Pamela Bradt, ICER CSO

ICER crit­i­cizes cost of 8 tar­get­ed im­mune mod­u­la­tors for UC, rec­om­mend­ing some deep dis­counts

While 8 tar­get­ed im­mune mod­u­la­tors (TIMs) on the mar­ket for ul­cer­a­tive col­i­tis have proved ben­e­fi­cial to pa­tients, non­prof­it cost-ef­fec­tive­ness watch­dog ICER called the drugs un­rea­son­ably ex­pen­sive, rec­om­mend­ing some deep dis­counts to match the drugs with their ac­tu­al val­ue.

In a re­port re­leased Fri­day, ICER as­sessed the cost vs. clin­i­cal ben­e­fit of mar­ket leader Hu­mi­ra — for which Ab­b­Vie has faced price goug­ing ac­cu­sa­tions — as well as Janssen’s Sim­poni, Ste­lara and Rem­i­cade, Mer­ck’s Ren­flex­is, Pfiz­er’s In­flec­tra and Xel­janz, and Take­da’s En­tyvio.

” … The costs of these drugs is sub­stan­tial, es­pe­cial­ly over time, and the prices for all of these ther­a­pies re­main above rea­son­able lev­els for the ben­e­fits pa­tients re­ceive,” ICER’s CSO Pamela Bradt said in a state­ment.

While Rem­i­cade’s prices have been re­duced in re­cent years, like­ly as a re­sult of com­pe­ti­tion with biosim­i­lars, Bradt sug­gest­ed that pric­ing for all eight TIMs need to come down fur­ther “to hit that sweet spot at which we are rich­ly re­ward­ing the ben­e­fits for pa­tients and en­cour­ag­ing fur­ther in­no­va­tion with­out ad­verse­ly con­tribut­ing to greater harms through the neg­a­tive ef­fects of ris­ing health care costs for pa­tients and fam­i­lies.”

UC, a chron­ic in­flam­ma­to­ry bow­el dis­ease, leads to long-last­ing in­flam­ma­tion and ul­cers in the di­ges­tive tract, and is char­ac­ter­ized by fre­quent di­ar­rhea, ab­dom­i­nal or rec­tal pain, weight loss and fa­tigue. ICER es­ti­mates that on av­er­age, UC pa­tients shell out be­tween $2,000 to $4,000 each year, out-of-pock­et. “Costs are es­pe­cial­ly oner­ous for pa­tients with­out in­sur­ance or those who are un­able to work due to their dis­ease,” the re­port states.

In a study pit­ting Take­da’s En­tyvio against Hu­mi­ra, ICER re­searchers found that En­tyvio achieved greater rates of re­sponse and re­mis­sion in bi­o­log­ic-naïve and bi­o­log­ic-ex­pe­ri­enced pa­tients. The oth­er TIMs were at least com­pa­ra­ble to Hu­mi­ra, with “no clear dif­fer­ences among them,” ac­cord­ing to the re­port.

The in­sti­tute came up with a health ben­e­fit price bench­mark (HBPB) — a price range in­di­cat­ing the high­est price a man­u­fac­tur­er should charge for a treat­ment, based on the amount of im­prove­ment in over­all health to pa­tients — for each of the eight TIMs. Hu­mi­ra, which can cost more than $72,000 a year, would need to be dis­count­ed by 90% to 92% to meet ICER’s sug­gest­ed range ($6,000 to $7,000 per year).

Source: ICER, 2020

Click on the im­age to see the full-sized ver­sion

Sim­poni’s whole­sale ac­qui­si­tion cost would need to be slashed by 90% to meet the HBPB of $6,300 to $7,600 per year. Rem­i­cade would need to come down by 61% to 68%; In­flec­tra by 52% to 61%; Ren­flex­is by 40% to 51%; Ste­lara by 89% to 95%; and En­tyvio by 73% to 80%, ac­cord­ing to ICER.

Source: ICER, 2020

Click on the im­age to see the full-sized ver­sion

At the start of the year, Ab­b­Vie upped Hu­mi­ra’s price by about 7%. And in 2017 and 2018, the biotech hiked the whole­sale ac­qui­si­tion cost by more than 19%, ac­cord­ing to ICER. Law­mak­ers, in­clud­ing Sen. Eliz­a­beth War­ren, have ac­cused the com­pa­ny of price goug­ing.

“Hu­mi­ra is used by mil­lions of pa­tients around the world to treat dis­eases like arthri­tis, pso­ri­a­sis, and Crohn’s dis­ease,” War­ren tweet­ed last year. “But its man­u­fac­tur­er, Ab­b­Vie, dou­bled its price — and used bla­tant­ly an­ti-com­pet­i­tive be­hav­ior to pre­vent a com­peti­tor from en­ter­ing the mar­ket.”

Unions and health care pur­chasers have filed class-ac­tion law­suits al­leg­ing Ab­b­Vie used a “patent thick­et” to cre­ate an il­le­gal mo­nop­oly, and that Ab­b­Vie col­lud­ed with the biosim­i­lar com­peti­tors to di­vide the mar­ket. Hu­mi­ra raked in $14.9 bil­lion in net sales last year, ac­cord­ing to the AJMC’s Cen­ter for Biosim­i­lars.

ICER will re­view its re­port on TIMs for UC in a vir­tu­al pub­lic Cal­i­for­nia Tech­nol­o­gy As­sess­ment Fo­rum on Sept 24.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.