Rena K. Goins

Here's an up-to-date review of the oncology therapeutic class, as today's specialty pharmacies need to learn the landscape from all perspectives.

	Orals with intravenous equivalents, REMS, products spanning medical and prescription benefit design, limited distribution networks (LDNs), and more—all of these are adding to the complexity facing specialty pharmacy in the oncology therapeutic class today. A continued new drug pipeline robust with oral oncolytics means that the landscape for pharmacists in this therapy will grow. New legislation pending on biosimilars, along with a monumental patent cliff, also impacts the products, treatments, and care for cancer patients. What once was an in-office infusion now becomes a prescription benefit opportunity for specialty pharmacy.

	Today’s specialty pharmacy faces unique challenges. The pharmacy may need to be “certified” by the manufacturer to dispense specific medications. This process, while tied to REMS requirements, is also based on capturing solid data, best clinical practices, and understanding market pull-through for the manufacturer community. A good example of this is Celgene’s Revlimid, which is only available through the RevAssist Program. Under this program, pharmacists must complete required training and are then registered through the program to allow them to dispense. Only certain pharmacies (and their pharmacists) have been authorized. Further, the actual patients must also be registered in the RevAssist program. This creates a local distribution network of specialty pharmacies able to fulfill patient needs for the product.

	A similar program, GlaxoSmithKline’s CARES program, which covers dispensing products such as Tykerb and Promacta, limits access to these cancer therapies to a network of pharmacies. Pharmacies interested in dispensing Promacta, a product with a REMS program, must first complete a form viewable online at www.promactacares.com/pdfs/Specialty_Pharmacy_Authorization_Form_for_PROMACTA_CARES.pdf.

	A component of these oncology programs mirrors other specialty medication areas in that the dispensing pharmacy and its staff receive specialized training and may have defined reporting criteria and patient-specific counseling requirements in conjunction with dispensing the products. It is rare that there is an exclusive specialty pharmacy. More typically 6 to 10 pharmacies are in these LDNs to provide broad geographic and payer coverage. For example, in the GSK CARES program, 23 pharmacies are listed but only certain ones may be certified for specific product (at press time).

	Further complicating the oncology therapy class, pharmacists who see oncology patients may only have access to limited patient information on other products the patient is receiving as part of a “chemo cocktail.” Managing side effects becomes increasingly complex with this incomplete picture of the patient’s therapy.

	Since the late 1980s, cancer care had moved increasingly to the physician office environment. Fueled by a host of injectable pharmaceuticals, patients migrated from hospital inpatient wards to the community oncology clinic. Reports by industry indicated for years that 80% or more of cancer care was provided in the physician office environment. Supplying these offices created a niche channel for manufacturers to deliver product right into the clinics—some say into as many as 5000 clinic locations via next -day 10:30 am service. This market has been dominated by specialty distributors (SDs) as suppliers. These SDs are often divisions within the larger wholesalers such as:

	• Cardinal Specialty Pharmaceutical Distribution, a division within Cardinal Health

	• Oncology Supply, a division within AmerisourceBergen Specialty Group, part of Amerisource Bergen Corporation

	• McKesson Specialty Care Solutions (formerly OTN), a division within McKesson (Note: McKesson Specialty recently acquired US Oncology, which was another SD in the marketplace).

	While these 3 dominated the market, there was still competitive activity represented by additional firms such as CuraScript (owned by ExpressScripts) and Florida infusion. But, as therapies changed and regional infusion centers began to form, additional competition arose through niche suppliers such as BDI Pharma, Metro Medical, and even traditional retail suppliers such as Dakota Drug, Rochester Medical, Morris & Dickson, and others began to see new opportunities in the oncology market. Specialty pharmacies have been able to leverage the traditional wholesale channels as well as these niche and SD suppliers in working to determine the best sourcing strategy to obtain needed oncology products to meet patient needs.

	Arising with these SD providers was a whole new network of group purchasing organizations (GPOs) such as ION and Onmark. Unlike the traditional GPOs, these firms aligned with a specific SD—eg, ION with Oncology Supply, or Onmark with McKesson Specialty. In loading their contracts only with their preferred supplier, they created closed access channels. Manufacturers benefited by having captive markets to work toward appropriate utilization programs and market share analysis. These GPOs also developed a host of reimbursement tools for their physician provider customers, including regimen selection tools and complex cost/reimbursement modeling that allowed therapy-based analysis, much like the tools in the retail channels for claim analysis prior to adjudication.

	These tools allowed practices to upload CMS fee schedules as well as commercial payer fee schedules for a true look at the economics for a given patient undergoing a given therapy. Basing therapy tools on national compendia, they brought fiscal and therapeutic analysis into the hands of thousands of oncologists in the community setting.

	Then came the growing number of oral cancer medications. Oral drugs represent about 35% of cancer medications in the pipeline. Burdened by managing the infused portfolios and unfamiliar with prescription benefit adjudication, practices sent these patients and their medication needs into the community pharmacy market. Conventional retail chains were unprepared to stock these high-dollar products, and more importantly, they were unfamiliar with the deeper counseling often tied to filling these oncolytics.

	A perfect opportunity for specialty pharmacy arose. Today, specialty pharmacies—both large national players and regional market specialists&mdash;have built strong relationships with the community oncologist to provide for the unique needs of their cancer patients.

	Another growing trend is the changing health plan benefit designs—drugs historically in the Part B medical benefit reimbursement bucket have now migrated to Part D prescription, or even special carve-out benefits, creating a growing medication portfolio requiring a high level of careful management. For some drugs, the indication, “patient capability to selfinject” or “special structure” means 1 product, like epotin alpha, could be adjudicated in either benefit, or both! Prior authorizations in this environment now take on a whole new level of complexity and processing for the specialty pharmacy provider.

	Today community oncology is shifting again—more and more private practices are closing their doors. Many practices are entering into joint venture or ownership models with hospitals. A recent study by lobbying group Community Oncology Alliance (COA) cited some dramatic shifts with respect to the footprint that community physician—based oncology clinics have in the marketplace. According to a COA study updated in July 2010, 865 clinics/practices during the past 3 years have been impacted as follows 1 :

	• 172 clinics closed—denotes individual sites that have closed.

	• 323 practices struggling financially—denotes practices (possibly comprising multiple clinic sites) that are struggling to pay bills and/ or stay open.

	• 44 practices sending patients elsewhere—denotes practices (possibly comprising multiple clinic sites) that are sending all of their patients elsewhere for chemotherapy. (Note: Numerous practices report sending some patients, especially Medicare patients without adequate secondary insurance, elsewhere for treatment.)

	• 224 acquired by hospitals— denotes practices (possibly comprising multiple clinic sites) that have been acquired by a hospital.

	• 102 merged/acquired by another entity—denotes practices (possibly comprising multiple clinic sites) that have merged or been acquired by a corporate entity.

	As of early 2010, COA reported 41 clinics had closed, representing a continuing trend of consolidation in communities and need for alternative solutions to providing cancer care access to patients. Still other practices are modifying their care to offer overall treatment planning and basic office visit services while directing patients to specialty pharmacy or infusion center locations for actual drug administration. A sobering situation will continue to impact cancer care:

	• American Society of Clinical Oncology studies have pegged average oncology physician ages above 55 with many more physicians retiring than joining the ranks, foreshadowing a significant practitioner shortage.

	• The Oncology Nursing Society cites similar gaps in number of new oncology nurses as compared with expected patient populations.

	• American Cancer Society and CMS reports of reduced fatalities in cancer also reflect more overall patient volumes and more people “living with cancer” as a more chronic condition.

	• Baby boomer population surges mean more potential patients and fewer workers subsidizing Medicare costs for these seniors.

	• Higher priced cancer therapies— witness Provenge at $31,000 2 per treatment or Avastin at about $88,000 3 for breast cancer treatment. Such costs mean continued strain on Medicare, Medicaid, and the commercial payer community to fund cancer treatments.

	• Continued legislative reform, accountable care organizations, etc, represent a crossroads looming in oncology and cancer care.

	All of these landscape changes combine to form an opportunity—and a challenge&mdash;for specialty pharmacies and their communities in providing quality cancer care to patients in a growing marketplace. Continued focus on understanding the care, the science behind the therapies, and the legislative landscape remain key for all the stakeholders at the table. SPT 

Rena K. Goins is senior director, specialty markets, D2 Pharma Consulting LLC. She has worked in a variety of specialty market initiatives including specialty distributor relations; IV infusion product sourcing and pricing management; niche group purchasing organization strategies; and aiding in supply chain, trade, and sales activities. Ms. Goins has 20 years of distribution and specialty expertise including leading OEM device launches, compliance product solutions, medical education programs, and reimbursement modeling. She is a member of ONS, MGMA, ACCC, and Leadership Health Care, a partnership with the Nashville Health Care Council. 

	1. COA studies. www.communityoncology.org/UserFiles/files/e6c14902-aebb-4368-8d8f-b14234f95161/COA%20Community%20Oncology%20Practice%20Impact%20Report%207-23-10.pdf. Accessed April 15, 2011.

	2. Dendreon sets Provenge price at $93,000, says only 2,000 people will get it in first year. www.xconomy.com/seattle/2010/04/29/dendreon-sets-provenge-price-at-93000-says-only-2000-people-will-get-it-in-first-year/.

 http://online.wsj.com/article/SB10001424052748703730704576066174286192748.html?KEYWORDS=avastin.

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The Oncology Landscape: Complexity, Cost, Care, and Coordination

Here's an up-to-date review of the oncology therapeutic class, as today's specialty pharmacies need to learn the landscape from all perspectives. 