Court acts on copay accumulators

Good news out of the D.C. District Court, which struck down a rule that allowed insurers and PBMs to pocket copay assistance intended for patients. We have details, plus today’s new episode of the I am BIO Podcast explores why we need women leadership in biotech and a lot more news.  (754 words, 3 minutes, 46 seconds)

Court bars insurers and PBMs from pocketing drug makers’ copay assistance

A federal court yesterday struck down a rule allowing insurers and pharmacy benefit managers (PBMs) to pocket copay assistance that drug manufacturers intended for patients.

The rule: The Notice of Benefit and Payment Parameters (NBPP) for 2021 allowed insurers and PBMs to use copay accumulator programs to prevent manufacturer assistance (like copay cards and coupons) from being counted toward patients’ copay.

Why it matters: Drug manufacturers provide copay assistance to reduce out-of-pocket costs for patients. But insurers and PBMs skim from that assistance, ultimately making patients pay more for prescriptions.

The case: The HIV+Hepatitis Policy Institute sued Health and Human Services (HHS) in the U.S. District Court in Washington, D.C. to void the NBPP.

The ruling: The court agreed with the plaintiffs, saying the NBPP conflicts with CMS and Affordable Care Act definitions of “cost sharing” and “is arbitrary and capricious for a variety of reasons, including that it defines the same statutory and regulatory language in two conflicting ways.”

What happens now: Insurers must abide by the previous federal rule, allowing copay accumulators only for brand-name drugs with a generic equivalent, when permitted by state law.

What they’re saying: “We are thrilled that the Court has taken the side of patients who have been struggling to afford their prescription drugs due to the greedy actions of insurers and their PBMs,” said Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute.

I am BIO Podcast: Striking at the glass ceiling

The day after Katalin Kariko became the 13th woman to win a Nobel Prize in medicine for enabling mRNA COVID vaccines, the new episode of the I am BIO podcast features three women BIO Board members about gender diversity in biotech.

The numbers: Fewer than 10% of Fortune 500 CEOs are women; research shows men’s projects received twice the funding and three times the staff. Meanwhile, 8.6% of VCs are women, and fewer than 5% of VC-funded firms have women on their executive teams.

“It’s better for biotech,” says Erika Smith, CEO of ReNetX Bio. “About 35% of executive teams have women, and about 20% are CEOs.”

Why it matters: “Organizations in the top quartile of gender diversity are 25% more likely to experience above-average profitability than those in the lowest quartile. Also, companies employing an equal number of men and women have up to 41% higher revenue,” says Vestaron President and CEO Anna Rath.

It’s not a trade-off: “The pie can be much bigger if we allow more women and people of color to be in positions of power,” bringing new ideas, says biotech executive Grace Colón. For example, women’s health, a huge area for growth, is underappreciated by men.

Women help women in biotech, including through the biotech sisterhood, an informal network in which women executives rely on one another for support and recommendations, Colón explains.

Listen: Catch the new episode at www.bio.org/podcast or your favorite podcast app.

More Reading:Meet the biotech sisterhood—women supporting women in the pharma sector

More News: 

The Hill (Opinion): Without the right IP protections, we might say goodbye to our biotech innovation sector
“Unfortunately, the United States appears to be moving toward repeating many of the same policy mistakes that destroyed Europe’s innovation ecosystem. Bad policy choices could weaken incentives to innovate, allowing nations like China to overtake us. We need to reverse course at once,” writes Frank Watanabe, President and CEO of Arcutis Biotherapeutics and BIO Board member. 

Novavax: R21/Matrix-M™ malaria vaccine with Novavax’s adjuvant technology receives WHO recommendation
“The vaccine contains R21 antigen developed by University of Oxford, specific to the malaria parasite, and Novavax’s Matrix-M, a saponin-based adjuvant that enhances the immune response, making it broader and more durable. The filing was submitted to the WHO by Oxford and the vaccine is being developed and manufactured by Serum Institute of India.

Little Black Book: Bayer CropScience drops ‘Roots Remastered,’ a country music album made from corn
“Roots Remastered is the world’s first music album made from corn created to uplift farmers by letting them physically hear what healthy roots sound like.” 

President Biden’s Tuesday: No official events scheduled.

What’s Happening on Capitol Hill: The House has until Wednesday to act on a motion by Rep. Matt Gaetz (R-FL) to remove Rep. Kevin McCarthy (R-CA) from House speakership. Meanwhile, ICYMI, Reps. Brian Higgins (D-NY), Mike Kelly (R-PA), Derek Kilmer (D-WA), and Brian Fitzpatrick (R-PA), co-chairs of the bipartisan House Cancer Caucus, last week introduced a resolution to recognize September 30, 2023, as Rare Cancer Day, “to highlight the challenges patients face and to unify individuals living with rare cancers for awareness and early diagnosis.”