Trump to un­veil pro­pos­al to re­duce prices on doc­tor-ad­min­is­tered drugs as midterms loom

Days away from a con­tentious midterm elec­tion bat­tle, the Trump ad­min­is­tra­tion is once again at­tempt­ing to throw its weight at ex­or­bi­tant drug prices, a hot but­ton is­sue the pres­i­dent has long ral­lied against but has so far done lit­tle about.

DC-based POLITI­CO re­port­ed last night that Trump is set to un­veil a pro­pos­al that would make sweep­ing changes to how Medicare pays for some drugs in a speech to the HHS on Thurs­day af­ter­noon, which some see as a ploy to dis­tract away from the Re­pub­li­can agen­da to over­haul Oba­macare.

The scourge of high drug prices has been met with ire on both sides of the aisle, with De­moc­rats lash­ing out at their GOP coun­ter­parts for not us­ing their con­trol of both Con­gress and the ex­ec­u­tive branch to com­pel changes to the free­wheel­ing fash­ion the in­dus­try op­er­ates on drug prices.  While on the cam­paign trail, both Hillary Clin­ton and Trump chas­tised drug­mak­ers for their pric­ing be­hav­ior and made pledges to hold the in­dus­try ac­count­able. And af­ter cap­tur­ing the pres­i­den­cy, Trump sus­tained his at­tack on the in­dus­try stan­dard of price hikes, pro­claim­ing drug­mak­ers were “get­ting away with mur­der.” In May, Trump an­nounced that drug com­pa­nies would make “mas­sive” price cuts with­in two weeks — none which ma­te­ri­al­ized. An analy­sis of brand­ed pre­scrip­tion drugs, re­leased by the As­so­ci­at­ed Press last month, found that for all in­tents and pur­pos­es it’s been busi­ness as usu­al for drug­mak­ers, with price hikes con­tin­u­ing to out­strip cuts. The on­ly sil­ver lin­ing is that the num­ber of in­creas­es has di­min­ished some­what, and are not as steep as in past years, the AP not­ed.

The mul­ti-pronged pro­pos­al that still needs re­fine­ment and pas­sage through the fed­er­al rule-mak­ing dock­et was sent to the White House last month, and is ex­pect­ed to save Medicare $17 bil­lion over five years, and shave the cost of cer­tain drugs by up to 30 per­cent, ac­cord­ing to POLITI­CO. The plan in­tends to uti­lize Medicare’s in­no­va­tion cen­ter to ne­go­ti­ate the prices for some drugs that are di­rect­ly ad­min­is­tered by doc­tors — not pre­scrip­tions pur­chased by pa­tients at phar­ma­cies — in a bid to keep them on par with low­er prices paid by oth­er na­tions, ac­cord­ing to the re­port.

The pro­pos­al will al­so out­line an “in­ter­na­tion­al pric­ing in­dex,” in which Amer­i­can drug prices would be bench­marked against 16 oth­er na­tions — such as Cana­da, Czech Re­pub­lic, Fin­land, France, Ger­many, Japan, Spain, Swe­den and the Unit­ed King­dom — where tar­get drug prices are col­lec­tive­ly 44 per­cent low­er. Prices would slow­ly be low­ered to in­ter­na­tion­al lev­els over five years. How­ev­er, this part of the pro­pos­al may run in­to trou­ble as many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

An­oth­er part of the new plan in­cludes let­ting pri­vate sec­tor ven­dors ne­go­ti­ate with drug­mak­ers, akin to how health in­sur­ers ne­go­ti­ate prices in Medicare’s part D pro­gram. Medicare would test this ap­proach for cer­tain ex­pen­sive drugs in cer­tain ge­o­graph­ic ar­eas, where par­tic­i­pa­tion would be manda­to­ry for physi­cians and hos­pi­tals. In ad­di­tion, of­fi­cials in­tend to amend the in­cen­tive doc­tors have to pre­scribe ex­pen­sive drugs. Amend­ing that sys­tem to a flat fee, in con­trast to a per­cent­age, could com­pel doc­tors to use the most ef­fec­tive rather than the most ex­pen­sive treat­ments, POLITI­CO said.

In 2016, Pres­i­dent Oba­ma at­tempts to af­fect change in­to the way physi­cian-ad­min­is­tered drugs were paid for fiz­zled out af­ter be­ing thwart­ed by De­moc­rats and Re­pub­li­cans alike, not to men­tion doc­tors, hos­pi­tals and the über-con­nect­ed drug lob­by. De­spite Trump’s sus­tained brava­do, his lat­est pro­pos­al may suf­fer a sim­i­lar fate.

The speech, Trump’s first ad­dress to the health de­part­ment, is ex­pect­ed at 2 pm. It fol­lows some mod­est, al­beit in­di­rect, suc­cess­es for the ad­min­is­tra­tion in push­ing back at the phar­ma­ceu­ti­cal in­dus­try.  This month an HHS pro­pos­al re­quir­ing drug­mak­ers to re­veal prices in their TV ads came to the fore, in ad­di­tion to the pas­sage of a law ban­ning gag-claus­es, which pre­vent phar­ma­cists from in­form­ing cus­tomers when it’s cheap­er to pay in cash for a drug in­stead of us­ing in­sur­ance, as STAT not­ed.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.