MMIT Reality Check on Multiple Sclerosis
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 46% 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 64% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 73% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 28% require multiple steps. Around 70% of payer-controlled pharmacy benefit covered lives require prior authorization, with 15% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
FDA Approves Ponvory
In March 2021, the FDA approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The company says the drug’s price will be similar to those of other comparable treatments.
Most Payers Plan to Manage New Drug to Label
Although there are more than 20 FDA-approved disease-modifying therapies for multiple sclerosis (MS), companies continue to bring new products to market. Zitter Insights found that the majority of payers expect to manage the newest entrant, the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod), to label. Almost two-thirds of the neurologists polled by Zitter Insights said they expect to prescribe Ponvory over certain MS therapies.
Prime: MS Spend Was Steady
More than 20 multiple sclerosis disease-modifying drugs currently are available in the U.S. But even with all the competition, prices for most of the agents are around $80,000 per year. Following updated professional treatment guidelines and the FDA approval of new therapies, including generics, Prime Therapeutics LLC conducted a study to determine spend and use of the agents over a two-year period. Spending for the class remained fairly steady, as generic use helped offset some costs.
Market Events Drive Changes
In March 2021, the FDA approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In February 2021, the agency approved a new intramuscular injection route of administration for Biogen’s Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis. The subcutaneous injection formulation, which the FDA first approved Aug. 15, 2014, remains available.
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.
Key Players in Market: