Major changes will impact healthcare and drug pricing in 2026 – from new federal pricing policies and regulations to a surge of high-impact drug launches. At ProAct, we’re already preparing with proactive formulary strategies, utilization management, and financial planning support to help our clients stay ahead and maintain strong clinical outcomes. Read more on the top 10 prescription drug management trends to anticipate in 2026:
1. Starting January 1, 2026, the first 10 Medicare Part D drugs will face Maximum Fair Prices (MFPs), with 15 more added in 2027. While some prices may change little due to existing rebates and biosimilars, drugs like Imbruvica and Enbrel could see meaningful impact.
2. Most Favored Nation (MFN) agreements require manufacturers to offer global benchmark pricing to all Medicaid beneficiaries. CMS introduced the voluntary GENEROUS Model to better align Medicaid drug prices with peer nations, but existing statutory rebates already lower costs significantly, so added savings may be limited. Manufacturers have also committed to:
- Increase U.S. R&D and manufacturing investment
- Repatriate more global revenue
- Expand direct‑to‑consumer purchasing options
- Keep U.S. launch prices at or below global levels
3. Direct-to-Consumer (DTC) programs grew rapidly in 2025 and will accelerate with the launch of http://TrumpRx.gov in January 2026. While they offer discounted cash‑pay options, they can:
- Add complexity for patients
- Disrupt continuity of care
- Provide limited value for insured patients—one key exception: GLP‑1 weight‑loss drugs, where DTC access can significantly reduce costs for patients without coverage.
4. Biomarker‑driven therapies are moving beyond oncology into neurology, cardiology, and rare diseases. High‑cost gene and targeted treatments will strain payer budgets and require new coverage models.
5. Starting in 2026, 340B discounts for selected drugs will move from point‑of‑sale to rebate‑based reimbursement—raising administrative burden and cash‑flow strain for covered entities, while improving transparency and reducing duplicate discounts.
6. The FDA is proposing major changes to biosimilar guidance:
- Comparative efficacy studies may no longer be required
- All biosimilars could be deemed interchangeable
This could speed approvals and increase market competition.
7. Federal PBM reform stalled in 2024–2025, but new legislation introduced in late 2025 signals renewed momentum, while states continue to layer on their own rules and add to the regulatory patchwork.
8. Key biosimilar launches to watch:
- Xolair (omalizumab)
- Eylea (aflibercept)
9. First-time generic launches in 2026 could unlock billions in savings, including:
- Januvia/Janumet
- Xeljanz
- Pomalyst
- Ofev
- Opsumit
10. Major FDA decisions in 2026 are expected in key therapeutic areas:
- Ophthalmology
- Endocrinology
- Neurology
- Pulmonary
