Ex­clu­sive: Bio­gen lead­ers warn sales teams: On­ly 2,000 pa­tients might ac­cess Aduhelm over the next sev­er­al years

Bio­gen ex­ecs on Thurs­day tried to lev­el with their Aduhelm sales staff and prep for a 28-day blitz to con­vince CMS to re­verse or loosen its re­cent de­ci­sion to on­ly cov­er the con­tro­ver­sial Alzheimer’s drug in clin­i­cal tri­als.

Its back against the wall, the com­pa­ny faces an Aduhelm launch that nev­er ma­te­ri­al­ized and grow­ing ire from in­vestors as they try to gen­er­ate some of the glit­ter­ing bil­lions in block­buster sales an­a­lysts once so con­fi­dent­ly fore­cast.

Ac­cord­ing to a record­ing of the Zoom call with sales teams, ob­tained by End­points News, Bio­gen VP of US mar­ket ac­cess and re­im­burse­ment Bren­dan Man­quin slammed the im­pli­ca­tions of the draft NCD, and said it means that even if Bio­gen runs a large, ran­dom­ized place­bo-con­trolled Phase III tri­al, on the or­der of 2,000 to 3,000 pa­tients (with 33-50% on place­bo), that means on­ly about 1,000 to 2,000 pa­tients will ac­cess Aduhelm “over the next sev­er­al years.”

“I’m not go­ing to sug­ar­coat it. This is an ex­tra­or­di­nar­i­ly re­stric­tive pro­pos­al,” he said.

Man­quin said Bio­gen is meet­ing with CMS next week to ad­dress some of the com­pa­ny’s ques­tions and a “num­ber of mis­char­ac­ter­i­za­tions and sci­en­tif­ic in­ac­cu­ra­cies” in the draft NCD.

“CMS has left a lot of ques­tions unan­swered. We don’t know if this were to be fi­nal­ized, what will hap­pen to pa­tients cur­rent­ly on treat­ment? CMS has left that com­plete­ly unan­swered,” Man­quin said. “Are we go­ing make pa­tients pay co-in­sur­ance and then put them on place­bo?”

Oth­er lead­ers stressed that Bio­gen would like­ly be on the hook for pay­ing for the CMS-ap­proved tri­al, with one se­nior leader not­ing that it’s like­ly that CMS would on­ly pay for the cost of the drug and one PET scan, un­less the pa­tient has al­ready had a PET scan in the past.

“But the rest of the cost of the study is go­ing to be on Bio­gen’s dime. So things like set­ting up the pro­to­col, work­ing with the sites, cov­er­ing ad­min­is­tra­tion costs, that would all fall un­der Bio­gen,” an­oth­er uniden­ti­fied ex­ec said.

While char­ac­ter­iz­ing the de­ci­sion from CMS as es­sen­tial­ly say­ing “the FDA made a mis­take,” and echo­ing com­ments from Bio­gen top ex­ecs ear­li­er in the day, Man­quin said: “We’re go­ing to be push­ing back on them on this on a num­ber of fronts.”

For in­stance, he not­ed that CMS made no dif­fer­en­ti­a­tion in its draft be­tween drugs ap­proved un­der FDA’s ac­cel­er­at­ed and the full ap­proval pro­grams.

Would oth­er Alzheimer’s drugs like Eli Lil­ly’s do­nanemab or Bio­gen’s lecanemab, if they have “per­fect Phase 3 read­outs” still need to do an­oth­er tri­al to gain ac­cess to cov­er­age? He ques­tioned.

“CMS wants to du­pli­cate what the FDA asked for, but they haven’t fig­ured out how to op­er­a­tional­ize that and that’s why we have con­fi­dence we can move the nee­dle,” an­oth­er se­nior leader who did not iden­ti­fy him­self said.

An­oth­er Bio­gen leader called the NCD “a large over­swing by CMS” — say­ing it’s a “sober­ing mes­sage” to think FDA would ap­prove a drug and CMS would re­ject the FDA’s process. He stressed that there will be “lots of noise from the broad­er in­dus­try,” but an­oth­er ex­ec con­firmed that Bio­gen, Lil­ly and Roche do not have a co­or­di­nat­ed mes­sag­ing cam­paign for the com­ment pe­ri­od.

Corey Thomas, Bio­gen’s se­nior prod­uct man­ag­er, joined the call af­ter Man­quin and went over “re­ac­tive” talk­ing points with the reps re­gard­ing the NCD, telling them, “It’s crit­i­cal­ly im­por­tant to make stake­hold­ers aware of the com­ment pe­ri­od.”

In ad­di­tion to of­fer­ing in­struc­tions on the eas­i­est way to di­rect doc­tors to the NCD dock­et, Thomas al­so stressed that staff should make physi­cians aware of the “tight time­line” to sub­mit com­ments, but to not go so far as sug­gest­ing what physi­cians should write.

Lat­er in the call, oth­er Bio­gen lead­ers told the sales teams to con­tin­ue to work with physi­cians to en­roll pa­tients on Aduhelm, as “noth­ing changes” from be­fore the draft NCD.

Cov­er­age de­ter­mi­na­tions for Aduhelm will still be made by the Medicare Ad­min­is­tra­tive Con­trac­tors and Medicare Ad­van­tage plans, the lead­ers said, as they were be­fore, and providers can con­tin­ue to sub­mit claims and pri­or ap­provals.

“We should not be dri­ving pa­tients to clin­i­cal tri­al re­cruit­ment,” an­oth­er uniden­ti­fied leader said near the mid­dle of the hour-long call. “Please do not go rogue on some­thing like this.”

Bio­gen lead­ers al­so cau­tioned em­ploy­ees against per­son­al­ly sub­mit­ting com­ments to CMS, even if they are not iden­ti­fied as Bio­gen em­ploy­ees, as one leader men­tioned End­points cov­er­age about how the com­pa­ny was plan­ning to en­list doc­tors and oth­ers to flood CMS with com­ments.

Near the end of the call, one of the lead­ers stressed to the sales teams that they’re “on the right side of this.”

“This is a draft,” he said in clos­ing the call, adding:

We be­lieve this draft will move, and we need to do every­thing we can to get pa­tients con­firmed for amy­loid da­ta, which is some­thing we’re do­ing, and try to get pa­tients who are ap­pro­pri­ate on ther­a­py. We can’t make firm com­mit­ments right now, I wish we could, but what I can tell you is that Bio­gen does not leave pa­tients in the lurch. We def­i­nite­ly un­der­stand some of our cus­tomers may have con­cerns about that.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.