CommercialPrior AuthMedium impact
Sirolimus Protein-Bound Particles for Injectable Suspension Albumin-Bound (Fyarro) (CPB 1001, reviewed 2026-03-25)
Aetna·Oncology·Medical Policy
Effective date
Mar 16, 2022
We identified it
Aug 16, 2026
Summary
Aetna has issued a new medical policy (CPB 1001, effective March 16, 2022, reviewed March 25, 2026) establishing coverage criteria for Fyarro (sirolimus protein-bound particles albumin-bound) for treatment of locally advanced unresectable/metastatic malignant PEComa and advanced/recurrent/metastatic uterine sarcoma. Precertification is required for all covered indications. Billing teams must implement prior authorization workflows and update systems to recognize covered diagnoses and the specific HCPCS code J9331.
Action Required
REQUIREMENTS:
- Immediately: Billing and precertification teams must establish prior authorization (precertification) workflow for Fyarro. Update billing system to flag claims with HCPCS code J9331 for mandatory precertification.
- Before next claim submission: Configure system to require precertification routing to Aetna at phone (866) 752-7021 or fax (888) 267-3277 for all Fyarro claims. All Aetna participating providers and members in applicable plan designs require precertification.
- Immediately: Train providers and billing staff that Fyarro is covered ONLY when prescribed for:
1) Locally advanced unresectable or metastatic malignant PEComa (ICD-10: C48.0-C48.2, C48.8, C49.4-C49.5, C49.8-C49.9)
2) Advanced, recurrent, metastatic, or inoperable uterine sarcoma (PEComa) (ICD-10: C55)
- Before claim submission: Require providers to submit Statement of Medical Necessity (SMN) precertification forms (available through Specialty Pharmacy Precertification portal) documenting that member meets one of two covered indications above and drug is used as single agent.
- Update billing software: Reject or hold any Fyarro claims (J9331) billed for other indications (will be classified as experimental/investigational/unproven). Route all off-label indication requests to precertification team for denial processing.
- For continuation of therapy: Precertification team must reauthorize Fyarro only when prior authorization shows no evidence of unacceptable toxicity or disease progression. Block reauthorization if either condition present.
- Billing team responsible: Failure to obtain precertification will result in claim denials. Ensure all claims include precertification authorization number from Aetna before processing.