Specialty Drugs Account for Nearly Half of Pharmacy Drug Spend in 2021


Keynote speaker at the AMCP Nexus conference discusses recent FDA approvals and those scheduled over the next year.

Specialty drugs accounted for approximately 49% of the pharmacy drug spending in 2021, compared with 51% for traditional drugs, of a total of $1,121 per-member, per-year, explained Aimee Tharaldson, PharmD, senior clinical pharmacist of emerging therapeutics for Evernorth, during a keynote presentation at the AMCP Nexus conference in National Harbor, Maryland. Specifically, Tharaldson noted that the leading specialty therapy classes were inflammatory conditions, cancer, HIV, and multiple sclerosis.

Tharaldson started by highlighting key market trends for specialty drugs, which are defined as those that have limited distribution and require frequent dosing or intensive clinical monitoring, intensive compliance assistance or patient training, and specialized administrative handling. The areas highlighted during the presentation were biosimilars and cancer and orphan drug development in particular.

The biosimilars sector has the potential to be a $71 billion market, with 103 patent expirations expected through 2025, Tharaldson noted. These include patents for immunosuppressive drugs adalimumab (Humira; AbbVie) in 2023 and eculizumab (Soliris; Alexion Pharmaceuticals) in 2025.

Additionally, Tharaldson explained that there are 39 FDA-approved biosimilars, 23 of which have launched. These include biosimilars for insulin glargine (Lantus; sanofi‐aventis US), an insulin drug; infliximab (Remicade, Janssen Biotech), an immunosuppressive; and rituximab (Rituxan; Genentech USA), which is used to treat autoimmune diseases and cancer.

In 2023, adalimumab biosimilars are expected to launch, while biosimilars for etanercept (Enbrel; Amgen), an autoimmune disease treatment, is likely delayed until 2029, Tharaldson explained.

On the cancer front, the FDA approved 15 drugs in 2021, down from a record high of 19 in 2020, Tharaldson noted. In 2022, the agency gave the green light to 6 new cancer drugs, with 9 more expected before the end of the year.

Cancer medications comprise 31% of the specialty drugs pipeline, while orphan drugs account for 49%, and other drugs, 20%. Overall, orphan drugs target more than 7000 rare diseases that affect as many as 30 million Americans, but no more than 200,000 individuals each.

Specialty drug approvals so far in 2022 include abrocitinib (Cibinqo; Pfizer) for atopic dermatitis; alpelisib (Vijoice; Novartis Pharmaceuticals Corporation) for PIK3CA-related overgrowth spectrum; betibeglogene autotemcel (Zynteglo; bluebird bio), an autologous hematopoietic stem cell-based gene therapy indicated for β-thalassemia; faricimab-svoa (Vabysmo; Genentech USA) for wet age-related macular degeneration and diabetic macular edema; mavacamten (Camzyos; MyoKardia) for obstructive hypertrophic cardiomyopathy; pacritinib (Vonjo; CTI Biopharma Corp.) for myelofibrosis; nivolumab/relatlimab-rmbw (Opdualag; Bristol-Myers Squibb Company) for melanoma; and sutimlimab-jome (Enjaymo; Genzyme Corporation) for cold agglutinin disease.

The specialty drug pipeline encompasses products in 8 therapy classes: Alzheimer disease, gene therapies, hemophilia, HIV, inflammatory conditions, multiple sclerosis, nonalcoholic steatohepatitis, and select specialty drugs. Drugs in the pipeline include axicabtagene ciloleucel (Yescarta; Kite Pharma) for diffuse large B cell lymphoma (DLBCL); baricitinib (Olumiant; Eli Lilly and Company) for atopic dermatitis; betibeglogene autotemcel (Zynteglo; bluebird bio) for β-thalassemia; bimekizumab (Bimzelx; UCB) for psoriasis; brexucabtagene autoleucel (Tecartus; Kite Pharma) for acute cell lymphoma and mantle cell lymphoma; ciltacabtagene autoleucel (Carvykti; Janssen Biotech) for multiple myeloma; idecabtagene vicleucil (Abecma; Bristol-Myers Squibb Company) for multiple myeloma; lisocabtagene maraleucel (Breyanzi; Bristol-Myers Squibb Company) for DLBCL; onasemnogene abeparvovec-xioi (Zolgensma; Novartis Gene Therapies) for spinal muscular dystrophy; talimogene laherparepvec (Imlygic; Amgen) for melanoma; tisagenlecleucel (Kymriah; Novartis Pharmaceuticals Corporation) for B-cell acute lymphoblastic leukemia; upadacitinib (Rinvoq; AbbVie) for axial spondyloarthritis and Crohn disease; and voretigene neparvovec-ryzl (Luxturna; Spark Therapeutics) for retinal dystrophy.


Tharaldson A. Specialty pharmaceuticals in development. Presented at: AMCP Nexus; Gaylord National Convention Center in National Harbor, Maryland: October 13, 2022.

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