Stelara patent cliff payer decisions 2025?

Stelara (ustekinumab) – Patent Cliff and 2025 Payer Landscape

| Topic | Key Points | What 2025 Payer Decisions Are Likely to Look Like |
|-------|------------|---------------------------------------------------|
| Patent Status | • BLA exclusivity: 12‑year exclusivity from FDA approval (Dec 2013) → expires Dec 2025.
• Product patents: 9‑year term (USPTO) on the antibody and formulation; most of these run out in 2024‑2025.
• Patent “cliff”: The last remaining U.S. patents on the drug expire in late‑2025 (see FDA Orange Book 2025 edition). | Payers are watching the exact expiration date because it triggers potential entry of biosimilar or generic competitors. |
| Biosimilar Pipeline | • Sandoz (Novartis) – Ustekinumab (biosimilar): NDA submitted 2025; FDA review expected Q2‑2026.
• Amgen – Ustekinumab (biosimilar): NDA submitted 2025; FDA review expected Q3‑2026.
• Regeneron – Ustekinumab (biosimilar): NDA submitted 2025; FDA review expected Q4‑2026.
• No U.S. biosimilar has yet been approved (last FDA approval was in 2019 for the EU market). | Payers will evaluate the incoming biosimilars once FDA approvals are announced (likely 2026). 2025 decisions will focus on price negotiation frameworks for the brand and the “first‑in‑class” status of any future biosimilar. |
| Pricing & Contract Landscape | • AbbVie announced a 30 % list‑price reduction for 2025 for all indications (psoriasis, Crohn’s, UC).
• AbbVie has entered into several value‑based contracts with commercial insurers for psoriasis (e.g., “no‑gap” coverage when certain clinical endpoints are met).
• For Medicare/Medicaid, AbbVie is pursuing “coverage with evidence development” (CED) agreements that tie reimbursement to post‑marketing outcomes. | In 2025, insurers will decide whether to:
– Keep Stelara on formulary as a preferred biologic (leveraging AbbVie’s discounts).
– Introduce step‑therapy that requires patients to try cheaper agents first.
– Negotiate rebates or risk‑sharing based on real‑world data. |
| Payer‑specific Trends (2025) | | |
| • Commercial Insurers | • Expect tiered coverage: Stelara may stay in the high‑tier but with a lower co‑pay (thanks to the 30 % price cut).
• Some payers (e.g., Aetna, Cigna) may require prior authorization for Crohn’s/UC but allow direct access for psoriasis. | |
| • Medicare Part D | • The drug is on the Medicare Part D “