Large coali­tion joins drug lob­by in de­nounc­ing Trump pro­pos­al to im­port drug prices for Medicare

Trump’s Oc­to­ber pro­pos­al to peg drug prices to over­seas rates for Medicare ben­e­fi­cia­ries has elicit­ed the ire of not just the all-pow­er­ful bio­phar­ma lob­by, but al­so a large coali­tion rep­re­sent­ing 339 or­ga­ni­za­tions which ear­li­er this week de­tailed their con­cern, deem­ing the pro­pos­al an “un­prece­dent­ed, manda­to­ry ex­per­i­ment” that could ir­repara­bly af­fect the 59 mil­lion Amer­i­cans who re­ly on the Medicare Part B pro­gram.

The HHS pro­pos­al — de­signed to save Medicare more than $17 bil­lion over five years — was re­vealed in late Oc­to­ber ahead of a con­tentious mid-term bat­tle. As part of the plan, the agency out­lined an “in­ter­na­tion­al pric­ing in­dex (IPI)” in which prices for drugs uti­lized by Medicare — the world’s largest drug pur­chas­er — would be bench­marked against oth­er na­tions, in­stead of the way drugs are cur­rent­ly priced: by cal­cu­lat­ing the av­er­age sales price and adding 6% for the providers who man­age the drug sup­ply. Es­sen­tial­ly, in­stead of al­low­ing cheap­er drugs to be im­port­ed in­to the Unit­ed States, Trump’s ba­sic plan is to hold on to the drugs and im­port the price.

Da­ta sug­gests that the Unit­ed States spends near­ly twice as much as 10 high-in­come coun­tries on health care — dri­ven by high cost of la­bor and goods, in­clud­ing phar­ma­ceu­ti­cals and de­vices — but ac­tu­al­ly per­forms worse on a num­ber of pop­u­la­tion health out­comes.

Fac­ing an un­prece­dent­ed change to the sta­tus quo by the po­ten­tial im­po­si­tion of for­eign price con­trols on US shores did not, un­sur­pris­ing­ly, in­spire cheer from the drug lob­by, with PhRMA and BIO is­su­ing state­ments dis­play­ing their con­tempt for the plan. On Mon­day, the Part B Ac­cess for Se­niors and Physi­cians (ASP) coali­tion wrote to top Wash­ing­ton law­mak­ers ex­press­ing con­cern that the mod­el would be a net neg­a­tive for pa­tients and providers, but like­ly a pos­i­tive for the bot­tom lines of ven­dors such as PBMs.

“Use of for­eign pay­ment poli­cies risks im­port­ing ac­cess de­lays to Medicare ben­e­fi­cia­ries, lim­it­ing pa­tient choice of provider, and po­ten­tial­ly im­ped­ing de­vel­op­ment of more ef­fec­tive med­i­cines for pa­tients. The pro­posed mod­el would put ven­dors with no clin­i­cal or med­ical ex­per­tise be­tween pa­tients and doc­tors. Ven­dors would in­evitably im­pose re­stric­tions on ben­e­fi­cia­ry ac­cess to drugs through for­mu­la­ries, dis­rupt­ing or de­lay­ing care in the pur­suit of prof­it,” they wrote.

The IPI mod­el could al­so slash ac­cess to treat­ment, they said, cit­ing a re­cent analy­sis that sug­gests the Unit­ed King­dom’s NICE en­sured near­ly 92% of on­col­o­gy treat­ments were sub­ject­ed to ac­cess re­stric­tions be­tween 2013 and 2017.

How­ev­er, de­spite hav­ing faster ac­cess to treat­ment in the Unit­ed States, crit­ics have ar­gued that a num­ber of drugs that are sanc­tioned ap­proval by the FDA do not con­fer large enough ef­fi­ca­cy im­prove­ments over ex­ist­ing med­ica­tions to war­rant the prices they com­mand, which ex­plains why agen­cies such as NICE de­lay or re­ject their do­mes­tic adop­tion.

Trump has long chas­tised drug­mak­ers for “get­ting away with mur­der,” and this pro­pos­al is one of the two that have been re­leased in re­cent months. But Trump’s gen­er­al brava­do against the phar­ma in­dus­try may not nec­es­sar­i­ly trans­late to ma­te­r­i­al change. In the first nine months of 2018, there were 96 price hikes for every price cut, ac­cord­ing to an analy­sis by the As­so­ci­at­ed Press pub­lished this Sep­tem­ber, and more re­cent­ly Pfiz­er $PFE said it planned to in­crease prices on 41 of its drugs in Jan­u­ary.


Im­age: Don­ald Trump. WHITE HOUSE BROAD­CAST

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.