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

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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