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.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.