Biogen has been criticised for the price of its next-generation multiple sclerosis drug Vulmerity, after pricing it at $88,000 for a year’s worth of treatment.
Biogen and partner Alkermes scored FDA approval for Vumerity (diroximel fumarate) on the 30 October for the treatment of relapsing forms of MS.
It then announced the price of the new drug – a wholesale acquisition cost (WAC) of $88,000 per year of treatment.
In a statement following the approval, Biogen said “we’ve made the decision to launch Vumerity in the US with the lowest annual WAC price for oral MS disease-modifying therapies at an annualised price of $88,000.”
However, according to the National MS Society, this price is significantly higher than what patients can afford. In comparison, Biogen’s older oral MS drug Tecfidera (dimethyl fumarate) entered the market with a price of $54,750 per year, but has since jumped to $94,991 – an increase of 73.5%.
“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,” said Bari Talente, executive vice president, advocacy, National MS Society.
Tecfidera is an important product for Biogen, with reported sales of almost $4.3bn last year, making it the company’s top-selling drug.
However, it is also under threat from a patent challenge levelled by generic drugmaker Mylan, which if it is successful, could shed years off Biogen’s marketing exclusivity for the drug in the US from 2028 to as early as 2020.
Vumerity is Biogen’s answer to the patent pressures on Tecfidera, but there have been concerns that
patients who are stable on Tecfidera will be unwilling to to transfer to the newer drug. Consensus estimates compiled by EvaluatePharma reflect this with forecast sales of Vumerity at a modest $111m in 2024.
“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,” added Talente.
As well as facing pricing pressures and legal battles, Biogen will also be challenged by newly launched or anticipated rival therapies including Novartis’ Mayzent (siponimod) and Roche’s Ocrevus (ocelizumab) which are already threatening to take market share from its MS products.