CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As Pres­i­dent Biden’s Build Back Bet­ter Act — and, with it, po­ten­tial­ly the De­moc­rats’ last shot at ma­jor drug pric­ing re­forms in the fore­see­able fu­ture — re­mains on life sup­port, the Con­gres­sion­al Bud­get Of­fice isn’t help­ing their case.

The CBO last week re­leased a new slide deck, out­lin­ing an up­date to its mod­el on how Medicare ne­go­ti­a­tions might take a bite out of new drugs mak­ing it to mar­ket. The new mod­el es­ti­mates a 10% long-term re­duc­tion in the num­ber of new drugs, where­as a pre­vi­ous CBO re­port from Au­gust es­ti­mat­ed that 8% few­er new drugs will en­ter the mar­ket over 30 years.

“The re­sults dif­fer from the re­sults of the Au­gust 2021 work­ing pa­per be­cause of tech­ni­cal im­prove­ments to the mod­el that now al­low it to ac­count for,” CBO said, not­ing three new fac­tors: “the pol­i­cy’s ef­fects on fi­nanc­ing costs, its ef­fects on de­ci­sions made dur­ing pre­clin­i­cal de­vel­op­ment, and an ac­cel­er­at­ed ap­proval process.”

Like the up­dat­ed mod­el, that pri­or re­port eval­u­at­ed House Speak­er Nan­cy Pelosi’s drug pric­ing pro­vi­sions, which were gen­er­al­ly the ba­sis for what’s in­clud­ed in the BB­BA, and which CBO said pre­vi­ous­ly would re­sult in 59 few­er new drugs over three decades.

Un­der the new mod­el, the pric­ing pro­vi­sions would have lit­tle ef­fect in the first decade af­ter the bill’s en­act­ment, CBO says, but a 10% re­duc­tion over the long run would mean that where­as the old mod­el saw 34 few­er drugs in the third decade, this new mod­el would see 40 few­er drugs.

The new mod­el al­so shows how drugs ap­proved un­der the FDA’s ac­cel­er­at­ed ap­proval pro­gram would see larg­er de­creas­es in ear­li­er phase tri­als com­pared to drugs ob­tain­ing a stan­dard ap­proval.

What this up­dat­ed CBO mod­el means in terms of the like­li­hood that drug pric­ing pro­vi­sions are en­act­ed re­mains un­known. Just be­fore Christ­mas, Sen. Joe Manchin de­railed De­moc­rats’ ef­forts to fin­ish what the House had start­ed and pass the BB­BA, but he has main­tained his sup­port for the drug pric­ing pro­vi­sions.

Alex Law­son

Alex Law­son, ex­ec­u­tive di­rec­tor of So­cial Se­cu­ri­ty Works who has worked close­ly on the Hill on the BB­BA, told End­points News that he thinks the drug pric­ing pro­vi­sions will re­main in what­ev­er scaled back leg­is­la­tion that even­tu­al­ly gets passed, be­cause Medicare ne­go­ti­a­tions are “one of the most sol­id pro­vi­sions” in the tril­lion-dol­lar-plus pack­age.

“Noth­ing has re­al­ly changed for 4 or 5 months. Just con­tin­ue ne­go­ti­at­ing for Manchin’s vote,” he said. But he al­so warned that if De­moc­rats try to pass Medicare ne­go­ti­a­tions as a stand­alone bill, that would like­ly end up as “a very big fail­ure.”

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.”

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.

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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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.

Sen. Bill Cassidy (R-LA) (J. Scott Applewhite/AP Images)

Sen­ate un­veils its ver­sion of ac­cel­er­at­ed ap­proval re­forms as bi­par­ti­san duo calls on FDA and PTO to work to­geth­er

The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff.

While Sen. Richard Burr (R-NC) warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.

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