Trump ad­min­is­tra­tion opens the door to low­er drug prices as Medicare Ad­van­tage plans are pushed to step ther­a­py ap­proach

The Trump ad­min­is­tra­tion has tak­en an­oth­er step to­wards low­er­ing drug costs for con­sumers, this time aim­ing at the mil­lions of mem­bers in Medicare Ad­van­tage plans.

Un­der new rules an­nounced late Tues­day, the ad­min­is­tra­tion is giv­ing these plans the right to set up what’s called step ther­a­py plans for physi­cian-ad­min­is­tered and oth­er Part B drugs. These plans, com­mon­ly used among pri­vate in­sur­ers, man­date that mem­bers use the least ex­pen­sive drugs avail­able for their con­di­tions be­fore mov­ing on to prici­er ther­a­pies if need­ed.

The move came just hours be­fore Pres­i­dent Don­ald Trump told a gath­er­ing of busi­ness ex­ec­u­tives Tues­day night that he was prep­ping an an­nounce­ment next week that would bring down drug prices “re­al­ly sub­stan­tial­ly.” That gath­er­ing re­port­ed­ly in­clud­ed J&J CEO Alex Gorsky, who jumped off of one of the pres­i­dent’s busi­ness ad­vi­so­ry groups af­ter a con­tro­ver­sy brewed up over Trump’s com­ments re­gard­ing a white su­prema­cist ral­ly in Vir­ginia.

As an ex­am­ple of the new Medicare ap­proach, the gov­ern­ment says that step ther­a­py plans — which should roll out Jan­u­ary 1 — can start re­quir­ing mem­bers to use less-ex­pen­sive biosim­i­lars. And half of the sav­ings are in­tend­ed to be passed on to mem­bers.

“For the first time ever, we’re go­ing to un­leash these plans, which are so good at ne­go­ti­at­ing, to try to get dis­counts on Part B drugs,” said HHS Sec­re­tary Alex Azar in an in­ter­view with Bloomberg. “This is a very im­por­tant change in terms of drug pric­ing as well as just in man­ag­ing and mod­ern­iz­ing how Medicare func­tions.”

But ad­vo­cat­ing step ther­a­py ap­proach­es with gener­ic or low-cost pref­er­ences is not nec­es­sar­i­ly the same thing as lever­ag­ing low­er prices.

Azar and Trump have wres­tled com­mit­ments from a long line­up of ma­jor bio­phar­ma com­pa­nies to hold back on any fur­ther price in­creas­es un­til at least the end of this year. That ef­fort was mocked, though, af­ter many of these com­pa­nies had al­ready pushed through price in­creas­es that were al­ready planned for 2018. And De­moc­rats have been push­ing the ad­min­is­tra­tion to sup­port more ag­gres­sive ap­proach­es to al­low­ing Medicare to cre­ate for­mu­la­ries to ne­go­ti­ate for low­er costs.

Ac­cord­ing to the state­ment, this new ap­proach at Medicare is avail­able on­ly for new­ly pre­scribed drugs.

“Un­der the Pres­i­dent’s lead­er­ship, for the first time ever, CMS is bring­ing ne­go­ti­a­tions to physi­cian-ad­min­is­tered drugs and de­liv­er­ing on our promise to low­er drug prices for pa­tients,” said CMS Ad­min­is­tra­tor Seema Ver­ma in a pre­pared state­ment. “For too long, Medicare Ad­van­tage plans have not had the tools to ne­go­ti­ate a bet­ter deal for pa­tients. To­day we be­gin lift­ing those bar­ri­ers so plans can use pri­vate-sec­tor tools to dri­ve down the cost of ex­pen­sive drugs while al­so of­fer­ing new care co­or­di­na­tion and drug ad­her­ence pro­grams, to en­sure that pa­tients are get­ting high qual­i­ty care at low­er cost.”

It’s not sit­ting well with the top play­ers, though. The in­dus­try trade group PhRMA swift­ly pushed back against the ad­min­is­tra­tion’s move.

“PhRMA has se­ri­ous con­cerns with the new CMS guid­ance re­gard­ing Medicare Ad­van­tage cov­er­age of Part B med­i­cines and the im­pli­ca­tions for pa­tients suf­fer­ing from com­plex con­di­tions. Step ther­a­py will de­lay many pa­tients’ ac­cess to med­i­cines they need, in­ter­fere with the pa­tient-physi­cian re­la­tion­ship and in­crease bur­dens on physi­cians to com­ply with new, more com­pli­cat­ed re­quire­ments. The bot­tom line is this guid­ance pri­or­i­tizes the in­ter­ests of mid­dle­men while in­creas­ing out-of-pock­et costs for some pa­tients.”

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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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

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.