Provider Briefing: Yervoy (Ipilimumab) Access in 2026

As an oncology provider, you know that treatment delays can have real consequences for your patients. Yervoy (Ipilimumab) — Bristol Myers Squibb's CTLA-4 checkpoint inhibitor — remains a cornerstone of immunotherapy regimens for multiple cancer types. This briefing provides an up-to-date picture of Yervoy's availability, cost landscape, and practical tools to help you keep your patients on track.

Current Supply Status

As of early 2026, Yervoy is not listed on the FDA Drug Shortage database and is not flagged by ASHP as being in active shortage. Manufacturing and distribution through specialty channels appear to be functioning normally.

However, the absence of a formal shortage designation does not eliminate access barriers. Providers continue to report challenges related to:

• Insurance prior authorization delays, particularly for newer indications
• Specialty pharmacy lead times, especially at smaller practice sites
• Variability in hospital formulary decisions regarding vial size stocking (50 mg vs. 200 mg)

Proactive ordering and early initiation of prior authorization remain the most effective strategies for preventing treatment delays.

Timeline: Key Developments

Understanding the recent timeline helps contextualize the current landscape:

• March 2011: FDA approves Ipilimumab (Yervoy) for unresectable or metastatic melanoma
• 2015–2022: Sequential FDA approvals expand indications to include RCC, NSCLC, CRC (MSI-H/dMMR), HCC, mesothelioma, and esophageal SCC — all in combination with Nivolumab
• March 2025: Core composition-of-matter patent for Ipilimumab expires in the United States
• April 2025: Sandoz and Henlius announce collaboration to develop and commercialize a proposed biosimilar of Yervoy
• 2025: FDA converts accelerated approval of Nivolumab + Ipilimumab for MSI-H/dMMR CRC to full approval (patients 12+)
• Early 2026: No approved biosimilar available; Bristol Myers Squibb remains the sole manufacturer

Prescribing Implications

The current prescribing landscape for Ipilimumab involves several considerations:

Dosing Regimens by Indication

Yervoy dosing varies significantly by indication, which affects vial utilization and ordering:

• Melanoma (monotherapy): 3 mg/kg IV every 3 weeks × 4 doses
• Melanoma (adjuvant): 10 mg/kg IV every 3 weeks × 4 doses, then every 12 weeks for up to 3 years
• RCC, NSCLC, mesothelioma, esophageal SCC (with Nivolumab): 1 mg/kg IV every 6 weeks
• CRC MSI-H/dMMR (with Nivolumab): 1 mg/kg IV every 3 weeks × 4 doses
• HCC (with Nivolumab): 3 mg/kg IV as a single dose

Dose-rounding and vial-sharing protocols should be reviewed to minimize waste, especially given the high per-vial cost.

Immune-Mediated Adverse Event Management

Yervoy's boxed warning addresses severe and fatal immune-mediated adverse reactions, including colitis, hepatitis, dermatitis (including TEN), neuropathy, and endocrinopathy. Providers should ensure robust monitoring protocols are in place, particularly for combination regimens with Nivolumab, which carry higher toxicity rates.

Key management points:

• Grade 2+ immune-mediated reactions require withholding doses and initiating corticosteroids
• Grade 3–4 reactions typically require permanent discontinuation
• Endocrinopathies may require lifelong hormone replacement even after resolution of other toxicities

For a patient-facing resource, consider sharing our Yervoy side effects guide and drug interactions reference.

Availability Picture

Yervoy is distributed exclusively through specialty channels:

• Specialty pharmacy networks contracted with Bristol Myers Squibb
• Hospital pharmacy departments with oncology formulary inclusion
• Buy-and-bill arrangements at physician offices with oncology infusion suites

Providers operating in smaller practices or rural settings may face longer lead times. Establishing backup ordering relationships with multiple specialty distributors can mitigate this risk.

Cost and Access Landscape

The cost of Yervoy remains significant:

• AWP: ~$7,308 per 50 mg vial; ~$29,232 per 200 mg vial
• Per-treatment-course estimate (melanoma, 4 doses): $120,000–$150,000+
• Reimbursement: Medicare Part B covers physician-administered Yervoy under the buy-and-bill model; commercial payers typically require prior authorization

For patients struggling with cost, direct them to:

• BMS Oncology Co-Pay Assistance Program (commercially insured): 1-800-861-0048
• Bristol Myers Squibb Patient Assistance Foundation (uninsured): bmspaf.org, 1-800-736-0003
• Additional resources: PAN Foundation, NeedyMeds, RxAssist

For a patient-facing guide on financial assistance, see how to save money on Yervoy.

Tools and Resources for Providers

Several tools can help streamline Yervoy access for your patients:

• Medfinder for Providers: Search real-time availability of Yervoy at infusion centers and specialty pharmacies. A practical tool for locating stock when your usual channels are delayed.
• BMS Access Support: Dedicated provider support line at 1-800-861-0048 for prior authorization assistance, reimbursement coding, and supply sourcing.
• NCCN Guidelines: Refer to current NCCN guidelines for approved Ipilimumab-containing regimens and evidence-based alternatives when switching is necessary.

Alternative Agents When Yervoy Is Unavailable

When Yervoy access is delayed, the following agents may be considered based on indication:

• Tremelimumab (Imjudo): CTLA-4 inhibitor approved for HCC (with Durvalumab) and NSCLC (with Durvalumab + chemo). Most pharmacologically similar to Ipilimumab.
• Pembrolizumab (Keytruda): PD-1 inhibitor with broad approvals across melanoma, NSCLC, RCC, and multiple other tumor types.
• Nivolumab (Opdivo) monotherapy: If the Nivo/Ipi combination is disrupted, Nivolumab monotherapy may be appropriate depending on indication and line of therapy.
• Durvalumab (Imfinzi): PD-L1 inhibitor approved for NSCLC, SCLC, HCC, and biliary tract cancer.

For detailed comparison, see our alternatives to Yervoy overview.

Looking Ahead

The biosimilar landscape for Ipilimumab is beginning to take shape. With the core patent expired and Sandoz/Henlius actively pursuing development, a biosimilar could reach the U.S. market as early as 2027–2028. This would introduce price competition and potentially improve access.

In the meantime, new combination regimens incorporating Ipilimumab continue to emerge from clinical trials, which may further expand indications and increase demand. Providers should monitor supply chain conditions and maintain flexible ordering protocols.

Final Thoughts

Yervoy remains a critical tool in the immuno-oncology arsenal. While formal shortage conditions are not present in early 2026, real-world access barriers persist. Proactive prior authorization, flexible sourcing strategies, and awareness of patient assistance programs are essential for keeping your patients on treatment.

Use Medfinder for Providers to check Yervoy availability in real time. For a step-by-step workflow on helping your patients find Yervoy, see our provider's guide to finding Yervoy in stock.