CurrentAvMedPolicy N/A

Ultomiris (ravulizumab-cwvz) IV for Paroxysmal Nocturnal Hemoglobinuria (PNH) — Coverage Criteria

Defines AvMed medical prior authorization and reauthorization criteria, dosing limits, and documentation requirements for Ultomiris (ravulizumab-cwvz) when used to treat PNH for covered members.

Policy Summary

PayerAvMed

PolicyUltomiris (ravulizumab-cwvz) IV for PNH — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain medical prior authorization and submit flow cytometry, labs (including LDH and hemoglobin), chart notes, and documentation of meningococcal vaccination or rationale for delay.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

6 monthsReauthorization duration

13 vials/56dMax quantity limit

>=10% clonesFlow cytometry threshold

Coverage Criteria for Ultomiris (ravulizumab-cwvz)

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization - core requirements: Medication prescribed by or in consultation with a hematologist or nephrologist; prescriber enrolled in the Ultomiris REMS program; member is at least 1 month of age

From initial authorization section

Diagnostic confirmation: Confirmed diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) with detection of PNH clones of at least 10% by flow cytometry; flow cytometry/pathology report must demonstrate at least 2 different GPI-deficient cell lineages>=10% PNH clones

Flow cytometry report must be submitted

Clinical indication(s): Member must have ONE of: transfusion dependence (transfusion within the last 12 months plus either hemoglobin ≤7 g/dL OR symptomatic anemia with hemoglobin ≤9 g/dL), high LDH (≥1.5× ULN with symptoms), presence of a thrombotic event (e.g., DVT, PE), organ damage secondary to chronic hemolysis, or pregnancy where potential benefit outweighs fetal risk

Policy Summary

PayerAvMed

PolicyUltomiris (ravulizumab-cwvz) IV for PNH — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain medical prior authorization and submit flow cytometry, labs (including LDH and hemoglobin), chart notes, and documentation of meningococcal vaccination or rationale for delay.

SourceLink

On This Page

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Reauthorization/Continuation Therapy

Covered when ALL of the following are met for reauthorization:

Reauthorization - continued eligibility: Member continues to meet the initial authorization criteria and provider attests absence of unacceptable toxicity (e.g., serious meningococcal infections, infusion reactions, serious infections)

Provider must document lack of serious infections or infusion reactions

Evidence of clinical benefit: At least ONE of: reduction in LDH from baseline (recent within 3 months), stabilized hemoglobin (maintained >7 g/dL or >9 g/dL if baseline was >7 and <9 g/dL), reduction in transfusions/units from baseline, or reduction in thrombotic events (e.g., DVT, PE)

Results and supporting documentation must be submitted

Provider Responsibilities and Documentation

Prior Authorization

Prior authorization required for Ultomiris (J1303)

Medical prior authorization is required for Ultomiris (J1303) IV. The prescribing physician must sign and clearly print their name on the prior authorization request form and ensure the prescriber is enrolled in the Ultomiris REMS program; required documentation must be submitted for approval.

Drug requested: Ultomiris IV (J1303)
Prescriber must sign and clearly print name on the request form (preprinted stamps not valid)
Prescriber must be enrolled in the Ultomiris REMS program

Step Therapy

No concurrent PNH complement inhibitors

Ultomiris will not be prescribed concurrently with another FDA‑approved product for PNH; concurrent use with listed PNH complement inhibitors is excluded.

Examples of products listed: Bkemv™, Epysqli™, PiaSky®, Soliris®, Empaveli®, Fabhalta®

Documentation Required

Required supporting documentation

Submit supporting clinical and laboratory documentation with the prior authorization: flow cytometry pathology reports showing PNH clone percentage and GPI‑deficient lineages, recent labs (including LDH and hemoglobin), and chart notes documenting the indication (e.g., transfusion history, symptoms, thrombotic events, organ damage); document meningococcal vaccination or rationale for delay.

Flow cytometry report demonstrating ≥10% PNH clones and at least 2 different GPI‑deficient cell lineages
Recent LDH and hemoglobin results (LDH reduction from baseline may be required for reauthorization)
Chart notes documenting transfusion dependence, symptoms, thrombotic events, or organ damage
Documentation of meningococcal vaccination at least 2 weeks prior to initiation or documented rationale for delaying vaccination

Denial Risk

Incomplete documentation may delay or cause denial

Incomplete, incorrect, or illegible information on the prior authorization form can delay processing or result in denial of the authorization.

Ensure phone and fax numbers and all required fields are complete and legible
Preprinted signature stamps are not valid — the prescribing physician must sign and clearly print their name

Background

Ultomiris (ravulizumab-cwvz) is a complement C5 inhibitor indicated for treatment of paroxysmal nocturnal hemoglobinuria (PNH). Prior to initiation, the medication must be prescribed by or in consultation with a hematologist or nephrologist, the prescriber must be enrolled in the Ultomiris REMS program, and the member must have a confirmed diagnosis of PNH by flow cytometry showing at least 10% PNH clones (flow cytometry and pathology demonstrating at least two GPI‑deficient cell lineages must be submitted).

Initial authorizations are issued for 6 months; reauthorization requires documentation that the member continues to meet initial criteria, there is absence of unacceptable toxicity or serious infection, and evidence of clinical benefit (for example, reduction in LDH from baseline, stabilized hemoglobin, or decreased transfusion requirement).

Definitions Used in This Policy

Transfusion dependent — defined as having a transfusion within the last 12 months

Transfusion dependent — definitionHaving received a transfusion within the last 12 months

Documentation to submitChart notes documenting transfusion dates and indication plus hemoglobin values (e.g., ≤7 g/dL or symptomatic anemia with ≤9 g/dL)

Use in criteriaOne qualifying indication for initiation of therapy when combined with other required criteria

High LDH — defined as LDH ≥ 1.5 times the upper limit of normal with clinical symptoms

High LDH — definitionLDH ≥ 1.5 times the upper limit of normal (with clinical symptoms)

Clinical correlation requiredMust submit recent LDH result(s) and documentation of corresponding clinical symptoms

Role in coverage decisionMeets one of the qualifying indications for initiation of therapy when combined with other required criteria

OpenPayer

Ultomiris (ravulizumab-cwvz) IV for Paroxysmal Nocturnal Hemoglobinuria (PNH) — Coverage Criteria

Coverage Criteria for Ultomiris (ravulizumab-cwvz)

Coding and Clinical Thresholds

Provider Responsibilities and Documentation

Background

Definitions Used in This Policy