CMS will quickly determine whether or not Medicare program will cowl Aduhelm, Biogen’s $56,000-a-year Alzheimer’s drug that the Meals and Drug Administration just lately authorized underneath controversy.
The company kicked off its evaluate course of on Monday, noting that the end result of its evaluation will apply to aducanumab, marketed as Aduhelm, and different monoclonal antibodies focusing on amyloid for the remedy of Alzheimer’s illness.
The general public may have 30 days to submit feedback earlier than CMS posts its proposed nationwide protection willpower, which will even be open for remark. The company plans to host two public listening classes this month.
“Alzheimer’s is a devastating sickness that has touched the lives of thousands and thousands of American households, and as CMS opens our Nationwide Protection Willpower evaluation, we invite stakeholders to take part,” mentioned CMS Administrator Chiquita Brooks-LaSure in a press release. “We need to think about Medicare protection of latest therapies very fastidiously in gentle of the proof out there. That is why our course of will embrace alternatives to listen to from many stakeholders, together with affected person advocacy teams, medical consultants, states, issuers, business professionals, and relations and caregivers of these residing with this illness.”
Medicare Administrative Contractors presently determine whether or not to cowl Aduhelm, however that might change if CMS chooses to cowl it nationwide. In accordance with the Kaiser Household Basis, Medicare beneficiaries would pay about $11,500 out-of-pocket for the drug annually.
It could price the Medicare program nearly $29 billion yearly, rather more than all different drugs. It may make up 1% of all nationwide healthcare spending by the center of the last decade, in keeping with the not-for-profit analysis group Altarum.
The FDA granted Biogen accelerated approval for Aduhelm final month, though consultants are debating whether or not it is an efficient remedy for Azheimer’s illness. The company may pull the drug from the market if comply with up research present that it is ineffective, however that is unlikely.