CMS says private Medicare plans can’t automatically deny Biogen’s ALS drug

In a rare move, the U.S. agency behind Medicare is warning insurers who provide Medicare Advantage plans that they can’t automatically deny coverage of Qalsody, a Biogen drug approved to treat amyotrophic lateral sclerosis.

Medicare Advantage, or MA, plans are a privatized form of Medicare, the federal health insurance program for people aged 65 or older. These plans must cover the same drugs as traditional Medicare. And yet, the government agency that oversees the program says it’s observed some “inappropriately denying” coverage of Qalsody by classifying the drug as “experimental and investigational.”

In a letter dated Dec. 9, the Centers for Medicare and Medicaid services wrote it is “impermissible” for MA plans to use this reasoning as the basis for blanket coverage policies that exclude Qalsody. Insurers can still use their own criteria to determine whether the drug is reasonable and necessary for any individual patient. But policies that outright reject coverage and don’t consider the patient’s medical history would violate federal regulations, CMS wrote.

In April 2023, Qalsody was granted a type of clearance that allows drugs with limited supporting data to enter the market while their developers collect more evidence to confirm they are effective. CMS notes how, in terms of coverage, there should be no difference between drugs given this so-called accelerated approval versus a traditional approval.

Qalsody, which is administered by a healthcare professional, is specifically meant for patients with a rare genetic mutation. The Food and Drug Administration estimates less than 500 of the roughly 30,000 people in the U.S with ALS have these mutations. Qalsody’s approval was based on data from a failed late-stage study, wherein the drug didn’t significantly slow the progression of the disease but was able to lower levels of a protein tied to nerve cell damage.

CMS now expects all MA plans that classify Qalsody as experimental and investigational to immediately stop, and to “expeditiously” contact enrollees who were denied coverage because of that classification and inform them the coverage policies have changed.

“This is a victory for the entire ALS community,” said Calaneet Balas, CEO of The ALS Association, a patient advocacy group, in a statement.

“We hope this sends a message to the entire rare disease community and pharmaceutical industry that new treatments can be developed and made accessible to those who will benefit from them,” Balas added. The ALS Association, which helped fund Qalsody’s development, says it “played a key role” in the new CMS directive by “participating and advocating for the research, approval, and accessibility” of the drug.

ALS is a uncommon, fatal disease where the progressive erosion of nerve cells robs patients of the ability to walk, talk, eat and breathe. The disease advances fast, with most patients living just two to five years following a diagnosis. It’s also proven exceedingly difficult to treat. At the beginning of this year, there were four main FDA-approved medicines for ALS, but that list got shorter in April when one, Relyvrio, was pulled from market.

Priced at $158,000 for a year’s supply, Relyvrio also faced some insurance challenges before its withdrawal. One of the country’s largest insurers, Cigna, had by early 2023 changed its policy to not cover the drug. Cigna said at the time it considered Relyvrio “experimental, investigational or unproven,” despite the drug having received full FDA approval.

When Relyvrio first debuted on the market, patients and caregivers expressed concerns about whether insurance companies would restrict access to it, as they had in the past with other ALS therapies.

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