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AetnaCommercial · Coverage · Medical Policy · Hematology, OncologyMedium impact

Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) (CPB 0904, reviewed 2026-06-08)

Effective date
Not stated in the notice
Identified
Aug 13, 2026

Summary

Aetna considers daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro) medically necessary for the listed indications, including multiple myeloma regimens, systemic light chain amyloidosis, HIV-related plasmablastic lymphoma used with dose-adjusted EPOCH, relapsed or refractory T-cell acute lymphoblastic leukemia, POEMS syndrome, plasma cell-related monoclonal immunoglobulin deposition disease, and plasma cell-related monoclonal gammopathy of renal significance, when each listed criteria set is met. Continuation of therapy is considered medically necessary on reauthorization when there is no evidence of unacceptable toxicity or disease progression on the current regimen. Aetna considers all other indications experimental, investigational, or unproven.

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What to do

Action · 7 steps
01Precertification is required for daratumumab (Darzalex) and daratumumab and hyaluronidase-fihj (Darzalex Faspro) for all Aetna participating providers and members in applicable plan designs.
02Billing team: request precertification using the phone line or fax number in the policy, and use the Statement of Medical Necessity forms referenced there where needed.
03Precertification requests should show that the member meets the criteria for the diagnosis and the combination regimen listed in the policy, such as the prior therapies or refractory status named for each multiple myeloma regimen.
04For reauthorization, document that there is no evidence of unacceptable toxicity or disease progression on the current regimen.
05For newly diagnosed systemic light chain amyloidosis on daratumumab and hyaluronidase-fihj, the maximum treatment duration is 24 months.
06Indications not listed in the criteria, including the lymphomas, leukemias and solid tumors named in the policy, are considered experimental, investigational, or unproven.
07Combined daratumumab with obinutuzumab or with rituximab for steroid-resistant nephrotic syndrome is considered experimental, investigational, or unproven.

Codes mentioned

38206382419641396416J9144J9145J1100J7512J8530J8540J8541J8560J8600J9000J9041J9046J9047J9048J9049J9051J9054J9071J9072J9073J9074J9075J9076J9176J9181J9245J9246J9248J9249J9301J9311J9312J9370Q2049Q2050C90.00C90.01C90.02C91.00C91.02D47.2D47.9D47.Z9E85.81Z76.82C83.30C83.A

Original notice

Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) (CPB 0904, reviewed 2026-06-08)
aetna.com · Always check the source before changing claims.
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Related policy hubs

Aetna policiesHematologyOncologyCode 38206Code 38241Code 96413Code 96416Code J9144Code J9145Code J1100Code J7512Code J8530Code J8540Code J8541Code J8560Code J8600Code J9000Code J9041Code J9046Code J9047Code J9048Code J9049Code J9051Code J9054Code J9071Code J9072Code J9073Code J9074Code J9075Code J9076Code J9176Code J9181Code J9245Code J9246Code J9248Code J9249Code J9301Code J9311Code J9312Code J9370Code Q2049Code Q2050Code C90.00Code C90.01Code C90.02Code C91.00Code C91.02Code D47.2Code D47.9Code D47.Z9Code E85.81Code Z76.82Code C83.30Code C83.A

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