CMS: anti-amyloid drug Leqembi (lecanemab) doesn’t meet the “reasonable and necessary” standard required for wider Medicare coverage

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CMS Sticks to Sharply Lim­it­ed Cov­er­age of New Alzheimer’s Drug, Leqem­bi (Man­aged Health­care Executive):

For now, CMS (Note: Cen­ters for Medicare & Med­ic­aid Ser­vices) is stick­ing to the cov­er­age deci­sion it made for Aduhelm (adu­canum­ab) and apply­ing it Leqem­bi (lecanemab). The deci­sion lim­its Medicare cov­er­age of the two Alzheimer disease’s drugs to Medicare ben­e­fi­cia­ries who have enrolled in clin­i­cal tri­als of the drugs

The deci­sion, which was announced in a press release yes­ter­day, was denounced in strong lan­guage by the Alzheimer’s Association.

“CMS’ role is to pro­vide health care cov­er­age” said Joanne Pike, Dr.Ph., the organization’s pres­i­dent and CEO, in a pre­pared state­ment. “Their role is not to sin­gle out peo­ple liv­ing with Alzheimer’s and decide that their lives, their inde­pen­dence and their mem­o­ries are not necessary.”

When CMS announced its “cov­er­age with evi­dence devel­op­ment” for Aduhelm in April 2022, it said the pol­i­cy would apply not just to Aduhelm but to “any future mon­o­clon­al anti­bod­ies direct­ed against amy­loid approved by the FDA with an indi­ca­tion for use in treat­ing Alzheimer’s dis­ease.” That announce­ment said CMS believes “impor­tant ques­tions still need to be answered to sup­port peo­ple with Medicare, care­givers, and their refer­ring and treat­ing physi­cians to make informed, appro­pri­ate deci­sions about use of any drug in this par­tic­u­lar class” and that the data col­lect­ed from hav­ing peo­ple enroll in tri­als “may be used to assess whether out­comes seen in care­ful­ly con­trolled clin­i­cal tri­als (e.g., FDA tri­als) are repro­duced in the real-world and in a broad­er range of patients.”

The Announcement:

Response to Alzheimer’s Association’s Request to Recon­sid­er the Final Nation­al Cov­er­age Deter­mi­na­tion (CMS Statement):

… After care­ful review of the request and sup­port­ing doc­u­men­ta­tion, we are mak­ing this deci­sion because, as of the date of this let­ter, there is not yet evi­dence meet­ing the cri­te­ria for recon­sid­er­a­tion. CMS’s let­ter to the Alzheimer’s Asso­ci­a­tion out­lines the key ques­tions that need to be addressed for recon­sid­er­a­tion. As defined in statute, to pro­vide cov­er­age nation­al­ly, CMS is required to exam­ine whether a med­ica­tion is rea­son­able and nec­es­sary. This stan­dard dif­fers from the cri­te­ria used by the FDA to assess whether med­ica­tions are safe and effec­tive. We are aware that addi­tion­al pub­li­ca­tions may be forth­com­ing that include infor­ma­tion rel­e­vant to the ques­tions includ­ed in the cur­rent NCD. CMS will expe­di­tious­ly review any new evi­dence that becomes avail­able that could lead to a recon­sid­er­a­tion and change in the NCD, such as evi­dence that answers the Cov­er­age with Evi­dence Devel­op­ment (CED) ques­tions or approval by the FDA based upon evi­dence of clin­i­cal benefit.

If a mon­o­clon­al anti­body direct­ed against amy­loid for the treat­ment of Alzheimer’s dis­ease sub­se­quent­ly receives tra­di­tion­al FDA approval, CMS will pro­vide broad­er cov­er­age using the frame­work we announced last year, under CED, on the same day. As not­ed in the NCD, cov­er­age through CED includes reg­istry-based stud­ies that reflect real-world care. Reg­istry-based stud­ies could answer the CED ques­tions and poten­tial­ly pro­vide greater access nation­wide at more treat­ment sites, more rapid­ly, than any oth­er cov­er­age path­way. The CED could also help fill evi­dence gaps for patients who were vast­ly under­rep­re­sent­ed in ini­tial tri­als. CMS looks for­ward to dis­cussing with patients, their fam­i­lies, and oth­er stake­hold­ers how reg­istries could enable wide­spread access.

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