CBO warns of al­most 60 few­er new drugs over three decades with Medicare drug ne­go­ti­a­tions bill

As drug pric­ing leg­is­la­tion be­gins to gain steam on Capi­tol Hill mov­ing in­to the fall, the Con­gres­sion­al Bud­get Of­fice is of­fer­ing an up­dat­ed look at the ef­fects that House Speak­er Nan­cy Pelosi’s drug pric­ing bill, known as HR 3, would have in chill­ing bio­phar­ma R&D over 30 years.

Nan­cy Pelosi

CBO said in a new re­port Thurs­day that its up­dat­ed mod­el used to es­ti­mate the ef­fects of HR 3 would, in part, al­low for wide­spread Medicare ne­go­ti­a­tions on drug prices, lead­ing to a 15% to 25% re­duc­tion in ex­pect­ed re­turns for drugs in the top quin­tile of ex­pect­ed re­turns.

Last Feb­ru­ary, the CBO es­ti­mat­ed that Medicare ne­go­ti­a­tions un­der the same bill would re­duce prices by be­tween 57% and 75%, rel­a­tive to cur­rent prices.

The lat­est es­ti­mates could lead to 2 few­er drugs in the first decade, 23 few­er in the sec­ond decade, and 34 few­er in the third decade, CBO said. While that to­tal of 59 few­er new drugs over three decades would like­ly re­sult in the loss of mean­ing­ful new drugs, the to­tal doesn’t align with in­dus­try lob­by­ing group PhRMA’s es­ti­mate in May that HR 3 could re­duce by 90%+ the num­ber of med­i­cines de­vel­oped by small and emerg­ing biotechs, or 61 few­er drugs over 10 years.

But where­as PhRMA says such a change could threat­en ac­cess to med­i­cines, the CBO stopped short of try­ing to tease out ex­act­ly what the loss of those drugs might mean, par­tic­u­lar­ly as the FDA ap­proves plen­ty of me-too or slight­ly im­proved ver­sions of cur­rent­ly mar­ket­ed drugs each year.

“The il­lus­tra­tive pol­i­cy’s ex­act im­pli­ca­tions for the health of fam­i­lies in the Unit­ed States are un­clear. CBO has es­ti­mat­ed nei­ther which types of drugs may be af­fect­ed nor how the re­duc­tion in the num­ber of new drugs will af­fect health out­comes. In ad­di­tion, the pol­i­cy may lead to low­er prices and in­creased us­age for drugs al­ready on the mar­ket. CBO has not de­ter­mined the over­all ef­fect of the pol­i­cy on health out­comes,” the re­port says.

The re­lease of the re­port al­so comes as it seems un­like­ly that the Sen­ate will take up HR 3 in its en­tire­ty, which passed the House in 2019.

Ron Wyden

Sen­ate fi­nance com­mit­tee chair Ron Wyden (D-OR), who’s craft­ing his own leg­is­la­tion, ear­li­er this sum­mer vowed to in­clude some form of Medicare ne­go­ti­a­tions in the Sen­ate’s pack­age, which like­ly won’t need Re­pub­li­can votes to make it in­to law.

And while the CBO lays out its ex­pect­ed new drug loss­es over three decades, the gov­ern­ment agency al­so made clear how dif­fi­cult it can be to pre­dict what drugs will prove pos­i­tive in mul­ti­ple stages of clin­i­cal tri­als and win ap­proval.

“The ef­fects could be small­er if ex­pen­di­tures in late-phase hu­man tri­als are larg­er, for ex­am­ple. Al­ter­na­tive­ly, the ef­fects could be larg­er if the cost of cap­i­tal is larg­er,” the CBO said.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.