December 6, 2023

CMS Sticks to Sharply Lim­it­ed Cov­er­age of New Alzheimer’s Drug, Leqem­bi (Man­aged Well being­care Government):

For now, CMS (Be aware: 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 medicine to Medicare ben­e­fi­cia­ries who’ve enrolled in clin­i­cal tri­als of the medicine

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 usually are not 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.”

The Announcement:

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 may be not but evi­dence meet­ing the cri­te­ria for recon­sid­er­a­tion. CMS’s let­ter to the Alzheimer’s Asso­ci­a­tion out­strains 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 secure 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, comparable 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 yr, underneath CED, on the identical day. As not­ed within the NCD, cov­er­age by way of CED contains reg­istry-based stud­ies that mirror real-world care. Reg­istry-based stud­ies might reply the CED ques­tions and poten­tial­ly professional­vide better entry nation­large at extra deal with­ment websites, extra speedy­ly, than any oth­er cov­er­age path­manner. The CED might additionally assist fill evi­dence gaps for sufferers who had been huge­ly underneath­rep­re­despatched­ed in ini­tial tri­als. CMS appears for­ward to dis­cussing with sufferers, their fam­i­lies, and oth­er stake­maintain­ers how reg­istries might allow large­unfold entry.

Information in Context: