Mul­ti­ple block­busters from Gilead, Pfiz­er, Ver­tex see (list) price hikes to start 2022

Kick­ing off 2022, hun­dreds of phar­ma­ceu­ti­cals, in­clud­ing some block­busters, saw their list prices rise by about 5% on av­er­age. But over­all, net drug prices (cost af­ter re­bates) de­clined for the fourth year in a row, po­ten­tial­ly com­pli­cat­ing al­ready stalled drug price re­form ef­forts.

Among the drugs see­ing new in­creas­es as of Jan. 1 are Gilead’s bevy of block­buster HIV drugs.

Bik­tarvy, which pulled in more than $7 bil­lion in world­wide sales in 2020, saw a 4.8% price in­crease in 2021, and now, an­oth­er 5.6% in­crease in 2022, ac­cord­ing to a new re­port from the non­prof­it 46brook­lyn Re­search.

Gilead of­fered the same 5.6% price hikes for its oth­er HIV drugs: De­scovy, which saw sales of more than $1.8 bil­lion in 2020; Gen­voya, which brought in more than $3 bil­lion in 2020; and Odef­sey, which had $1.7 bil­lion in 2020 sales.

Pfiz­er, which is set to reap tens of bil­lions, pos­si­bly even hun­dreds of bil­lions, from its Covid-19 vac­cine and pill this year and next year, al­so hiked the price of its block­buster can­cer drug Ibrance by 6.9% to start this year. Oth­er Pfiz­er med­i­cines, in­clud­ing sev­er­al an­tibi­otics and a form of chemo, saw their prices in­crease by 10% to start the year, ac­cord­ing to GoodRx.

Mean­while, Ver­tex in­creased the price of its block­buster CF drug Trikaf­ta by 4.9% in 2022. That might not seem like a big spike in the grand scheme of things, but the drug’s list price is cur­rent­ly set at $311,000 per year, so that’s a more than $15,000 per pa­tient, per year in­crease.

ICER pre­vi­ous­ly es­ti­mat­ed that Ver­tex would need to low­er the list price of Trikaf­ta to be­tween $67,900 and $85,500 per year in or­der to bring the cost in line with its ben­e­fits.

An­to­nio Ciac­cia

Analy­ses of the hun­dreds of price in­creas­es across the spec­trum have to be tak­en in­to con­text, and 46brook­lyn says that at first look, the de­gree of price in­creas­es in 2022 ap­pears to be “rel­a­tive­ly greater than the 2021 be­hav­ior.”

And ever since the in­for­mal 9.9% price hike ceil­ing was en­act­ed across phar­ma and biotech com­pa­nies, change in net prices over­all con­tin­ues to de­cline in 2022, af­ter three straight years of net price de­clines, ac­cord­ing to Adam Fein, CEO of the Drug Chan­nels In­sti­tute.

“Ob­vi­ous­ly the dev­il’s in the de­tails,” An­to­nio Ciac­cia of 46brook­lyn told End­points News.

Some brand drugs that have lost ex­clu­siv­i­ty have much high­er re­bates than true brand drugs. Ad­di­tion­al­ly, with launch prices be­ing a greater em­pha­sis point, it dis­torts the con­ver­sa­tion around re­bate vs list growth over time. And last­ly, since PBMs, in­sur­ers, and these new­er re­bate GPOs aren’t ob­lig­at­ed to pass through all those drug­mak­er con­ces­sions, even if net prices are go­ing down, that would be pure­ly from the view of the drug­mak­er, and the ac­tu­al pay­er may be hear­ing that net prices are go­ing down and won­der­ing, “huh?”

The news of the price in­creas­es comes as Con­gress is still try­ing to forge a deal around a rec­on­cil­i­a­tion bill that might in­clude drug pric­ing pro­vi­sions. Just be­fore the hol­i­day break, Sen. Joe Manchin (D-WV) halt­ed progress on a deal that would’ve al­lowed Medicare to ne­go­ti­ate on drug prices. among oth­er pro­vi­sions.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.