Spotlight on Market Access

An ongoing lawsuit over the use of copay accumulators is drawing to a close following the defendants’ and plaintiffs’ motions to dismiss their appeals. The ball is now in the federal government’s and state insurance commissioners’ courts to enforce a district court judge’s ruling, which states that manufacturer assistance must be counted toward patients’ out-of-pocket responsibility unless a brand-name drug has a medically appropriate generic equivalent.

Health plans and PBMs several years ago began implementing copay accumulators — and then a new iteration known as copay maximizers that declare certain drugs non-essential health benefits to avoid covering them per the Affordable Care Act (ACA) — to counter manufacturer copay assistance programs. Before these tools, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators and maximizers, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

Founded in 1938 as the California Physicians' Service, Blue Shield of California is now the fifth-largest insurer in its home state. While nearly 70% of its members are enrolled in employer-based insurance products, Blue Shield of California also offers Medicare Advantage and Affordable Care Act exchange plans. It acquired the Medicaid insurer Care1st Health Plan in 2015, which now operates as Blue Shield of California Promise Health Plan. In August 2023, the insurer made headlines for breaking with its longtime pharmacy benefits manager CVS Caremark in favor of a transparency-focused model in partnership with Amazon Pharmacy and Mark Cuban Cost Plus Drug Company, among others.

Biosimilar uptake is higher for Medicare Advantage beneficiaries than their traditional Medicare (TM) counterparts, with MA members up to 2.3 times more likely to be prescribed a biosimilar, according to new research published in JAMA Health Forum. The FDA has approved 45 biosimilars so far, with more approvals expected this year.

Researchers from CMS, the FDA and policy research firm Acumen LLC studied claims and encounter data to calculate market share for 20 biosimilars across seven product categories. Biosimilar uptake was higher for MA members in every category but bevacizumab, the generic name for Genentech’s targeted cancer therapy Avastin. Avastin currently has four biosimilars available, with a fifth approved last month.

PBM and drug pricing regulation will continue to be hot topics at the state level after several years of busy lawmaking, experts predict, even as PBM reforms are diluted and stalled in Congress. They predict that more states than ever will continue to embrace or pursue policies like drug affordability review boards.

“I do think the momentum is still strong, because states have the ability to do a lot more,” Kate Sikora, associate principal at Avalere Health, tells AIS Health, a division of MMIT. “Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier — a little bit more robust — in terms of what they attempt to do.”

In 2023, the FDA continued to rebound from a drop in approvals, marking the highest number in years. The agency’s Center for Drug Evaluation and Research (CDER) approved 55 novel drugs last year, and its Center for Biologics Evaluation and Research (CBER) approved 17 agents. That’s up from 37 CDER-approved therapies in 2022 and 51 in 2011. In 2022, CBER OK’d 13 agents, up from 10 in 2021. Specialty agents, such as cell and gene therapies, continued to make up a large portion of those new approvals, while the FDA approved several biosimilars, including a handful that were the first versions of their reference drugs. AIS Health, a division of MMIT, spoke with industry experts about what they view as the most notable FDA approvals of 2023.