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.

Bren­dan Man­quin

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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.