Cum­mings: Trump of­fers a high-five on Medicare drug price ne­go­ti­a­tions, a fed­er­al for­mu­la­ry and im­ports

Rep. Eli­jah Cum­mings came out of a meet­ing with Pres­i­dent Trump on Wednes­day with a high-pow­ered en­dorse­ment on Medicare ne­go­ti­a­tions and an­oth­er chill­ing mes­sage to bio­phar­ma ex­ecs that their day of judg­ment is at hand.

Meet­ing with re­porters af­ter the sit-down, Cum­mings said that Trump had en­thu­si­as­ti­cal­ly backed their plan to re­peal the law that pre­vents the huge fed­er­al agency from bar­gain­ing over drug prices and wants to go even fur­ther than that on price ne­go­ti­a­tions as he de­liv­ers a large dose of pay­back pre­scribed by his base.

Rep. Eli­jah Cum­mings

Trump “felt that they have been treat­ed very un­fair­ly by the drug com­pa­nies and he said that it was some­thing that he re­al­ly wants to do,” Cum­mings added, ac­cord­ing to a re­port from The Hill. “He said that he would join us in push­ing a bill through.”

Re­peal­ing the non-in­ter­fer­ence clause that ties Medicare’s hands is just one part of the for­mu­la, and it’s some­thing that Trump has re­peat­ed­ly promised his sup­port­ers. The dev­il in any bill that gets through Con­gress will be in the de­tails, and Cum­mings — a long­time crit­ic of drug prices — has a plan that the in­dus­try al­ready hates.

In ad­di­tion, Cum­mings says that the pres­i­dent sur­pris­ing­ly ex­pressed sup­port for a bill back­ing low-cost drug im­ports to help com­bat high prices.

In the view of bio­phar­ma’s lob­by­ists, drug prices are un­der con­trol, kept in line by cheap gener­ics that oblit­er­ate drug fran­chis­es once they lose patent pro­tec­tion. And many in the in­dus­try have re­cent­ly pledged to hold back on the big an­nu­al price in­creas­es that have sparked a new de­bate among law­mak­ers. The fi­nal dis­count price that pay­ers cov­er is much less than the pub­lished list price. And the re­al cul­prits be­hind drug in­fla­tion are the mid­dle men who man­age ben­e­fits.

Cum­mings, though, is in­tro­duc­ing a new bill that would blow right through that po­si­tion and push for deep dis­counts, lever­ag­ing the full pow­er of the fed­er­al gov­ern­ment to slash prices.

In ad­di­tion to strik­ing the non-in­ter­fer­ence clause, Cum­mings bill al­so de­mands that Medicare set up a for­mu­la­ry, lever­ag­ing big dis­counts from drug mak­ers who want to get their drugs in front of mil­lions of pa­tients.

In a re­lease, Cum­mings not­ed that the Con­gres­sion­al Bud­get Of­fice de­ter­mined that sim­ply al­low­ing price ne­go­ti­a­tions at Medicare would have lit­tle ac­tu­al ef­fect on prices, but es­tab­lish­ing a for­mu­la­ry would cre­ate a struc­ture en­sur­ing deep dis­counts.

Trump is like­ly to face con­sid­er­able op­po­si­tion from mem­bers of his own par­ty who sup­port the non-in­ter­fer­ence clause. But with an al­ly in the White House who has re­peat­ed­ly at­tacked out­ra­geous drug prices, vow­ing to dereg­u­late drug de­vel­op­ment in or­der to re­duce the cost of R&D, De­moc­rats may be close to achiev­ing some­thing they could nev­er get un­der Barack Oba­ma.

Ex­act­ly what that brand of dereg­u­la­tion will ac­tu­al­ly look like re­mains in the air, along with Trump’s pick for FDA com­mis­sion­er. But we should know a lot more on that score in the next few weeks. Un­til then, we’re left with Trump’s most re­cent tweet on the top­ic of drug prices.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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