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.

The Pelosi bill would em­pow­er the De­part­ment of Health and Hu­man Ser­vices to ne­go­ti­ate with com­pa­nies on ef­fec­tive­ly na­tion­al prices for the 250 most ex­pen­sive pre­scrip­tion drugs with­out at least two com­peti­tors. The fed­er­al gov­ern­ment is barred by law to ne­go­ti­ate drug prices for Medicare, as na­tion­al ser­vices in oth­er coun­tries, such as the UK’s NHS do.

Ne­go­ti­a­tions would be pegged to the cost of drugs in those oth­er coun­tries un­der a pro­posed “in­ter­na­tion­al price in­dex.” This is in line with the pres­i­dent’s stat­ed po­si­tion. In Ju­ly, Trump an­nounced he would sign an ex­ec­u­tive or­der lim­it­ing US prices to those paid in oth­er coun­tries — a legal­ly du­bi­ous move — al­though there’s been lit­tle move­ment on that front since.

The White House has yet to com­ment on the plan, but the ap­par­ent in­ter­est align­ment has scared in­vestors and sent Pfiz­er and Mer­ck stock on a gen­tle, Thurs­day morn­ing slide.

There is “a pal­pa­ble fear among some in­vestors that Speak­er Pelosi and Pres­i­dent Trump may have a mind meld on drug pric­ing,” wrote Ve­da Part­ners an­a­lyst Spencer Perl­man, ac­cord­ing to Bloomberg. 

For­mal­ly, the bill would like­ly re­peal or work-around a pro­vi­sion in the 2003 Medicare Pre­scrip­tion Drug, Im­prove­ment, and Mod­ern­iza­tion Act. That bill gave medicare ben­e­fi­cia­ries en­ti­tle­ment ben­e­fits for pre­scrip­tion drugs for the first time in a com­pro­mise deal that al­so pre­vent­ed the US gov­ern­ment from di­rect­ly ne­go­ti­at­ing Medicare drug prices. In 2007, the De­mo­c­ra­t­i­cal­ly con­trolled House passed a bill re­peal­ing the ban, but that law was as­sured a ve­to from Pres­i­dent Bush and didn’t ad­vance in the Sen­ate.

The Pelosi plan would al­low the gov­ern­ment to ne­go­ti­ate on be­half of Medicare re­cip­i­ents and ex­tend those ben­e­fits to the pri­vate mar­ket by steeply pe­nal­iz­ing health in­sur­ances who re­fused to do so. Com­pa­nies who refuse to ne­go­ti­ate would be pe­nal­ized 65% of the gross price of the drug. Those who over­charge medicare or don’t ex­tend the ne­go­ti­at­ed price to the pri­vate mar­ket would be fined 10 times the dif­fer­ence be­tween the ne­go­ti­at­ed price and the sale price.

The plan would have retroac­tive el­e­ments de­signed to deal with re­cent price spikes that sparked na­tion­al con­ver­sa­tion. It would man­date phar­ma­ceu­ti­cal com­pa­nies that have raised prices above the in­fla­tion rate since 2016 to low­er the cost or pay re­bates equal to the to­tal price above in­fla­tion.

Grass­ley’s plan, far more lim­it­ed in scope, would cap Medicare Part D re­cip­i­ents’ out-of-pock­et pay at $3,100 start­ing in 2022. Those re­cip­i­ents are not cov­ered un­der the 2003 law. Pelosi’s plan would cap their an­nu­al spend­ing at $2,000.

Ac­cord­ing to NPR, Grass­ley has been telling Re­pub­li­can col­leagues that if they do not co­a­lesce around a mod­er­ate plan to bring to Trump, the pres­i­dent will side Pelosi on an is­sue pop­u­lar among vot­ers.

A Ju­ly Kaiser Fam­i­ly Foun­da­tion poll found 79% of Amer­i­cans thought the cost of drugs was “un­rea­son­able,” al­though 74% of those who take them, said they were “easy” to pay for.  The sur­vey found 86% of re­spon­dents fa­vored gov­ern­ment ne­go­ti­a­tion of prices for peo­ple with Medicare, the third most pop­u­lar pol­i­cy op­tion, be­hind mak­ing it eas­i­er for gener­ics to hit the mar­ket and in­clud­ing prices in drug ads (a pro­pos­al the pres­i­dent has un­suc­cess­ful­ly tried to en­act).

Amer­i­cans rate the phar­ma­ceu­ti­cal in­dus­try dead last among 25 dif­fer­ent in­dus­tries, be­hind oil and gas and even the fed­er­al gov­ern­ment it­self.

The phar­ma­ceu­ti­cal lob­by has amped up spend­ing to un­prece­dent­ed lev­els as pub­lic pres­sure on drug pric­ing swelled and the specter of gov­ern­ment reg­u­la­tion loomed clos­er and clos­er.

Phar­ma­ceu­ti­cal com­pa­nies have long ar­gued such ne­go­ti­a­tions would sti­fle drug de­vel­op­ment and ul­ti­mate­ly hurt con­sumers, both by long-term re­duc­ing the in­cen­tive for com­pa­nies to in­vest in R&D and in in­stances where the gov­ern­ment re­jects the price and the treat­ment doesn’t be­come avail­able, a dilem­ma show­cased in Ver­tex’s re­cent fraught ne­go­ti­a­tions over CF drugs in the UK.

The same KFF poll found on­ly 23% of peo­ple sup­port­ed “al­low­ing Medicare drug plans to ex­clude more drugs.”

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Horizon Therapeutics CEO Tim Walbert fronts the pharma company's new

Q&A: Hori­zon CEO Tim Wal­bert goes from C-suite to face of the brand

Horizon Therapeutics CEO Tim Walbert runs a rare disease company, but he’s also a patient. While his condition hasn’t been a secret, Walbert is stepping out for the first time as the face of rare disease in Horizon’s new corporate campaign called “It’s Personal.”

Or rather, as one of the faces of rare disease — other Horizon employees will also share their stories as patients and caregivers as part of the effort.

Walbert is familiar with the typical long path of rare disease patients. He was first diagnosed as a junior in college with an autoimmune disease similar to rheumatoid arthritis, but he spent another 10 years before receiving a second rare disease diagnosis. More recently, he unfortunately added the role of caregiver to a child with a rare disease when his 13-year-old son was diagnosed last year with two autoimmune conditions.

Walbert joined Horizon as CEO in 2008 after working at Abbott — now AbbVie — in immunology on the launch of anti-inflammatory biologic Humira. Before that he worked at Searle, now part of Pfizer, on pain med Celebrex. The then-fledging Horizon had only a handful of employees and no office space, literally working from Walbert’s living room.

Lately though, Horizon’s been on a tear. Despite a pair of major setbacks with the pandemic closing infusion centers just weeks after its key Tepezza thyroid eye disease approval and then later when Catalent cancelled Tepezza manufacturing slots to prioritize Covid-19 vaccine production, the company reported $820 million in Tepezza sales in 2020. That accounted for about 40% of the pharma’s record $2.2 billion in 2020 sales, blasting past $1.3 billion in 2019 sales.

While “It’s Personal” is Horizon’s first corporate branding effort, the growing pharma company has long relied on direct-to-consumer advertising as a key part of its commercialization strategy. It’s also invested heavily in unbranded awareness campaigns including RareIs which began as a social media awareness campaign that’s evolved into a rare disease resource and support community platform.

Walbert recently talked to Endpoints MarketingRx senior editor Beth Snyder Bulik about Horizon’s new campaign, and the rare personal journey that’s helped steer his career.

How did the new “It’s Personal” campaign come about? Can you talk about your personal connection and why you wanted to do it?

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