A review of market access for multiple sclerosis treatments shows that under the pharmacy benefit, about 62% of the lives under commercial formularies are covered with utilization management restrictions. Around 47% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 46% of the lives under commercial policies are covered with utilization management restrictions. Almost 60% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 74% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 33% require multiple steps. Around 70% of payer-controlled pharmacy benefit covered lives require prior authorization, with 16% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
In December 2022, the FDA approved TG Therapeutics, Inc.’s Briumvi (ublituximab-xiiy) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The agent is the first and only anti-CD20 monoclonal antibody approved to treat RMS that can be administered in a one-hour infusion after the initial dose. Dosing is 150 mg administered via four-hour infusion on day one, 450 mg administered in one hour on day 15 and then 450 mg via a one-hour infusion every 24 weeks. The company says it expects the product to launch in first-quarter 2023. The drug’s annual price is $59,000.
Three FDA-approved multiple sclerosis treatments and one MS drug that the FDA is currently reviewing are not cost effective, according to an analysis from the Institute for Clinical and Economic Review (ICER). Jon Campbell, Ph.D., ICER’s senior vice president for health economics and one of the report’s authors, also tells AIS Health that there was “insufficient evidence” to differentiate the clinical effectiveness of any of those four drugs, which are known as monoclonal antibodies.
In October 2022, Glenmark Pharmaceuticals Inc., USA launched fingolimod capsules 0.5 mg, a generic of Novartis Pharmaceuticals Corp.’s Gilenya 0.5 mg. Gilenya is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in people at least 10 years old.
Market Events Drive Changes
In December 2022, the FDA approved TG Therapeutics, Inc.’s Briumvi (ublituximab-xiiy) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In December 2021, the agency approved Handa Neuroscience, LLC’s Tascenso ODT (fingolimod) 0.25 mg orally disintegrating tablet for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, in pediatric patients 10 years of age and older and weighing less than or equal to 40 kg. Cycle Pharmaceuticals Ltd commercialized Tascenso ODT in the beginning of the first quarter of 2023. In March 2021, the FDA approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod) to treat adults with RMS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Competitive Market Landscape
Contracting is prevalent among the interferons, where formulary preference drives choice. The orals are all different molecules. Contracting is expected to occur for these drugs but not to compete against the other brands. Competitive contracting on all the monoclonal antibodies (MABs) is also expected.
Pharmacy, Medical Benefit Implications
Interferons and Teva Pharmaceutical Industries Ltd.’s Copaxone (glatiramer acetate), as well as its generics, are considered first line in the treatment pathway. There are no true generics for the interferons. But with Copaxone generics, including Novartis AG division Sandoz Inc.’s Glatopa, available, some plans require those to be used. Interferons, Copaxones and orals are generally covered under the pharmacy benefit, although some coverage is seen for interferons under the medical benefit. MABs can be covered under both benefits, while infusible MABs appear most often on the medical benefit policies. All drugs for this indication are considered specialty drugs.