HHS Sec­re­tary Azar pitch­es nam­ing and sham­ing tac­tics on drug price cam­paign, sin­gling out Cel­gene's Revlim­id

Cel­gene $CELG wasn’t sin­gled out by name in a speech by HHS Sec­re­tary Alex Azar Mon­day, but the big biotech got cast in the role of main vil­lain in his out­line of what ails Medicare — and how that should be fixed.

The price on Cel­gene’s wide­ly used Revlim­id — Ever­core ISI’s Umer Raf­fat made the con­nec­tion to Azar’s speech in a note Mon­day af­ter­noon — was jacked by 20% over the last year, which means that Medicare pa­tients pay an ex­tra $115 month, mov­ing from $575 to $690 per month, for their share of a drug that had cost $11,500 a month in 2015. 

Be­cause it’s a can­cer drug, Azar adds, its one of six pro­tect­ed class­es of ther­a­pies that Medicare is re­quired to cov­er. And as a re­sult, the fed­er­al gov­ern­ment is pay­ing an av­er­age 6% dis­count on these drugs, while pri­vate pay­ers are able to gain dis­counts of 20% to 30%.

“A 6 per­cent dis­count — I’m sor­ry, that is not ne­go­ti­at­ing,” said the HHS Sec­re­tary.

Azar went to some length on Mon­day to ex­pand on the drug price plan that he and Pres­i­dent Don­ald Trump pre­sent­ed on Fri­day — amid con­sid­er­able re­lief by Big Phar­ma play­ers and their in­vestors who quick­ly shrugged it off as large­ly a non-event.

In the speech to­day, Azar at­tacked two of the big weapons that have been sug­gest­ed for rein­ing in prices, but al­so said they would like­ly re­main on the ta­ble un­less the in­dus­try played ball in ne­go­ti­at­ing bet­ter terms for drugs like Revlim­id. And he broached the is­sue of merg­ing Part B drugs in­to Part D, so they could use bet­ter ne­go­ti­at­ing pow­ers to bring down their cost. 

Di­rect Medicare ne­go­ti­a­tions, lever­ag­ing the buy­ing pow­er of the fed­er­al pro­gram, wouldn’t ac­tu­al­ly lead to sig­nif­i­cant sav­ings, Azar point­ed out, cit­ing a CBO re­port. What would, he added by im­pli­ca­tion, is a for­mu­la­ry ap­proach adopt­ed by pri­vate pay­ers, threat­en­ing to drop drugs or pro­vide ex­clu­sive po­si­tions in ex­change for dis­counts. The sin­gle pay­ers’ so­lu­tion in set­ting prices, he added, was a non-starter.

Nev­er­the­less, he held those mea­sures out as a threat the in­dus­try has to deal with now by of­fer­ing bet­ter prices on drugs used by the fed­er­al pro­gram. From his pre­pared re­marks:

We don’t be­lieve ei­ther of these pro­pos­als would put Amer­i­can pa­tients first. They would move us to­ward the kind of so­cial­ized med­i­cine sys­tems that have such a no­to­ri­ous rep­u­ta­tion for poor qual­i­ty and ac­cess. This stacks right up there with the false promis­es of Oba­macare: that if you like your plan, you can keep it, and if you like your doc­tor, you can keep see­ing him.

But I don’t ex­pect these ideas to go away, no mat­ter how un­like­ly they are to work. If the phar­ma­ceu­ti­cal in­dus­try wants this idea off the ta­ble en­tire­ly, the on­ly way is to come to the ta­ble with us, to en­gage in mean­ing­ful ne­go­ti­a­tion with Medicare Part D plans, and to stop the price hikes.

For­get about reim­por­ta­tion, said Azar.

Cana­da sim­ply doesn’t have enough drugs to sell them to us for less mon­ey, and drug com­pa­nies won’t sell Cana­da or Eu­rope more just to have them im­port­ed here.

And un­safe drugs from un­re­li­able man­u­fac­tur­ers could be used to plug the gap.

Azar’s list of pro­pos­als, which will like­ly be the sub­ject of con­sid­er­able lob­by­ing with Con­gress, in­cludes over­turn­ing the cap law­mak­ers put in place on penal­ties for rais­ing drug prices be­yond the rate of in­fla­tion — a com­mon in­dus­try prac­tice for years. And he wants to in­cor­po­rate pri­vate dis­counts in­to the av­er­age man­u­fac­tur­er price — or AMP — used to set Med­ic­aid prices.

HHS al­so plans to use sham­ing tac­tics against any drug mak­ers that refuse to make sam­ples avail­able for gener­ic man­u­fac­tur­ers to use for their de­vel­op­ment work, call­ing them out on any abus­es they find. In a sense, Azar — a for­mer top ex­ec at Eli Lil­ly — is muscling the en­tire in­dus­try to back off some fa­vorite talk­ing points he once used him­self and get re­al with their pric­ing strate­gies.

For too long, there’s been a lot of talk on drug prices and no ac­tion. Drug com­pa­nies have in­sist­ed we can have new cures or af­ford­able prices, but not both.

I’ve been a drug com­pa­ny ex­ec­u­tive—I know the tired talk­ing points: the idea that if one pen­ny dis­ap­pears from phar­ma prof­it mar­gins, Amer­i­can in­no­va­tion will grind to a halt.

I’m not in­ter­est­ed in hear­ing those talk­ing points any­more, and nei­ther is the Pres­i­dent.

Af­ter the phar­ma ral­ly on Fri­day af­ter­noon, the Trump ad­min­is­tra­tion still seems set on il­lus­trat­ing its get-tough ap­proach to rein­ing in drug prices in the US, which far out­strip the prices al­lowed in any oth­er in­dus­tri­al­ized na­tion. Giv­en the lat­est fluc­tu­a­tions on the mar­ket, though, Trump and Azar have a con­sid­er­able dis­tance to go.

Cel­gene’s stock is up 1% to­day.

Im­age: HHS Sec­re­tary Alex Azar at the May 11 speech. WHITE HOUSE via YOUTUBE

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.