In her review of the specialty drug pipeline, Evernorth's Aimee Tharaldson said upcoming approvals for Crohn’s and colitis drugs could further shift the drug spend from the medical benefit to the pharmacy one.
Last year, specialty drug trend accounted for more than half of per member per year spending, according to Evernorth’s drug trend data. Treatments for inflammatory conditions accounted for about one-third of the spending in specialty drugs, reaching $225 in per-member, per-year spending last year, Aimee Tharaldson, Pharm.D., clinical program consultant, emerging therapeutics at Evernorth, said in her keynote address this morning at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 meeting in Orlando.
The inflammatory conditions include chronic, autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and lupus. Treatment options include tumor necrosis factor inhibitors, biologics and oral therapies.
Tharaldson's sweeping review of the specialty drug pipeline covered dozens of drugs in late-stage development, including several that are likely to be approved by the FDA in the remaining months of 2023.
Two of the drugs on the brink of getting an FDA OK could significantly shift more of what payers spend on drugs from management on medical benefit to management on the pharmacy benefit.
Tharaldson said Celltrion’s subcutaneous formulation of infliximab could be approved as early as next week. The subcutaneous formulation could shift a sizable chunk of market share from the medical to the pharmacy benefit, Tharaldson explained, because the subcutaneous formulation will be self-administered at home instead of being of being delivered as an infusion in a doctor's office or clinic. Submission is based on results from data from two phase 3 pivotal trials that assessed the subcutaneous form of infliximab as maintenance therapy in patients with moderate-to-severe active ulcerative colitis and Crohn’s disease.
Tharaldson said another product that might shift spend from the medical to the pharmacy benefit is Takeda’s Entyvio (vedolizumab) for maintenance therapy in Crohn’s disease and ulcerative colitis. It is currently available in the United States as an intravenous formulation, although a subcutaneous form is available in other countries. The application for the subcutaneous formulation in ulcerative colitis was submitted in April 2023, and last week Takeda submitted the application for Crohn’s.
Celltrion has experience with infliximab. The company developed and received FDA approval in 2016 for Inflectra, an intravenous biosimilar to Remicade, to treat patients with inflammatory bowel disease (IBD), an umbrella term for Crohn's disease and ulcerative colitis. Pfizer holds U.S. commercialization rights to Inflectra, which is approved for several indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriatic and plaque arthritis.
Tharaldson discussed other new IBD drugs in her whirlwind review. Last week, the FDA approved Pfizer’s Velsipity (etrasimod) to treat adults with moderately to severely active ulcerative colitis. Velsipity is once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator. It targets a specific part of immune that plays a role in the inflammation process involved in ulcerative colitis. It will be available in late November 2023 and will have a wholesale acquisition cost of $6,164 for a 30-day bottle (approximately $75,000 a year).
Velsipity is the second S1P receptor modulator approved by the FDA. The first was Bristol Myers Squibb’s Zeposia, which was approved in May 2021 to treat adults with moderately to severely active ulcerative colitis. The agency also approved Zeposia to treat patients with relapsing forms of multiple sclerosis in March 2020. A 30-day supply of Zeposia has list price of $8,182.
Eli Lilly’s mirikizumab, if approved, could be the first interleukin 23 (IL-23) inhibitor to treat patients with ulcerative colitis. Inflammation from over-activation of the IL-23 pathway is thought to play a critical role in ulcerative colitis and Crohn’s disease. This would also be administered monthly as subcutaneous injection for maintenance dosing, and phase 3 trials to demonstrate efficacy and biologic naive and biologic failure patients, Tharaldson said.
Earlier this year, the FDA had issued a complete response letter for Lilly’s application because of manufacturing concerns; there were no concerns about the safety or efficacy. Company officials at the time said they are working with regulatory officials to address concerns and launch as soon as possible.
Lilly is also studying mirikizumab for patients with Crohn’s. Last week, the company released data from a phase 3 trial that found that more than half of patients with Crohn’s disease were able to achieve clinical remission with mirikizumab at week 52. The trial also demonstrated non-inferiority versus ustekinumab. Lilly plans to submit an application for Crohn’s next year.