CurrentAvMedPolicy Pub. 100-2

Ultomiris (ravulizumab-cwvz) for atypical hemolytic uremic syndrome (aHUS) — Prior authorization and medical necessity criteria

Prior authorization and step-edit form and medical necessity criteria for IV Ultomiris (ravulizumab-cwvz) in the treatment of atypical hemolytic uremic syndrome for AvMed members.

Policy Summary

PayerAvMed

PolicyUltomiris (ravulizumab-cwvz) for aHUS — coverage criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prescriber-signed prior authorization form with required clinical documentation and baseline labs to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

6 moReauthorization duration

13 vials/56dMax quantity

>=1 mo / >=5 kgMin age/weight

Coverage Criteria for Ultomiris (ravulizumab-cwvz)

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Prescribing physician is or has consulted with a hematologist, oncologist or nephrologist; prescriber is enrolled in the Ultomiris REMS program; patient is at least 1 month of age and weighs at least 5 kg; confirmed diagnosis of atypical hemolytic uremic syndrome (aHUS) with supporting chart notes and laboratory data; thrombotic thrombocytopenic purpura (TTP) has been ruled out with ADAMTS-13 activity level >10%; Shiga toxin E. coli–related HUS (STEC-HUS) has been ruled out; other causes of thrombotic microangiopathy have been excluded (examples: bone marrow or solid organ transplantation, malignancy, autoimmune disorder, drug‑induced malignant hypertension, HIV infection, Streptococcus pneumoniae or Influenza A (H1N1) infection, cobalamin deficiency); baseline labs submitted (serum LDH, serum creatinine/eGFR, platelet count) and documentation of plasma exchange/plasma infusion requirement; no systemic infection present; therapy will NOT be used in combination with other complement inhibitor therapy (e.g., eculizumab); meningococcal vaccination given at least 2 weeks prior to initiating Ultomiris OR documentation that the risks of delaying therapy outweigh the risks of meningococcal infectionall required

Initial authorization duration 6 months

Reauthorization

Covered when ALL of the following are met:

Policy Summary

PayerAvMed

PolicyUltomiris (ravulizumab-cwvz) for aHUS — coverage criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prescriber-signed prior authorization form with required clinical documentation and baseline labs to support medical necessity.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Reauthorization: Member continues to meet all initial authorization criteria; member has not experienced unacceptable toxicity from Ultomiris (examples: serious meningococcal infection such as septicemia or meningitis, infusion reactions, or other serious infections); provider submits clinical notes and laboratory data documenting a positive clinical response or stabilization as evidenced by at least ONE of the following: increase in platelet count from baseline; maintenance of normal platelet counts and LDH for at least 4 weeks; a 25% reduction in serum creatinine sustained for at least 4 weeks; absence for at least 12 weeks of a >25% decrease in platelet count from baseline, plasma exchange/plasma infusion, and new dialysis requirementall required

Reauthorization duration 6 months

Therapy will NOT be approved if the member has a history of unresolved meningococcal disease or any systemic bacterial or significant infections that have not been treated with appropriate antibiotics.

Ultomiris must not be used in combination with other complement inhibitor therapy (for example, eculizumab). Therapy is also inappropriate when the member has unresolved or untreated systemic infections or unresolved meningococcal disease.

Billing and Coding

Affected HCPCSHCPCS

J1303

Ultomiris (ravulizumab-cwvz) injection

Maximum vials per period

Maximum quantity limit13 vials every 56 days

Dosage schedule summaryWeight-based loading dose, then maintenance every 4 or 8 weeks depending on weight

Note on switching from eculizumabGive Ultomiris loading dose 2 weeks after last eculizumab infusion, then maintenance every 8 weeks

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: The prescribing physician must complete and sign the prior authorization request. Fax the fully completed form to 1-877-535-1391. Failure to provide complete, legible, and accurate information (including phone and fax numbers) may delay processing. For urgent reviews, contact AvMed Pre-Authorization Department if a standard review would seriously jeopardize the member's life, health, or ability to regain maximum function.

Prescribing physician signature required (preprinted stamps not valid).
Fax completed form to 1-877-535-1391.
Include accurate phone and fax numbers to avoid delays.

Documentation Required

Samples and Verification

Samples do not satisfy prior authorization or step-edit requirements. Initiation of therapy with drug samples will not meet criteria for approval. Prior therapies and treatment history will be verified through pharmacy paid claims and/or submitted chart notes.

Drug samples alone do not fulfill prior authorization requirements.
Previous therapies will be verified via pharmacy claims or chart notes.

Denial Risk

Required Documentation and Risk of Denial

Incomplete documentation or missing required attachments (e.g., prescriber-signed form, chart notes, baseline labs such as LDH and serum creatinine/eGFR, platelet count, ADAMTS-13 level, vaccination documentation) may result in denial or delay of the request. For reauthorization, all supporting documentation demonstrating continued benefit (clinical notes and labs) must be submitted.

Include prescriber-signed request form (no stamps).
Attach chart notes confirming diagnosis and clinical history.
Attach baseline labs: LDH, serum creatinine/eGFR, platelet count.
Provide ADAMTS-13 activity level to rule out TTP (activity >10%).
Provide documentation regarding meningococcal vaccination timing or clinical rationale if vaccine not given prior to therapy.

Background

Atypical hemolytic uremic syndrome (aHUS) is a complement-mediated thrombotic microangiopathy that can cause thrombocytopenia, hemolytic anemia, and renal impairment. Complement C5 inhibitors such as ravulizumab (Ultomiris) act by inhibiting terminal complement activation to control disease activity. Before initiating therapy, providers must exclude alternative causes of thrombotic microangiopathy—including thrombotic thrombocytopenic purpura (TTP), Shiga toxin E. coli–related HUS (STEC-HUS), transplant- or drug-related causes, infections, and cobalamin deficiency—and document baseline laboratory values (LDH, serum creatinine/eGFR, platelet count) as part of the authorization process.

Definitions and Diagnostic Rules

TTP rule-out

TTP rule-out requirementADAMTS-13 activity level >10% must be demonstrated to rule out TTP

Evidence to submitProvide ADAMTS-13 laboratory result as part of required documentation

Context within initial criteriaTTP exclusion is one of multiple required confirmations before initiating Ultomiris for aHUS