When Medicare be­gins ne­go­ti­at­ing prices for some of the most ex­pen­sive drugs in 2026, Har­vard re­searchers are call­ing on CMS to en­sure they are not pay­ing more than what they would for rea­son­able ther­a­peu­tic al­ter­na­tives.

The call comes as new re­search pub­lished in JA­MA on Tues­day by co-au­thors from Har­vard’s Pro­gram on Reg­u­la­tion, Ther­a­peu­tics, and Law (POR­TAL) shows that 55% of the top-sell­ing Medicare drugs in 2020 “had a low added ther­a­peu­tic rat­ing,” ac­cord­ing to health tech­nol­o­gy as­sess­ments from Ger­many, Cana­da and France.

“De­spite lim­it­ed or no ev­i­dence that these drugs of­fer ben­e­fits to pa­tients over ex­ist­ing treat­ments, these 27 drugs ac­count­ed for 11% of net Medicare pre­scrip­tion drug spend­ing in 2020,” they wrote.

The re­searchers called on the fed­er­al gov­ern­ment to a bet­ter job of un­der­stand­ing what its for­eign coun­ter­parts pay for cer­tain drugs, and how rat­ings by these HTA or­ga­ni­za­tions could be used in CMS’ ne­go­ti­a­tion process.

“Con­gress should pass leg­is­la­tion to fund an HTA body that seeks to rep­re­sent our val­ues and pri­or­i­ties as Amer­i­cans and its as­sess­ments are used to in­form cov­er­age de­ci­sions by our var­i­ous pub­lic pay­ers (e.g., VA, CMS, etc.),” study co-au­thor Alexan­der Egilman told End­points News via email, adding:

I’d like to see such a body con­duct its own as­sess­ments, but it could cer­tain­ly use the work of ICER as well as HTA or­ga­ni­za­tions in oth­er coun­tries to help in­form such as­sess­ments. Pri­or to the es­tab­lish­ment of a na­tion­al HTA body, as­sess­ments by ICER and promi­nent for­eign HTAs could be used by CMS, state pre­scrip­tion drug af­ford­abil­i­ty boards, and oth­er stake­hold­ers to in­form their cov­er­age de­ci­sions and price ne­go­ti­a­tions, par­tic­u­lar­ly when there is con­sen­sus across mul­ti­ple HTA bod­ies.

For 2026, the first year of the ne­go­ti­a­tions, HHS will se­lect 10 Part D high-ex­pen­di­ture, sin­gle-source drugs for ne­go­ti­a­tion. An ad­di­tion­al 15 Part D drugs will be added for ne­go­ti­a­tion in 2027, and then 15 more Part B or Part D drugs will be ne­go­ti­at­ed in 2028, lead­ing up to adding 20 more Part B or Part D drugs for 2029 and sub­se­quent years.

How this most­ly non-pub­lic, po­ten­tial­ly year-long drug price ne­go­ti­a­tion process will work: Be­gin­ning Oct. 2, 2023, se­lect drug­mak­ers in­clud­ed in this top 10 list (pub­lished Sept. 1) will have to sign an agree­ment with CMS and con­fi­den­tial­ly pro­vide in­for­ma­tion on R&D costs, and the ex­tent to which these costs have been re­couped (aban­doned and failed drug costs will be con­sid­ered), as well as unit costs of pro­duc­tion and dis­tri­b­u­tion, fed­er­al fi­nan­cial sup­port for the drug’s dis­cov­ery and de­vel­op­ment, da­ta on pend­ing and ap­proved patent ap­pli­ca­tions and ex­clu­siv­i­ties, da­ta on rev­enue and sales vol­ume, and more.

But Re­pub­li­cans and in­dus­try have raised con­cerns with the process and re­cent guid­ance, vow­ing to re­peal the leg­is­la­tion. Rep. Chip Roy (R-TX) said to­day he wants a re­peal of the IRA to be in­clud­ed in any debt lim­it ex­ten­sion leg­is­la­tion.

Oth­er Re­pub­li­can lead­ers in the House and Sen­ate sent a let­ter late last week to HHS and CMS chiefs to ex­press their “dis­ap­point­ment and con­cern with re­cent im­ple­men­ta­tion guid­ance for the drug price-set­ting pro­vi­sions in­clud­ed in the In­fla­tion Re­duc­tion Act.”

PhRMA even went so far as to call part of the guid­ance un­con­sti­tu­tion­al.

But JA­MA co-au­thor Aaron Kessel­heim told End­points via email that more work needs to be done in this space as “an Ex­ec­u­tive Or­der or new leg­is­la­tion could cre­ate a pan­el to pro­vide rapid-turn­around ev­i­dence-based re­ports on new drugs’ added clin­i­cal val­ue. It should not be hard to find the re­sources for such an im­por­tant en­deav­or. Every­one who be­lieves that mar­ket­places func­tion best with more in­for­ma­tion should sup­port this idea.”

Sim­i­lar­ly, a pa­per pub­lished in JA­MA In­ter­nal Med­i­cine this week called on Con­gress to pur­sue fu­ture ex­pan­sions of Medicare price ne­go­ti­a­tion, re­lax cer­tain el­i­gi­bil­i­ty cri­te­ria and use net spend­ing when se­lect­ing drugs for its ne­go­ti­a­tions in or­der to “sub­stan­tial­ly in­crease es­ti­mat­ed sav­ings.”

Vaxcyte is set to raise $500 million via a stock sale to fund its work on a pneumococcal vaccine it hopes can supplant Pfizer’s Prevnar 20.

The San Carlos, CA biotech plans to use the money to fund the Phase III program in older adults for VAX-24, its 24-valent pneumococcal vaccine that has each of the the 20 serotypes in Prevnar 20, plus four more. It also plans to build up its manufacturing process and capacity for an initial launch of the vaccine, according to an SEC prospectus.

Cancer diagnostics and genomic profiler Foundation Medicine is laying off about 135 staffers, the company disclosed earlier this month.

The Roche subsidiary, valued at about $5.3 billion when the Swiss Big Pharma fully bought it out a few years ago, has liquid- and tissue-based biopsy tests approved by the FDA for various solid tumors and works with biopharma partners on companion diagnostics for their clinical trials, including Bristol Myers Squibb.

GSK is dishing out $2 billion to acquire Bellus Health, the British pharma giant announced Tuesday morning, stoking more M&A buzz amid a widespread slowdown for biotech dealmaking.

In offering $14.75 per share — a 103% premium to Bellus’ closing price on Monday — GSK is buying its way into a blockbuster rivalry with Merck. For years, Bellus Health has built its story around challenging giant Merck in developing a P2X3 receptor antagonist to treat chronic cough. Now, it’s up to GSK to prove Bellus’ camlipixant — provided the Phase III data do turn up positive.

Eisai is teaming up with a group of head and neck cancer advocates to draw attention to the under-recognized condition. The “Made of More” campaign uses interactive artwork with a click-to-reveal feature to read about six different people affected by head and neck cancer (HNC).

The people profiled include men and women varying in age and include both patients and caregivers. One young woman Allison, for instance, talks about her experience as a caregiver to her husband while also managing a career and child, eventually turning her non-profit group for caregivers into a full-time job.

Welcome to the mRNAge. That’s the idea behind Moderna’s new global corporate advertising campaign launching today.

In the debut TV commercial, a red string turns into a ribbon and weaves its way through a series of vignettes crisscrossing Moderna’s mRNA technology.  For example, a pregnant woman riding the subway is a nod to its work in cytomegalovirus (CMV), while a teenage boy playing video games with friends in a hospital bed signals its ambitions in rare disease. A woman ringing a bell after treatment connects to its cancer work, while young African girls playing soccer and a man driving a race car represent its global and speedy work in vaccines.

ORLANDO – Two years after Amgen won approval for a drug going after one of cancer’s most frustrating genetic targets, researchers believe they’re finally beginning to scratch the surface of the class’ potential.

The target, known as KRAS, is a protein regulating how cells grow and divide. Mutations can cause the protein to get stuck in the “on” position, triggering uncontrolled malignant cell growth. The first generation of KRAS inhibitors, which include Amgen’s Lumakras (sotorasib) and Mirati’s Krazati (adagrasib), target a mutation called G12C to lock the protein in “off” mode.

Gilde Healthcare, a Dutch investment firm out to back healthcare companies that can bring new products to the market at affordable prices, has another €600 million (close to $657 million) to bet on a new slate of companies.

As with its previous funds, Gilde will continue to look across Europe and North America for companies working on digital healthcare, medical technology and therapeutics — a “holistic approach” that can lead to the “most optimal and cost-effective solution for the individual patient,” according to managing partner Pieter van der Meer.

Many have wondered how the biopharma industry might take CMS to court over its new drug price negotiations plans, and lobbying group PhRMA offered a hint with a new comment on the implementation of the negotiation provisions of the Inflation Reduction Act.

The section of the guidance in question, known as Section 40.2.2, tells biopharma manufacturers that CMS intends to require that all info received during the negotiation period from CMS “shall be destroyed within 30 days of a determination by CMS that the drug or biologic no longer qualifies as a selected drug, except as may be required by applicable state or federal law.”