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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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As TRIPS coun­cil meets, the IP waiv­er for vac­cines is on life sup­port ahead of a De­cem­ber dead­line

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.