cell transplantation, there are no approved treatment options. Ruxolitinib is an oral tablet that is taken twice daily. Incyte filed for approval of ruxolitinib in June 2011 and the FDA approval is expected in early December 2011.

 is another novel, oral cancer medication in the pipeline. It is known as a hedgehog pathway inhibitor that is in development for the treatment of patients with advanced basal cell carcinoma (BCC) who are not candidates for surgery. Vismodegib is an oral medication that is taken once daily. BCC is the most common type of skin cancer with approximately 800,000 cases diagnosed each year in the United States. Only a small subset of those patients will be candidates for treatment with vismodegib since the majority of BCC cases can be removed with surgery. Genentech filed for approval of vismodegib in September 2011. If priority (6-month) review is granted, vismodegib may receive FDA approval in the first quarter of 2012.

 is a chloride channel activator that increases mucus clearance in patients with cystic fibrosis. CF is a life-threatening genetic disease that affects approximately 30,000 patients in the United States. It is caused by a defective gene that results in the build-up of abnormally thick, sticky mucus in the lungs and pancreas causing serious lung infections and digestive problems. VX-770 treats the underlying disease of CF; it is most effective in patients in whom the G551D mutation is primarily responsible for causing the chloride transport defect that results in increased mucus production. Approximately 4% of patients with CF have at least 1 copy of the G551D mutation. VX-770 is an oral tablet formulation that is taken twice daily. VX-770 may reach the market by the end of 2012. Several other medications for CF may also reach the market within the next 2 years.

Dr. Tharaldson is senior clinical consultant, Emerging Therapeutics, at Express Scripts.

New Product Pipeline

Near-Term Specialty Pipeline Highlights November 2011

The FDA has granted acceleration approval for Adcetris (brentuximba vedotin) for the treatment of Hodgkin lymphoma.

The FDA has granted accelerated approval to Seattle Genetics, Inc’s Adcetris (brentuximab vedotin). Adcetris is indicated for the treatment of Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not candidates for ASCT. It is also approved for the treatment of systemic anaplastic large cell lymphoma (ALCL) after failure of at least 1 prior multiagent chemotherapy regimen. Both indications are based on response rates; no data are available to demonstrate that patients using Adcetris experienced an improvement in outcomes or survival.

	Adcetris is the first new FDAapproved agent for HL in more than 30 years and the first agent ever specifically approved for ALCL.

	Adcetris is a CD30-directed antibodydrug conjugate (ADC). When the ADC binds to the CD30-expressing cells, the ADC-CD30 complex is internalized, and monomethyl auristatin E (MMAE) is released via proteolytic cleavage. When MMAE binds to tubulin, the microtubule network within the cell is disrupted, leading to cell cycle arrest and cellular apoptosis.

	Age, gender, and race do not appear to affect the pharmacokinetics of Adcetris. The influence of renal and/ or hepatic impairment on the pharmacokinetics of Adcetris has not yet been determined.

	Adcetris should be given as a 1.8 mg/ kg intravenous infusion over 30 minutes every 3 weeks. Adcetris should not be administered as an intravenous bolus or push. Treatment should be continued until a maximum of 16 cycles are completed, disease progression occurs, or unacceptable toxicity occurs.

	Dose modification is required if the following occur:

		Peripheral neuropathy, new or worsening Grade 2 or 3: hold until neuropathy improves to Grade 1 or baseline, then restart at 1.2 mg/kg.

		Peripheral neuropathy, Grade 4: discontinue Adcetris.

		Neutropenia, Grade 3 or 4: hold until neutropenia resolves to baseline or Grade 2 or lower. Consider growth factor support for subsequent cycles.

		Neutropenia, recurrent Grade 4 despite growth factors: consider discontinuation or dose reduction to 1.2 mg/kg.

	Adcetris was studied in a single-arm trial of 102 patients with HL who had relapsed after ASCT. Seventy-three percent of patients achieved the primary end point of complete or partial cancer shrinkage or disappearance, 32% of whom experienced complete remission and 40% of whom experienced partial remission. The average duration of response was 6.7 months.

	The single-arm trial that evaluated the role of Adcetris for the treatment of ALCL consisted of 58 patients in whom the disease had relapsed. The primary end point of complete or partial cancer shrinkage or disappearance was achieved by 86% of patients, 57% of whom experienced complete remission and 29% of whom experienced partial remission. The average duration of response was 12.6 months.

Contraindications, Warnings, and Precautions 

	There are no contraindications to treatment with Adcetris. Patients should be monitored for peripheral neuropathy and the dose of Adcetris should be adjusted appropriately if peripheral neuropathy occurs. If an infusion reaction occurs, the infusion should be interrupted and the reaction should be managed with appropriate medical intervention. If a patient experiences anaphylaxis during the infusion, the infusion should be stopped immediately and medical management initiated.

	Complete blood counts should be monitored prior to each dose of Adcetris. Patients in whom the tumor is rapidly proliferating and who have a high tumor burden are at risk for tumor lysis syndrome and should be monitored accordingly. Adcetris should be discontinued immediately if Stevens-Johnson syndrome occurs.

	Adcetris is Pregnancy Category D. Women who are pregnant should be aware of the potential for fetal harm during treatment with Adcetris. Adcetris is not approved for use in pediatric patients. Close monitoring is required for patients receiving strong CYP3A4 inhibitors during treatment with Adcetris. 

Monica Holmberg, PharmD, BCPS, is a clinical pharmacist who resides in Phoenix, Arizona. 

	1. Adcetris complete prescribing information. www.adcetris.com/_pdf/Adcetris_USPI_2011.pdf. Accessed September 2011.

	2. FDA approves Adcetris to treat two types of lymphoma. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm. Accessed September 2011.

	3. Seattle Genetics announces FDA accelerated approval of ADCETRIS™

	(brentuximab vedotin) for two indications. www.adcetris.com/_pdf/FDA_Approval_FINAL_19Aug11.pdf. Accessed September 2011.

New Drug Review

The FDA has granted accelerated approval to Seattle Genetics, Inc's Adcetris (brentuximab vedotin). Adcetris is indicated for the treatment of Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not candidates for ASCT.

Seattle Genetics, Inc's Adcetris 

Audits are a powerful tool for health care and should be used to measure outcomes and performance. Our columnist share his personal view on what he sees in the current climate. 

	I think all stakeholders would agree that health care reform is inevitable. Our health care system needs an overhaul. The solution should include 3 simple parts: we need to cut costs, improve care, and make access easier. Of course, the goal must be to improve patient outcomes in a manner that reduces waste and errors and that is fiscally responsible. We need to consider being proactive with preventative care and then consistently measure and publish the results for public review.

	The patient must be considered a key stakeholder within the health care paradigm and be allowed to make joint decisions on his or her therapy and course. Today, the number 1 reason people search the Internet is for healthrelated information. If knowledge is power, then we need to ensure that patients, physicians, and payers all have accurate, factual, unbiased information with which to make decisions.

	Our pharmacy recently went through 2 audits by one of the national audit companies. The audit company sent 2 separate letters dated the same day, one stating they would be doing an onsite audit for one of the 3 largest PDP plans, and other letter stated they were doing a desk audit of another of the largest PDP plans.

	When the onsite auditor spent 6 hours at our facility, I commented on the fact that all the claims reviewed were for Medicare, Medicaid, or dual-eligible patients that were being treated for HIV, cancer, hepatitis C, or a dual diagnosis. When I asked why the PDP and her audit company choose the sickest, poorest patients to audit, the response was, “We are not looking at the patients, just their prescriptions. Medicare is looking to recoup dollars and I would expect more of these audits.” She also went on to state that our pharmacy had the highest compliance rate that she had ever audited. Those comments really made me think about how we are going about health care reform.

	Audits are a powerful tool for health care and should be used to prevent fraud, validate proper use and dose, ensure accurate payment of contractual terms, and most importantly, measure outcomes and performance. Instead we have allowed a necessary and important tool to become “big business.” First, we allowed simple claim processors to become multibillion dollar profiting companies controlling market share, patient choice, and ultimately, medical decisions.

	Now, we are watching audit companies being bought by major corporations investing in technology using complex algorithms to comb through claims data in order to “recoup dollars” for payers. How did we get here? Could our pharmacy’s exceptional compliance rate actually alarm one of these programs and trigger additional audits? Isn’t the patient and their outcome still the priority? Do the PDP mail order and specialty pharmacies get audited?

	If we are truly looking for solutions, manufacturers should not limit distribution, insurance companies should not steer patients, PBM plan designs should include more than just their own specialty pharmacies, and audit companies should not use entrapment style programs. The system should be easier, cheaper, and better. Let’s not overcomplicate things. 

Nicholas Karalis, RPh, is a specialty pharmacist and co-owner of Elwyn Specialty Care, which offers specialty pharmacy services in HIV, oncology, hepatitis C, multiple sclerosis, rheumatoid arthritis, Crohn’s disease, psoriasis, and other areas. A leading voice in community pharmacy, he is a founding member and board member of the Community Specialty Pharmacy Network, as well as a board member of the Cardinal Health National Home Health Care Advisory Board. Mr. Karalis is an editorial board member of 

Specialty Speaks

Audits: Necessary Tools or Big Business?

Here's a guide to data integration strategies for utilization, financial, and compliance reporting.

	In the last issue, we reviewed the implementation of a Specialty Pharmacy Data Warehouse project from a 10,000-foot perspective. Specifically, we reviewed requirements gathering, hardware and software considerations, cloud computing, and vendor selection. Taking our data warehouse implementation discussion a step further, we will now focus on data integration. The scope of this article includes data integration strategies for utilization, financial, and compliance reporting.

	For most pharmacies, the bulk of the data populating your data warehouse will come directly from your pharmacy management system. In support of this practice, most systems offer canned data extracts primarily utilized for finance and accounting purposes. While these data extracts are geared toward accounts receivable and member copay collections, they can also serve as a baseline for populating your data warehouse.

	While the center of your data warehouse project will focus on receiving prescriptions filled/claims data extracts, special considerations should be in place for obtaining additional data elements such as Rxs (patient prescription information), client information, and medication and physician data. Some of the challenges typically observed in obtaining this data may include:

Information used to identify a particular client/payer can be especially challenging to implement. Quite often the pharmacy management system will not identify or group clients/payers via the same coding methods as the finance/ accounting system. As a result, the data warehouse will probably need cross reference tables linking and grouping to manage client hierarchy across systems.

 Information used to align a physician with their specialty is usually unreliable, as inconsistencies may exist across multiple data sources. As a result, special initiatives may be needed to gather and correct this information.

Information used to group physicians into offices or identify a physician across multiple offices is often a requirement, however may prove difficult to implement and support due to the shifting nature of this information.

	A critical data integration point for your data warehouse is shipping information. The timeliness of your deliveries is critical to your clients and your company’s Utilization Review Accreditation Commission (URAC) requirements. Essential shipping information data typically includes shipping costs, tracking numbers, and delivery notifications. If your pharmacy management software package already contains this information, integrating these data into your data warehouse will be fairly straightforward and should be included in your nightly extracts. If these data is not in your pharmacy management software, you may be able to retrieve it from your manifesting system or via an Application Programming Interface (API) from the shipping carrier. Utilizing an API route may be complex, however will provide near-real-time information regarding the status of a shipment and help to reduce the resources currently expended to search for a package status via an Internet application.

	Another critical component for managing and measuring operational performance is call volume statistics. Common metrics include Average Speed to Answer (ASA), Call Abandonment Rate, Agent Uptime or Utilization, and Issue Resolution Percentage (percentage of customer issues resolved in a single call, ie, “One and Done”). Depending on the capabilities of your Private Branch Exchange (PBX)/Call Center Reporting Tools, this information may be accessed in near real-time or downloaded daily to your data warehouse. Keeping in mind that call center statistics may need to be reported back to your clients, upfront consideration for dedicated 800 numbers and optimal call flows may be necessary to support your reporting needs given your particular hardware and software PBX solution.

	Quite often you will want to integrate external data within your environment to track the effectiveness of your sales staff or track changes in prescriber habits associated with office visits from your sales force. External metrics such as this are typically accomplished through daily extracts obtained from established interfaces between your data warehouse and your contact management software (for example, tools such as Salesforce.com). In order to utilize external data to support integrated metrics, you will need to map to your prescription utilization via the prescriber or the prescriber’s practice. You can then correlate changes in prescribing with office visits by your sales team. Depending on the contact management software you are using, you may need to upgrade software licenses to achieve a streamlined extract. Planning for this is key, as this can be pricey.

	Lastly, margin calculations will be more complete if they include actual payroll information. In order to accomplish this, the data warehouse will need to know the actual payroll dollars associated with each operation. It is important to understand how payroll data correlates to specific operations, as there may be limitations as to how this data is gathered. Payroll tracking may occur through time clocks and software, which can be interfaced to or through manual entry by payroll clerks. In addition, payroll dollars may be summarized by hour, by day, or by week. Finally, consider how individuals and their functions will be identified— for example, you will probably want to identify pharmacists as part of your margin calculation, but not include accounting clerks. 

Jim Maguire is the chief executive officer of BioMed Intelligence Inc, a firm specializing in health care information technology support solutions. Contact Jim at 

Technology

Data Acquisition 101

 has been reaching our readers for just over a year now, and we take great pride in the fact that we are the only publication in this space that tackles the important topics in depth. Industry leaders have joined with us to share their key insights into what makes specialty pharmacy tick. Specialty pharmacy is the fastest growing sector in pharmacy today, and we are committed to bringing the players in this field what they need to be successful.

	As Editor-in-Chief Dan Steiber, RPh, says in this issue, specialty pharmacy is both a profession and a business—and the constant need for rich information is keen in a changing world. That world is changing so fast, in fact, that our cover story discusses the current demand for more trained specialty pharmacists. Where will they get their training? How can real-world situations be a part of that training? We have seen that specialty pharmacists display an incredible entrepreneurial spirit that will surely find a solution to this workforce dilemma. In fact, I’m certain specialty pharmacists will thrive and rise to the challenges in the coming years. Our mission at 

 is to serve as a guide for the challenges and opportunities you face.

	In today’s climate, where companies of every size are forced to maneuver through government’s mazes—especially in the health care arena&mdash;it is important for individuals to maintain their balance and sense of responsibility. Specialty pharmacists are doing this in many ways with the programs they have put in place to help patients receive the specialty pharmaceuticals they need to tackle complex and chronic conditions. In each issue, we bring you “Specialty Speaks” by Nicholas Karalis, RPh, co-owner of Elywn Specialty Care and a founding member of the Community Specialty Pharmacy Network, to bring to life the realities of working with patients who need this unique, special care.

	Because specialty pharmacy involves such complex health issues and revolves around a community of professionals from a wide variety of fields, cooperation and collaboration are pivotal to success. To that end, we’ve called on leaders from the industry to help make 

 relevant, timely, and a must-read. Your response has been terrific, so we plan to bring this unique journal to your door 6 times next year. You can also access 

 on your iPad as well as online with a brand-new, enhanced Web site—

From the Chairman

Challenges and Opportunities 

The velocity of growth in the specialty pharmacy field presents challenges to both academia and industry leaders as we examine our readiness.

	Specialty pharmacy is on an evolutionary fast track and will grow to consume greater than 60% of the total US payer drug spend by 2013—the pharmacy and medical benefit combined. Disease states will continue to expand as new life-saving products come into the market, and more patients will require highly-trained medical professionals. As a result, the demand for uniquely qualified specialty pharmacists will intensify.

	The velocity of such growth presents special challenges to employers such as managed care providers, industry, and highly-focused pharmacy operations that may be seeking pharmacists who not only understand the drug and disease aspects of specialty pharmacy practice, but also how this market sector differs from other pharmacy practice settings.

	Today, there is limited coursework and practice settings (rotations) specifically on specialty pharmacy being offered in schools of pharmacy or through other accredited bodies. Interviews with some of the country’s top pharmacy school educators indicate that, while they have an eye on this emerging practice setting, their core curriculum continues to be focused on a “generalist” training that broadly prepares their students for serving the largest segments of the population. Pharmacy schools do an exceptional job of academically preparing pharmacists but are challenged by the rapidly growing volume of drug and medical information that must be communicated in preparing students for the real world of specialty practice. Some schools have expanded their curricula to meet the information demand using enhanced technologies such as online databases, networked PDAs/iPads tied to specialized software. Even with additional courses and content, schools have not been able yet to make specialty pharmacy a fully integrated part of their educational programs, short of expanding the curriculum beyond the present 6-year programs leading to a PharmD.

	In a nonscientific survey of specialty pharmacists from several different pharmacy schools, all reported that none of their academic or experiential training prepared them for the actual practice of specialty pharmacy as it exists today. Even those conditions and drugs that are frequently encountered by a specialty pharmacist (such as multiple sclerosis, rheumatoid arthritis, hepatitis C, and so on) were only briefly taught in pharmacy school. Further, all of the pharmacists reported that the concept of specialty pharmacy as a practice setting was not mentioned during coursework. Internships and experiential training with specialty pharmacies were of great value in learning about this practice setting, but these opportunities have not been widely available to pharmacy students. Perhaps leaders in specialty pharmacy should consider offering rotations to nearby pharmacy schools. Students can be an excellent resource to specialty operations, including taking on tasks for the operation, adding to their efficiency.

	Understandably, pharmacy schools are responsible for providing society with professionals who can care for the most prevalent conditions, offering the greatest good to the broadest population. However, these schools recognize it is their role to continue to improve what they teach, and how they teach it, as the field pharmacy evolves along with the larger health care system.

	As mentioned before, the greatest area of growth is specialty products—and to educate the next generation of pharmacists. Academia and specialty pharmacy practice must take on greater responsibility, or else our pharmacists will be obsolete prior to entering practice.

	As the United States struggles with the overall cost of health care, pharmacists are on the front lines of balancing the demand for costly specialty pharmaceuticals by small patient populations with the larger societal call for more affordable medications. Specialty pharmacy, therefore, is a logical part of the educational preparation that new pharmacists should receive. As evidenced by government and private payer concerns about the diseases and treatments that fall under the specialty pharmacy “umbrella,” a very clear shift of focus has occurred and will only continue to increase. Specialty pharmacy has the ability to optimize patient care with these high cost products and provide optimal outcomes. In the absence of quality pharmaceutical care, costs run the risk of going up.

Systems vs. Disease Approach—A Better Educational Model?

	While many schools of pharmacy gain insights from business sector advisory groups, it is unlikely that a unique specialty pharmacy curriculum can or will be developed and implemented as a short-term priority. However, instituting a systems approach (eg, managed care, hospital, home care, long-term care, radiopharmaceutical, and specialty) versus a drug and disease approach might help bridge the educational gap. Other creative concepts mentioned by pharmacy schools include optional specialty pharmacy educational tracks, residencies, post-graduation specialized training, survey courses, and “tool kits” that can all prepare pharmacists for specialty pharmacy practice.

	A collaborative educational process can be developed if academia and specialty pharmacy align around a set of electives whereby students can opt-in to courses and practical experiences around specialty practice. An informal survey of specialty pharmacy peers validates that specialty pharmacy is ready to provide the resources—if academia can wrap around the real world setting of specialty practice.

	Currently, most specialty pharmacy training happens on the job, although some experiential programs exist as feeder programs for PBMs and other companies. A more strategic approach would follow traditional pharmacy training, leading to a more prepared and expert specialty pharmacy workforce.

	Specialty pharmacy, and its growing importance to society and health economics, offers an exciting career opportunity for pharmacists. To ensure the best possible educational and practice outcomes, our profession must examine its readiness as the specialty stampede heads its way. 

Randell J. Correia, PharmD, is a senior vice president of Prescription Solutions by OptumRx, an innovative pharmacy benefit management organization managing the prescription drug benefit of commercial, Medicare, and other governmental health plans, as well as those of employers and unions. One of the Optum companies of UnitedHealth Group, Prescription Solutions serves members through a national network of 64,000 community pharmacies and state-of-the-art mail service pharmacies in Carlsbad, California, and Overland Park, Kansas. Dr. Correia is responsible for the mail service and specialty pharmacy business lines, which serve more than 200 clients and 13 million mail service covered lives and more than 180 clients and 22 million specialty pharmacy covered lives, respectively, with a service area spanning the entire United States and territories. 

Features

The velocity of growth in the specialty pharmacy field presents challenges to both academia and industry leaders as we examine our readiness.


Workforce Trends: How Will the Market Supply the Growing Demand for Specialty Pharmacists?

The interpretation of Fair Market Value is not so black and white.  Here's how a pharmacy or pharmaceutical manufacturer can put policies on place to bring clarity. 

Navigating the Perils of Fair Market Value

, October 2010), we reviewed and defined Fair Market Value (FMV), bona fide services, and how organizations can establish a process and create a benchmark of their service offerings. The overall intent of the FMV contracting methodology is to bring clarity and transparency to the financial relationship between 2 contracted organizations.

	This sounds easy in principle, but the reality is that due to the wide variety and complexities of products and their required services, it is not so black and white. So how can a pharmacy or pharmaceutical manufacturer put policies in place to adhere to the interpretation of the law?

 is to embrace the contracting practice and methodology of Fee For Services (FFS) at FMV. This can be difficult for pharmacies to fully execute, as some pharmaceutical manufacturers have not yet transitioned or are partially transitioned to FFS contracts, but the trend is certainly shifting toward a more transparent and benchmarked process. Many manufacturers over the past 18 to 24 months have been steadily researching ways to properly transition contracting methodologies, and are also evaluating services and their associated fee structures. This is partially due to general awareness of these trends, but more recently there has been a dramatic shift and urgency to the process.

	Why? There is a perception that this is partially due to the awareness of “new” government practices. Numerous articles have discussed how the government is now enforcing the practice of holding pharmaceutical manufacturer executives accountable for “misbehavior” on their watch. This bold step has direct repercussions for the manufacturer and all of its vendors down the entire supply chain.

	If a manufacturer is held accountable for violations of health care laws, the organization or executives could be excluded from participation in any federal health-related programs— meaning Medicaid, Medicare, and an extensive list of other federally sponsored programs. As such, anything that touches a government program is being re-reviewed internally at most manufacturers. With state, federal, and employer budget shortfalls continuing, pharmaceuticals prices/contracts and related services are targets of focus. When audits occur, any participant in the supply chain can be impacted.

The second step for a pharmacy includes: 

		Identify current services offered to the marketplace

		Stratify/break down services into basic (offered to everyone), enhanced, and custom

		Investigate the internal cost of each service; this will serve as your internal benchmark for the low end of your organization’s FMV range

		Make sure no fees are for referrals or the marketing/promotion of the product

		Make sure services are bona fide and have a commercial need

		Gain independent external input as to the valuation of services; this will serve as a potential benchmark for the high end of your organization’s FMV range

		Finalize the “list of services” and the associated “FMV range”/grid

		Develop a “standardized process” to benchmark each contract/ opportunity to the grid

		Document, document, document all communication and evaluation transparently

		If a deviation from the grid is needed, assure a fully documented escalation process

		Routinely evaluate if the services that are contracted are being completed and discrepancies are being documented

	The goal for a pharmacy is to have a solidified process, benchmark/grid of what it is consistently charging for services, audit accordingly, and document everything. If it is not documented, you did not do it.

 will need to take is to have the legal/regulatory team embrace the contracting methodology of FFS at FMV. Most trade relations teams ultimately manage the process with legal team oversight. The process is easier to establish for new emerging companies than existing companies. With established manufacturers, existing contacts are in place that could be many years old before the advent of FFS at FMV practices.

are unique to each individual manufacturer but can be stratified into the following categories:

		Break down services and fees by product

		Develop a grid of all services offered for all product lines

		Identify any inconsistencies between products/contracts (does one contract have a different fee than another contract for a similar/ same service?)

		Identify contract expiration/termination dates and evergreen (renewal) clauses

		Identify contract renegotiation or change clauses

		Externally/independently benchmark industry fee ranges for all services provided by product and all products

		Stratify client base by importance: this can be by payer coverage, data collection and reporting abilities, location, size of patient population serviced, general services, unique differentiated services, and other. This process can be done from historical experience but is often supported and documented via a transparent RFP process.

		Development of implementation/ outreach strategy

		Development of a solidified contracting process if not already established

		Development of a solid audit process based on the frequency of services performed by the vendors. (If weekly activities, there should be monitoring weekly to insure services are completed and timely according to the parameters of the contract. If not documented, risks for the manufacturer increase and could be perceived as paying for a service that is not actually performed.)

	The goal for a manufacturer is virtually the same as a pharmacy—with a few nuances. It is best to have a solidified process, benchmark/grid of what you are consistently charging for services, audit accordingly, and document everything. Additionally, many manufacturers now use the information of capabilities reviewed through a request for proposal process for documentation and justification for limiting distribution networks.

	Similarly, if a pharmacy does not have such best-in-class processes with an understanding of FMV methodology, it is increasingly perceived as a potential risk for the manufacturer, and thus another reason for exclusion in a distribution network.

	In summary, embrace the practice, develop a solidified process, establish a benchmark/reference grid with both internal and external information, audit consistently, and always document, document, document. 

David Suchanek, RPh, is senior vice president of Biotech and Specialty Services at D2 Pharma Consulting LLC (D2), a consulting firm focusing exclusively on pharma services in the life sciences industry. D2 assists emerging and established pharmaceutical and biopharmaceutical companies to develop and execute strategic business initiatives, including the development of contracts that meet Fair Market Value requirements. Mr. Suchanek is a member of the 

Fair Market Value, Part 2: Embracing the Practice 

CVS Caremark is expanding into the realm of specialty oncology management for drugs covered under the medical benefit and traditionally administered in physician offices or clinics.

 of this 2-part series (May 2011), Dr. Troy Brennan, CVS Caremark Chief Medical Officer, articulated the challenges and our organizational guiding principles for improving care and lowering cost of specialty drugs used to treat patients with cancer as the following:

		Promote quality care through use of evidence-based criteria that reduce widespread treatment variances for cancer care.

		Use of technology that emphasizes electronic communication yet reduces physician office administrative burdens.

		Where applicable, implement preferred agent strategies in which drugs are essentially interchangeable as supported by evidence- based criteria.

		Ensure that oral oncology drugs are managed through specialty pharmacy, taking advantage of consistency in high-touch patient care management.

		Creation of new scientific advisory boards made up of worldclass experts who are free of conflicts of interest with pharmaceutical manufacturers.

	Based on these guiding principles, CVS Caremark is now expanding into the realm of specialty oncology drug management for drugs covered under the medical benefit and traditionally administered in physician offices or clinics. Independent analysis indicates that more than 50% of 2010 specialty drug spend is covered under the medical benefit and that this spend is expected to increase 60% by 2015. CVS Caremark research further highlights that oncology drugs, inclusive of drugs used to mitigate the side effects of cancer drug therapy, comprise more than 50% of total specialty drug spend under the medical benefit.

	For many payers, oncology drug trend under the medical benefit can approach as much as 30% annually and traditional drug management programs have met with little success in either identifying high-quality care or effectively addressing trend. Historically, key challenges to oncology drug management have included:

		Political sensitivity and legislative mandates requiring cancer drug coverage

		Increasingly aging population that is more susceptible to cancer

		Limited clinical data visibility due to current medical claims processes

		Misaligned financial incentives due to physician drug buying and billing model

		Increasing number of cancers being treated as a chronic condition

		Emergence of oral formulations as a core therapy option for certain cancers

		Innovative, highly targeted, yet very high cost drug treatment options

	For specialty pharmacy, previous attempts to manage oncology drugs under the medical benefit were relegated to mandatory vendor imposition (MVI), requiring physicians to relinquish drug buying and billing and obtain all medications from a specialty pharmacy provider. Also known as “brown bagging” or “white bagging,” indicating drug fulfillment directly to the patient (brown bagging) or to physician offices (white bagging), these programs may have created the impression of drug savings; however, they also created unintended operational burdens on physician offices.

	We have long recognized the nuances of drug therapy for cancer patients and the potential for frequent dosing or regimen changes and that mandatory vendor imposition programs can actually create undesired drug waste and increasing rather than decreasing costs to payers. While there may be some market areas with successful MVI programs, it is generally recognized that broad adoption by oncologists and hematologists remains highly unlikely. One only needs to look at the limited physician adoption of the Centers for Medicare & Medicaid Services (CMS) competitive acquisition program, which was subsequently withdrawn from the market.

	Other historical oncology drug management programs have relied heavily on prior authorizations to establish medical necessity; reducing physician drug reimbursement by implementing average selling price (ASP)-based models, or changing benefit designs, thereby requiring patients to accept more cost responsibility through increased copay or coinsurance requirements. Most of these programs focused on expensive individual drugs yet did not necessarily emphasize quality of care or recognize therapies consisting of complex multidrug regimens that are a mainstay of oncology drug therapy.

CVS Caremark is expanding into the realm of specialty oncology management for drugs covered under the medical benefit and traditionally administered in physician offices or clinics

November 2011