Sen. Bernie Sanders (Michael Brochstein/Sipa via AP Images)

‘A mess across the board’: Sen­ate com­mit­tee kicks off talks on drug pric­ing re­forms

The US is still the on­ly coun­try in the world that doesn’t ne­go­ti­ate phar­ma­ceu­ti­cal prices across the board, ex­perts told a Sen­ate com­mit­tee on Tues­day, but how ex­act­ly to fix that re­mains un­clear and few of the so­lu­tions dis­cussed will sur­prise any­one watch­ing the pric­ing de­bate play out over the last decade.

Set­ting the tone for the hear­ing, which fea­tured com­ments from a type 1 di­a­betes pa­tient, Elia Spates, who has seen her in­sulin costs triple over about a decade, Sen. Bernie Sanders (I-VT) honed in on the fact that Spates is not alone, and 1 out of 5 Amer­i­cans could not af­ford their pre­scrip­tion drugs last year.

“How crazy is that?” he asked rhetor­i­cal­ly.

Sanders re­cent­ly in­tro­duced three bills co-spon­sored by oth­er De­moc­rats to tack­le drug prices, of­fer­ing re­cy­cled ideas on peg­ging the price of drugs in the US to for­eign coun­tries’ prices (an idea al­so float­ed by for­mer Pres­i­dent Trump), al­low­ing HHS to ne­go­ti­ate drug prices un­der Medicare Part D (which has been de­bat­ed for more than a decade), and al­low­ing drug im­ports from Cana­da (which is al­ready on­go­ing).

Aaron Kessel­heim

Ex­perts at the hear­ing of­fered their own so­lu­tions for what should be done. Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, ex­plained a more de­tailed ap­proach – call­ing for the US to eval­u­ate new drugs up­front based on a re­view of their clin­i­cal ben­e­fits and then al­low­ing the gov­ern­ment to ne­go­ti­ate prices based on their find­ings. He al­so called for the fed­er­al gov­ern­ment to crack down on price in­creas­es “well be­yond in­fla­tion,” and to en­sure that patents for new med­i­cines are le­git­i­mate.

“The phar­ma­ceu­ti­cal lob­by is large and well-fund­ed and will ar­gue that any re­duc­tion in rev­enues will harm in­no­va­tion. But most drugs ap­proved each year are not tru­ly in­no­v­a­tive and in a re­view of 2017 new ap­provals, on­ly a mi­nor­i­ty of those re­viewed by in­de­pen­dent ex­pert bod­ies of­fered more than min­i­mal clin­i­cal ad­van­tages over avail­able treat­ments,” he said in his writ­ten tes­ti­mo­ny.

But De­moc­rats hold a ra­zor-thin ma­jor­i­ty in the Sen­ate, mean­ing Re­pub­li­cans will need to be won over to get a stand­alone bill passed.

Alex Law­son, the ex­ec­u­tive di­rec­tor of So­cial Se­cu­ri­ty Works who’s been work­ing be­hind the scenes on drug pric­ing on Capi­tol Hill, told End­points News in a phone in­ter­view that he thinks ma­jor drug pric­ing re­forms will be tagged on­to an­oth­er in­fra­struc­ture bill, which has to hap­pen be­fore Sep­tem­ber, be­cause it would be im­pos­si­ble for the De­moc­rats to get 60 votes to pass a stand­alone bill.

Alex Law­son

“I think ne­go­ti­a­tion will be the heart of what it is – some form of ne­go­ti­a­tion,” he said. “In­dus­try thinks that they won’t have to deal with ex­tra­or­di­nar­i­ly high drug prices be­cause the vac­cines are turn­ing the cor­ner on this pan­dem­ic, and I think they’re sore­ly mis­tak­en.”

The idea of hav­ing the sav­ings from high drug prices pay for new in­fra­struc­ture is al­so at­trac­tive to De­moc­rats, he not­ed.

But some Re­pub­li­cans, hes­i­tant to harm a biotech ecosys­tem that is flour­ish­ing and has brought the US mul­ti­ple Covid-19 vac­cines in less than a year, fo­cused their com­ments Tues­day on ways to re­duce pa­tients’ out-of-pock­et ex­pens­es with­out hurt­ing drug­mak­ers’ bot­tom lines, as well as ways to in­crease trans­paren­cy and en­sure re­bates end up in pa­tients’ pock­ets.

Louisiana Re­pub­li­can Bill Cas­sidy al­so ex­pressed con­cerns about the fed­er­al gov­ern­ment set­ting drug prices uni­lat­er­al­ly, which could have a chill­ing ef­fect on VCs that fund the work that takes a com­pound from the bench to a tri­al, and are ex­pect­ing a re­turn on their in­vest­ments.

Re­pub­li­can Su­san Collins of Maine not­ed she hopes Con­gress can find com­mon ground on the is­sue of drug prices be­cause “when a doc­tor pre­scribes a need­ed med­ica­tion, an in­sur­mount­able is­sue should not be the cost.”

In­di­ana Re­pub­li­can Mike Braun, how­ev­er, went in the oth­er di­rec­tion and in­di­cat­ed a will­ing­ness to let the gov­ern­ment step in, call­ing the cur­rent drug pric­ing sys­tem “a mess across the board.” He al­so said of the phar­ma­ceu­ti­cal in­dus­try, “There is no oth­er sec­tor of our econ­o­my that has less trans­paren­cy, less com­pe­ti­tion and more bar­ri­ers to en­try and dis­en­gaged con­sumers. One al­ter­na­tive is to bring in gov­ern­ment.”

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.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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