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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,800+ biopharma pros reading Endpoints daily — and it's free.