Small-molecule drugs and biologics may produce similar health benefits, but because small molecules tend to be priced lower than biologics, they often represent better value, according to a recent Health Affairs study. And the study authors argued those findings suggest it could be worth revising how the Medicare Drug Price Negotiation Program is set up.

The Inflation Reduction Act of 2022 requires that Medicare negotiate a Maximum Fair Price for selected small-molecule drugs nine years after they were approved by the FDA. Whereas for selected biologics, the negotiated price takes effect after 13 years.

With Donald Trump set to be the 47th president and Republicans in control of both chambers of Congress, 2025 is shaping up to be a year in which the GOP has enough political might to pass PBM reform — if it has the political will.

Yet two pharmaceutical industry trade groups do not appear to be counting on Republicans’ ability to quickly prioritize a health care issue. Instead, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Association of Manufacturers (NAM) are both launching ad blitzes aimed at pressing Congress to target PBMs before the year is over.

Copay maximizer programs are gaining popularity among payers while copay accumulators appear to be losing some of their appeal, according to the annual Copay Accumulator & Maximizer Programs Special Report published by AIS Health’s parent company, MMIT. The report was based on surveys of 35 commercial insurers and PBMs representing 121.0 million lives.

About 39% of people were enrolled in plans with copay accumulators in 2024 on average, down from 47% in 2023. And 47% of enrollees were in plans with copay maximizer programs. On average, payers anticipated that about 48% and 57% of plan members will be covered by plans with copay accumulators and maximizers within the next 12 months, respectively.

A Medicare Part D policy forbidding plan sponsors’ formularies from excluding nearly all drugs in six “protected” classes hinders payers’ ability to negotiate prices and may lead to significantly higher costs to the health care system, according to a recent analysis published in Health Affairs. The study’s lead author notes this is the first peer-reviewed trial suggesting Part D plans “can’t negotiate as high of rebates as they might otherwise be able to” for drugs in the protected classes.

Starting on Jan. 1, 2025, most Blue Shield of California commercial plan enrollees will have access to a Humira (adalimumab) biosimilar with a $0 copay as part of the insurer’s Pharmacy Care Reimagined model. Blue Shield announced the initiative on Oct. 1 and said it would partner with Fresenius Kabi, which manufactures a Humira biosimilar, and Evio Pharmacy Solutions, a company that Blue Shield and other Blues plans founded in 2021. As part of the agreement, Blue Shield will purchase the Humira biosimilar for a monthly price of $525, significantly below the net price of $2,100 per month for branded Humira. Blue Shield revealed the Pharmacy Care Reimagined model in August 2023 and noted it would shift from a traditional PBM contract with CVS Health Corp.’s Caremark to a pharmacy benefits arrangement with five different vendors.

Employers expect their health care costs will increase next year at a higher rate than in previous years, as they continue to deal with inflation and other headwinds, according to recent surveys and database analyses from major benefits brokers. Actuaries from two of those firms tell AIS Health, a division of MMIT, that the increases are being driven by a few factors, including higher reimbursement for hospitals and providers, a rise in care utilization now that the coronavirus pandemic is over, and a higher percentage of people using expensive specialty medications and GLP-1 drugs.

Aon predicts the average cost for employer-sponsored health plans will increase by 9% in 2025, up from a 5.8% increase this year. Meanwhile, WTW projects a 7.7% increase in health care costs next year compared with a 6.9% increase this year and a 6.5% increase last year. Mercer anticipates a 7% increase in costs for employer plans in 2025.

Sen. Bernie Sanders (I-Vt.) said during a Senate hearing that major PBMs promised to expand access to Ozempic and Wegovy if Novo Nordisk agrees to lower the list price. In a tense hearing on Sept. 24 held by the Senate Health, Education, Labor and Pensions Committee, Sanders, the committee chair, sought answers from Novo CEO Lars Jorgenson as to why the company’s semaglutide list prices top $1,000 a month in the U.S., noting that the drugs can cost anywhere from $130 to even $59 in other countries. Ozempic and Wegovy, both GLP-1 drugs, treat Type 2 diabetes and obesity, respectively. Sanders challenged Jorgenson to lower the U.S. list price, noting that The Cigna Group’s Express Scripts, CVS Health Corp.’s Caremark and UnitedHealth Group’s Optum Rx pledged to expand coverage of the diabetes and obesity medications. Jorgenson did not commit to a price reduction, saying “I don’t know under which conditions such a promise comes,” but he seemed to remain open to the idea if it helps patients access more affordable medicine. Jorgenson also noted that the $1,000 drug list price is a starting point for payer negotiations and said the company pays 75 cents per dollar received due to discounts, fees and rebates.

Health policy experts appear to largely agree that regardless of the partisan makeup of Congress and the White House next year, PBM reform will continue to be a key priority. Opinions are mixed, however, as to whether Democrats or Republicans would be more likely to take the hardest line against a highly scrutinized industry.

During a recent webinar hosted by Faegre Drinker Consulting, Nick Manetto, a principal at the firm, said Democrats are “maybe a hair” more likely to embrace PBM reforms that go beyond enacting new transparency requirements. PBM critics have said that while they support transparency, more data-reporting requirements aren’t enough to drive meaningful change in the industry.

Employers and health plans are less satisfied with the “Big Three” PBMs — CVS Health Corp.’s Caremark, UnitedHealth Group’s Optum Rx and The Cigna Group’s Express Scripts — compared with their smaller peers in the pharmacy benefits industry, according to a Pharmaceutical Strategies Group (PSG) survey published this month. While the Big Three have taken steps in recent months to offer more transparent models, Michael Lonergan, PSG’s president, tells AIS Health those companies have faced numerous challenges to their businesses that have made them more unpopular among clients.

For instance, he mentions the Federal Trade Commission (FTC) lawsuit filed on Sept. 20 against the Big Three PBMs and their affiliated group purchasing organizations (GPOs), accusing them of inflating the list price of insulin medications and restricting access to those drugs. The FTC also issued an interim report in July that was highly critical of the Big Three, which together account for about 80% of the U.S. prescription drug claim processing market.

Point32Health CEO Cain Hayes has departed the company to pursue other opportunities, according to a Sept. 13 press release. Eileen Auen, Point32Health’s chair of the board, took over as interim CEO until the company can find a permanent replacement for Hayes, who had led Point32 since its inception in 2021 through the merger of Harvard Pilgrim Health Care and Tufts Health Plan. Auen has worked in health care management roles for more than 25 years, including as CEO of APS Healthcare, a behavioral health company, and PMSI, a PBM.