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.

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.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.