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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.