FDA to come to a decision on Eisai’s and Biogen’s treatment Leqembi in July

The Food and Drug Administration will make a call on whether to completely approve Eisai and Biogen‘s Alzheimer’s treatment Leqembi by July 6, the businesses announced Monday.

Leqembi is an antibody treatment that targets brain plaque related to the mind-robbing disease. It is run intravenously twice a month and slowed the progression of early Alzheimer’s disease by 27% in clinical trials. Nevertheless, it also carries risks of brain swelling and bleeding and costs $26,500 a 12 months.

Although the FDA approved Leqembi on an expedited basis in January, access to the treatment is virtually nonexistent without delay. Medicare will only cover classes of medication like Leqembi that receive expedited approval for people participating in clinical trials.

The Centers for Medicare and Medicaid Services said in January that it would offer broader coverage of Leqembi as soon because it receives full FDA approval.

Though coverage can be broader, the number of people that could access the drug will still likely be limited. Medicare has agreed to cover drugs like Leqembi once they receive full approval, but just for individuals who take part in research studies, called registries, so Medicare can collect real-world data.

It would take time to establish those studies; health-care providers and research institutes need to be recruited, and patients would also need to comply with participate. The health-care system would also need more capability to manage the diagnostic tests and infusions needed to manage the drug.

The Alzheimer’s Association called on CMS in December to supply unrestricted coverage of treatments like Leqembi. Members of Congress have also asked Medicare to supply broader coverage, arguing that the restrictions put individuals who live in rural communities at a drawback because providers that take part in such studies are often in greater cities.

CMS rejected the Alzheimer’s Associations request to supply unrestricted coverage last month, however the agency reiterated that it is going to cover Leqembi more broadly on the identical day it receives full FDA approval.

 “As defined in statute, to supply coverage nationally, CMS is required to look at whether a medicine is cheap and essential,” the agency said in its statement. “This standard differs from the factors utilized by the FDA to evaluate whether medications are secure and effective.”

The Alzheimer’s Association said it was “appalled” by CMS’ decision. The group estimates that 2,000 people ages 65 and older progress from mild dementia to a more advanced state of the disease daily, making them ineligible for Leqembi.

“CMS’ role is to supply health care coverage. Their role shouldn’t be to face between a patient and a physician when deciding what FDA-approved treatments are appropriate. Their role shouldn’t be to single out people living with Alzheimer’s and choose that their lives, their independence and their memories usually are not essential,” said the association’s president, Joanne Pike.

Eisai’s U.S. CEO, Ivan Cheung, told CNBC last month that it’s possible Medicare could comply with provide coverage with no restrictions after Leqembi receives full approval if CMS determines there’s strong evidence to support the treatment.

“With a high level of evidence … the restrictions needs to be very limited, or perhaps even no restrictions and that’s Eisai’s position,” Cheung said. “We imagine Medicare beneficiaries must have unimpeded access, broad and straightforward access to Leqembi because the info fulfill those criteria,” Cheung said.