Medicare says it will pay for new Alzheimer’s drugs that are granted full approval from the FDA, although it will require physicians to collect data on how well the drugs perform in the real world.
Accelerated approval is for medications that “fill an unmet medical need,” according to the FDA. In order to gain full approval, the drugmakers need to conduct additional clinical trials.
Doctors who prescribe the drugs will need to use a government registry to track how well patients are doing. In a statement Thursday, the Alzheimer's Association said requiring physicians to submit data in a registry is an"unnecessary barrier." "We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents," the group said in a statement.
The move Thursday came ahead of an FDA advisory committee meeting on June 9 at which a panel of experts is expected to vote on whether to recommend that the FDA grant full approval to Leqembi. Clinical trials showed the drug appeared to slow the progression of the disease in people at an early stage or with mild cognitive impairment., making it out of reach for most people. But if the advisory committee meeting goes well and the FDA grants traditional approval, people on Medicare who want the drug should be able to get it under the new Medicare rules.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Medicare Plans to Cover Alzheimer’s DrugsMedicare plans to widen coverage of Alzheimer’s drugs that could win full approval as soon as this summer
Read more »
Medicare to expand coverage for a new class of costly Alzheimer’s drugsMedicare officials announced plans to broadly cover a new class of Alzheimer’s drugs following an intense lobbying campaign by patient advocates and drugmakers pressing for access to the first medications shown to slow cognitive decline from the disease.
Read more »
Medicare unveils plan for coverage of new Alzheimer’s drugsPatient registry could be a barrier to coverage of new treatments, critics say.
Read more »
Medicare details plan to cover Alzheimer's treatmentsPatients will have to participate in registries that collect real-world data on how the drug works as a condition of coverage.
Read more »
Two teens arrested in deaths of two men in Fairfax County Memorial Day drug robberyFairfax County Police arrested two teens in connection with the shooting and stabbing deaths of two men in Idylwood, Virginia, on Memorial Day.
Read more »