The National Multiple Sclerosis Society has criticized Biogen for the $88,000 yearly list price it placed on Vumerity (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases with Tecfidera (dimethyl fumarate), Biogen’s similar oral DMT for relapsing-remitting MS (RRMS).
While Biogen and Vumerity were specified, the rising costs of effective therapies for MS and other chronic diseases are drawing ire across the board. A recent study into Medicare Part D payments by MS patients found a 7.2-fold jump in out-of-pocket costs, from $372 to $2,673, in the 10 years covering 2006–16.
Vumerity has shown comparable efficacy to Tecfidera in clinical trials, but with notably fewer gastrointestinal side effects. It was developed by Alkermes in collaboration with Biogen, but Biogen owns worldwide rights to market this newly approved treatment.
Reports suggest that Biogen expects many of those now using Tecfidera, which is set to lose all patent protections by 2028, will choose to move to Vumerity.
“Vumerity is an efficacious and tolerable treatment option for people with relapsing MS, but being priced only $500 lower than the least expensive oral disease modifying treatment, does not show the commitment to affordable access that we had hoped,” Bari Talente, executive vice president for advocacy with the National MS Society (NMSS), said in a press release.
In announcing Vumerity’s price, Biogen and Alkermes specifically noted they “made the decision to launch Vumerity … with the lowest annual WAC [wholesale acquisition cost] price for oral MS disease-modifying therapies” available on the U.S. market.
Older oral DMTs for MS patients are generally lower-priced, and include: Gilenya (fingolimod), approved by the FDA in 2010; Aubagio (teriflunomide), approved in 2012; and Tecfidera, approved in 2013. When Tecfidera was approved, Biogen announced it would cost less than Gilenya, which had a yearly list price of $60,000 per patient in 2013.
But since its launch, Tecfidera’s wholesale price has risen by $40,241, an increase of 73.5%. It entered the market at $54,750 a year, and now carries an annual per-person list price of $94,991, the NMSS reported.
“We know that high wholesale acquisition cost (WAC) prices for MS disease modifying treatments put a heavy burden on people with MS. Too many are forced to take on high out-of-pocket costs, navigate through complex systems, and face varied and unpredictable decisions by public and private payers and pharmacy benefit managers,” Talente said.
“We urge Biogen and Alkermes to publicly commit to keeping price increases lower than the rate of inflation,” she said.
Biogen, to an email request for a response, said it “will work to maximize patient access to VUMERITY through their insurance benefits, including potential value-based agreements with payers based on real-world patient outcomes.”
A recent report based on the study into MS treatment costs, citing the NMSS, noted that when targeted treatments began first winning approvals in the 1990s, their annual list prices were roughly between $8,000 and $11,000. Today, list prices for these DMTs top $80,000 a year, rising even as competition in MS therapies has grown.
“Medications can change lives only if they are accessible — a sevenfold increase in out-of-pocket costs is not accessible,” Talente was quoted as saying in the report.