The White House re­view of drug prices: Don't hate the play­er — hate the game

For­eign na­tions are spong­ing off Amer­i­can in­vest­ment in­to phar­ma­ceu­ti­cal R&D and tak­ing ad­van­tage of by US pa­tients by sys­tem­at­i­cal­ly un­der­pay­ing for drugs, a new study by the White House has con­clud­ed.

Surg­ing drug prices in the Unit­ed States are a thorny yet rare bi­par­ti­san is­sue as an­oth­er pres­i­den­tial elec­tion beck­ons. While Pres­i­dent Trump strug­gles to make good on his promise to low­er drug prices, the bio­phar­ma in­dus­try, which has long thrived in its lais­sez-faire ecosys­tem, has per­sis­tent­ly ar­gued that gov­ern­ment in­ter­ven­tion will sti­fle in­no­va­tion.

Mean­while, US law­mak­ers left, right and cen­ter have ar­gued drug prices in the Unit­ed States are too high — and the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self. In De­cem­ber, the HHS opened the door to a pol­i­cy that al­lows for the lim­it­ed im­por­ta­tion of drugs from Cana­da.

This new White House analy­sis, how­ev­er, sug­gests that US drug prices aren’t un­rea­son­able — its that for­eign gov­ern­ments aren’t pay­ing enough for Amer­i­can phar­ma­ceu­ti­cal break­throughs.

This new study — con­duct­ed by the Coun­cil of Eco­nom­ic Ad­vis­ers (a White House group tasked with of­fer­ing the US pres­i­dent ad­vice on eco­nom­ic pol­i­cy) — com­pared the prices of 200 top-sell­ing brand­ed drugs in the Unit­ed States against 15 de­vel­oped coun­tries. Eu­ro­pean coun­tries went from pay­ing about half (51%) of US prices for many best­selling drugs in 2003 to about a third (32%) by 2017, the re­port found, not­ing that gov­ern­ments abroad ne­go­ti­ate drug prices on be­half of their cit­i­zens and there­by ar­ti­fi­cial­ly de­press prices.

“These prac­tices abroad dis­pro­por­tion­ate­ly cost U.S. pa­tients and tax­pay­ers be­cause they pre­vent the Unit­ed States from un­der­tak­ing do­mes­tic poli­cies to low­er drug prices with­out slow­ing down the pace at which new and bet­ter prod­ucts en­ter the mar­ket,” the re­searchers wrote.

“We find that if free-rid­ing abroad was re­duced and for­eign rel­a­tive drug prices re­flect­ed rel­a­tive GDP per capi­ta, to­tal in­no­va­tor rev­enues from those coun­tries would have been $194 bil­lion high­er in 2017, rais­ing glob­al rev­enues by 42 per­cent. Re­duc­ing for­eign price con­trols would in­crease prof­its and in­no­va­tion, there­by lead­ing to greater com­pe­ti­tion and low­er prices for U.S. pa­tients.”

For in­stance, Cana­da paid 35% of US prices in 2017 — even though its GDP per capi­ta is 78% of the Unit­ed States. If Cana­da were to shoul­der a pro­por­tion­ate cost — it would have paid $27.2 bil­lion in­stead of the ac­tu­al $12.2 bil­lion it part­ed with that year, CEA re­searchers claimed.

In oth­er words, the White House is sug­gest­ing its im­po­tence in im­ple­ment­ing drug price con­trols is linked to for­eign gov­ern­ments not pay­ing their fair share for ben­e­fit­ting from Amer­i­can in­vest­ment in­to phar­ma­ceu­ti­cal R&D.

Crit­ics of that ar­gu­ment will be quick to note that drug prices in the Unit­ed States — a frac­tured sys­tem of health care that runs on pub­lic and pri­vate in­sur­ance, fur­ther com­pli­cat­ed by phar­ma­cy ben­e­fit man­agers — are un­rea­son­ably high and are not nec­es­sar­i­ly linked to the in­vest­ments in R&D. An­nu­al and some­times bian­nu­al hikes that of­ten ex­ceed the rate of in­fla­tion add an­oth­er lay­er of frus­tra­tion.

GoodRx, a com­pa­ny that tracks pre­scrip­tion drug prices in the Unit­ed States and of­fers dis­counts on med­ica­tions, has found that since 2014 (when it start­ed track­ing the da­ta) the pace of an­nu­al price hikes has in­creased, and the num­ber of drugs that are get­ting price up­grades has al­so be­come pro­nounced.

How­ev­er, as po­lit­i­cal scruti­ny in­to drug pric­ing in­ten­si­fied in re­cent years, a hand­ful of big drug­mak­ers pledged to keep their an­nu­al price hikes un­der 10% — and the gen­er­al spot­light on pric­ing has al­so be­gun to thaw the over­all mag­ni­tude of hikes.

This Jan­u­ary, over 100 drug­mak­ers raised the price for 619 brand­ed drugs by an av­er­age of 5.2%. In Jan­u­ary 2019, 486 brand­ed drugs saw in­creas­es by an av­er­age of 5.2%, while 580 brand­ed drugs in­creased by an av­er­age of 8% in Jan­u­ary 2018, ac­cord­ing to GoodRx da­ta. These num­bers should look dif­fer­ent when the to­tal num­ber of hikes over the rest of the year are ac­count­ed for.

Drug man­u­fac­tur­ers of­ten ar­gue that they raise list prices to ac­count for high­er re­bates that are ne­go­ti­at­ed by PBMs — and that net prices and what the pa­tient on av­er­age pays in cer­tain cas­es are in fact low­er.

“Re­bates are kind of hard to no­tice be­cause they’re kind of very hush-hush,” Tori Marsh, a GoodRx health in­sights an­a­lyst, not­ed in an in­ter­view with End­points News.

When list prices in­crease, that hike is passed on to in­sured pa­tients through co-pay­ments and pre­mi­ums, she said. “And so in­evitably, lat­er on down the line, they’re like­ly go­ing to be pay­ing more be­cause drug prices are just in­creas­ing — so they might not ex­pe­ri­ence it im­me­di­ate­ly at the phar­ma­cy but it will trick­le down.”

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

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.