How to appeal a Highmark melanoma & melanoma-immunotherapy denial

The framework that applies to your appeal

Federal law gives you the right to a full and fair internal appeal, then an external review by an independent third party.

Highmark-specific note: Operates BCBS in PA (western), WV, DE, NY (western). Owns Allegheny Health Network.

What Highmark's policy requires for melanoma & melanoma-immunotherapy

Cited policy: BCBS Kimmtrak (Tebentafusp-tebn) for Uveal Melanoma

HLA-A*02:01-positive (must submit HLA typing report) metastatic or unresectable uveal melanoma. Age ≥18. ECOG 0-1. Inpatient or monitored outpatient first 3 doses (cytokine release syndrome monitoring). Step-up dosing weekly: 20 mcg → 30 mcg → 68 mcg.

How Highmark denies melanoma & melanoma-immunotherapy — and how to counter it

Where Highmark pushes back: 1) HLA typing not documented; 2) Uveal melanoma 'rare — try systemic ICI first'; 3) Site-of-care monitoring requirements not met.

Counter-arguments that hold up: FDA Jan 25, 2022 — first and only FDA-approved therapy with OS benefit in metastatic uveal melanoma. IMCgp100-202 (Nathan NEJM 2021; Hassel NEJM 2023 3-yr): OS HR 0.51 vs investigator's choice (incl. dacarbazine/Yervoy/Keytruda). Cutaneous-melanoma checkpoint inhibitors do NOT show OS benefit in uveal — uveal has low TMB, distinct biology. Submit HLA-A*02:01 typing + step-up dosing protocol; CRS monitoring per FDA REMS.

What Highmark typically denies for melanoma & melanoma-immunotherapy

Across Highmark's commercial and Medicare books, denials cluster around a small number of patterns. For melanoma & melanoma-immunotherapy, expect:

• Prior auth on biologics
• PA on advanced imaging
• OON balance bills

Treatments most often denied in this category

These are the melanoma & melanoma-immunotherapy treatments most often flagged for prior auth, step therapy, or medical necessity review:

• Keytruda (pembrolizumab)
• Opdivo (nivolumab) mono
• Yervoy (ipilimumab)
• Opdivo + Yervoy combo
• Opdualag (nivo+rela)
• Tafinlar + Mekinist

How to submit the appeal to Highmark

1. Read the denial letter — note the exact denial reason code and the appeal deadline (180 days from the date on the letter).
2. Gather supporting documentation: physician letter of medical necessity, relevant clinical notes, peer-reviewed citations supporting the treatment for your indication, and the policy or coverage document Highmark cited in the denial.
3. File the appeal through Highmark's portal (members: https://www.highmark.com ; providers: https://www.highmark.com/provider). Standard decision returns within 30 days; expedited urgent appeals return within 72 hours.
4. If denied again, request external review by an independent reviewer within 4 months of the final internal denial. In PA, the state insurance department coordinates external review for fully-insured plans; ERISA self-funded plans use a federal external review through DOL/EBSA.

Clinician or prior-auth team handling this on the practice side? See Highmark's prior-authorization criteria by drug: Highmark PA criteria on ApprovalHelp.