UP­DAT­ED: In­dus­try gets the edge: Medicare drug price ne­go­ti­a­tions will on­ly cost bio­phar­ma 10 drugs over the next 30 years

The House on Fri­day morn­ing passed a bill that will al­low Medicare to ne­go­ti­ate pre­scrip­tion drug prices for a lim­it­ed num­ber of sin­gle source drugs, but it’s a deal that will on­ly make a mi­nor dent in the pock­et­book of the bio­phar­ma in­dus­try.

The ne­go­ti­a­tions and oth­er pric­ing pro­vi­sions, like in­sulin and se­nior out-of-pock­et caps, are part of a sprawl­ing $1.8 tril­lion spend­ing pack­age that the De­moc­rats and Biden have been push­ing for all sum­mer. The bill, which re­lies on the phar­ma-re­lat­ed sav­ings to help pay for it, now moves to the Sen­ate.

PhRMA im­me­di­ate­ly blast­ed the bill’s pas­sage Fri­day, say­ing it will “throw sand in the gears of med­ical progress,” but the bill is large­ly a vic­to­ry for the in­dus­try.

CBO said Thurs­day that al­low­ing Medicare to ne­go­ti­ate drug prices — the plan is to start with ne­go­ti­a­tions on 10 of the most ex­pen­sive drugs in 2025 and work up to 20 drugs by 2028 — will save the gov­ern­ment (and cost in­dus­try) about $76 bil­lion over 10 years, and about $85 bil­lion in in­fla­tion re­bate penal­ties if drug prices rise above cer­tain lev­els.

That’s a far cry from House Speak­er Nan­cy Pelosi’s for­mer drug price ne­go­ti­a­tions bill, known as HR3, which the CBO scored in Au­gust as $456 bil­lion in sav­ings over 10 years. The lat­est bill and CBO score show the ex­tent to which the phar­ma in­dus­try’s lob­by­ists wa­tered down the Build Back Bet­ter Act.

Loren Adler, as­so­ciate di­rec­tor of the USC-Brook­ings Scha­ef­fer Ini­tia­tive for Health Pol­i­cy and a drug pric­ing ex­pert, told End­points News, “Def­i­nite­ly in­ter­est­ing to see that even the scaled-back ne­go­ti­a­tion pol­i­cy is ex­pect­ed to save $76 bil­lion over 10 years,” or about 17% of what the full HR3 ne­go­ti­a­tion would save in an ap­ples-to-ap­ples com­par­i­son.

Even with the re­bates, to­tal­ing about $160 bil­lion over 10 years — which is about what the to­tal cost will be to the phar­ma in­dus­try (since the re­bate rule was go­ing away any­ways), “is a pret­ty small slice” of the in­dus­try’s to­tal rev­enues, Adler said.

PhRMA, which man­aged to turn cer­tain mem­bers of Con­gress with fund­ing and al­ter the ne­go­ti­a­tions with an army of lob­by­ists, pre­vi­ous­ly es­ti­mat­ed about $560 bil­lion in to­tal rev­enue from bio­phar­ma­ceu­ti­cal busi­ness­es in 2017 alone, so $150 bil­lion over 10 years would be about 3% of in­dus­try rev­enue over the same pe­ri­od.

Sim­i­lar­ly, the CBO es­ti­mat­ed that about 10 few­er drugs (out of a cal­cu­lat­ed to­tal of 1,300 drug ap­provals) over 30 years would not be de­vel­oped as a re­sult of the lost funds.

“The amounts in this es­ti­mate are in the mid­dle of the dis­tri­b­u­tion of pos­si­ble out­comes, by CBO’s as­sess­ment, and they are sub­ject to un­cer­tain­ty. CBO did not pre­dict what kind of drugs would be af­fect­ed or an­a­lyze the ef­fects of for­gone in­no­va­tion on pub­lic health,” the score said.

While House Re­pub­li­cans said Thurs­day evening that the CBO warned these lost drugs could spell the end for im­por­tant can­cer or Alzheimer’s treat­ments in de­vel­op­ment, the re­al­i­ty is that the bill’s en­act­ment could just as well spell the end of de­vel­op­ing 10 more me-too drugs, or 10 more ex­pen­sive drugs with no im­proved ben­e­fits over cur­rent treat­ments.

What the pas­sage of such a bill might do, how­ev­er, is open up the flood­gates for more drug pric­ing ne­go­ti­a­tions in the fu­ture.

“BB­BA’s ne­go­ti­a­tion process will cer­tain­ly give us ex­pe­ri­ence with drug price reg­u­la­tion that will pro­vide a lot of in­for­ma­tion and in­form fu­ture re­form ef­forts. As a re­sult, it prob­a­bly in­creas­es the odds of ne­go­ti­a­tion get­ting ex­pand­ed in the fu­ture, es­pe­cial­ly be­cause rel­a­tive­ly small changes to the process could gen­er­ate sub­stan­tial deficit re­duc­tion,” Adler not­ed.

Oth­er pro­vi­sions in the bill would cap out-of-pock­et spend­ing for se­niors at $2,000, be­gin­ning in 2024, and lim­it what peo­ple pay out-of-pock­et for in­sulin to $35 per month, be­gin­ning in 2023 (but that doesn’t in­clude a cap for those who have di­a­betes and are unin­sured). The bill al­so pro­vides $300 mil­lion for FDA in­fra­struc­ture.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Common performs onstage, December 2020 (Getty Images)

Com­mon, Jamie Foxx among celebs stand­ing up for clin­i­cal tri­als in star-stud­ded can­cer group's pan­dem­ic push

Healthcare screenings and clinical trial enrollment were battered by the pandemic. But the well-known celebrity-backed Stand Up To Cancer non-profit, along with pharma and advocacy partners, has been working to reverse that and make up lost ground, by stepping up awareness campaigns.

Twelve campaigns launched in 2020 and another five in 2021 amplify the need for cancer screening and care, especially for underserved communities. While pharma companies have long been donors to the cancer research group, Covid brought new support — and increased awareness efforts.

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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UP­DAT­ED: Am­gen halts some drug dis­counts for safe­ty net hos­pi­tals as SCO­TUS takes on 340B case

Amgen will soon be the 10th biopharma company to pull back on offering drug discounts to contract pharmacies of safety-net hospitals under a federal program. Like its peers, Amgen argues that the growth of these contract pharmacies has ballooned in recent years and needs to be reigned in.

Beginning Jan. 3, 2022, Amgen’s policy will only allow 340B covered hospitals to designate a single pharmacy location, with the exception of federal grantees and contract pharmacies wholly owned by a 340B hospital, or that have common ownership with a health system.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”