Just ten years ago, almost all patients using “specialty” pharmaceuticals were being treated in infusion centers or hospitals. Today, the opposite is true, and single-specialty or large multispecialty practices are more likely to be managing patients who need novel biologics, oncolytics, and immunosuppressant therapies. Just as new technologies supported the migration of urologic procedures from inpatient to office settings, novel formulations of specialty drugs have shifted the treatment of patients taking oncologic and biologic agents from infusion centers to the doctor’s office.

	An oral oncology drug, abiraterone acetate (Zytiga, Janssen Biotech, Inc), for men with advanced, metastasized prostate cancer, is one example of this shift of care into urology offices. Another is the introduction of home-administered “self-injectable” biologics used by patients with rheumatoid arthritis and multiple sclerosis. Specialty pharmacy providers (SPPs) deliver prefilled syringes or other injection devices to community pharmacies, prescribers’ offices, or directly to patients. Even patients who need infused drugs often receive treatment at home from a visiting infusion service, which is also supplied by specialty pharmacies.

	Certainly the easiest way to get drug therapy is to swallow a pill, and manufacturers of biologic therapies are moving as many agents as possible into oral tablet formulations. In 2011, SPPs reported that 58% of the cancer prescriptions they handled were oral agents.

 Generally, patients and their doctors agree that the shift from hospital-administered therapies is a positive change. First, it is much more convenient for the patient. In addition, it lowers the risk of infection associated with inpatient care and it lowers the cost of drug administration. In fact, an average 6% of oral oncology drugs and 12% of self-injectables that are covered by insurance are distributed by SPPs to physician offices, where they are administered to patients.

	Managing Patients Who Take Biologic Therapies

	While distribution of orals or self-injectables may be fairly easy for a practice, managing a patient’s use of such specialty drugs can be daunting. Zytiga again illustrates the point. The drug manufacturer has filed applications in the United States and Europe for a new indication: treatment of prostate cancer patients who have never had chemotherapy. The current indication is more limited, for treatment of metastatic castration-resistant prostate cancer that has progressed after treatment with chemotherapy. Zytiga prescriptions are likely to triple if the earlier-use indication is approved.

 Urologists will be managing more prostate cancer patients spanning a broader disease-progression period.

	By definition, biologic therapies, even in pill form, are both complex and costly. Consequently, patient monitoring is often intensified, and comprehensive treatment may include management of difficult side effects and the careful avoidance of drug-drug interactions common among patients being treated for serious diseases. Managing use of a biologic regimen puts pressure on patients, doctors, and the entire clinical team.

	Helping patients obtain ongoing coverage or financial assistance for such therapy is also time-consuming and is a task that often falls to the practice administrator. So, meeting the needs of these patients takes more time, different resources, more information, better data tracking, smoother transitions of care—more of just about everything.

	Thomas Paivanas, MHSA, the executive director of the CUSP Group, offered a view of how urologists have responded to the changing treatment advances in their field. The CUSP Group is a “provider-centric” uro-oncology trials management organization composed of 15 large, integrated urology practices. Their organization was formed, explained Paivanas, “to collect clinical, operational, and cost data that support a ‘systemic urology therapy’ approach to patient care across the full progression of disease.”

	“Everything is changing in the uro-oncology field,” Paivanas said, “including guidelines that support a standard of care, treatment pathways that insurers use to predict cost of treatment for specific conditions, and the way urology practices are defragmenting the delivery of care by integrating complete treatment services in large practices.”

		According to the National Cancer Institute, a biologic drug is a substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases.

		URAC, the leading healthcare accreditation organization for specialty pharmacy companies, concedes that definitions of a specialty drug vary, but that most would agree that specialty drugs are expensive and complex.

 URAC also reported that the specialty drugs segment of the industry represented 17% of total pharmaceutical revenues in 2011, a percentage that would more than double by 2020.

		The Centers for Medicare & Medicaid Services defines drugs that cost more than $600 per month as specialty drugs, while other health plans put the threshold at $1200 per month.

		The Foundation for Managed Care Pharmacy investigated the question of what defined a specialty drug by surveying pharmaceutical management companies to submit their own criteria for defining and including drugs on specialty drug lists.

					Specialty drugs typically cost $500 or more per dose or $6000 or more per year, and have one or more of the following characteristics:

					Specialized patient training and coordination of care required prior to therapy initiation or during therapy

					Unique patient compliance and safety monitoring requirements

					Unique requirements for handling, shipping, and storage

					Potential for significant waste due to the high cost of the drug

				National Cancer Institute at the National Institutes of Health. Available at: 

http://www.cancer.gov/dictionary?cdrid=426407

				URAC. Specialty Pharmacy White Paper. Washington, DC: URAC. October 6, 2011. Available at: 

https://www.urac.org/press/cmsDocument.aSPx?id=771

	Practices such as the CUSP Group usually have evolved to include internal subspecialists who manage patients with advanced or complex conditions, such as cancer. Patients whose disease has progressed beyond standard initial treatment are often referred internally to a subgroup of physicians who conduct research and make use of the most progressive therapies. Paivanas suggests that it is usually these physicians who tend to drive practice-wide change, such as new product adoption.

	As practices have taken on the management of patients who need biologic therapies, such as prostate cancer patients, they may also have entered new business relationships with SPPs. Paivanas believes that it is likely to be the physician-researchers within an integrated urology practice who “will drive a new collaborative model in partnership with SPPs.”

	Certainly SPPs have become a major presence in oncology practices. Some aspects of these relationships have been helpful to physicians and their patients. Others—most notably the erosion of oncologists’ direct purchasing of oncology drugs&mdash;have caused deep contention. Nevertheless, interactions between SPPs and specialist practices are likely to expand because specialty products now account for 21% of the total US pharmaceutical market revenue, and that percentage is expected to grow to 25% by 2014.

	For the present, in urology practices, most patients taking specialty drugs have cancer. Urology practices care for patients with prostate, kidney, testicular, and bladder cancers—four fairly common types. Also, the national patient population is aging, and cancer risk increases with age. Older age is associated with an especially high risk for prostate cancer.

 Currently recommended biologic agents for the cancer patients managed in urology practices include not only oncology drugs but also hormonal agents and immunologics.

	Paivanas estimates that from 10% to 25% of urology practices in the United States have begun to adopt a “true systemic therapeutic approach to treatment.” In this practice model, as he describes it, “once a patient is diagnosed with cancer, all subsequent therapeutic needs of that patient can be addressed by the practice. Care is truly integrated in the most efficient and effective manner possible.”

	Maintaining the level of care that Paivanas describes has historically proven to be a tall expectation for any specialty practice, and most use outside services to support the practice in some ways, such as for data collection, in which SPPs have a natural position as the keeper of pharmacy data.

	A less well-known reason that use of SPPs by urology practice partners may increase is that drug pipelines are laden with new biologic therapies, and an estimated 72% of specialty drugs are distributed by SPPs.

 The role of SPPs has expanded as the number of specialty drugs has expanded. In 2010, 887 of the more than 3000 medicines and vaccines under development in the United States were for treatment of cancer: lung (98), prostate (80), colorectal (55), solid tumors (240), and all others (323).

 It is expected that by 2016, biologic drugs treating cancer will be among the top 10 selling pharmaceuticals in the country.

	Specialty drug distribution has long been an integral part of delivering oncology agents. As these agents entered the market, SPP companies were the obvious choice for distribution, and their service base has rapidly expanded through patient and drug management services that ease the introduction of fragile, costly, and toxic agents into the marketplace.

	SPPs have carved out a secure space in the market because their services are not only useful to manufacturers, but also to insurers, and increasingly to physicians and patients. At the least, an SPP tracks the business of drug distribution to doctors, institutions, and patients, as well as the purchase and reimbursement data as determined by contract. Their distribution streams include mail order, and delivery to homes, offices, and community pharmacies.

	In fact, the diversity of their services presented a challenge to the Centers for Medicare & Medicaid Services (CMS) to define what constitutes a “specialty pharmacy.” The criteria for the definition is important because the CMS requires pharmaceutical industry groups to include drug sales to “specialty pharmacies” in its calculations of Medicaid’s average manufacturer price (AMP), which is used for insurance reimbursement. CMS opted to delay both the definition and the directive until 2013. If it takes on the challenge then, it will be the first time that 

	Almost all SPPs have assumed clinical management roles, which muddies definitional waters but may be serving to clarify what kind of attention to patients works best. SPPs document encounters and interventions with specific patients, supplied through their disease management and case management services.

	However, SPPs rarely contract directly with clinical organizations. Their contracts are with drug manufacturers and insurers, both of which have a stake in making sure biologic agents are used correctly and by the right patients. Like with many specialty drugs, Zytiga was launched with a list of specialty pharmacies that had contracts to distribute the drug and to provide a patient support program called “ZytigaOne.”

 The opt-in program is selected through an enrollment form that is provided to physicians to distribute to their patients.

	SPP contracts with manufacturers and insurers affect not only the price of the drug, but also have the ability to affect overall costs of specialty therapy because these contracts seek to ensure quality of care and safety. Although many services are available, the core contracted services are listed below.

		Distribution or volume guarantees affecting inventory availability

		Reporting responsibility to meet FDA Risk Evaluation and Mitigation Strategy (REMS) requirements

		Assistance with prior authorization and physician documentation

		Assistance with obtaining financial help for patients

	To tighten control further, “limited drug distribution” contracts are common. Such agreements sometimes name only a few specific SPPs for distribution to clinical networks, which affects downstream purchases by hospitals, physician practices, other care facilities, and patients. However, manufacturers want to support a reasonable regional coverage, especially for distribution of oral agents that are usually dispensed directly to patients through community pharmacies. Zytiga was launched with 16 SPP distributors.

	Some physician practices welcome patient support services for their patients and work cooperatively with the SPP vendor. Others see the patient-based services as an intrusion in the physician-patient relationship and the therapeutic process. As an industry, SPPs have adopted a long-term business focus on building therapeutic expertise, which may conceivably make them more valuable as a clinical extension of the physician practice: performing tests that monitor effects of therapy, recommending dosing changes, and monitoring physician use of clinical guidelines.

 The question for the practice is, “What aspects of patient management do we want to hang on to, and which are we better off letting go of?” The answer is never simple.

	Oncology practice managers report that they dedicate countless hours arranging prior authorizations and financial assistance for patients who cannot afford prescribed therapies.

 Infectious disease practices found themselves almost swamped by patient management needs when new, genetically targeted agents for hepatitis B and C were introduced in 2011. Managing growing numbers of patients on complex regimens usually requires careful record keeping and higher levels of information technology within the practice. And, there are no measures of how much harder it will be to keep up with therapeutic education. Information overload is a constant challenge for all doctors.

	Paivanas also commented on the need for information. “There is such a cascade of data arising from genetic research, it’s like trying to drink from a fire hose. We all have to adapt and become facile with these new tools and information.” He predicts that as more biologic therapies become available, the early adopters in the urology field will pursue combinations and sequencing of therapies in order to provide optimal treatment to the patient over the full course of disease. Because the burden of education about new biologic therapies usually falls to the manufacturers, and by delegation, to the contracted specialty pharmacy group, this could also become a benefit of collaboration with SPPs.

	How the physician practice and a specialty pharmacy can or will interact is far from predictable. Practices and SPPs vary endlessly. However, considering the market and the linchpin-like spot SPPs occupy in the distribution of biologic drugs, urology practices may see an opportunity to use SPPs in achieving a common goal: a successful therapeutic outcome for the patient.

The 2012 Genentech Oncology Trend Report: Perspectives From Managed Care, Specialty Pharmacy Providers, Oncologists, Practice Managers, and Employers.

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http://www.fiercepharma.com/story/bigger-zytiga-marketstep-closer-jjs-approval-filings/2012-06-18

Specialty Pharmacy Management: Industry Overview and Assessment of Leading SPM Companies.

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http://www.phrma.org/sites/default/files/1000/medicinesindevelopmentcancer2011_0.pdf

			Correia R. Oral oncology therapies: specialty pharmacy’s newest challenge. Pharmacy Times. Available at: 

http://www.pharmacytimes.com/publications/issue/2011/May2011/Oral-Oncology-Therapies-Specialty-Pharmacys-Newest-Challenge-

			Steinke S. Manufacturers seek CMS definition of “specialty pharmacy.” 

http://www.zytiga.com/support_and_resources

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