J1303, Injection, ravulizumab-cwvz, 10 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- When applying this Medical Policy, review the member's benefit contract or Summary Plan Description (SPD) to determine defined coverage, exclusions, and any dollar or duration limits.
- Documentation supporting the diagnosis of aHUS by ruling out both of the following: Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); and Thrombotic thrombocytopenia purpura (TTP) (e.g., rule out ADAMTS13 deficiency) and Laboratory results, signs, and/or symptoms attributed to aHUS (e.g., thrombocytopenia, microangiopathic hemolysis, thrombotic microangiopathy, acute renal failure, etc.); and Patient is treatment naïve with the requested product; and The requested product is dosed according to the US FDA labeled dosing for aHUS; and Prescribed by or in consultation with a hematologist or nephrologist; and Initial authorization will be for no more than 12 months
- Continuation of Therapy o One of the following: Patient is on Soliris and meets the criteria in the Preferred Product Criteria section; or Patient is on Bkemv, Epilishi, or Ultomiris and o Documentation demonstrating a positive clinical response from baseline (e.g., reduction of plasma exchanges, reduction of dialysis, increased platelet count, reduction of hemolysis); and The requested product is dosed according to the US FDA labeled dosing for aHUS; and Prescribed by, or in consultation with, a hematologist or nephrologist; and Reauthorization will be for no more than 12 months
Key Coverage Criteria
- Medically necessary for initial therapy of aHUS when: documentation ruling out STEC-HUS and TTP; diagnosis with signs of aHUS; treatment-naïve; FDA-labeled dosing for aHUS; prescribed by hematologist/nephrologist; initial authorization up to 12 months. Continuation requires positive clinical response and dosing per FDA labeling, with reauthorization up to 12 months.
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Ravulizumab-cwvz may be medically necessary to reduce hemolysis for individuals ≥1 month old with PNH who meet the diagnostic criteria for PNH (flow cytometry of erythrocytes for CD59 deficiency or granulocytes for CD59/CD55).
- This policy addresses only the determination of medical necessity for the hospital outpatient setting for infusion and injectable therapy; the medical necessity of the pharmacologic or biologic medication itself may be reviewed separately.
- Requests for select medications intended for administration in a hospital outpatient setting will be directed to a preferred alternative site of care (non-hospital affiliated outpatient facility or home).
- Ravulizumab-cwvz is medically necessary for individuals one month of age and older for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
13 Active Policies
UHC-POL-complement-inhibitors, Complement C5 Inhibitors
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
BCBSIL-RX501.107, Ravulizumab-cwvz
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
BCBSMT-RX501.107, Ravulizumab-cwvz
Related Codes
Have a follow-up question?
Ask Verity about documentation requirements, denial risks, or coverage in your state.