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Pharmacy Times
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Specialty pharmacy is often considered one of the fastest growing and least understood segments of health care.
Specialty pharmacy is often considered one of the fastest growing and least understood segments of health care.1 In 2015, a projected 67% growth, compared with 40% in 2014, of specialty medications illustrates how rapidly changes are occuring.2 This unique niche within pharmacy generally focuses on expensive, complex medication therapy for the treatment of chronically ill patients. As specialty pharmacy continues to expand, retail pharmacies may attempt to incorporate specialty medications within their workflow, forcing retail pharmacists to strengthen their knowledge of these medications and the disease states they manage. Disease states frequently managed in this realm of pharmacy include cancer, hepatitis C, HIV/AIDS, multiple sclerosis, rheumatoid arthritis, and various other rare genetic conditions (Table3).
The specialty pharmacy marketplace encompasses not only a vast amount of products, but a significant amount of provisions, as well,1 created to govern the handling and service requirements of specialty medications, which pharmacies were traditionally not fully equipped to manage. Retail pharmacies are typically known to handle fast-moving products and online claims adjudication to support their primary business model.1 With a focus on dispensing, distribution reimbursement, case management, and other services specific to patients’ disease states, specialty pharmacies have gained traction within the pharmacy community.3
As part of this patient-focused model and their standard of care, specialty pharmacies offer comprehensive services above and beyond those typically offered at the retail level. These may include the following4:
• 24-hour access to pharmacists
• Adherence management
• Benefits investigation
• Communication and follow up with physicians
• Dispensing of specialty pharmaceuticals and shipping coordination
• Enrollment in patient assistance programs
• Financial assistance
• Patient education and medication adverse effect (AE) counseling
• Patient monitoring for safety and efficacy
• Payer and/or manufacturer reporting
• Proactive patient outreach for prescription refill and renewal
• Prior authorization assistance
The space limitations for the stocking of items has created barriers for retail pharmacies when dealing with specialty medications.1 Specialty medications are not frequently prescribed, resulting in them remaining in stock for prolonged periods of time. Historically, physicians purchased and stocked specialty medications in their own office space. This permitted them to provide medications directly to patients and to enhance revenue by increasing medication prices while still earning a profit.1 As stated previously, these medications are expensive and require proper handling. Many offices, however, may not have the resources to stock these medications due to their expense and storage requirements. These reasons further developed the niche for specialty pharmacies in addition to the government placing caps on medication prices and limiting the amount of physician reimbursement.1
In 2015, there will be an estimated 1,658,370 new cancers diagnosed and 589,430 cancer deaths within the United States.5 Cancer treatment options depend on multiple variables, such as cancer stage, therapy AEs, patient preference, and Eastern Cooperative Oncology Group status.6 The most common cancer treatments include surgery, chemotherapy, radiation therapy, and targeted therapy.5 Specialty medications often used in these cancer treatments are currently the largest selling class of therapeutic agents within specialty pharmacy.1 Annual specialty drug spending is expected to surpass $400 billion by 2020, with the largest portion of costs stemming from oncology medications.2
Oncology agents routinely distributed from specialty pharmacies include selfinjectable therapy (eg, erythropoiesisstimulating agents), oral oncolytics, parenteral chemotherapy, and biologics.7 These medications are associated with numerous serious AEs, including bone marrow suppression, thromboembolic development, gastrointestinal distress, and other medication- specific issues. With the development of selfadministering therapies, patients play a larger role in their care, as it requires them to administer medications in the privacy of their own home. As a result, prescribers have to ensure that patients have adequate instruction on how to safely and effectively administer their medication, as there is no direct prescriber oversight.7
Specialty pharmacies employ pharmacists with a disease-specific expertise in oncology to encourage communication, identify potential safety concerns, help prevent unwarranted drug expenditures, and ensure medication adherence, all of which lead to improved health outcomes.7 Adherence has been defined as the “active, voluntary, and collaborative involvement of the patient in a mutually acceptable course of behavior to produce a therapeutic result.”8 In cancer patients, nonadherence has been proven to have a negative impact on desired outcomes and to increase costs of care. The effectiveness of medications and their benefits depends on adherence to a prescriber’s instructions.7 Patient support 24/7 remains vital in optimizing treatment outcomes, as problems have the potential to arise at any given time.1
Recent research revealed patients requiring oral oncolytic therapy are approximately 50% more likely to adhere to their treatment regimen when receiving their medications from a specialty pharmacy.7 This data has helped prove specialty pharmacy’s worth within our health care system and exhibits why the field continues to grow.
Dr. Moore is an assistant professor at Howard University College of Pharmacy.
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