How to appeal a Highmark adult car-t cell therapy 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 adult car-t cell therapy

Cited policy: BCBS Federal Employee Program Medical Policy — Brexucabtagene Autoleucel (Tecartus)

FDA-approved indication: r/r mantle cell lymphoma after >=2 prior lines including a BTK inhibitor (Jul 2020 ZUMA-2) OR adult (>=18) r/r B-cell precursor ALL (Oct 2021 ZUMA-3). Age >=18. ECOG 0-1. ANC >=1000, plt >=75K, LVEF >=50%, CrCl >=60, AST/ALT <2.5x ULN, total bili <1.5. No active CNS disease. Administered at FACT-accredited REMS-certified ATC. Bridging + Flu/Cy LD bundled.

How Highmark denies adult car-t cell therapy — and how to counter it

Where Highmark pushes back: 1) 'Try allo-HSCT first' for adult B-ALL; 2) Prior BTKi requirement strict-interpretation for MCL; 3) MRD+ disease deemed insufficient.

Counter-arguments that hold up: ZUMA-2 (Wang NEJM 2020) — Tecartus 87% ORR / 62% CR in r/r MCL post-BTKi → FDA Jul 24 2020. ZUMA-3 (Shah Lancet 2021) — Tecartus 71% CR/CRi in adult r/r B-ALL → FDA Oct 1 2021. NCCN ALL v2.2024 + NCCN B-cell Lymphomas v6.2024 list Tecartus as preferred regimen. Allo-HSCT carries 20-30% TRM vs Tecartus much lower TRM; many B-ALL patients ineligible for allo-HSCT due to age/comorbidity/no donor. ZUMA-3 entry criteria included MRD+ relapse; MRD+ qualifies as r/r disease per NCCN + IWG. Prior BTKi requirement met by any covalent or non-covalent BTKi exposure.

What Highmark typically denies for adult car-t cell therapy

Across Highmark's commercial and Medicare books, denials cluster around a small number of patterns. For adult car-t cell therapy, expect:

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

Treatments most often denied in this category

These are the adult car-t cell therapy treatments most often flagged for prior auth, step therapy, or medical necessity review:

• Yescarta
• Kymriah
• Tecartus
• Breyanzi
• Carvykti
• Abecma

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.