Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects

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

The pow­er­ful Alzheimer’s Dis­ease lob­by is fight­ing a mul­ti-bil­lion-dol­lar bat­tle on two fronts. It is qui­et­ly try­ing to lim­it restric­tions the Food and Drug Admin­is­tra­tion puts on the use of new drugs aimed at slow­ing the pro­gres­sion of the brain dis­ease. And it is pub­licly press­ing Medicare to pay for the wide­spread use of the mon­o­clon­al anti­bod­ies FDA already has con­di­tion­al­ly approved as well as oth­ers in the pipeline.

While the FDA approves drugs for use, it doesn’t decide who pays for them. And, for now, the Cen­ters for Medicare and Med­ic­aid Ser­vices (CMS) per­mits Medicare to pay for these med­ica­tions under only lim­it­ed circumstances…

While these deci­sions should be based on sci­ence, the Alzheimer’s lob­by is rolling out its polit­i­cal big guns. Mem­bers of Con­gress are demand­ing that Medicare pay. Advo­cates allege racial bias in Medicare’s reluc­tance to cov­er the drugs. Why? Because they say tri­als and even reg­istries are less like­ly to include Black and His­pan­ic patients as well as those liv­ing in rur­al communities.

In one unusu­al advo­ca­cy move, drug­mak­er Eli Lil­ly, which has applied for FDA approval of its own mon­o­clon­al anti­body, pur­chased what effec­tive­ly was a two-hour infomer­cial pre­sent­ed by the online news ser­vice The Hill. It fea­tured law­mak­ers, researchers, and rep­re­sen­ta­tives of advo­ca­cy groups all urg­ing CMS to pay for these drugs. No researchers who ques­tioned the drug’s safe­ty or effi­ca­cy were interviewed.

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

…In Europe, where cost-con­scious coun­tries rig­or­ous­ly weigh new drugs before adopt­ing their use, nine neu­rol­o­gists and researchers across six coun­tries told Reuters lecanemab is unlike­ly to be wide­ly used if approved. Their views under­pin ana­lyst esti­mates sug­gest­ing Europe will be a small mar­ket for the drug.

Some doc­tors said its effect on the dis­ease may not be clin­i­cal­ly mean­ing­ful enough when weighed against the risk of brain swelling, its like­ly high price, and lim­it­ed per­son­nel and resources to admin­is­ter twice month­ly infu­sions and mon­i­tor for brain 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 (cost: $28,200 a year, down from the ini­tial $56,000 price) and treat­ments like it only for ben­e­fi­cia­ries with Medicare Part B who are enrolled in a clin­i­cal tri­al approved by the agency or by the Nation­al Insti­tutes of Health…

In ear­ly June, CMS said that if the FDA grants tra­di­tion­al approval to drugs slow­ing the pro­gres­sion of Alzheimer’s, Medicare will cov­er the cost for qual­i­fy­ing ben­e­fi­cia­ries who also have a doc­tor par­tic­i­pat­ing in a spe­cial registry.

Some crit­ics think a reg­istry could be cum­ber­some for doc­tors and patients and might exclude patients in rur­al and under­served areas.

Ongoing petition by a number of scientists and doctors:

Lecanemab is nei­ther safe nor effec­tive for Alzheimer’s patients: Against the FDA approval — Sign the Peti­tion! https://t.co/ahkiJts8hj via @Change

In my opin­ion we are going down a dan­ger­ous road. We need to con­sult our maps and re-ori­ent our­selves. Please con­sid­er signing.

— Karl Her­rup (@KarlHerrup) June 18, 2023

News in Context:

• Should doc­tors pre­scribe lecanemab (Leqem­bi) to women? The answer, giv­en avail­able evi­dence, is prob­a­bly No