Sen. Joe Manchin (D-W.Va.) (Francis Chung/E&E News/POLITICO via AP Images)

Manchin plays spoil­er again, but drug pric­ing re­forms re­main on the ta­ble

West Vir­ginia De­mo­c­rat Sen. Joe Manchin has made loud and clear how much his sin­gle vote mat­ters for the Sen­ate Dems, and their even 50-50 split with Re­pub­li­cans, once again lay­ing guardrails around a rec­on­cil­i­a­tion pack­age that could pass with that sim­ple ma­jor­i­ty — thanks to VP Ka­mala Har­ris.

But for the for­mer My­lan CEO’s fa­ther, Manchin’s al­ready forged an agree­ment on drug pric­ing re­forms, which his daugh­ter’s for­mer in­dus­try group of­fi­cial­ly op­pos­es. The CBO has since pro­ject­ed the new ne­go­ti­a­tions will save the fed­er­al gov­ern­ment $288 bil­lion through 2031, a far cry from Nan­cy Pelosi’s HR 3, but could re­duce drug­mak­ers’ po­ten­tial out­put of about 1,300 to­tal drug ap­provals over 30 years by about 10 drugs.

A Manchin spokesper­son told the New York Times that he hasn’t walked away from the ne­go­ti­at­ing ta­ble but the Wash­ing­ton Post and the Times both re­port­ed last night that Manchin has de­cid­ed to cut out cli­mate and tax pro­vi­sions from the pack­age, which “dealt a crush­ing blow to Pres­i­dent Biden’s do­mes­tic agen­da, ef­fec­tive­ly rul­ing out ac­tion on any­thing be­yond pre­scrip­tion drug pric­ing and health care sub­si­dies.”

Sen­ate Dems last week un­veiled their new Medicare drug price ne­go­ti­a­tions bill, which be­gin­ning in 2026 would al­low for the ne­go­ti­a­tion of 10 el­i­gi­ble drug prices, and build up to 20 by 2029.

As news of the bill broke, com­pa­nies con­tin­ued with their typ­i­cal mid-year price in­creas­es, with dozens rais­ing 112 whole­sale ac­qui­si­tion cost, or WAC, prices. By com­par­i­son, in Ju­ly 2012, there were 397 WAC price in­creas­es, ac­cord­ing to new 46brook­lyn re­search da­ta.

More re­cent­ly, com­pa­nies have pledged to stay be­low the 10% in­crease thresh­old, and Pfiz­er on Ju­ly 1 no­tably raised three drugs more than any oth­ers so far this month, with 10% price in­creas­es for Ben­zylpeni­cillin, al­so known as peni­cillin G, blood pres­sure drug Cor­lopam, and its blood thin­ner Frag­min.

The gener­ic drug in­dus­try group, the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines and its Biosim­i­lars Coun­cil an­nounced its op­po­si­tion to the new Sen­ate pric­ing re­forms, say­ing they will in­crease risks for gener­ic and biosim­i­lar man­u­fac­tur­ers as the com­pa­nies will have “no way to know whether a brand-name drug will be se­lect­ed for ne­go­ti­a­tion or what the ne­go­ti­at­ed price may be” un­til well af­ter a copy­cat’s de­vel­op­ment would need to al­ready be­gin.

If the Sen­ate price ne­go­ti­a­tion bill pass­es, com­pa­nies that don’t com­ply with the new prices can be as­sessed penal­ties of up to $1 mil­lion per day, ac­cord­ing to the bill text. And any man­u­fac­tur­er that “know­ing­ly pro­vides” false in­for­ma­tion al­so can be sub­ject to fines of $100 mil­lion per in­frac­tion.

The Sen­ate pro­pos­al, which mir­rors the pre­vi­ous ef­forts in the Build Back Bet­ter Act, which Manchin pre­vi­ous­ly tor­pe­doed, would al­so cap se­niors’ drug costs un­der Medicare at $2,000 an­nu­al­ly, but it no­tice­ably does not in­clude a $35 month­ly cap on in­sulin costs for those with in­sur­ance, which Sen. Chuck Schumer (D-NY) has twice pledged to vote on.

The CBO yes­ter­day re­vealed that the Sen­ate in­sulin cap would cost the fed­er­al gov­ern­ment $23 bil­lion over the next decade, which came to about dou­ble what the House ver­sion would cost, ex­plain­ing:

CBO es­ti­mat­ed that H.R. 6833 would have no net ef­fect on the fed­er­al deficit over 10 years and that the in­sulin-re­lat­ed pro­vi­sions of the bill would in­crease fed­er­al deficits by $11.4 bil­lion over that pe­ri­od. This es­ti­mate for the Sen­ate leg­is­la­tion re­flects the dif­fer­ences be­tween the two bills in­clud­ing an es­ti­mat­ed in­crease in the av­er­age net price of in­sulin re­sult­ing from the cer­ti­fi­ca­tion process, an es­ti­mat­ed in­crease in Med­ic­aid spend­ing re­sult­ing from a re­duc­tion in re­bates paid by in­sulin man­u­fac­tur­ers, and changes to lim­its on cost shar­ing. The Sen­ate leg­is­la­tion al­so does not in­clude the pro­vi­sions that would de­lay im­ple­men­ta­tion of the rule re­lat­ed to man­u­fac­tur­er re­bates.

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.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,200+ biopharma pros reading Endpoints daily — and it's free.

European Commissioner for Health Stella Kyriakides (AP Photo/Francisco Seco, Pool)

One fi­nal push: EU phar­ma in­dus­try group de­mands com­pe­ti­tion check on in­com­ing leg­isla­tive over­haul

The Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) this morning called on the European Commission to ensure that it adequately assesses how its re-writing of the 20+-year-old pharma legislation, which is due to be released before the end of the month, damages the competitiveness of the pharma industry.

EFPIA’s opposition to the changes has lingered since the beginning, and its latest estimate is that the rewritten legislation could cost the industry €640 million ($688 million).

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.