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.”

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.