December 8, 2023


Healthy Always

Rising controversy over function of FDA and Medicare in selling anti-amyloid medication given restricted profit, excessive value, extreme side-effects

4 min read

The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbes):

The pow­er­ful Alzheimer’s Dis­ease lob­by is battle­ing a mul­ti-bil­lion-dol­lar bat­tle on two fronts. It’s qui­et­ly attempt­ing to lim­it restric­tions the Meals and Drug Admin­is­tra­tion places on using new medication aimed toward gradual­ing the professional­gres­sion of the mind dis­ease. And it’s pub­licly press­ing Medicare to pay for the huge­unfold use of the mon­o­clon­al anti­bod­ies FDA already has con­di­tion­al­ly accepted in addition to oth­ers within the pipeline.

Whereas the FDA approves medication to be used, it doesn’t resolve who pays for them. And, for now, the Cen­ters for Medicare and Med­ic­help Ser­vices (CMS) per­mits Medicare to pay for these med­ica­tions below solely lim­it­ed circumstances…

Whereas these deci­sions must be primarily based on sci­ence, the Alzheimer’s lob­by is rolling out its polit­i­cal huge weapons. Mem­bers of Con­gress are demand­ing that Medicare pay. Advo­cates allege racial bias in Medicare’s reluc­tance to cov­er the medication. Why? As a result of they are saying tri­als and even reg­istries are much less like­ly to incorporate Black and His­pan­ic sufferers in addition to these liv­ing in rur­al communities.

In a single unusu­al advo­ca­cy transfer, drug­mak­er Eli Lil­ly, which has utilized for FDA approval of its personal mon­o­clon­al anti­physique, pur­chased what effec­tive­ly was a two-hour infomer­cial pre­despatched­ed by the web information ser­vice The Hill. It fea­tured regulation­mak­ers, researchers, and rep­re­sen­ta­tives of advo­ca­cy teams all urg­ing CMS to pay for these medication. No researchers who ques­tioned the drug’s protected­ty or effi­ca­cy have been interviewed.

Euro­pean Alzheimer’s experts uncon­vinced by new Eisai, Bio­gen drug (Reuters):

…In Europe, the place cost-con­scious coun­tries rig­or­ous­ly weigh new medication earlier than undertake­ing their use, 9 neu­rol­o­gists and researchers throughout six coun­tries informed Reuters lecanemab is not like­ly to be huge­ly used if accepted. Their views below­pin ana­lyst esti­mates sug­gest­ing Europe can be a small mar­ket for the drug.

Some doc­tors mentioned its impact on the dis­ease might not be clin­i­cal­ly imply­ing­ful sufficient when weighed towards the danger of mind swelling, its like­ly excessive worth, and lim­it­ed per­son­nel and sources to admin­is­ter twice month­ly infu­sions and mon­i­tor for mind swelling with MRI scans.

Does Medicare pay for Alzheimer’s drugs? The answer is com­pli­cat­ed and chang­ing (For­tune):

Typ­i­cal­ly, Medicare cov­ers what the FDA approves.

In April 2022, CMS decid­ed that Medicare would cov­er Adul­helm (value: $28,200 a yr, down from the ini­tial $56,000 worth) and deal with­ments prefer it just for ben­e­fi­cia­ries with Medicare Half B who’re enrolled in a clin­i­cal tri­al accepted by the company or by the Nation­al Insti­tutes of Well being…

In ear­ly June, CMS mentioned that if the FDA grants tra­di­tion­al approval to medication gradual­ing the professional­gres­sion of Alzheimer’s, Medicare will cov­er the price for qual­i­fy­ing ben­e­fi­cia­ries who even have a doc­tor par­tic­i­pat­ing in a spe­cial registry.

Some crit­ics suppose a reg­istry could possibly be cum­ber­some for doc­tors and sufferers and would possibly exclude sufferers in rur­al and below­served areas.

Ongoing petition by a lot of scientists and docs:

Information in Context:

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