- The FDA has approved Vumerity, a new drug to treat relapsing forms of multiple sclerosis.
- Experts say Vumerity is effective and has fewer side effects than current medications.
- Biogen has set the annual price of Vumerity at $88,000, drawing criticism from the National Multiple Sclerosis Society.
Biogen has released the annual price it will charge for a new oral treatment for relapsing forms of multiple sclerosis.
The company said the price for Vumerity will be $88,000 per year.
The company sent a statement to Healthline saying it is taking steps to make sure the drug is affordable for customers.
“Biogen 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,” the statement read.
The announced price tag brought quick criticism from the National Multiple Sclerosis Society.
“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, advocacy, National MS Society, said in a statement.
She noted the price of Tecfidera, another Biogen treatment for MS, has risen $40,000 to almost $95,000 since it debuted in 2013.
“We urge Biogen to publicly commit to keeping price increases lower than the rate of inflation,” Talente said.
Vumerity is expected to be similar in results to Tecfidera but with fewer side effects.
“Both drugs use a unique mechanism of action that is not offered by other treatments,” Kathy Costello, a nurse practitioner at the Johns Hopkins Multiple Sclerosis Center in Maryland and the vice president of healthcare access for National Multiple Sclerosis Society, told Healthline.
Past research has shown that Tecfidera has success on multiple sclerosis with a 53 percent reduction of relapses, 38 percent reduction in the likelihood of disability progression, and 90 percent reduction on active contrast MRI lesions.
However, “Tecfidera has bad side effects, especially in the beginning,” noted Costello. “Vumerity is different and has less gastrointestinal problems.”
Costello explained that people with uncomfortable side effects may not adhere to a treatment.
Considered a follow-up drug to Tecfidera, doctors predict better adherence with Vumerity due to the fewer side effects.
The active ingredient in Vumerity is diroximel fumarate, which is rapidly converted to monomethyl fumarate in the body.
Tecfidera is a dimethyl fumarate and also converts to monomethyl fumarate.
“[The drugs] become identical in what they do in the body. But, how they get there is different,” explained Costello.
“We expect Vumerity to provide the same benefits as Tecfidera, but we are waiting [on] results,” Dr. Barry Singer, neurologist at Missouri Baptist Medical Center in St. Louis, a trial site for the EVOLVE-MS study, told Healthline.
Singer is also the director and founder of The MS Center for Innovations in Care.
“The research I presented at ECTRIMS in September 2019 showed approximately 30 percent of those on Vumerity had gastrointestinal side effects but less than 1 percent discontinue due to this side effect,” Singer told Healthline. “The full results from the EVOLVE-MS trials are pending.”
Vumerity is approved for clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS.
It’s not approved for primary progressive or secondary progressive MS that’s not active.
But, “it may work for other forms of MS,” said Costello.
“We want the DMTs to be a positive experience,” Singer said. “Vumerity provides another option for MS.”
The drug’s warning label does include progressive multifocal leukoencephalopathy (PML) as a possible risk.
Flushing and stomach problems are the most common reactions, especially at the start of therapy.
Gastrointestinal issues are common but not to the extent with Tecfidera. Other warnings are allergies, liver damage, and low white blood cell count.
“There are very rare cases of PML with Tecfidera in MS patients with very low lymphocytes (white blood cell type) for numerous months in patients over age 50. Simple blood counts should be done to monitor,” said Singer.
“The goal with Vumerity is to achieve success of Tecfidera with better tolerability,” explained Singer.
Biogen offers customer-assisted programs to help reduce or eliminate costs.
Costello explained that both Tecfidera and Vumerity have a unique mechanism of action, unlike any other drug. This provides people with options and different ways to reduce inflammation with MS.
Treatment choices are up to doctors and their patients making a shared decision. Costello suggests talking about goals, risk tolerance, monitoring, and your ability to adhere to a specific treatment.
“The disease, plus the person’s goals and values, is the conversation that drives the medication choice,” said Costello.