The 2025 FDA Drug Pipeline: Implications for Self-Insured Employer Groups

Journavx is big news.

We have most of 2025 still ahead of us, but this drug approved by the FDA in January, a pioneering non-opioid analgesic to treat moderate to severe pain, may be the most significant drug approved this year. We’ll have to wait and see; the FDA is expected to approve some potential blockbuster drugs in 2025.

Last year, the FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new “novel” drugs. Novel drugs are new drugs never before approved or marketed in the U.S. The FDA can also approve additional treatments for existing drugs, such as Zepbound (tirzepatide), which was initially approved to treat obesity in 2023, and then approved in December 2024 to treat obstructive sleep apnea.

Among the new drugs approved last year expected to significantly impact health and the market are Tryvio (aprocitentan) for treating high blood pressure and Neffy (epinephrine) for severe allergic reactions. New drugs also come with new, often very high, costs. The median annual list price for new drugs is expected to increase by more than $300,000.

As we look ahead to 2025, the FDA drug pipeline is brimming with promising new treatments, including groundbreaking therapies in areas such as oncology, rare diseases, and neurodegenerative disorders. While these advancements offer hope for improved patient outcomes, they also present cost challenges for self-insured plans.

Cost Management

Many drugs in the 2025 FDA pipeline are specialty medications, typically with high price tags. Self-insured employers may need to prepare for potential increases in plan costs as these innovative treatments become available. To mitigate financial risks, employers should consider implementing robust prior authorization processes, exploring value-based contracts, and enhancing stop-loss coverage to protect against catastrophic claims.

Additionally, self-insured employers can utilize pharmacy market check tools to ensure their plan aligns with industry standards for coverage and cost.

Biosimilars: A Cost-Saving Opportunity

While new specialty drugs may drive up costs, the increasing availability of biosimilars offers a potential counterbalance. Biosimilars are highly similar versions of existing biologic drugs, often available at a lower price. Today, 64 biosimilars are available in the market, with estimated cost savings from biosimilar use at $28.4 billion from 2021-2025.

Data Analytics Means Plan Visibility

Considering the evolving drug pipeline and its potential impact on self-insured employer groups, leveraging pharmacy data analytics can provide crucial visibility into plan costs and utilization. A robust pharmacy data analytics solution can offer real-time insights into drug utilization patterns, helping employers identify trends and anticipate the impact of new pipeline drugs on their plan.

By providing transparency into plan pricing compared to benchmarks such as National Average Drug Acquisition Cost (NADAC) and Average Wholesale Price (AWP), these tools empower employers with the leverage they need to get the best value on high-cost drugs. By comparing their negotiated rates against these industry benchmarks, employers can identify potential overcharging, negotiate more effectively with pharmacy benefit managers (PBMs), and make informed decisions about formulary design.

Miracle drugs like Journavx will be approved by the FDA, providing incredible health benefits and significant cost challenges. Staying informed and developing flexible plans to respond to new drugs will be the key to employer-sponsored health plan success.