CMS: anti-amyloid drug Leqembi (lecanemab) does not meet the “affordable and essential” normal required for wider Medicare protection
CMS Sticks to Sharply Limited Coverage of New Alzheimer’s Drug, Leqembi (Managed Well beingcare Govt):
For now, CMS (Notice: Centers for Medicare & Medicsupport Services) is sticking to the coverage decision it made for Aduhelm (aducanumab) and applying it Leqembi (lecanemab). The decision limits Medicare coverage of the 2 Alzheimer illness’s medication to Medicare beneficiaries who’ve enrolled in clinical trials of the medication
The decision, which was introduced in a press launch sureterday, was denounced in robust language by the Alzheimer’s Affiliation.
“CMS’ position is to professionalvide well being care coverage” mentioned Joanne Pike, Dr.Ph., the group’s president and CEO, in a prepared statement. “Their position is to not single out people living with Alzheimer’s and resolve that their lives, their independence and their memories aren’t essential.”
When CMS introduced its “coverage with evidence development” for Aduhelm in April 2022, it mentioned the policy would apply not simply to Aduhelm however to “any future monoclonal antibodies directed in opposition to amyloid authorized by the FDA with an indication to be used in deal withing Alzheimer’s disease.” That announcement mentioned CMS believes “important questions nonetheless have to be answered to support people with Medicare, caregivers, and their referring and deal withing physicians to make knowledgeable, appropriate decisions about use of any drug on this particular class” and that the information collected from having people enroll in trials “could also be used to evaluate whether or not outcomes seen in carefully controlled clinical trials (e.g., FDA trials) are reproduced within the real-world and in a broader vary of sufferers.”
Response to Alzheimer’s Association’s Request to Reconsider the Final National Coverage Determination (CMS Assertion):
… After careful overview of the request and supporting documalestation, we’re making this decision as a result of, as of the date of this letter, there’s not but evidence meeting the criteria for reconsideration. CMS’s letter to the Alzheimer’s Association outtraces the important thing questions that have to be addressed for reconsideration. As outlined in statute, to professionalvide coverage nationally, CMS is required to examinationine whether or not a medication is reasonready and necessary. This standard differs from the criteria utilized by the FDA to evaluate whether or not medications are protected and effective. We’re conscious that additional publications could also be forthcoming that embrace information relevant to the questions included within the curlease NCD. CMS will expeditiously overview any new evidence that turns into availready that might result in a reconsideration and alter within the NCD, similar to evidence that solutions the Coverage with Evidence Development (CED) questions or approval by the FDA primarily based upon evidence of clinical profit.
If a monoclonal antiphysique directed in opposition to amyloid for the deal withment of Alzheimer’s disease subsequently receives traditional FDA approval, CMS will professionalvide broader coverage utilizing the bodywork we introduced final 12 months, below CED, on the identical day. As noted within the NCD, coverage by CED contains registry-based studies that replicate real-world care. Registry-based studies may reply the CED questions and potentially professionalvide better entry nationhuge at extra deal withment websites, extra speedyly, than any other coverage pathmethod. The CED may additionally assist fill evidence gaps for sufferers who have been hugely belowrepredespatcheded in initial trials. CMS appears to be like forward to discussing with sufferers, their families, and other stakemaintainers how registries may allow hugeunfold entry.