Contributed by: Sheila M. Arquette, RPh, President & CEO, National Association of Specialty Pharmacy
Specialty pharmacy continues to be dynamic, demanding, and disruptive. As the market continues to demand specialization in drug distribution and clinical management of complex patients and therapies, specialty pharmacy continues to evolve. Keeping pace with scientific discovery and medical innovation is relentless and challenges all providers along the care continuum to find new ways to support specialty patients and control costs.
Specialty pharmacies connect patients diagnosed with life altering and often life-threatening complex health conditions with the medications prescribed for their conditions. The expert services that specialty pharmacies provide drive adherence, proper management of medication dosing and side effects, and ensure safe and appropriate medication use. Specialty pharmacy’s patient-centric model is designed to provide a comprehensive and coordinated model of care ensuring patients achieve superior clinical and economic outcomes while expediting their access to care. Specialty pharmacy is defined not by the site of care but the model of care and the type of patient management and care coordination services it provides.
2024 key trends, challenges, and opportunities to watch include:
Pipeline
Specialty, niche, and orphan disease drugs comprise the largest proportion of new medicines launched in the past decade. Specialty medicines account for around 75% of the approximately 7,000 new drugs under development.
This tremendous growth presents us with incredible benefits but also some compelling challenges. Specialty pharmacy delivers significant value as an integral member of the patient’s healthcare delivery team. Medication access and affordability issues compounded by our aging population and an increased number of specialty drugs being approved for conditions traditionally treated with small molecule therapies, signal the specialty market will remain strong; but the stakes are high, not only for those inside the specialty arena, but for all of us.
Drug Shortages
Over the past five-and-a-half years, an average of more than 25 new molecule shortages have occurred each year, with 160 in total added through June of 2023 and only 51 resolved. Oncology has experienced a growing number of shortages since 2020, with four new molecule shortages between March and June 2023 alone.
Drug shortage associated treatment delays, therapy interruptions, clinical complications, suboptimal treatment and adverse drug reactions coupled with increased medication costs and patient financial toxicity can all negatively impact patient outcomes.
As trusted medication experts, specialty pharmacists serve as critical interdisciplinary team members working collaboratively to identify and approve alternative therapeutic regimens to address drug shortages, mitigate their impact and promote optimal, clinical, and cost-effective outcomes.
Cell and Gene Therapies
Today, there are 27 FDA-approved cell and gene therapies in the United States, with more than 2,000 therapies in development worldwide. Just as the biologic landscape has evolved over the last decade, so too will gene therapy. Recent research suggests that the number of gene therapies on the market is likely to increase to over 60 by 2030, and today’s $5.2 billion gene therapy market is estimated to grow tenfold by 2031.
Specialty pharmacy has the unique opportunity to demonstrate and define how their white glove, patient centric model of care can contribute to the optimal management of these patients.
Inflation Reduction Act
The Inflation Reduction Act of 2022 includes several provisions to lower prescription drug costs for Medicare beneficiaries and reduce the federal government’s drug spending. The Congressional Budget Office estimates that the drug pricing provisions in the law will reduce the federal deficit by
$237 billion over 10 years (2022-2031). Will restructuring the Medicare Part D standard benefit and the $2,000 beneficiary out-of-pocket limit reduce affordability-related non-adherence and increase overall utilization of specialty drug therapies? Will Part D Plans increase the use of prior authorization, step therapy, and other utilization management tools to try to control drug spending? Only time will tell.
DSCSA
The Drug Supply Chain Security Act (DSCSA) requires manufacturers, distributors, and pharmacies required to track, trace, and verify down to the unit level every prescription product they handle and maintain records of such for a minimum of six years. Could the serialized data being created and shared as a part of DSCSA legislation be an opportunity for specialty pharmacy to capitalize and commercialize this data to provide new value to upstream stakeholders? With the enforcement of certain Drug Supply Chain Security Act (DSCSA) requirements delayed until November 27, 2024, now is the perfect time for all specialty pharmacy stakeholders to engage in the discussion.
Biosimilars
Biosimilar adoption is key to delivering on the promise of reduced health care costs. An estimated $21 billion in savings to healthcare systems over the past six years has been attributed to biosimilar competition with savings over the next five years projected to exceed $100 billion. In the U.S., there are 40 FDA-approved biosimilars across 15 reference biologic products.
Specialty pharmacists continue to lead educational efforts to help increase confidence and improve uptake of biosimilars across the health care continuum, with the realization of significant savings that can be directed to newer and innovative therapies.
Rare and Orphan Drugs
These products are no longer niche. The orphan drug market is growing over twice as fast as the traditional drug market. By 2026, orphan drug therapies will be 20% of all prescription drug sales, and almost a third of the global drug pipeline’s value.
While these treatments represent new and potentially life-saving options for patients, they can be extremely expensive and require the high touch, white glove level of service, intensive patient management, and care coordination that only specialty pharmacy can provide.
Artificial Intelligence
Emerging and evolving technologies are driving exponential change in the delivery of specialty pharmacy care.
By helping to streamline pharmacy processes and automate labor intensive tasks, artificial intelligence has the potential to revolutionize medication management and clinical decision making, promote the delivery of personalized therapeutic regimens, enhance clinical and cost-effective outcomes, and increase operational efficiencies and patient satisfaction. Specialty pharmacies continue to invest heavily in technology to better engage patients, decrease total cost of care and enhance patient satisfaction while complying with all laws designed to protect patient privacy and safety.
Federal and State Legislation and Regulations
The new year brings both promise and challenge for specialty pharmacy as the community braces for the official implementation of the Medicare Part D rule that revised the definition of negotiated price and pharmacy price concessions and moved all price concessions to the point of sale to reduce beneficiary cost sharing. NASP spent 2023 diligently working to advance legislative reforms to protect pharmacy from unreasonable reimbursement rates and to establish protections for pharmacy reimbursement, allow for pharmacy appeals of terms against these protections, and standardize and oversee pharmacy performance measures, among other reforms. In 2024, specialty pharmacy needs to be persistent and vocal, focusing efforts to continue improving lawmaker awareness of the important role specialty pharmacy plays in the management of some of our most vulnerable patients and helping more Members of Congress feel connected to specialty pharmacies that serve constituents in their districts and states to ensure its priorities are addressed before Congressional policymaking is taken over by 2024 election year politics.
Scientific innovation and medical advancements allow us to live longer, healthier lives but the ethical and financial challenges caused by access and affordability issues necessitate crucial conversations about how healthcare is delivered. It is critical that all specialty pharmacy industry stakeholders continue to work collaboratively to embrace challenges that become opportunities, and opportunities that become solutions, all designed to advance and enhance patient care.
The future of specialty pharmacy is a future we all share. From our perspective, there is so much to look forward to.
ABOUT NASP
The National Association of Specialty Pharmacy (NASP) is a 501(c)(6) non-profit trade organization and is the only national association representing all stakeholders in the specialty pharmacy industry. The mission of NASP is to elevate the practice of specialty pharmacy by developing and promoting continuing professional education and certification of specialty pharmacists while advocating for public policies that ensure patients have appropriate access to specialty medications in tandem with critical services. The association provides an online education center offering accredited continuing pharmacy education programs, hosts an Annual Meeting & Expo that offers educational sessions and continuing education credits, and is the only organization that offers a certification program for specialty pharmacists. NASP members include the nation’s leading specialty pharmacies, pharmaceutical and biotechnology manufacturers, group purchasing organizations, patient advocacy groups, integrated delivery systems and health plans, technology and data management vendors, wholesalers/distributors, logistics providers and practicing pharmacists, pharmacy technicians, nurses, and healthcare professionals.
