Allergan CEO Brent Saunders (via AP images)

The list gets longer: Mer­ck, Al­ler­gan, No­var­tis is­sue 2020 drug price hikes — re­port

The price train con­tin­ues chug­ging in one di­rec­tion.

On Fri­day, a trio of drug­mak­ers — US-based Mer­ck, Ire­land-head­quar­tered Al­ler­gan and Swiss drug­mak­er No­var­tis — is­sued a round of hikes on more than 100 med­i­cines, vault­ing the to­tal num­ber of price rais­es on 445 drugs in 2020, Reuters re­port­ed, cit­ing health­care re­search firm 3 Ax­is Ad­vi­sors.

These spikes fol­low those by a cadre of drug­mak­ers in­clud­ing GSK, Pfiz­er, Gilead, Bris­tol-My­ers, Bio­gen, Lil­ly, and Te­va ear­li­er in the first week of 2020. In most cas­es, the stick­er price in­creas­es have been lim­it­ed to the mid-sin­gle-dig­it per­cent­ages. As the spot­light on drug pric­ing in­ten­si­fied, with pa­tients, pol­i­cy­mak­ers, and politi­cians de­cry­ing the mag­ni­tude and fre­quen­cy of hikes, a raft of drug­mak­ers — led by Al­ler­gan CEO Brent Saun­ders — pre­vi­ous­ly pledged to not raise their prices by more than 10% an­nu­al­ly.

“We don’t have all the da­ta yet,” 3 Ax­is Ad­vi­sors’ co-founder An­to­nio Ciac­cia not­ed in an in­ter­view with End­points News. His­tor­i­cal­ly, the bulk of the price in­creas­es for the year are typ­i­cal­ly is­sued by the sec­ond week of Jan­u­ary.

The biggest of­fend­er in terms of price in­creas­es is hard to iso­late not just be­cause all the price in­creas­es not been rev­e­lat­ed yet, but be­cause list prices are not re­li­able in­di­ca­tors of re­al, av­er­age, out-of-pock­et costs for in­sured Amer­i­cans.

“The amount of in­creas­es that we’ve seen so far are pret­ty well in line with pri­or years, at least over the last five years. It’s im­pos­si­ble to tell who the bad guy is,” Ciac­cia said. “Like if they raised the price by 7%, where that 7% is go­ing — is it go­ing back to…share­hold­ers or is it flowed back to the sup­ply chain in terms of a pro­pri­etary dis­count that’s go­ing to the in­sur­ers and the PBMs.”

In the lat­est round of hikes on Fri­day, both No­var­tis and Al­ler­gen (which is the process of be­ing swal­lowed by Ab­b­Vie) said the net prices on their price boost­ed med­i­cines would be ei­ther flat or low­er in 2020.

No­var­tis is lift­ing the prices of 7% of its US med­i­cines — but the drug­mak­er told Reuters that af­ter dis­counts and re­bates those net prices will de­crease by 2.5%. Mean­while, Al­ler­gan is boost­ing prices on 25 drugs by 5%, and on two more med­i­cines by 2-3%, but fol­low­ing dis­counts and re­bates, its net prices will work out flat-to-low­er in 2020, the com­pa­ny claimed to the wire ser­vice.

In ad­di­tion, Mer­ck el­e­vat­ed the stick­er price on 15 drugs — in­clud­ing its di­a­betes drugs Janu­via and Janu­met — by an av­er­age of 5%. The price of the drug­mak­er’s flag­ship im­munother­a­py, Keytru­da — which gen­er­at­ed near­ly $8 bil­lion in the first nine months of 2019 and is on track to be­come the world’s best sell­ing med­i­cine by 2024 — is go­ing up by 1.5%. Mer­ck’s hikes are “con­sis­tent with its com­mit­ment to not raise US net prices by more than in­fla­tion an­nu­al­ly,” the com­pa­ny told Reuters.

“I think over the last three, four years man­u­fac­tur­ers have rel­a­tive­ly speak­ing, tak­en their foot off the gas,” Ciac­cia said. “They’re lay­ing low, they’re keep­ing the in­creas­es un­der 10%. But for the most part, I feel like they’re keep­ing things with­in the realm that hope­ful­ly keeps them out of the news­pa­pers.”

As of Fri­day, Ciac­cia said there was one small drug­mak­er that boost­ed the price of its med­i­cine by more than 10%: Neos Ther­a­peu­tics lift­ed the price of its at­ten­tion deficit dis­or­der drug, Con­tem­pla XR, by 13.24%.

Some­times, drug­mak­ers don’t just take an­nu­al hikes — they al­so take ad­di­tion­al mid-year in­creas­es, al­though the prac­tice has grad­u­al­ly wilt­ed as the scruti­ny in­to pric­ing in­ten­si­fies.

“His­tor­i­cal­ly speak­ing, mid-year price heights have re­al­ly erod­ed…we’re not see­ing the amount of fig­ure price in­creas­es that we used to,” Ciac­cia said. “It’s hard to have a crys­tal ball, but if we’re, just judg­ing on past ex­pe­ri­ence, maybe price in­creas­es will like­ly go down again.

Surg­ing drug prices in the Unit­ed States are a thorny yet key bi­par­ti­san is­sue as an­oth­er pres­i­den­tial elec­tion beck­ons. While US Pres­i­dent Trump strug­gles to make good on his promise to low­er drug prices, the in­dus­try, which has long thrived pric­ing its prod­ucts with­out gov­ern­ment in­ter­fer­ence, per­sis­tent­ly ar­gues that any kind of in­ter­fer­ence will sti­fle in­no­va­tion.

Law­mak­ers left and right all ar­gue drug prices in the Unit­ed States are too high — and the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again. Last month, the HHS opened the door to a pol­i­cy that al­lows for the im­por­ta­tion of drugs from Cana­da.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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UP­DAT­ED: CMS to re­strict cov­er­age of Bio­gen's con­tro­ver­sial Alzheimer's drug to on­ly clin­i­cal tri­als

The Centers for Medicare and Medicaid Services on Tuesday said it will only pay for Biogen’s Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies for Alzheimer’s disease under CMS-approved randomized controlled trials.

The draft national coverage decision, which insurers nationwide are likely to follow, makes clear that CMS will be looking for randomized controlled trials that “demonstrate a clinically meaningful benefit in cognition and function.” That will be a tough task for Biogen, which previously showed conflicting benefits from past Aduhelm trials that were initially cut short due to futility and then resurrected for the accelerated approval.

CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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