The specialty pharmacy industry has evolved over the years to meet the challenging needs of patients receiving specialty medications for diseases such as rheumatoid arthritis, multiple sclerosis, cancer, HIV, hepatitis C, growth deficiency, hemophilia, pulmonary arterial hypertension and infertility. This list will surely grow as talented scientists in pharmaceutical research continue to search for new ways to treat complex human health conditions and unmet medical needs. As with any industry or business, it either evolves by keeping pace with innovations, or it deteriorates by failing to develop or stay abreast with marketplace changes, especially legislative/regulatory, as it is with the entire continuum of pharmacy and pharmaceutical care.
Advancements in medication treatment are continually evolving and improving. We’ve witnessed pioneering treatment regimens and the application of medications to treat a range of diseases that have helped to ensure ever increasing positive patient outcomes. The life expectancy 100 years ago (1913) was 50.3 years for a man, and 55 years for a woman. The life expectancy today for a man is 76 years and 81 years for females.1 It is my belief that there is a direct correlation between the discovery and application of medications and the increasing rate of life expectancy in America—not just the length of life, but also the quality of a life lived.
As stated in the 2012 Pharmaceutical Care: Policies and Practices for a Safer, More Responsible and Cost-effective Health System report by the European Directorate for the Quality of Medicines & HealthCare (EDQM):
“Pharmaceutical care is a quality philosophy and working method for professionals within the medication process. It is indispensable for helping to improve the good and safe use of medicines, thus realizing the best possible outcome of medicines for the patient. It contributes to the optimization of outcomes from medicines and the prevention of harm and inappropriate use. This is achieved through the promotion of medication-related health literacy, the involvement and participation of patients in their medication, and the assignment and acceptance of responsibilities in an appropriate manner within the medication process. Together, these factors improve the quality of life of patients and their families; the utilization of resources; and help reduce inequalities in healthcare. By increasing the cost-efficiency of medicine use, pharmaceutical care will contribute to efficient and effective consumption of existing resources.”
From my perspective, this statement speaks to the necessary and important work of the specialty pharmacy and the service that these pharmacies provide to patients in not only getting the medication to them, but also conducting the follow-up to facilitate patient adherence, compliance and persistence to the prescribed regimen while simultaneously determining the patients overall response to the prescribed therapy.
Specialty pharmacy (or the specialty pharmacy provider—SPP) had its beginnings in the late 1980s and early 1990s when a few pharmacies began to offer and manage specialty medications in the treatment of cancers and infertility. During this period, researchers in their various settings also developed specialty medications to help treat autoimmune diseases and HIV, medications to stave off organ rejection in transplantation, growth hormone treatment, multiple sclerosis and rheumatoid arthritis. With the advent and increase of these innovative specialty medications in the marketplace, health plans began to carve-out the use and management of these medications to insure that each patient was receiving the quality care needed for optimal patient outcomes.
Hence, with the development of these innovative medications, along with the need to ensure quality patient care, the birth of specialty pharmacy as a recognized “class of trade” began.
A High-Touch Approach
Early on, specialty pharmacies began to differentiate themselves from other forms of pharmacy practice through the methodical manner of patient in-take processing (patient enrolling) to use a specialty medication. These pharmacies’ in-take processes are an essential component in patient care. They help to ensure that the relevant patient-specific information is gathered and applicable to the medication being delivered. To these pharmacies, expertise in talking with the patient regarding their medication treatment regimen is paramount.
This “high-touch” approach to care is an integral part of an advanced care model through which patient and medication care information is continually input and accessed by disease state and specialty pharmacy medication professionals.
At this time, there is no “specialty drug/specialty medication” definition put forward by the U.S. Food and Drug Administration (FDA), although typically a medication is considered as “specialty” if it exceeds anywhere from $600 to $1,200 per month and requires special handling and administration. Some of these medications may require unique inventory management and could “…have an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) program in place that requires more intense support, such as physician certifications, diagnostic results, physician/pharmacist training, and/or other requirements that must be met prior to dispensing.”2
A Patient-centric Approach
Although, while no agreed upon definition of “specialty drug/specialty medication” exists, the trade class of “Specialty Pharmacy” is defined as:
A unique category of professional pharmacy practice that incorporates a comprehensive and coordinated model of care for patients with chronic illnesses and complex medical conditions. Specialty pharmacies dispense and distribute FDA approved medications, coupled with integrated therapy management services, patient education and counseling.
Integrated standard-of-care services expedite start of therapy, drive adherence, compliance & persistence, monitor and manage patient dosing, and drug effectiveness & appropriateness. This patient-centric model is organized to provide reliable access to typically high-cost, injectable, infusible and oral and other hard-to-manage therapies within a collaborative, quality-driven framework designed to achieve superior clinical, humanistic, and economic outcomes.
Specialty pharmacy incorporates three synergistic components:
1. The specialty pharmacy service model is structured to include the patient as an integral member of the care team through “high-touch” patient-centric therapy management and support services.
2. Satisfaction with the specialty pharmacy patient journey is achieved by meeting or exceeding the unique clinical and administrative needs of patients on these medication regimens, in an environment of continuous quality improvement.
3. The specialty pharmacy standard of care is structured to support expert and reliable therapy fulfillment according to rigid quality and patient-safety standards, and the efficient resolution of administrative and financial barriers to access.3
Working Together on Medication Adherence, Compliance and Persistence
As part of their standard of care model, these pharmacies offer services above and beyond those typically offered at the retail level. This care model requires all patients, physicians, payers and pharma manufacturers to communicate with one another. Specialty pharmacies provide the conduit for communication and the flow of information to the stakeholders. They work together to ensure medication adherence, compliance and persistence, and track patient outcomes and quality of life as related to their medication treatment.
These “collaborations between specialty pharmacies, retail settings, hospitals, and [pharmaceutical/biotech] manufacturers are becoming increasingly commonplace. And they can enhance patient access to specialty pharmaceuticals and the high-touch services a specialty pharmacy can provide, thereby improving patient care.”4
In this regard, an SPP works to ensure patient quality and coordinate the flow of information to all stakeholders. These pharmacies work with the patient on medication access and care; with the provider (physician) on updates; with the payer to administer and coordinate patient medication coverage; and with the pharmaceutical manufacturer to provide aggregated information on aggregated medication use and efficacy.
Collaborating with ACOs
Moving forward in the Accountable Care Organization (ACO) environment, specialty pharmacy will be exceptionally positioned with the ability to provide information, data, essential and necessary to “…convince ACOs to view medications as a tool, not simply an expense. When these medications are appropriately used, they can contribute significantly to improving patient outcomes and reducing overall costs.”5 Instead of making either sales or purchase strategy decisions based purely on quantity (volume-based, consumption based), the stakeholders will be able to make decisions based on value (quality and cost).
In a white paper published online through the American Journal of Managed Care (AJMC), the National Pharmaceutical Council (NPC) stated, “In an environment where only costs are considered, medications are viewed narrowly as a siloed expense item and medication management efforts traditionally focus on medication selection and their associated cost. In a value-based environment, an integrated approach to medications is critical. Without this integration, it is difficult to calculate and recognize the cost offsets and quality benefits that can occur from optimized pharmaceutical use.”6
The NPC cautioned that the transition from a fee-for-service, volume-based, purchase decision-making environment to a value-based system may have its challenges, but noted that if done correctly, a “…value-based healthcare [system] can enable patients to gain access to and support in using needed medications while simultaneously lowering cost growth and achieving the quality benchmarks that the marketplace will demand.”6
With their ability to collaborate with those providing care, facilitate patient care management, to capture and aggregate data and offer clinically compliant services in a cost-effective manner, specialty pharmacies are positioned to provide information and analysis to the stakeholders on the value of these medications.
It will be the pharmaceutical manufacturer’s challenge to move from the volume driven, consumption-based system, in which the primary focus of specialty pharmacies was concerned with patient market access, patient capture and medication adherence, to a results driven, ultimate patient improvement model that is based on demonstrable data confirmed through patient improvement—individually and across patient populations.
2. Haas, Jon. “Managed Markets Monday: What’s So Special About Specialty Pharmacy?” http://www.palio.com/managed-markets-monday-what%E2%80%99s-so-special-about-specialty-pharmacy.
3. Specialty Pharmacy Association of America.
4. Jennifer Hagerman, PharmD AE-C; Stephanie Freed, PharmD; and Gary Rice, BSPharm, MS, MBA. “Specialty Pharmacy: A Unique and Growing Industry.” American Pharmacists Association. Pharmacy Today. July 01, 2013; http://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry.
5. Barnes, Mark K. “Specialty Pharmaceuticals: Manufacturers Must Consider a New Supply Chain.” Specialty Pharmacy Times. Published Online: Tuesday, December 18, 2012. http://www.specialtypharmacytimes.com/publications/specialty-pharmacy-times/2012/December-2012/Specialty-Pharmaceuticals-Manufacturers-Must-Consider-a-New-Supply-Chain.
6. Robert W. Dubois, MD, PhD; Marv Feldman, RPh, MS; John Martin, MPH; Julie Sanderson-Austin, RN; and Kimberly D. Westrich, MA. “Role of Pharmaceuticals in Value-Based Healthcare: A Framework for Success.” AJMC. Published Online: July 12, 2012; http://www.ajmc.com/publications/issue/2012/2012-7-vol18-n7/role-of-pharmaceuticals-in-value-based-healthcare-a-framework-for-success/2.