Scoop: VA de­cides against adding Bio­gen's Aduhelm to its for­mu­la­ry as PBM shuns con­tro­ver­sial Alzheimer's drug

The De­part­ment of Vet­er­ans Af­fairs has de­cid­ed to not in­clude Bio­gen’s pricey new Alzheimer’s drug Aduhelm on its for­mu­la­ry, and its PBM even went so far as to rec­om­mend against of­fer­ing it, not­ing “the lack of ev­i­dence of a ro­bust and mean­ing­ful clin­i­cal ben­e­fit and the known safe­ty sig­nal.”

The de­ci­sion, which is one of the first na­tion­wide de­ter­mi­na­tions on whether to cov­er the con­tro­ver­sial new drug, al­so rec­om­mends that if Aduhelm is to be used by ex­cep­tion, then it should be used “on­ly in high­ly se­lect­ed pa­tients by ex­perts and cen­ters that have the nec­es­sary di­ag­nos­tic and man­age­ment ex­per­tise — and on­ly by those with the need­ed re­sources for close mon­i­tor­ing to as­sure safe­ty,” End­points News has learned.

“It is not be­ing added to the VA Na­tion­al For­mu­la­ry due to the risk of sig­nif­i­cant ad­verse drug events and to the lack of ev­i­dence of a pos­i­tive im­pact on cog­ni­tion,” con­firmed a spokesper­son for the VA on Wednes­day, af­ter we re­port­ed the move.

Aduhelm has been un­der con­stant fire since its ap­proval, as two ma­jor health sys­tems — the Cleve­land Clin­ic and Mount Sinai — are now re­fus­ing to ad­min­is­ter the drug, and as af­fil­i­ates of Blue Cross Blue Shield are de­clin­ing to cov­er it while oth­er in­sur­ers re­main in a wait-and-see-what-Medicare-does mode. The HHS in­spec­tor gen­er­al has al­so opened an in­ves­ti­ga­tion in­to the close ties be­tween FDA and Bio­gen, and oth­er con­gres­sion­al in­ves­ti­ga­tions are on­go­ing.

In a list­ing post­ed on the VA web­site, in which the de­part­ment says that ad­u­canum­ab is not on the for­mu­la­ry, the drug is grouped with oth­er Alzheimer’s drugs (VA Drug Class CN900), in­clud­ing some like galan­t­a­mine, which are in­clud­ed on the VA’s for­mu­la­ry.

“We are pleased the De­part­ment of Vet­er­ans Af­fairs (VA) rec­om­men­da­tion will al­low ac­cess to ADUHELM for vet­er­ans who meet the cri­te­ria as pub­lished in the ‘Place in Ther­a­py’ sec­tion of the clin­i­cal mono­graph,” a Bio­gen spokesper­son told End­points News in a state­ment. “Bio­gen re­mains com­mit­ted to en­sur­ing vet­er­ans have ac­cess to the lat­est ther­a­pies for Alzheimer’s and we will con­tin­ue to en­gage close­ly with the VA as they eval­u­ate po­ten­tial up­dates to their guid­ance.”

End­points re­viewed a copy of the mono­graph, which in­cludes the “Place in Ther­a­py” sec­tion, mak­ing clear that the VA PBM rec­om­mends against Aduhelm giv­en the un­clear ev­i­dence and safe­ty con­cerns.

The mono­graph al­so lays out ex­ten­sive safe­ty stan­dards that should be ad­hered to if the drug is used, in­clud­ing en­sur­ing that ApoE geno­type has been ob­tained and doc­u­ment­ed, and the pa­tient has a re­cent brain MRI, meets clin­i­cal cri­te­ria for mild cog­ni­tive im­pair­ment with Alzheimer’s pathol­o­gy or mild AD, and has an amy­loid PET imag­ing that is con­sis­tent with Alzheimer’s pathol­o­gy, and/or CSF analy­sis. It al­so in­cludes a half dozen con­di­tions un­der which Aduhelm should not be ad­min­is­tered.

Bio­gen pre­vi­ous­ly said it was work­ing to fi­nal­ize a mul­ti-year agree­ment in or­der to sup­port ac­cess for vet­er­ans through­out the VHA sys­tem, which in­cludes 9 mil­lion en­rolled vet­er­ans, ap­prox­i­mate­ly 48% of which are over the age of 65. The VA said it es­ti­mates the num­ber of US vet­er­ans with Alzheimer’s de­men­tia in FY 2021 is about 457,000.

The VA’s de­ci­sion to not in­clude Aduhelm on its for­mu­la­ry does not mean that ac­cess to the drug will nec­es­sar­i­ly be re­strict­ed. As VA doc­tors have ex­plained to End­points, every VA fa­cil­i­ty has the abil­i­ty to re­quest ac­cess, elec­tron­i­cal­ly, to a drug not on the for­mu­la­ry. And since all vet­er­ans over the age of 65 are en­rolled in Medicare, the de­ci­sion may be a cost-sav­ing one, es­pe­cial­ly if Medicare de­cides to not cov­er the drug. That 9-month process is on­go­ing.

The VA al­so ex­plains this process for ob­tain­ing a drug not on its for­mu­la­ry, not­ing that such prod­ucts may be ap­proved un­der cer­tain cir­cum­stances, such as if there are no al­ter­na­tive ther­a­pies on the for­mu­la­ry or if a pa­tient has pre­vi­ous­ly re­spond­ed to a non­for­mu­la­ry agent and risk is as­so­ci­at­ed with a change to a for­mu­la­ry agent.

Sep­a­rate­ly, Aduhelm al­so ap­pears to be in­clud­ed in the VA’s Non-Pro­motable List, which is a list of drugs that are not to be pro­mot­ed or de­tailed by phar­ma sales rep­re­sen­ta­tives.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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