Joe Biden on the North Lawn of the White House, April 27, 2020 (Evan Vucci/AP Images)

Opin­ion: Mean­ing­ful drug pric­ing re­forms are head­ed nowhere fast

Pres­i­dent Biden is tak­ing a page out of for­mer Pres­i­dent Trump’s drug pric­ing play­book: of­fer big promis­es around tough ne­go­ti­a­tions with drug­mak­ers, but fail to of­fer a vi­able path for get­ting it done.

Warn­ing signs that drug pric­ing would no longer be a pri­or­i­ty for the pres­i­dent’s mar­quee leg­is­la­tion came over the past week from the Wash­ing­ton Post and Wall Street Jour­nal. To the cha­grin of House Speak­er Nan­cy Pelosi (D-CA) and oth­er De­moc­rats, Pres­i­dent Biden’s mas­sive, $1.8 tril­lion so­cial safe­ty net plan to help Amer­i­can fam­i­lies, de­tails of which were un­veiled Wednes­day morn­ing, does not in­clude a ma­jor push to cur­tail drug prices.

Al­though Biden is sup­posed to of­fer more specifics in his speech to Con­gress tonight, in­clud­ing a de­mand for leg­is­la­tion on price ne­go­ti­a­tions this year, stand­alone leg­is­la­tion on ne­go­ti­a­tions is not like­ly to make head­way in the dead­locked Sen­ate, es­pe­cial­ly if it needs 60 votes for pas­sage.

Biden whiffed on an op­por­tu­ni­ty to spell out what he wants in writ­ing.

“Pres­i­dent Biden has a plan to build on the Af­ford­able Care Act and low­er pre­scrip­tion drug costs for every­one by let­ting Medicare ne­go­ti­ate prices,” the White House said Wednes­day. That was the on­ly men­tion of drug prices in the White House fact sheet on the safe­ty net over­haul.

Se­nior Biden of­fi­cials tried to down­play this gap­ing hole where Biden should ex­plain what he wants on drug prices, telling re­porters on a call on Tues­day evening that Biden “has been very, very clear that he re­mains ful­ly com­mit­ted to ne­go­ti­a­tions to re­duce pre­scrip­tion drug prices — that, you will hear him re­it­er­ate as a very top pri­or­i­ty and some­thing he deems ur­gent.”

But the broad­er nar­ra­tive is that drug pric­ing as a pri­or­i­ty is slip­ping, and no one knows why ex­act­ly, con­sid­er­ing the sup­port from House and Sen­ate De­moc­rats and even some Re­pub­li­cans. Per­haps the phar­ma­ceu­ti­cal lob­by has al­ready got­ten to Biden? Per­haps the Biden team doesn’t want to pun­ish drug­mak­ers af­ter how quick­ly they were able to de­vel­op Covid vac­cines?

What­ev­er the rea­son, those as­sur­ances from se­nior staffers mean very lit­tle as the House and Sen­ate re­main di­vid­ed on how to pur­sue drug prices. House De­moc­rats last week rein­tro­duced their land­mark (or dead in the wa­ter, de­pend­ing on which par­ty you lis­ten to) drug pric­ing bill, HR 3, which passed along par­ty lines in the House in De­cem­ber 2019 but was nev­er con­sid­ered by the Sen­ate.

At­tempts to re­vive that bill and oth­ers will be­gin in earnest next week at a House En­er­gy & Com­merce Com­mit­tee hear­ing. But if drug pric­ing leg­is­la­tion is re­al­ly go­ing to make head­way, the Sen­ate will need to weigh in.

Some Sen­ate Re­pub­li­cans have al­ready raised red flags about gov­ern­ment price ne­go­ti­a­tions (even as the US is the on­ly coun­try in the world to not ne­go­ti­ate) and fo­cused their plans in­stead on low­er­ing out-of-pock­et costs.

How the leg­is­la­tion makes it across the fin­ish line re­mains murky, but the need for such leg­is­la­tion is as clear as ever.

A new GAO analy­sis on Wednes­day found that for 20 brand-name drugs in 2020, es­ti­mat­ed US prices paid at the re­tail lev­el by con­sumers and oth­er pay­ers (such as in­sur­ers) were more than two to four times high­er than prices in Aus­tralia, Cana­da and France.

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.

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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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Alaa Halawa, 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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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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