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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

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Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

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Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.