FDA

Beyond the clinic: Can digital therapeutics (DTx) help boost mental health in the workforce at scale?

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Hop­ing to Avoid Pear’s Fate, Behav­ioral Health-Focused DTx Com­pa­nies Look to Employ­er Mar­ket (Behav­ioral Health Business):

The dig­i­tal ther­a­peu­tics (DTx) indus­try is at a cross­roads after one of the most promi­nent com­pa­nies in the space, Pear Ther­a­peu­tics, filed for bank­rupt­cy ear­li­er this year. The tur­moil comes after DTx began catch­ing on in the behav­ioral health field.

Despite Pear’s set­back, some believe there’s now a chance for oth­er dig­i­tal ther­a­peu­tics com­pa­nies to learn from their competitor’s mis­takes and pave the way for DTx. One of the most chal­leng­ing ques­tions for the bur­geon­ing sec­tor remains pay­ment strat­e­gy. [Read more…] about Beyond the clin­ic: Can dig­i­tal ther­a­peu­tics (DTx) help boost men­tal health in the work­force at scale?

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)

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

On cognitive-physical training, brain biomarkers, dementia, ketamine, brain teasers, riddles and more

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Wel­come to the last 2022 edi­tion of Sharp­Brains e‑newsletter, fea­tur­ing a few select­ed brain health news and fun teasers to chal­lenge your brain and help us all think out­side the box.

#1. “Every­one agrees that Google Glass failed when it came to mar­ket, but to me, it’s a sym­bol of hope … It inspired peo­ple to think beyond tra­di­tion­al ways of mov­ing about our envi­ron­ment. Instead of look­ing down at a device, we could look out at the world and have an over­lay of dig­i­tal infor­ma­tion. It was one of the first steps in physical–digital con­ver­gence that we are see­ing today through­out many indus­tries. And as some­one who has cre­at­ed many inven­tions that nev­er left the lab or were too ear­ly for the mar­ket, I love the fact that Glass came out at all!” — wise words by neu­rotech entre­pre­neur Dr. Cori Lath­an in her new (and excel­lent) book. See Tech­nol­o­gy as a bridge in time: Shap­ing the future of brain health via today’s innovations–including those that “fail”

#2. “Some peo­ple want to do cog­ni­tive train­ing while mov­ing rather than sit­ting down, and that real­ly spoke to me as a pos­si­bil­i­ty for real ben­e­fits giv­en anec­do­tal sto­ries about games like ‘Dance Dance Rev­o­lu­tion.’” — Joaquin A. Anguera, asso­ciate pro­fes­sor at UCSF and direc­tor of Neuroscape‘s Clin­i­cal Divi­sion. See Study: A com­bined cog­ni­tive-phys­i­cal train­ing approach may enhance both mind and body as we age

#3. “Giv­en that ketamine’s rapid action and unex­pect­ed dis­so­cia­tive effects make it a poten­tial­ly worth­while option for treat­ing men­tal health prob­lems, we are on a mis­sion to unpack this mys­tery, at the cross­roads between phar­ma­col­o­gy and neu­ro­science.” See Study iden­ti­fies cog­ni­tive ben­e­fits of ket­a­mine in patients with treat­ment-resis­tant depression

#4. “The grat­i­tude writ­ing group main­tained grat­i­tude lev­els and decreased stress and neg­a­tive affect at one-month post-inter­ven­tion” — that main­te­nance aspect is espe­cial­ly inter­est­ing. See Thanks­giv­ing works: Grat­i­tude jour­nal­ing seen to low­er stress and neg­a­tive cog­ni­tive processes

#5. Impres­sive new funding–especially giv­en mar­ket conditions–with a goal to iden­ti­fy “brain bio­mark­ers by ana­lyz­ing EEG activ­i­ty, behav­ioral task per­for­mance, wear­able data, genet­ics, and oth­er fac­tors to match each patient with the right Alto drug.” See Pre­ci­sion psy­chi­a­try pio­neer Alto Neu­ro­science rais­es $35M to advance dig­i­tal bio­mark­er-to-treat­ment platform

#6. Some bad news. See The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)

#7. And some great news: “(Péter Hudomi­et, study’s lead author) said it’s also pos­si­ble that, giv­en numer­ous stud­ies being released on steps to take to avoid demen­tia, some of the decline may be attrib­uted to peo­ple heed­ing such advice.” See Study finds sharp decrease (near­ly one-third) in the preva­lence of demen­tia among those 65+ in the Unit­ed States

#8. Final­ly, here are a few brain teasers to stim­u­late those neu­rons in your tem­po­ral lobes and to help us all think out­side the box.

 

Have a healthy and won­der­ful 2023!

 

The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

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FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus):

The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency ear­ly on that it lacked the legal author­i­ty to ful­ly imple­ment pathway.

In 2017, the FDA pro­posed the idea of a Pre-Cert pro­gram that would act as a new path­way for soft­ware as a med­ical device (SaMD) prod­ucts, through which the agency could green-light such prod­ucts based on how much reg­u­la­tors trust the man­u­fac­tur­er. The agency has been run­ning a pilot pro­gram to test the fea­si­bil­i­ty of the pro­gram, but in a new report, FDA con­cedes it does not have the legal author­i­ty need­ed to cre­ate the pro­gram as orig­i­nal­ly envi­sioned. [Read more…] about The FDA ends pre­cer­ti­fi­ca­tion (Pre-Cert) pilot pro­gram, say­ing new author­i­ty required to reg­u­late soft­ware as a med­ical device (SaMD)