Spotlight on Market Access

A lawsuit filed by an employee against Johnson & Johnson could signal that significant changes in the legal obligations of commercial plan sponsors and PBMs around drug pricing are coming, experts say. The suit alleges that J&J violated its fiduciary obligations as a health plan sponsor under the Employee Retirement Income Security Act (ERISA) of 1974 by overpaying the plan’s PBM for employees’ medications.

If it’s successful, the suit could expose plans, plan sponsors and PBMs to significant, ongoing legal risk, experts say. However, they add that the opacity and complexity of drug pricing dynamics mean that the suit’s success is far from certain.

In late 2023, the FDA approved a new treatment regimen for urothelial cancer that represents a “paradigm change,” according to one industry expert. The cost of the therapy, however, could pose a barrier to its uptake.

On Dec. 15, 2023, the FDA approved Pfizer Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) in combination with Merck & Co., Inc.’s Keytruda (pembrolizumab) for the treatment of people with locally advanced or metastatic urothelial cancer (la/mUC). The agency gave accelerated approval to this combination for people with la/mUC who are not eligible for cisplatin-containing chemotherapy on April 3, 2023. The newest approval converts that accelerated approval to full and expands the labeled indication to include the treatment of people eligible for cisplatin chemotherapy. The application had priority review and breakthrough therapy designation.

The pharmaceutical and health products industry, which has consistently outspent all other industries on federal campaign contributions and lobbying, spent nearly $378.6 million in 2023 to further policy goals, according to data compiled by OpenSecrets.

With the 2024 presidential election around the corner, the pharma/health products industry nearly evenly distributed their donated campaign funds to Democratic and Republican lawmakers during the 2023-2024 election cycle. Among the 20 lawmakers who received the most contributions from the industry, nine are Democrats. President Joe Biden, who is running for re-election this year, topped the list, receiving over $232,000.

The FDA approved the highest number of novel therapies in years in 2023, and multiple potential blockbusters are slated for decisions in 2024. In addition, the Inflation Reduction Act looms large over the pharma industry as HHS negotiates the prices of the initial 10 Medicare Part D agents and lawsuits over the legality of the IRA play out. And while life sciences dealmaking was down a bit in 2023, the new year already looks to be more promising. AIS Health, a division of MMIT, spoke with some industry experts about their outlook for 2024.

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.