Effective specialty pharmacies learn to meet the changing needs of patients and stakeholders.
In 1995, spending for oncology medications made up just 3% of total drug expenditures in the United States. In 2020, that number climbed to 15%. Oncology medication is now one of the single largest drivers of specialty spending—increasing on a net basis by an astonishing 316% since 2011. In the next 5 years alone, 100 new oncology medications are expected to reach the global market, culminating in over $300 billion in oncology drug spending by 2026.1
Oncology treatment is rapidly evolving. So, too, are the needs of patients, prescribers, pharmaceutical manufacturers, and payors. As the health care industry in the United States pivots toward a value-based system, specialty pharmacies play an increasingly important role in advancing positive health outcomes, controlling costs, and providing real-world insights into the impact of specialty medications used to treat cancer. This article examines the evolution of specialty pharmacy to meet the needs of patients and other health care stakeholders in the oncology space.
A Brief History of the Rise of Specialty Pharmacy
Beginning in the late 1970s and early 1980s, treatment advancements and new therapies made home management for patients with rare or chronic health conditions possible. Despite these advancements, retail pharmacies were largely unequipped to serve patients with conditions such as cancer, HIV/AIDS, hemophilia, multiple sclerosis, or other rare diseases. Medications to treat these conditions were costly and clinically complex; they required specialized handling and/or administration routes. The therapies also posed an additional risk for traditional pharmacies—it was often difficult to obtain required timely third-party reimbursement, particularly when compared with the process for reimbursement for common therapies dispensed in a retail setting.2
Specialty pharmacies emerged as a solution to these problems, facilitating medication access, easing the coordination of billing and reimbursement support, and providing the high-touch patient services required for effective home management of rare and chronic health conditions.
The Evolution of Oncology Treatment
As specialty pharmacies began to form during the 1980s and 1990s, oncology treatment was experiencing an evolution that would establish the need for today’s oncology-focused specialty pharmacy. Treatment during this time still primarily consisted of surgery, radiation, intravenous chemotherapy, or some combination of the 3. These methods often destroyed healthy cells in addition to cancerous ones and relied on treatment primarily in the inpatient setting. Further, they were associated with a litany of challenging adverse effects. Scientific advancements during this time led to promising research and exploration of new treatments, including targeted therapies and immunotherapies.3
In addition, the late 1990s and early 2000s saw the advent of oral chemotherapy, which significantly improved treatment convenience and ease of administration.4 At the same time, cancer survivorship was increasing, and the medical community began to focus on treating and managing cancer as a chronic health condition rather than an acute disease.5 These treatment advancements and the emerging view of cancer as a chronic condition contributed to the need for increasingly specialized, oncology-focused pharmacy services and support.
Today, oncologists are deploying highly targeted treatment plans tailored to the genomic composition of tumors. The growing field of precision medicine combines sophisticated cancer diagnostics with targeted specialty drugs to slow or halt cancer progression.
“The growing field of precision medicine, limited distribution drugs, combination therapies, and the push for value-based programs have created the need for additional pharmacy specialization,” said Marc Stranz, PharmD, chief clinical officer of BioMatrix Specialty Pharmacy. “Understanding distribution requirements, drug response, adverse events, compliance support, cost-containment strategies, data management, and patient assistance programs are just a few of the drivers influencing the ongoing evolution of oncology pharmacy.”
The Center of Excellence
During the 1990s, fewer than 30 specialty drugs were on the market.6 Today, there are hundreds of specialty medications and a robust pipeline of new treatments for patients with chronic and rare diseases.
Although still focused primarily on providing medication access and clinical and other support services, the modern specialty pharmacy has evolved to better meet the needs of unique patient populations and their health care stakeholders, including prescribers, pharmaceutical manufacturers, and payors.
“With an increasing number of specialty medications and the advent of precision medicine [to treat] cancer, the importance of clinical support and interventions provided by oncology-experienced specialty pharmacists continues to grow,” said Royce Burruss, MBA, RPh, FASCP, corporate director of clinical services at BioMatrix Specialty Pharmacy. “We continue to focus on updating and enhancing our support services and drug treatment guidelines while leveraging our deep experience in oncology to effectively support the evolving needs of those we serve.”
Any state-licensed pharmacy can designate itself as a specialty pharmacy.7 As specialty pharmacies proliferated in the 2000s, accreditation became a critical means to validate competency, measure quality, and differentiate services. In 2015, 378 pharmacy locations in the United States held specialty pharmacy accreditation from leading health accreditation agencies, the Utilization Review Accreditation Commission (URAC) and/or the Accreditation Commission for Health Care (ACHC). Today, that number is over 1200.8
Accreditation has quickly emerged as the gold standard of how specialty pharmacies demonstrate value to health care stakeholders. In addition to standard specialty pharmacy accreditation, organizations such as the URAC and the ACHC have established standards and best practices that allow pharmacies to demonstrate a deeper level of specialization in categories such as oncology and rare disease.
In addition to accreditation and as an answer to the evolving complexity of our health care system, forward-facing specialty pharmacies are centralizing their clinical and administrative expertise on creating centers of excellence (COEs) that focus on key therapeutic categories, such as oncology. Health care in the United States is fragmented, complex, and currently pivoting from a system focused on volume to a system focused on value. The COE model fundamentally aligns with value-based health care principles and allows specialty pharmacies to provide a consistent experience and meaningful support throughout the patient journey.9
“As the function of specialty pharmacy has evolved, our oncology COE applies advanced clinical expertise with a focus on timely access to therapy, enhanced visibility, and exceptional communication,” said Joshua Stoneking, PharmD, vice president of oncology at BioMatrix Specialty Pharmacy. “The COE streamlines all pharmacy operational efforts. Patient outcomes are improved when therapy is accessed quickly, enhanced communication provides prescribers [with] confidence [that] their patients are not ‘falling through the cracks,’ and pharmaceutical manufacturers, providers, and payors benefit from visibility into real-world data demonstrating the impact of prescribed therapies.”
Additionally, through the combination of institutional and individual employee expertise, the COE model empowers staff to deploy customized solutions to modern health care challenges.
“Many of our oncology COE employees have over a decade of experience or specialized board certifications,” Stoneking explained. “These employees are extremely passionate about what they do—the COE model enables and empowers them to provide precision, custom solutions to navigate real-world, day-to-day challenges occurring within our health system.”
The specialization required to meet accreditation standards and establish an effective COE can also have a positive impact on employees and organizational culture. The COE model establishes clear performance indicators, unites employees under shared goals, and fosters a collective understanding of what constitutes value.
“A COE creates a pool of resources focused on very specific outcomes. That specificity engages staff, simplifies training, and promotes continuous process improvement,” Stranz explained.
An Ongoing Evolution
By 2023, it is predicted that 65% of new drug launches will be specialty therapies treating cancer and other rare diseases.9 The push for value-based care, the ongoing pandemic, rising rates of cancer incidence, and a shortage of medical oncologists are among just a few of the factors that will continue to influence the need for and evolution of specialty pharmacy.
Currently, pharmacies primarily are meeting the changing needs and expectations of patients and health care stakeholders with accreditation and COE modeling. Effective specialty pharmacies will embrace this evolution, focusing their expertise on improving clinical and support services while providing solutions to existing and emerging health care challenges.
Justin Lindhorst, MBA, is marketing director/regional care coordinator at BioMatrix Specialty Pharmacy in Plantation, Florida.