Fight! Trump kicks off a war of words with the drug lob­by, propos­ing to peg Medicare prices to over­seas rates

Pres­i­dent Don­ald Trump has just fired an­oth­er shot across the bow of the glob­al bio­phar­ma in­dus­try. And the in­dus­try quick­ly fired back in what promis­es to be a live­ly bat­tle over drug prices.

Bioreg­num Opin­ion Col­umn by John Car­roll

Trump’s HHS pro­posed Thurs­day af­ter­noon to drop the cur­rent way that Medicare cov­ers drugs un­der Part B — cal­cu­lat­ing the av­er­age sales price and adding 6% to the providers who man­age the drug sup­ply — and switch to a new sys­tem that pegs US prices against the much low­er rates that have been es­tab­lished by sin­gle-pay­er sys­tems abroad.

With just days to go ahead of the mid-term elec­tion, Trump pro­posed a pi­lot pro­gram cov­er­ing half of the Part B spend, with the gov­ern­ment mov­ing to an av­er­age bas­ket price cal­cu­lat­ed from sin­gle pay­ers abroad at a 20% dis­count per year over 5 years. 

Trump is out to kill a whole flock of birds with one stone. 

First, he’s ac­cused oth­er coun­tries of free­load­ing on the US, ne­go­ti­at­ing ar­ti­fi­cial­ly low­er drug prices cov­ered by a well-doc­u­ment­ed US pre­mi­um. If man­u­fac­tur­ers are held li­able for their for­eign pric­ing, of­ten set af­ter some hard bar­gain­ing that can in­clude a re­fusal to cov­er it at all, they’d be less like­ly to of­fer a deep dis­count abroad. That could pres­sure oth­er coun­tries to pay more.

Sec­ond, he’s promis­ing to sig­nif­i­cant­ly re­duce heavy Medicare spend­ing, lop­ping bil­lions of dol­lars off of drug costs.

And third he’s mov­ing to a new sys­tem that would be­gin to force com­pa­nies to cut prices af­ter re­peat­ed­ly ac­cus­ing them of “get­ting away with mur­der” on drug prices in the US.

In­stead of a con­tro­ver­sial at­tempt to al­low cheap­er drugs to be im­port­ed in­to the US, Trump is say­ing he wants to keep the drugs and im­port the price. In this in­dus­try, that’s rad­i­cal.

Iron­i­cal­ly, the pro­pos­al that Trump came up with fol­lows a sea change in the in­dus­try’s at­ti­tudes to­ward pric­ing in the US, which con­trols the fate of its prof­itabil­i­ty. Start­ing with Pfiz­er, Trump has forced the ma­jors to at least pause their steady march to high­er prices. For many, the prospect of leav­ing their port­fo­lio prices in place would put tremen­dous pres­sure on their promis­es to in­vestors who con­trol their stock prices. And that would leave many to do some­thing they have nev­er done: ef­fi­cient­ly de­vel­op new block­busters in their R&D groups.

You can al­so ex­pect plen­ty of kick­back from the provider side of the equa­tion, who won’t like the new ven­dor sys­tem that would in­sti­tute a new sys­tem with flat fees for man­ag­ing drug sup­plies. For years physi­cians and the groups who rep­re­sent them slap back at changes that could im­pact their in­come by vow­ing to quit Medicare and leave poor pa­tients on their own.

Faced with a pro­pos­al that could start to shift the US to a new ap­proach dic­tat­ed by the sin­gle-pay­er pric­ing sys­tem — the in­dus­try’s night­mare — PhRMA and BIO came out against the pro­pos­al with all guns blaz­ing.

From PhRMA:

The ad­min­is­tra­tion is im­pos­ing for­eign price con­trols from coun­tries with so­cial­ized health care sys­tems that de­ny their cit­i­zens ac­cess and dis­cour­age in­no­va­tion. These pro­pos­als are to the detri­ment of Amer­i­can pa­tients. The Unit­ed States has a com­pet­i­tive mar­ket­place that con­trols costs and pro­vides pa­tients with ac­cess to in­no­v­a­tive med­i­cines far ear­li­er than in coun­tries with price con­trols, and it’s why we lead the world in drug dis­cov­ery and de­vel­op­ment. Amer­i­cans have ac­cess to can­cer med­i­cines on av­er­age about two years ear­li­er than in de­vel­oped coun­tries like in the Unit­ed King­dom, Ger­many and France.

The pro­posed Medicare Part B mod­el would jeop­ar­dize ac­cess to med­i­cines for se­niors and pa­tients with dis­abil­i­ties liv­ing with dev­as­tat­ing con­di­tions such as can­cer, rheuma­toid arthri­tis and oth­er au­toim­mune dis­eases. The ad­min­is­tra­tion’s pro­pos­al will al­so hin­der pa­tient ac­cess by se­vere­ly al­ter­ing the mar­ket-based Medicare Part B pro­gram by re­duc­ing physi­cian re­im­burse­ment and in­sert­ing mid­dle­men be­tween pa­tients and their physi­cians.

BIO’s Jim Green­wood had this to say:

Con­trary to the pres­i­dent’s re­peat­ed promis­es to end ‘for­eign free-load­ing,’ this pro­pos­al em­braces it and ex­ac­er­bates its harm­ful ef­fects. By adopt­ing for­eign price con­trols on the very small num­ber of in­no­v­a­tive med­i­cines that make it to mar­ket, this pro­pos­al will se­vere­ly chill in­vest­ment in new cures and ther­a­pies for Amer­i­ca’s se­niors.

To make mat­ters worse, the pro­pos­al con­tin­ues a trou­bling trend to­wards un­der­min­ing the Medicare Part B drug pro­gram. This pro­gram sup­ports the sick­est, most vul­ner­a­ble Medicare pa­tients and ac­counts for on­ly a small frac­tion of all Medicare spend­ing.  BIO will strong­ly op­pose short-sight­ed and harm­ful changes to a pro­gram that is so vi­tal to the health and well-be­ing of our se­niors.

In­ter­est­ing­ly, the Trump pro­pos­al isn’t be­ing ad­vanced as a rule-change, just a pro­pos­al for dis­cus­sion aimed at at­tract­ing at­ten­tion to an is­sue that plays well with his base of sup­port­ers. Re­pub­li­can law­mak­ers may not sup­port it, but with their fates in­ter­twined with the sen­si­tive pres­i­dent, crit­i­cism will be mut­ed. 

De­moc­rats on the oth­er hand may well leap at the chance to tack­le drug prices with the pres­i­dent.


Im­age: Pres­i­dent Don­ald Trump speaks at the De­part­ment of Health and Hu­man Ser­vices in Wash­ing­ton, DC, on Oc­to­ber 25, 2018 Nicholas Kamm  AFP

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

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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.

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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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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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[via AP Images]

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

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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.

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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. 

Jason Kelly. Mike Blake/Reuters via Adobe

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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.

David Grainger [file photo]

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