Ei­sai prices Alzheimer's drug at $26,500, be­low part­ner Bio­gen's Aduhelm

Ei­sai and Bio­gen will price their new Alzheimer’s treat­ment Leqem­bi at $26,500 per year, US CEO Ivan Che­ung tells End­points News. With out­cries over the pric­ing of the drug­mak­ers’ pre­vi­ous drug, Aduhelm, all eyes are on the stick­er price for the duo’s new treat­ment cleared by the FDA on Fri­day.

Leqem­bi will like­ly be in­fused in few pa­tients at this stage, as the US gov­ern­ment’s in­sur­er for those over the age of 65 puts a lim­it on cov­er­age of an­ti-amy­loid drugs fol­low­ing the Aduhelm nod. Pa­tients es­sen­tial­ly have to be in a clin­i­cal tri­al to get cov­er­age from the Cen­ters for Medicare & Med­ic­aid Ser­vices.

Com­mu­ni­ca­tions with CMS have been on­go­ing for months and Ei­sai said it doesn’t ex­pect the lim­i­ta­tion to get re­vised or lift­ed ahead of a full ap­proval, which could come lat­er this year as the drug­mak­er says it will al­most im­me­di­ate­ly file to turn the ac­cel­er­at­ed nod in­to a tra­di­tion­al one.

CMS said in a state­ment it is “ex­am­in­ing avail­able in­for­ma­tion and may re­con­sid­er its cur­rent cov­er­age based on this re­view,” and if tra­di­tion­al ap­proval is grant­ed, the gov­ern­ment in­sur­er “would pro­vide broad­er cov­er­age us­ing the frame­work we an­nounced last year, un­der cov­er­age with ev­i­dence de­vel­op­ment, on the same day.”

David Rind

Ahead of the ac­cel­er­at­ed ap­proval, pric­ing watch­dog ICER said the drug would be “cost-ef­fec­tive” at $8,500 to $20,600, al­beit the De­cem­ber analy­sis was pre­lim­i­nary and on­ly con­sid­ered a draft. In a state­ment emailed to End­points, ICER med­ical chief David Rind said any­thing above that “would not meet typ­i­cal thresh­olds of cost-ef­fec­tive­ness.”

“Giv­en the large num­ber of pa­tients with Alzheimer’s dis­ease, it is par­tic­u­lar­ly im­por­tant that new ther­a­pies be priced in line with their val­ue to pa­tients,” Rind said.

Ei­sai said it es­ti­mates “the di­ag­nosed el­i­gi­ble Ear­ly AD pop­u­la­tion will reach ap­prox­i­mate­ly 100,000 in­di­vid­u­als by year 3.

Ivan Che­ung

Che­ung says the Tokyo drug­mak­er priced Leqem­bi be­low the ap­prox­i­mate­ly $37,000 “so­ci­etal val­ue of med­i­cine” that Ei­sai an­a­lysts formed af­ter Phase III da­ta showed the an­ti­body led to a 27% de­cline on a cog­ni­tive func­tion test at 18 months.

Us­Again­stAlzheimer’s told End­points via email, “This drug should be avail­able now.”

“But with­out Medicare cov­er­age, on­ly the wealthy who can af­ford to pay $26,500 a year will have ac­cess to this treat­ment, leav­ing it out of reach for mil­lions of peo­ple liv­ing with Alzheimer’s,” the ad­vo­ca­cy group said in a state­ment.

Howard Fil­lit, co­founder and CSO of the Alzheimer’s Drug Dis­cov­ery Foun­da­tion, told End­points via phone: “The is­sue isn’t so much the month­ly pric­ing or the an­nu­al pric­ing, but al­so the the bud­get im­pact that this could po­ten­tial­ly have. Medicare is not sup­posed to con­sid­er that, so I think we’re ba­si­cal­ly talk­ing about the cost-ef­fec­tive­ness mod­els.”

The av­er­age whole­sale price of bi­o­log­i­cals for mul­ti­ple scle­ro­sis is ap­proach­ing about $3,500 to $4,000 per month, so “it’s prece­dent for bi­o­log­i­cals like this to have the kind of pric­ing that’s be­ing pro­posed here,” Fil­lit said.

The Alzheimer’s As­so­ci­a­tion called for “eq­ui­table ac­cess” of new treat­ments, say­ing last week that drugs should be “priced ap­pro­pri­ate­ly.” A spokesper­son for the pub­lic ad­vo­ca­cy group de­clined to de­fine what that equates to in dol­lar fig­ures.

Most new med­i­cines re­ceive scruti­ny over pric­ing, but Leqem­bi will be par­tic­u­lar­ly picked apart be­cause of the Aduhelm fi­as­co, de­bates over clin­i­cal mean­ing­ful­ness, height­ened safe­ty con­cerns in the wake of re­ports of pa­tient deaths, as well as the sheer num­ber of pa­tients who might one day re­ceive the drug since there are no oth­er op­tions to al­ter the course of dis­ease. Aduhelm was ini­tial­ly priced at $56,000, caus­ing up­roars in Con­gress and else­where. The an­nu­al price was even­tu­al­ly slashed to $28,200, but sales have been abysmal in com­par­i­son to the bil­lions in sales Bio­gen once ex­pect­ed.

A day be­fore the ap­proval came out, Jef­feries an­a­lysts thought Aduhelm and Leqem­bi might be priced sim­i­lar­ly, writ­ing in a note: “In­vestors ex­pec­ta­tions are an­chored close to the $28,000 an­nu­al price that Bio­gen and Ei­sai lat­ter­ly adopt­ed for Aduhelm.”

Bio­gen took the lead on Aduhelm pric­ing, where­as Ei­sai was in the dri­ver’s seat this time around. Lars Lan­n­felt, the in­ven­tor of Leqem­bi and ap­prox­i­mate­ly 33% share­hold­er of Ei­sai part­ner BioArc­tic, called the Aduhelm pric­ing a “mis­take” in an in­ter­view, but wouldn’t com­ment on Leqem­bi’s price oth­er than say­ing it should be ac­ces­si­ble to every­one who can ben­e­fit from it.

Ed­i­tor’s note: This sto­ry has been up­dat­ed to in­clude a state­ment from Cen­ters for Medicare and Med­ic­aid. 

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.