J&J sues com­pa­ny over al­leged abuse of its cost as­sis­tance pro­gram

John­son & John­son Health Care Sys­tems is su­ing a New Jer­sey mid­dle­man to stop it from in­creas­ing drug costs for pa­tients.

Ac­cord­ing to the law­suit, the ac­tion is in­tend­ed to stop SaveOn­SP from con­duct­ing a scheme to pil­fer tens of mil­lions of dol­lars from the fi­nan­cial sup­port pro­gram that J&J Health­care Ser­vices pro­vides for pa­tients.

SaveOn­SP, based in New York state, runs a co-pay ad­just­ment strat­e­gy that in­tends to build on ex­ist­ing in­sur­er-dri­ven co-pay ad­just­ment pro­grams. The pro­gram is run in part­ner­ship with PBM Ex­press Scripts and op­er­at­ed in con­junc­tion with spe­cial­ty phar­ma­cy Ac­cre­do.

The scheme works by cir­cum­vent­ing the con­straints on the lev­el of co­pay costs that pay­ers can re­quire pa­tients to pay for pre­scrip­tion drugs. This will then in­flate pa­tients’ co­pay costs to in­crease the funds ex­tract­ed from J&J’s pa­tient as­sis­tance pro­gram, called Janssen CarePath. Once drugs are in­clud­ed in the SaveOn­SP Pro­gram, the drug’s co-pay is al­so in­flat­ed to en­sure the pay­er cap­tures the to­tal amount of co-pay as­sis­tance avail­able re­gard­less of the num­ber of times the pa­tient fills the pre­scrip­tion.

SaveOn­SP was charg­ing pay­ers “25% of the sav­ings that are achieved.” These sav­ings were from pa­tient as­sis­tance pro­gram funds. To fa­cil­i­tate this pay­ment, pay­ers signed a 25% join­der agree­ment, which al­lows in­sur­ers to bill pa­tients for that fee on a pa­tient’s ad­min­is­tra­tive in­voice.

The law­suit al­leges that SaveOn­SP has ex­tract­ed near­ly $100 mil­lion in pa­tient as­sis­tance sup­port from CarePath.

J&J al­leges SaveOn­SP is cir­cum­vent­ing the Af­ford­able Care Act’s pa­tient pro­tec­tions by re­clas­si­fy­ing crit­i­cal med­ica­tions as “non-es­sen­tial,” re­gard­less of the pa­tient’s ac­tu­al needs as de­ter­mined by the pa­tient’s doc­tor.

To this date, SaveOn­SP has not tak­en J&J’s drugs off its list and is con­tin­u­ing to break CarePath’s terms and con­di­tions. More­over, J&J feels that dam­ages for on­go­ing and fu­ture wrong­do­ing are in­ad­e­quate be­cause SaveOn­SP is tak­ing con­cert­ed mea­sures to avoid de­tec­tion.

J&J de­mands a ju­ry tri­al with the dam­age amount to be de­cid­ed at tri­al. They al­so want the court to is­sue an in­junc­tion pre­vent­ing SaveOn­SP from im­ple­ment­ing its pro­gram with Janssen drugs, among oth­er de­mands.

This isn’t the on­ly le­gal mea­sure J&J filed re­cent­ly. Last week, it filed suit in New York against dis­trib­u­tors and phar­ma­cies that have al­leged­ly sold coun­ter­feit HIV med­ica­tion be­ing ad­ver­tised as their prod­uct.

Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.