Medicare

Hopes and Questions raised by Alzheimer’s drug Leqembi (lecanemab)

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The FDA has approved Leqem­bi, the first dis­ease-mod­i­fy­ing treat­ment for ear­ly-stage Alzheimer’s and a pre­cur­sor con­di­tion, mild cog­ni­tive impair­ment. Medicare has said it will pay for the ther­a­py. Med­ical cen­ters across the coun­try are scram­bling to final­ize poli­cies and pro­ce­dures for pro­vid­ing the med­ica­tion to patients, pos­si­bly by summer’s end or ear­ly autumn.

It’s a fraught moment, with hope run­ning high for fam­i­lies and oth­er promis­ing ther­a­pies such as donanemab on the hori­zon. Still, med­ical providers are cau­tious. “This is an impor­tant first step in devel­op­ing treat­ments for com­plex neu­rode­gen­er­a­tive dis­eases, but it’s just a first step,” said Ronald Petersen, direc­tor of the Mayo Clinic’s Alzheimer’s Dis­ease Research Cen­ter in Rochester, Min­neso­ta. [Read more…] about Hopes and Ques­tions raised by Alzheimer’s drug Leqem­bi (lecanemab)

Price tag for a questionable Alzheimer’s treatment: $109,000 per patient, per year. Unclear yet: For how many years?

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The real costs of the new Alzheimer’s drug, Leqem­bi — and why tax­pay­ers will foot much of the bill (CBS News):

The first drug pur­port­ing to slow the advance of Alzheimer’s dis­ease is like­ly to cost the U.S. health care sys­tem bil­lions annu­al­ly even as it remains out of reach for many of the low­er-income seniors most like­ly to suf­fer from dementia.

Medicare and Med­ic­aid patients will make up 92% of the mar­ket for lecanemab, accord­ing to Eisai Co., which sells the drug under the brand name Leqem­bi. In addi­tion to the com­pa­ny’s $26,500 annu­al price tag for the drug, treat­ment could cost U.S. tax­pay­ers $82,500 per patient per year, on aver­age, for genet­ic tests and fre­quent brain scans, safe­ty mon­i­tor­ing, and oth­er care, accord­ing to esti­mates from the Insti­tute for Clin­i­cal and Eco­nom­ic Review, or ICER. [Read more…] about Price tag for a ques­tion­able Alzheimer’s treat­ment: $109,000 per patient, per year. Unclear yet: For how many years?

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

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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. [Read more…] about Grow­ing con­tro­ver­sy over role of FDA and Medicare in pro­mot­ing anti-amy­loid drugs giv­en lim­it­ed ben­e­fit, high cost, severe side-effects

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. [Read more…] about CMS: anti-amy­loid drug Leqem­bi (lecanemab) doesn’t meet the “rea­son­able and nec­es­sary” stan­dard required for wider Medicare coverage

Update on the aducanumab (Aduhelm) saga, retirement, financial advice, cognitive health, excessive worrying, neurotech, and more

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Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, pro­vid­ing this time a sum­ma­ry of the saga around the FDA approval of adu­canum­ab (Aduhelm) as a sup­posed treat­ment for Alzheimer’s Dis­ease, plus a range of time­ly research find­ings and resources for life­long brain health.

First, below are some key reads to nav­i­gate “prob­a­bly the worst drug approval deci­sion in recent U.S. his­to­ry” — Dr. Aaron Kessel­heim, the Pro­fes­sor of Med­i­cine at Har­vard Med­ical School who resigned rom the FDA Advi­so­ry Com­mit­tee in protest.

#1. Grow­ing back­lash against the FDA approval of unproven Alzheimer’s treat­ment Aduhelm, by Bio­gen:

“The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm by Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with known harms.”

#2. First, do no harm? Six rea­sons to approach anti-amy­loid drug Aduhelm cau­tious­ly, if at all:

“The FDA’s approval of Aduhelm rais­es more ques­tions and cre­ates more prob­lems than a new drug approval should. It’s time for gov­ern­men­tal, pro­fes­sion­al, and advo­ca­cy enti­ties to step in where Bio­gen and the FDA have failed and explain to patients, care­givers, and clin­i­cians how this drug is not the “new day” in the fight against Alzheimer’s dis­ease and needs to be approached cau­tious­ly, if at all.” — Dr. Sam Gandy, Pro­fes­sor of Neu­rol­o­gy and Psy­chi­a­try at the Icahn School of Med­i­cine at Mount Sinai, where he holds the Mount Sinai Chair in Alzheimer’s Research

#3. Can the con­tro­ver­sial FDA approval of Aduhelm back­fire and delay the dis­cov­ery of actu­al Alzheimer’s treat­ments? (Yes, it can):

“In short, while the amy­loid hypoth­e­sis has fal­tered, the approval of adu­canum­ab, which is based pri­mar­i­ly on this the­o­ry, sug­gests that the the­o­ry may once again dom­i­nate research, and could reduce the chances of find­ing more promis­ing treat­ments. For exam­ple, tau pro­tein, which also accu­mu­lates in the brains of Alzheimer’s patients — long before the amy­loid pro­tein does — has been shown to be close­ly asso­ci­at­ed with the cog­ni­tive impair­ment result­ing from the dis­ease … we must not inter­rupt research on bio­mark­ers and new ther­a­peu­tic approaches.”

#4. US Sen­a­tor Joe Manchin calls for a new FDA Com­mis­sion­er to replace cur­rent (act­ing) one who “has repeat­ed­ly ignored pub­lic health con­cerns and shown a dere­lic­tion of duty” over opi­oids and adu­canum­ab:

“I write today con­cern­ing the lack of per­ma­nent lead­er­ship at the Food and Drug Admin­is­tra­tion (FDA), and the con­tin­ued tenure of Dr. Janet Wood­cock as inter­im com­mis­sion­er. Just last week, the FDA grant­ed approval for Aduhelm (adu­canum­ab), a treat­ment for Alzheimer’s, despite its advi­so­ry pan­el vot­ing near­ly unan­i­mous­ly against its approval, with no pan­el mem­ber vot­ing in favor of approval”

(Let’s hope some­thing use­ful emerges from this very unhealthy FDA deci­sion. Quite dis­turb­ing, though, to notice the links between the opi­oid epi­dem­ic and the recent Aduhelm approval.)

#5. Health payers–including Medicare and Point32Health–to ques­tion Aduhelm pric­ing and its “rea­son­able and nec­es­sary” use:

“Under the broad label that FDA approved, the drug is avail­able to all Alzheimer’s patients, and the agency did not place lim­its on treat­ment dura­tion sug­gest­ing that patients could remain on the drug indef­i­nite­ly. We are trou­bled by reports that those fac­tors could lead the drug to com­mand “some­where between” the $37 bil­lion we cur­rent­ly spend on Medicare Part B and the $90 bil­lion we cur­rent­ly spend on Medicare Part D. This lev­el of poten­tial new spend­ing, par­tic­u­lar­ly for just one prod­uct with lim­it­ed evi­dence of clin­i­cal effi­ca­cy thus far, tests the program’s resiliency.”

The stakes could­n’t be higher.

Now let’s review oth­er impor­tant devel­op­ments in June.

#6. Debate: What is the role of finan­cial advi­sors and plat­forms in detect­ing and address­ing cog­ni­tive decline among old­er clients?:

” … big do-it-your­self invest­ing and trad­ing venues like Van­guard Group, Fideli­ty Invest­ments and Charles Schwab Corp. are strength­en­ing some of the ways they detect pos­si­ble signs of decline. Among oth­er things, all three firms check for clients’ dif­fi­cul­ty nav­i­gat­ing secu­ri­ty pro­to­cols or need for fre­quent pass­word resets. In such cas­es, a des­ig­nat­ed fam­i­ly mem­ber might be informed.

Van­guard also checks client-call record­ings for keywords—such as “con­fused” and “dementia”—that might sig­nal trouble.”

#7. Study in Chi­na finds that retire­ment may accel­er­ate cog­ni­tive decline, even for those with sta­ble income:

“While retire­ment schemes like the 401(k) and sim­i­lar pro­grams in oth­er coun­tries are typ­i­cal­ly intro­duced to ensure the wel­fare of aging adults, our research sug­gests they need to be designed care­ful­ly to avoid unin­tend­ed and sig­nif­i­cant adverse con­se­quences. When peo­ple con­sid­er retire­ment, they should weigh the ben­e­fits with the sig­nif­i­cant down­sides of a sud­den lack of men­tal activ­i­ty. A good way to ame­lio­rate these effects is to stay engaged in social activ­i­ties and con­tin­ue to use your brains in the same way you did when you were working.

In short, we show that if you rest, you rust.”

#8. The explo­sion of men­tal health apps rais­es sub­stan­tial opportunities–and tough ques­tions:

“Dig­i­tal men­tal health can be viewed as a way to extend the men­tal resources that we have,” said David Mohr, who directs the Cen­ter for Behav­ioral Inter­ven­tion Tech­nolo­gies at the North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine. A step-care mod­el, for exam­ple, would allow patients with milder symp­toms to be treat­ed via tech­nol­o­gy while reserv­ing in-per­son care for patients who need some­thing more.

#9. Pre­scrip­tion soft­ware firm Pear Ther­a­peu­tics to go pub­lic via $1.6 bil­lion SPAC deal, har­ness­ing 3 FDA-autho­rized prod­ucts and 14 can­di­dates:

“Pear is one of nine com­pa­nies invit­ed to par­tic­i­pate in the U.S. Food and Drug Administration’s (FDA) Pre­cer­ti­fi­ca­tion Pilot Pro­gram. Pear has devel­oped and com­mer­cial­ized the first three FDA-autho­rized PDTs, has 14 prod­uct can­di­dates, and is scal­ing its plat­form for third-par­ty prod­uct dis­tri­b­u­tion oppor­tu­ni­ties. The Company’s three FDA-autho­rized prod­ucts, reSET®, reSET‑O® and Som­ryst®, address large mar­ket oppor­tu­ni­ties with more than 20 mil­lion patients suf­fer­ing from sub­stance and opi­oid use dis­or­ders and more than 30 mil­lion from chron­ic insom­nia, in the U.S. alone, respectively.”

#10. Don’t wor­ry, be hap­py: How exces­sive wor­ry­ing may influ­ence the rate of neu­rode­gen­er­a­tion:

“(Research find­ings) sug­gest that cog­ni­tive func­tion may need to be mon­i­tored close­ly in indi­vid­u­als with affec­tive dis­or­ders, as these indi­vid­u­als may be at par­tic­u­lar risk of greater cog­ni­tive decline.”

#11. Smarter cars are com­ing soon … : Eye-track­ing pio­neer Smart Eye acquires MIT spin-off Affec­ti­va to aug­ment dri­ver mon­i­tor­ing sys­tems and more

#12. And, much more: DARPA-fund­ed non­sur­gi­cal neu­rotech­nolo­gies push the fron­tier of brain-machine interfaces

Final­ly, a quick cog­ni­tive exer­cise. Giv­en the uni­ver­sal beau­ty of math, you don’t need to speak Span­ish to try this quick teas­er: Brain teasers en español: ¿cuál es el número que fal­ta en el cuar­to triángulo?

Wish­ing you a hap­py and healthy summer,

The Sharp­Brains Team

Health payers–including Medicare and Point32Health–to question Aduhelm pricing and its “reasonable and necessary” use

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State’s Sec­ond-Largest Health Insur­er Slams Bio­gen For Cost­ly Alzheimer’s Drug (The Boston Globe):

The state’s sec­ond-biggest health insur­er is threat­en­ing to lim­it or not cov­er Biogen’s new Alzheimer’s drug, accus­ing the Cam­bridge biotech of putting “exces­sive cor­po­rate prof­its” ahead of patients by charg­ing $56,000 a year for the con­tro­ver­sial treat­ment. Michael Sher­man, chief med­ical offi­cer for Point32Health, the insur­ance com­pa­ny formed by the recent merg­er of Tufts Health Plan and Har­vard Pil­grim Health Care, said Bio­gen should cut the cost of the drug called Aduhelm by a fac­tor of rough­ly 10, to $5,400, giv­en the medicine’s ques­tion­able ben­e­fits and poten­tial risks.

Sen­a­tors Call On Con­gress To Exam­ine Expen­sive New Alzheimer’s Drug (STAT):

Sens. Eliz­a­beth War­ren (D‑Mass.) and Bill Cas­sidy (R‑La.) want Con­gress to take a deep­er look at how Biogen’s con­tro­ver­sial and pricey new Alzheimer’s drug, Aduhelm, will affect the Medicare pro­gram, they wrote in a let­ter Wednes­day. The bipar­ti­san duo is press­ing the Sen­ate Finance Com­mit­tee to take on “the vex­ing new ques­tions and chal­lenges that approval rais­es for the Medicare pro­gram and oth­er health pro­grams” the pan­el over­sees, they wrote.

[Read more…] about Health payers–including Medicare and Point32Health–to ques­tion Aduhelm pric­ing and its “rea­son­able and nec­es­sary” use