The industry has concentrated its efforts on developing new therapies with few or no competitors.
OCTOBER WILL MARK the tenth year in which Pharmacy Times® has led the charge in specialty pharmacy publications. In 2010, our crystal ball told us that over the next decade, there would be a significant shift in the market toward specialty, with large concentration in the oncology space. Just in the past year alone, from 2018 to 2019, specialty products grew from 44.7% to 47.7% of all spending on prescription drugs (FIGURE 1).1
What makes this observation even more significant is that specialty products are used in only 2% of the patient population.1 The industry has concentrated its efforts on developing new therapies with few or no competitors. Given that we and our readers concentrate our efforts in the pharmacy space, we always want to keep a perspective on where that focus fits within the larger scheme of health care costs. If we were to spread the cost of prescription drugs as it relates to a dollar of spend, prescription medications would be about 23.3 cents. That means that 11.1 cents of every health care dollar go to specialty drug therapies.2
Oncology and Specialty Pharmacy
Thankfully, the pharmaceutical industry took on the challenge of developing therapies to combat cancer many decades back. The treatment of cancer actually traces back in time to ancient Egypt and Greece, where the only solution was to cut out the tumor and hope for the best. It wasn’t until the 1940s that researchers discovered chemotherapy with cytotoxic antitumor drugs for the treatment of hematological and solid tumors. Then, in the 1980s, science evolved to better understand molecular and cellular biology, resulting in the discovery of specific drugs that were able to target cancer cells. This targeted approach to oncology therapy has been able to significantly improve cancer survival rates. Today, primarily as a result of the discovery of monoclonal antibodies and immune checkpoint inhibitors, we are seeing an explosion of new therapies.
Oncology and oncology support drugs comprise 43% of total medical pharmacy spend in commercial and 58% in Medicare (FIGURE 2). By 2022, the number of billion-dollar drugs will have risen 26% in 5 years, to 43 drugs from 34 in 2017. Within oncology, chimeric antigen receptor T-cell therapy alone is expected to increase by 530% from 2017 to 2022.3
The data give us a sense of the growth of oncology products and supportive care.
Cancer research and subsequent new drug approvals are focused on the development of cell therapies, antitumor vaccines, and many other new therapies. In addition, many therapies or their variations have transitioned from the traditional infusion setting to oral oncology products. Many patients who could previously be treated only in a community oncology clinic or institution can now receive their therapy in a home setting. This trend has greatly contributed to the evolution and growth of specialty pharmacy, which began about the same time that oral chemo products, along with other new oral therapies for transplant and HIV, were being introduced.
Big Challenges With Oncology Therapies
In general, specialty pharmacy focuses on high-cost, high-touch medication therapy for patients with complex disease states such as cancer and multiple sclerosis, to name just 2. In 2019, the FDA approved 57 oncology drugs, of which 33 were oral medications.
Every year, the number of oncology products approved by the FDA increases, and the cost of these new products has led not only to insurance restrictions, but also to restrictions within specialty pharmacy, such as limited-distribution products. Often, access to these products is complicated by the very particular requirements of specialty shipping and handling, patient education, and the need for financial assistance. Navigating the payer landscape has become an art form for specialty pharmacy, and if a patient is covered by a government-sponsored program, the process becomes even more complex. Often, the application for coverage requires multiple signatures, including those of the patient and provider, as well as multiple financial documents to prove eligibility. This can often lead to long delays in therapy, and all too often, no therapy.
Pharmacist Specialization in Oncology Care
To properly manage complex oncology therapies, many pharmacists turned to specialization, which led to the development of certification. The Board of Pharmacy Specialties created a specific certification for oncology: board-certified oncology pharmacist (BCOP). Certification allows the qualified specialty pharmacist to practice at an advanced level of phar-macy practice in a complicated disease state and work in multiple practice settings. Many BCOPs can be found working in a team-based practice alongside a medical oncologist. In this setting, BCOPs work side-by-side with oncology teams, review patient histories, and help develop cancer treatment plans. With expertise in understanding the complex therapies, the BCOP can effectively monitor for, prevent, and manage drug-related adverse events.
The BCOP certification process and exam ensure that, once certified, a BCOP has a thorough knowledge of the pathophysiology and molecular biology of cancer; therapeutics; patient management and education; clinical trials and research; practice management; and public health. A BCOP is recognized by the pharmacy profession, peers, oncology institutions, payers, and other providers as someone who is well qualified as an oncology therapy expert on the health care team.
To qualify to become a BCOP, typically a candidate must do the following:
Recertification must occur every 7 years, and it can be accomplished through reexamination or completion of 100 hours of continuing education that is specifically designated as BCOP-appropriate.
Oncology-Specific Pharmacy Practice
The BCOP pharmacist often becomes the go-to expert in obtaining oncology therapy drug coverage on behalf of the patient with cancer. BCOPs are challenged with staying up-to-date not only on the latest treatment options and clinical reasoning, but to become experts in understanding how to provide staff education and in writing appeals to payers in order to help their patients gain access to high-cost therapies. BCOPs often are called upon to serve a dual role: to manage drug spend and revenue, and also to be directly involved with clinical and specialty pharmacy support. A common term in the oncology sphere is “financial toxicity,” in which the stress of paying for life-saving anticancer therapy often results in great hardship or bankruptcy on the part of the patient and their family. Often, high out-of-pocket costs result in treatment delays, abandonment, and higher overall costs of care.
BCOPs have become essential members of care teams. Patients have come to appreciate the BCOP as someone who is always available to answer their questions and who knows the ins and outs of complex treatment. BCOPs also help with providing new patient starter kits for oncology treatments, containing manufacturer information; calendars; pamphlets about adverse event management; pictorials of how the drug is dosed; diet advice; and drug monograph information. When patients become overwhelmed, as they often are, because of the amount of information to absorb and the number of new situa-tions and providers with whom they must interact, the BCOP becomes their drug navigator.
If you are a pharmacist interested in focusing your practice in oncology, you might want to explore becoming a BCOP.
Dan Steiber, RPh operates Genesis Pharma Consultants, a consulting practice responsible for commercial operations and trade-supply chain strategy development. Steiber has served in several senior positions in pharmacy, distribution, and industry over the course of his 40-year career. Steiber is a licensed pharmacist in Texas, Washington, California, and Pennsylvania. He is affiliated with several professional associationsand publications and a frequent speaker on behalf of many professional organizations. 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.