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.”

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.