Medicare Change: Will Now Pay For Drugs Having FDA Approval

Jo C.

Medicare will now pay for drugs that have FDA approval including newly approved drugs for dementia. MDs will have to report patient response:

https://www.aol.com/news/medicare-plans-pay-alzheimers-drugs-203839696.html

J.

M1

Jo I was reading about this in the Washington Post yesterday--none of the drugs yet has FULL FDA approval, which is what is required. Locembi is expected to receive it in July, but not a sure thing. A second one is on track for maybe December. And yes, all patients will have to be entered into registries to track the post-marketing experience. I think that's the right approach, as efficacy is not a sure thing and there are big, big risks and serious side effects. The Alzheimer's Association is lobbying against this approach.

Jo C.

I agree with you, M1. Tracking post-marketing experience in drugs such as these is important. Efficacy is one issue and another big issue are the very significant risks and what can be dreadful effects and outcomes. Hopefully this will stand and not be removed.

J.

BadMoonRising

Leqembi

A panel of outside experts will hold a hearing THIS Thursday, on June 9th. Information regarding the hearing can be found at the link below. In addition to documents that will be available for review, you will also find a link to the YouTube channel that will provide live coverage of the meeting.

https://www.fda.gov/advisory-committees/advisory-committee-calendar/june-9-2023-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting

BadMoonRising

Oops! June 9th is Friday. The panel meets Friday and documents have been updated since my prior post.

The Institute for Clinical and Economic Review "ICER" completed its review of Lecanemab and a copy of the Final Evidence Report was submitted to the FDA panel along with comments by interested parties.

ICER_Alzheimers-Disease_Final-Report_For-Publication_04172023.pdf

Lane Simonian

Thank you for posting the link to the advisory committee meeting, BadMoonRising. I have it on the background now, but my tolerance for Biogen/Eisai and the FDA's presentations is quickly wanning.

The companies and the FDA are downplaying the serious risk factors involving lecanemab/Leqembi, especially for APOE4 carriers. Some of the advisory committee members seem a little more skeptical.

It is phase 2 trial, lecanemab (then BAN2401) had almost no effect on non-carriers.

https://www.alzforum.org/news/conference-coverage/second-look-ban2401-data-still-positive-despite-snafu

In the phase 3 trial, the effects on non-carriers and carriers was essentially flipped so that those with two copies of the gene seemed to get worse on lecanemab. The reason this happened was that Eisai compared each group (APOE4++-two copies of the gene, APOE4+, and non-carriers) against a combined placebo group rather than the placebo decline in each group. APOE4 carriers progress more rapidly so that the placebo decline in this group would be higher than that of non-carriers. Combining these groups would obscure this difference. In the end the results from the phase 2 trial were the correct one: non-carriers benefit very little from Leqembi/lecanemab, whereas carriers on the drug progress modestly less than the placebo group.

Lane Simonian

The FDA advisory committee voted 6-0 that Leqembi was a clinically effective treatment for Alzheimer's disease without any convincing evidence of such (I originally counted seven members, but the patient representative must not be a voting member). They did have some concerns regarding the safety of Leqembi for APOE4 carriers (to a certain extent), for those taking anti-coagulants, and for those with cerebral amyloid angiopathy. There may be some kind of warning label for those taking anti-coagulants and for those who have visible signs of cerebral amyloid angiopathy.

I think that I am going outside to pull some weeds--more therapeutic.

BadMoonRising

It's startling that APOE4++ carriers are not eligible to receive Leqembi from the VA because of the heightened risk of edema and bleeds, while the FDA Advisory Committee apparently trusts the treating physician to inform the patient of the risk.

VA criteria: https://www.va.gov/formularyadvisor/DOC_PDF/CFU_Lecanemab-irmb_LEQEMBI_CFU.pdf

I found the non-Committee speakers to be more interesting and, unsurprisingly, more passionate than the Committee members. Although there were lay advocates providing heartfelt pleas, there were also healthcare professionals who were adamantly opposed to full approval. The entire meeting, including the testimony of the outside speakers, was videotaped and can be viewed at:

https://www.youtube.com/watch?v=CI9dAd0kaYA

Lane Simonian

I liked listening to the non-Committee speakers as well.