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AetnaCommercial · Prior Auth · Medical Policy · Hematology, NeurologyMedium impact

Ravulizumab-cwvz (Ultomiris) (CPB 0946, reviewed 2026-08-11)

Effective date
Not stated in the notice
Identified
Aug 15, 2026

Summary

Aetna considers ravulizumab-cwvz (Ultomiris) medically necessary for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) when the listed criteria are met. Aetna considers concurrent use of ravulizumab-cwvz and eculizumab experimental, investigational, or unproven. Aetna considers ravulizumab-cwvz experimental, investigational, or unproven for other indications, including amyotrophic lateral sclerosis (ALS), aplastic anemia and COVID-19, and notes that this list is not all-inclusive. Precertification is required of all Aetna participating providers and members in applicable plan designs. The policy was last reviewed 08/11/2026 and lists a next review date of 05/27/2027.

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What to do

Action · 13 steps
01Precertification of ravulizumab-cwvz (Ultomiris) is required.
02Call (1) 752-7021 or fax (2) 267-3277, and use the Statement of Medical Necessity forms under Specialty Pharmacy Precertification where applicable.
03Site of care: the Utilization Management Policy on Site of Care for Specialty Drug Infusion applies.
04For gMG and NMOSD, the medication must be prescribed by or in consultation with a neurologist.
05Due to the risk of meningococcal infections, Ultomiris is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, and prescribers must enroll in the program.
06HCPCS J1303 (ravulizumab-cwvz, 10 mg) is listed as covered if the selection criteria are met.
07ICD-10 codes G12.21, J12.82, U07.1 and D61.01 to D61.9 are listed as not covered for the indications in the policy.
08For PNH, the diagnosis must be confirmed by GPI-AP deficiency on flow cytometry, the member must show clinical manifestations of disease, and the medication will not be used with another complement inhibitor for PNH (concomitant use with Voydeya is allowed).
09For aHUS, Shiga toxin must be absent, ADAMTS 13 activity must be above 5%, and the medication will not be used with another complement inhibitor for aHUS.
10For gMG, the member must be anti-acetylcholine receptor (AChR) antibody positive, have MGFA clinical classification II to IV, have an MG-ADL total score of greater than or equal to 5, and meet one of the immunosuppressive therapy criteria in the policy.
11The medication will not be used with another complement inhibitor, a neonatal Fc receptor blocker, or Uplizna for gMG.
12For NMOSD, the member must be anti-aquaporin-4 (AQP4) antibody positive, exhibit a core clinical characteristic of NMOSD, and not receive the medication concomitantly with other biologics for NMOSD.
13For reauthorization, the member must show no evidence of unacceptable toxicity or disease progression on the current regimen and a positive response to therapy.

Codes mentioned

8605186052860539636596366J1303D59.30D59.39D59.5G36.0G70.00G70.01D61.01D61.9G12.21J12.82U07.1

Original notice

Ravulizumab-cwvz (Ultomiris) (CPB 0946, reviewed 2026-08-11)
aetna.com · Always check the source before changing claims.
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Related policy hubs

Aetna policiesHematologyNeurologyCode 86051Code 86052Code 86053Code 96365Code 96366Code J1303Code D59.30Code D59.39Code D59.5Code G36.0Code G70.00Code G70.01Code D61.01Code D61.9Code G12.21Code J12.82Code U07.1

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