CBO projects Sen­ate drug pric­ing bill would cut the de­vel­op­ment of 10 drugs over 30 years

The Con­gres­sion­al Bud­get Of­fice on Fri­day said that Sen­ate De­moc­rats’ pro­pos­al to al­low Medicare to ne­go­ti­ate cer­tain drug prices could low­er the fed­er­al deficit by about $288 bil­lion through 2031, and re­duce drug­mak­ers’ 1,300 to­tal drug ap­provals by about 10 drugs over the next three decades.

That trade-off, part of a larg­er Sen­ate rec­on­cil­i­a­tion pack­age on­ly need­ing a sim­ple ma­jor­i­ty of votes to pass, finds a mid­dle ground among the oth­er re­cent Con­gres­sion­al at­tempts to stem ris­ing drug prices.

CBO said Fri­day that the chill­ing ef­fect on the num­ber of drugs in­tro­duced to the US mar­ket would be about one drug over the first 10-year pe­ri­od, or 2023-2032, and about nine oth­ers over the next two decades. With ex­pec­ta­tions for about 1,300 drug ap­provals over the next 30 years, the CBO’s es­ti­mate means the num­ber of drugs lost due to this leg­is­la­tion amounts to less than 1% of es­ti­mat­ed ap­provals.

For House Speak­er Nan­cy Pelosi’s drug price ne­go­ti­a­tion bill, known as HR 3 and which sought deep­er pric­ing cuts, CBO pre­dict­ed at the time that it would re­sult in 59 few­er new drugs over three decades.

Rachel Sachs

“The rea­son the num­ber is small­er is that the pack­age has changed over time,” Rachel Sachs, a law pro­fes­sor at Wash­ing­ton Uni­ver­si­ty in St. Louis told End­points News. “The ne­go­ti­a­tion pro­vi­sions now not on­ly ap­ply to few­er drugs, but they are for­mal­ly lim­it­ed in that they on­ly be­gin af­ter a drug has been on the mar­ket for a cer­tain amount of time. So com­pa­nies have a pe­ri­od of time dur­ing which ne­go­ti­a­tion is not present. CBO like­ly con­sid­ered that, as well.”

But one thing the CBO doesn’t con­sid­er is what types of drugs might be af­fect­ed. As with oth­er drug pric­ing CBO scores, the bud­get of­fice made clear again that it “did not pre­dict what kind of drugs would be af­fect­ed or an­a­lyze the ef­fects of for­gone in­no­va­tion on pub­lic health.”

The of­fice re­cent­ly pub­lished a look at the up­dat­ed ver­sion of its mod­el used to in­form es­ti­mates of the ef­fects of HR 3 on the num­ber and tim­ing of new drugs en­ter­ing the US mar­ket.

In a Jan­u­ary slide deck on its new mod­el, CBO added, “A price ne­go­ti­a­tion pol­i­cy would have lit­tle ef­fect for the first ten years, but in the long run, such a pol­i­cy would de­crease the num­ber of new drugs en­ter­ing the mar­ket by 10%.”

While PhRMA and oth­er in­dus­try groups have lament­ed this po­ten­tial for ma­jor loss­es to in­no­v­a­tive med­i­cine due to drug pric­ing pro­vi­sions, some of these es­ti­mat­ed pipeline cuts may come from me-too drugs, oth­er lat­er en­trants, or even copy­cat drugs.

The gener­ic drug in­dus­try group, the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines, and its Biosim­i­lars Coun­cil on Mon­day came out in op­po­si­tion to the new Sen­ate pric­ing re­forms, say­ing they will ma­jor­ly in­crease risks for gener­ic and biosim­i­lar man­u­fac­tur­ers as the com­pa­nies will have “no way to know whether a brand-name drug will be se­lect­ed for ne­go­ti­a­tion or what the ne­go­ti­at­ed price may be” un­til well af­ter a copy­cat’s de­vel­op­ment would need to al­ready be­gin.

The CBO es­ti­mate on gov­ern­ment sav­ings al­so doesn’t match Pelosi’s for­mer drug price ne­go­ti­a­tions bill, which the CBO scored in Au­gust 2021 as sav­ing $456 bil­lion over 10 years, al­though it’s con­sid­er­ably more than the Sen­ate Dems’ last at­tempt at Medicare ne­go­ti­a­tions via the Build Back Bet­ter Act that Sen. Joe Manchin (D-WV) squashed, and which the CBO said would save about $76 bil­lion over 10 years.

Sen­ate Dems last week un­veiled the new leg­isla­tive lan­guage around Medicare drug price ne­go­ti­a­tions, which be­gin­ning in 2026 would al­low for the ne­go­ti­a­tion of 10 el­i­gi­ble drug prices, and build up to 20 drugs by 2029.

For com­pa­nies that don’t com­ply, CMS can as­sess penal­ties of up to $1 mil­lion per day, ac­cord­ing to the bill text. And any man­u­fac­tur­er that “know­ing­ly pro­vides” false in­for­ma­tion al­so can be sub­ject to fines of $100 mil­lion per in­frac­tion.

The Sen­ate pro­pos­al, which mir­rors the pre­vi­ous ef­forts in the Build Back Bet­ter Act, would al­so cap se­niors’ drug costs un­der Medicare at $2,000 an­nu­al­ly, but it no­tice­ably does not in­clude a $35 month­ly cap on in­sulin costs for those with in­sur­ance, which Sen. Chuck Schumer (D-NY) has twice pledged to vote sep­a­rate­ly on.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.