How to appeal a Highmark amyloidosis (cardiac attr + al) 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 amyloidosis (cardiac attr + al)

Cited policy: BCBS Darzalex Faspro + VCd (D-VCd) for Newly-Diagnosed AL Amyloidosis

Adult with newly-diagnosed systemic AL amyloidosis confirmed by tissue biopsy + mass-spec typing OR immunoelectron microscopy identifying kappa or lambda light chains. Mayo 2012/2014 stage I-IIIa (not IIIb in many policies). Measurable hematologic disease (dFLC >=50 mg/L OR involved/uninvolved sFLC ratio abnormal OR M-protein quantifiable). Not eligible for or post ASCT. Hematologist Rx.

How Highmark denies amyloidosis (cardiac attr + al) — and how to counter it

Where Highmark pushes back: 1) Bortezomib-based induction (CyBorD) without daratumumab is sufficient first-line; 2) Reserve daratumumab for relapsed/refractory; 3) Mayo stage IIIb excluded.

Counter-arguments that hold up: ANDROMEDA (Kastritis NEJM 2021) — D-VCd vs VCd in newly-dx AL (n=388): hematologic CR 53% vs 18%, cardiac response 42% vs 22%, MRD-negativity higher with D-VCd. FDA approved Darzalex Faspro D-VCd combination on January 15, 2021 — the ONLY FDA-approved regimen specifically for AL amyloidosis. NCCN Category 1 first-line. CyBorD-without-daratumumab is now considered inferior to D-VCd for daratumumab-eligible patients. Mayo stage IIIb requires individualized review with attention to cardiac safety (slow-titration bortezomib + reduced-dose dexamethasone).

What Highmark typically denies for amyloidosis (cardiac attr + al)

Across Highmark's commercial and Medicare books, denials cluster around a small number of patterns. For amyloidosis (cardiac attr + al), expect:

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

Treatments most often denied in this category

These are the amyloidosis (cardiac attr + al) treatments most often flagged for prior auth, step therapy, or medical necessity review:

• Vyndaqel / Vyndamax (tafamidis)
• Attruby (acoramidis)
• Amvuttra (vutrisiran) ATTR-CM
• Onpattro (patisiran)
• Wainua (eplontersen)
• D-VCd for AL

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.