What the future of specialty drugs holds for healthcare.
Generic and biosimilar competition is emerging in the specialty category, representing opportunities for savings for payers, according to Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics at Express Scripts.
In 2018, specialty drugs accounted for nearly half of drug spending for employer-funded plans, according to Tharaldson’s March 26, 2019 presentation “Specialty Pharmaceuticals in Development” at the Academy of Managed Care and Specialty Pharmacy Annual Meeting 2019 in San Diego.
“Understanding the pipeline of drugs in this space is critical for payers so they can prepare and create a sustainable pharmacy benefit for members,” she said. “Specialty drugs are typically high-cost medications with special handling and storage requirements (i.e., biologic therapies) that treat chronic and complex conditions such as multiple sclerosis, cancer, rheumatoid arthritis (RA), and rare diseases.”
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In the past four years, a number of specialty drug generic options have been approved, representing $14 billion in overall U.S. spending opportunities, with the potential for $24 billion in expected specialty generics in the next five years, according to Tharaldson.
Through 2023, 71 biologic drugs will have lost patent protection, representing a $55 billion biosimilar market opportunity.
“The biosimilar market keeps growing with as many as nine more agents that could receive FDA approval by the end of this year,” she said
In addition, the orphan drug pipeline is experiencing significant growth, and account for 53% of all current specialty drugs in the approval pipeline.
In the first quarter of 2019, five specialty drugs have already been approved:
Tharaldson also called attention to the developing drug pipeline in several therapeutic categories that are of high interest to payers.
Inflammatory conditions are the leading therapy class based on per-member, per-year spending ($153 billion). The pipeline includes:
Two MS drugs approved in March 2019. The first one, Mayzent (siponimod), a sphingosine 1âphosphate receptor modulator for secondary progressing MS, was approved March 26, 2019. The other, Mavenclad (cladribine) was approved March 29, 2019. It is a nucleoside analog that depletes B and T lymphocytes for relapsing MS (RMS).
In addition, there are also several MS drugs in development expecting approval in the next two years:
Oncology therapies in developed that are projected to be approved in 2019 include:
Tharaldson touched on other important pipeline categories to watch, including: