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

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.