PhRMA President and CEO Stephen Ubl

PhRMA's court win over HHS could be a boon for phar­ma pa­tient as­sis­tance pro­grams

As out-of-pock­et costs have risen for pa­tients in the US in re­cent years, phar­ma man­u­fac­tur­ers have of­fered fi­nan­cial as­sis­tance — in­clud­ing to those with com­mer­cial in­sur­ance — to bet­ter shoul­der these high­er costs.

Catch­ing on to the ex­tent of this fi­nan­cial as­sis­tance, com­mer­cial health in­sur­ers have sought to pock­et at least some of that ex­tra mon­ey, de­vis­ing com­plex schemes known as “ac­cu­mu­la­tor ad­just­ment pro­grams,” that ba­si­cal­ly carve out this phar­ma as­sis­tance when cal­cu­lat­ing an in­sured per­son’s an­nu­al de­ductible and co­pay­ment for a drug.

In essence, com­mer­cial in­sur­ers use an “ac­cu­mu­la­tor” to track an in­sured pa­tient’s pay­ments to­ward an in­di­vid­ual’s an­nu­al out-of-pock­et costs. The in­sur­ers can then ex­clude from these out-of-pock­et costs any fi­nan­cial as­sis­tance re­ceived from a man­u­fac­tur­er.

But now a new court rul­ing from the DC Dis­trict Court yes­ter­day takes a crack at these ac­cu­mu­la­tors, grant­i­ng a win to in­dus­try lob­by­ing group PhRMA, which sued the fed­er­al gov­ern­ment over a 2020 rule that would’ve re­quired man­u­fac­tur­ers to “en­sure the full val­ue of the as­sis­tance or ben­e­fit is passed on to the con­sumer or pa­tient” for any fi­nan­cial as­sis­tance to an in­sured pa­tient not to count to­ward the best price.

The agency had to ini­tial­ly de­lay the ef­fec­tive date of this rule change un­til Jan. 1, 2023, be­cause man­u­fac­tur­ers had voiced “con­cern[s] that they may not be able to en­sure their man­u­fac­tur­er as­sis­tance is go­ing to the pa­tient and not be­ing passed through to the health plan via an elec­tron­ic means right away.”

The gov­ern­ment’s view, how­ev­er, is that the al­leged in­juries of PhRMA’s mem­bers stem not from HHS’s re­cent rule­mak­ing, but from the 2007 and 2016 reg­u­la­tions, which means that no PhRMA mem­ber has suf­fered a harm trace­able to the 2020 ac­cu­mu­la­tor ad­just­ment rule.

“Put dif­fer­ent­ly, the gov­ern­ment ar­gues that man­u­fac­tur­ers have long had a du­ty to in­clude in their best price cal­cu­la­tions the ef­fects of ac­cu­mu­la­tor ad­just­ment pro­grams, and thus any harm to PhRMA’s mem­bers is trace­able to the 2007 and 2016 reg­u­la­tions and not the ac­cu­mu­la­tor ad­just­ment rule (which is the on­ly agency ac­tion chal­lenged here). The Court dis­agrees,” Tues­day’s rul­ing says.

Judge Carl Nichols ex­plains that be­cause phar­ma man­u­fac­tur­ers must “en­sure” that the full val­ue of the as­sis­tance stays with the pa­tient, “That new oblig­a­tion will im­pose on the man­u­fac­tur­ers nu­mer­ous com­pli­ance re­quire­ments that will af­fect pock­et­books. In­deed, even as­sum­ing that com­mer­cial health in­sur­ers share all rel­e­vant in­for­ma­tion with the drug com­pa­nies, those com­pa­nies must now adopt mech­a­nisms to en­sure that no fi­nan­cial as­sis­tance to pa­tients pass­es off to com­mer­cial health in­sur­ers (or that, if it does, it is in­clud­ed in the best price cal­cu­la­tion).”

He al­so points to an am­i­cus brief from McKesson not­ing that “es­tab­lish­ing ‘cov­er­age cri­te­ria’ to iden­ti­fy whether an ac­cu­mu­la­tor pro­gram ap­plies to a par­tic­u­lar pre­scrip­tion trans­ac­tion would prove cost­ly.”

PhRMA pres­i­dent and CEO Stephen Ubl praised the rul­ing in a state­ment yes­ter­day, adding:

The de­ci­sion to va­cate the pa­tient as­sis­tance penal­ty – a pro­vi­sion of a Med­ic­aid rule fi­nal­ized in 2020 – is a win for pa­tients. Man­u­fac­tur­ers pro­vide pa­tient as­sis­tance to do just that – as­sist pa­tients and ad­dress gaps in in­sur­ance – but in­stead in­sur­ers are si­phon­ing that mon­ey away for them­selves. We will con­tin­ue to work with pol­i­cy­mak­ers on so­lu­tions that make med­i­cines more af­ford­able and low­er what Amer­i­cans pay out of pock­et.

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.

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.”

#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

CANNES — When Tamara Rogers joined GSK back in 2018, “science was king and R&D were the gods.” Now the global chief marketing officer of consumer healthcare wants to make room for another supreme being: the consumer.

As health and wellness becomes more relevant to consumers amid the pandemic, four health-focused executives called on marketers to involve patients in their creative process in a panel discussion at the Cannes Lions advertising creativity festival.

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