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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”