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This policy governs medical necessity and prior authorization for Ultomiris for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), including initial and continued therapy, subject to formulary and benefit requirements.
Policy Summary
PayerWellcare Hawaii
PolicyRavulizumab-cwvz (Ultomiris) coverage
Policy CodePolicy N/A
Change TypeModified — aHUS coverage added
Effective Date06.01.19
Next Review DateN/A
Key ActionSubmit documentation supporting all applicable approval criteria for Ultomiris.
The policy added coverage criteria for the FDA-approved indication of atypical hemolytic uremic syndrome.
References were reviewed and updated during the annual review and policy adaptation process.
2FDA-approved indications addressed
6 monthsStandard approval duration
≥1 monthMinimum age for aHUS coverage
≥18 yearsMinimum age for PNH coverage
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J1303Referenced HCPCS code
Coverage Criteria
Initial Therapy – PNH
Covered for PNH when all criteria are met.
PNH initial therapy
PNH disease-severity pathway
Transfusion and hemoglobin pathway: Member has a history of at least one red blood cell transfusion in the past 24 months and documentation of hemoglobin below the applicable threshold.<7 g/dL without anemia symptoms; <9 g/dL with anemia symptoms
Thrombosis pathway: Member has a history of thrombosis.
Dose limits
Loading dose on Day 1: Weight-based loading dose is 2,400 mg for weight ≥40 to <60 kg, 2,700 mg for weight ≥60 to <100 kg, or 3,000 mg for weight ≥100 kg.
Maintenance dose: Weight-based maintenance dose is 3,000 mg for weight ≥40 to <60 kg, 3,300 mg for weight ≥60 to <100 kg, or 3,600 mg for weight ≥100 kg, administered on Day 15 and every 8 weeks thereafter.
Initial Therapy – aHUS
Covered for aHUS when all criteria are met.
aHUS initial therapy
TMA evidence: Member has a platelet count ≤150 x 10^9/L, hemolysis such as an elevation in serum LDH, and serum creatinine above the upper limit of normal or requires dialysis.
Exclusion testing: Documentation shows that the member does not have ADAMTS13 deficiency and does not have STEC-HUS.
Dose limits
Loading dose on Day 1: Weight-based loading dose is 600 mg for weight ≥5 to <20 kg, 900 mg for weight ≥20 to <30 kg, 1,200 mg for weight ≥30 to <40 kg, 2,400 mg for weight ≥40 to <60 kg, 2,700 mg for weight ≥60 to <100 kg, or 3,000 mg for weight ≥100 kg.
Continued Therapy – All Covered Indications
Covered for continuation of PNH or aHUS when all criteria are met.
Continued therapy
Positive response: For PNH, positive response is demonstrated by improvement in intravascular hemolysis, reduced need for red blood cell transfusions, increased or stabilized hemoglobin, less fatigue, improved health-related quality of life, or fewer thrombotic events; or for aHUS, by improved intravascular hemolysis, increased or stabilized platelet counts, improved or stabilized serum creatinine or eGFR, or reduced need for dialysis.
At least one applicable positive response parameter should be documented.
Dose-increase limits: For a requested dose increase, the new dose remains within the applicable PNH or aHUS weight-based maintenance limits.
Other Diagnoses/Indications
Other diagnoses or indications may be continued only under one of the following pathways.
Other diagnosis or indication continuation
Current therapy with positive response: Member is currently receiving the medication through the Centene benefit and documentation supports a positive response to therapy.
Off-label policy referral: The request is referred to the applicable off-label use policy when the diagnosis is not specifically listed under the diagnoses or indications for which coverage is not authorized.
Use CP.CPA.09 for Commercial, HIM.PHAR.21 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid.
Ultomiris is not indicated for STEC-HUS (Shiga toxin E. coli-related hemolytic uremic syndrome) and coverage is not authorized for this condition.
Non-FDA-approved indications not addressed by this policy are not authorized unless sufficient documentation supports efficacy and safety under the applicable off-label use policy or evidence of coverage. Applicable off-label policies are CP.CPA.09 for Commercial, HIM.PHAR.21 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid.
Ultomiris is contraindicated for patients with an unresolved Neisseria meningitidis infection or patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Ultomiris treatment outweigh the risks of developing a meningococcal infection. The policy also includes a boxed warning for serious meningococcal infections.
Required disease criterionMember must meet one of the qualifying PNH transfusion/hemoglobin or thrombosis pathways
Authorization and Documentation Requirements
Prior Authorization
Initial Authorization Required
Prior authorization is required for initial approval. Submit documentation supporting all applicable approval criteria and the requested approval duration. Initial approval is for 6 months.
Submit office chart notes, laboratory results, and other clinical information supporting medical necessity.
Document the applicable diagnosis, specialist prescriber or consultation, age, clinical findings, dosing, and exclusion criteria.
Initial approval duration: 6 months.
Prior Authorization
Continuation Authorization Required
Continuation authorization is required. Requests must document that the member is currently receiving Ultomiris through the Centene benefit or previously met initial approval criteria and is responding positively to therapy.
For PNH, document response such as improved hemolysis, reduced transfusions, increased or stabilized hemoglobin, less fatigue, improved quality of life, or fewer thrombotic events.
Clinical Policy Background
Ravulizumab-cwvz (Ultomiris) is a complement inhibitor. This policy addresses medical necessity and prior authorization for adult patients with paroxysmal nocturnal hemoglobinuria (PNH) and for adult and pediatric patients aged ≥1 month with atypical hemolytic uremic syndrome (aHUS), to inhibit complement-mediated thrombotic microangiopathy. Coverage includes initial and continued therapy, subject to the applicable criteria, dosing limits, formulary, and benefit requirements.
PNH initial therapy requires all diagnosis-specific clinical criteria and applicable weight-based dose limits.
PNH initial therapy
Qualifying disease-severity pathway
Transfusion and hemoglobin pathway: History of at least one red blood cell transfusion in the past 24 months and hemoglobin below the applicable threshold.<7 g/dL without anemia symptoms; <9 g/dL with anemia symptoms
Thrombosis pathway: History of thrombosis.
PNH dose limits:
Continuation Criteria
Continued Ultomiris Therapy
All covered indications require current therapy through the Centene benefit or prior satisfaction of initial criteria and positive response to therapy.
Continuation criteria
Positive response: For PNH, response includes improved intravascular hemolysis, reduced red blood cell transfusions, increased or stabilized hemoglobin, less fatigue, improved health-related quality of life, or fewer thrombotic events. For aHUS, response includes improved intravascular hemolysis, increased or stabilized platelet counts, improved or stabilized serum creatinine or eGFR, or reduced dialysis need.
At least one applicable positive response parameter should be documented.
Maximum dose for a requested increase: For PNH, the new maintenance dose does not exceed 3,000 mg every 8 weeks for weight ≥40 to <60 kg, 3,300 mg every 8 weeks for weight ≥60 to <100 kg, or 3,600 mg every 8 weeks for weight ≥100 kg. For aHUS, the new maintenance dose does not exceed the applicable weight-based limit, ranging from 300 mg every 4 weeks to 3,600 mg every 8 weeks.
Step Therapy Requirements
Step
Requirement
Timing
1
When switching from Soliris to Ultomiris, administer the Ultomiris loading dose.
2 weeks after the last Soliris infusion
Dose and Quantity Limits
Ultomiris for PNH
Weight ≥40 to <60 kgLoading Day 1: 2,400 mg; maintenance Day 15 and every 8 weeks: 3,000 mg
Weight ≥60 to <100 kgLoading Day 1: 2,700 mg; maintenance Day 15 and every 8 weeks: 3,300 mg
Weight ≥100 kgLoading Day 1: 3,000 mg; maintenance Day 15 and every 8 weeks: 3,600 mg
Ultomiris for aHUS
Weight ≥5 to <10 kgLoading Day 1: 600 mg; maintenance Day 15 and every 4 weeks: 300 mg
Weight ≥10 to <20 kgLoading Day 1: 600 mg; maintenance Day 15 and every 4 weeks: 600 mg
Weight ≥20 to <30 kg
Policy Summary
PayerWellcare Hawaii
PolicyRavulizumab-cwvz (Ultomiris) coverage
Policy CodePolicy N/A
Change TypeModified — aHUS coverage added
Effective Date06.01.19
Next Review DateN/A
Key ActionSubmit documentation supporting all applicable approval criteria for Ultomiris.
Weight-based maintenance dose is 300 mg every 4 weeks for weight ≥5 to <10 kg; 600 mg every 4 weeks for weight ≥10 to <20 kg; 2,100 mg every 8 weeks for weight ≥20 to <30 kg; 2,700 mg every 8 weeks for weight ≥30 to <40 kg; 3,000 mg every 8 weeks for weight ≥40 to <60 kg; 3,300 mg every 8 weeks for weight ≥60 to <100 kg; or 3,600 mg every 8 weeks for weight ≥100 kg.
PNH Hemoglobin Threshold Without Anemia Symptoms
Hemoglobin threshold< 7 g/dL
Anemia symptomsWithout anemia symptoms
Transfusion historyAt least 1 red blood cell transfusion in the past 24 months
PNH Hemoglobin Threshold With Anemia Symptoms
Hemoglobin threshold< 9 g/dL
Anemia symptomsWith anemia symptoms
Transfusion historyAt least 1 red blood cell transfusion in the past 24 months
aHUS Age
Minimum age≥ 1 month
Covered conditionAtypical hemolytic uremic syndrome (aHUS), or complement-mediated HUS
Specialist requirementPrescribed by or in consultation with a hematologist or nephrologist
aHUS Platelet Count
Platelet threshold≤ 150 x 10^9/L
Required findingOne of three required signs of thrombotic microangiopathy (TMA)
Other required TMA findingsHemolysis, such as elevated serum LDH, and serum creatinine above the upper limit of normal or dialysis requirement
For aHUS, document improved hemolysis, increased or stabilized platelet counts, improved or stabilized creatinine or eGFR, or reduced dialysis need.
For other indications, document current Centene-benefit therapy and positive response, or refer to the applicable off-label use policy when required.
Continuation approval duration is generally 6 months; for other diagnoses, it is the duration requested or 6 months, whichever is less.
Documentation Required
Clinical Documentation Required
Submit clinical documentation with every request. The record must support that the member meets all applicable approval criteria and should include sufficient information for clinical review.
Office or chart notes describing the diagnosis, treatment history, clinical status, and response.
Relevant laboratory results and other supporting clinical information.
Documentation supporting the requested dose, schedule, and approval duration.
Documentation Required
PNH Documentation
For initial PNH approval, document all applicable PNH requirements: diagnosis, hematology specialist involvement, age, flow-cytometry findings, transfusion or thrombosis history, hemoglobin information, and dosing.
Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH).
Prescribed by or in consultation with a hematologist; member is age 18 years or older.
Flow cytometry shows detectable GPI-deficient hematopoietic clones or at least 5% PNH cells.
Either at least 1 red blood cell transfusion in the past 24 months with hemoglobin <7 g/dL without anemia symptoms or <9 g/dL with anemia symptoms, or a history of thrombosis.
Document weight-based loading and maintenance dosing; if switching from Soliris, the loading dose is administered 2 weeks after the last Soliris infusion.
Documentation Required
aHUS Documentation
For initial aHUS approval, document the diagnosis, appropriate specialist involvement, age, evidence of complement-mediated thrombotic microangiopathy, exclusion of ADAMTS13 deficiency and STEC-HUS, and weight-based dosing.
Diagnosis of atypical hemolytic uremic syndrome (aHUS), with prescription by or consultation with a hematologist or nephrologist; member is at least 1 month old.
Signs of TMA: platelet count ≤150 × 109/L, hemolysis such as elevated serum LDH, and serum creatinine above the upper limit of normal or a need for dialysis.
Document that the member does not have ADAMTS13 deficiency or STEC-HUS.
Document weight-based loading and maintenance dosing; if switching from Soliris, the loading dose is administered 2 weeks after the last Soliris infusion.
Documentation Required
Continuation Documentation
For continuation requests, submit evidence of current Ultomiris therapy through the Centene benefit or prior satisfaction of the initial criteria, together with documentation of a positive clinical response. Any dose increase must remain within the applicable continuation dose limits.
Document current therapy or prior approval under the initial criteria.
Document objective or clinical response for the applicable indication, including hemolysis, transfusion, hemoglobin, platelet, renal, dialysis, fatigue, quality-of-life, or thrombosis measures.
For other diagnoses or indications, provide documentation of positive response when therapy is being continued through the Centene benefit.
Denial Risk
Excluded or Off-Label Indications
Coverage is not authorized for STEC-HUS. Non-FDA-approved indications not addressed by this policy are not authorized unless supported under the applicable off-label use policy or evidence of coverage documents.
Ultomiris is not indicated for Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).
Non-FDA-approved indications not addressed in the policy require sufficient documentation of efficacy and safety under the applicable off-label policy.
Applicable policies include CP.CPA.09 for commercial, HIM.PHAR.21 for health insurance marketplace, and CP.PMN.53 for Medicaid.
Unsupported block type: denial_riskেvariant
Denial Risk
Criteria or Dose Limits Not Met
A request may be denied when the diagnosis, specialist involvement, age, laboratory or clinical evidence, exclusion documentation, dosing, or continuation requirements are not met.
PNH: required diagnosis, hematology involvement, age ≥18 years, flow-cytometry findings, transfusion or thrombosis history, and hemoglobin documentation must be supported.
aHUS: required diagnosis, specialist involvement, age ≥1 month, platelet count, hemolysis, renal impairment or dialysis, and exclusion of ADAMTS13 deficiency and STEC-HUS must be supported.
Initial and continuation doses must not exceed the applicable weight-based limits and schedules; switching from Soliris requires the specified 2-week interval before the loading dose.
Continuation requests must show current or previously qualifying therapy and positive response; dose increases must remain within continuation limits.
TMA
AbbreviationTMA
DefinitionThrombotic microangiopathy
aHUS assessmentaHUS signs include thrombocytopenia, hemolysis, and renal impairment or dialysis requirement
Coverage statusUltomiris is not indicated for treatment of STEC-HUS
ADAMTS13
AbbreviationADAMTS13
Expanded nameA disintegrin and metalloproteinase with thrombospondin type 1 motif, member 13
aHUS criterionDocumentation must exclude ADAMTS13 deficiency
GPI
AbbreviationGPI
DefinitionGlycosyl phosphatidylinositol
PNH assessmentFlow cytometry must show detectable GPI-deficient hematopoietic clones or at least 5% PNH cells
Dose does not exceed the applicable loading and maintenance limits: loading dose on Day 1 of 2,400 mg for weight ≥40 to <60 kg, 2,700 mg for weight ≥60 to <100 kg, or 3,000 mg for weight ≥100 kg; and maintenance dose on Day 15 and every 8 weeks thereafter of 3,000 mg, 3,300 mg, or 3,600 mg for the corresponding weight ranges.
Switching from Soliris: If switching therapy from Soliris, the loading dose is administered 2 weeks after the last Soliris infusion.
Initial Therapy – aHUS
aHUS initial therapy requires all diagnosis-specific clinical criteria and applicable weight-based dose limits.
aHUS initial therapy
aHUS dose limits: Dose does not exceed the applicable loading and maintenance limits: loading dose on Day 1 of 600 mg for weight ≥5 to <20 kg, 900 mg for weight ≥20 to <30 kg, 1,200 mg for weight ≥30 to <40 kg, 2,400 mg for weight ≥40 to <60 kg, 2,700 mg for weight ≥60 to <100 kg, or 3,000 mg for weight ≥100 kg; and maintenance dose on Day 15 and thereafter of 300 mg every 4 weeks for weight ≥5 to <10 kg, 600 mg every 4 weeks for weight ≥10 to <20 kg, 2,100 mg every 8 weeks for weight ≥20 to <30 kg, 2,700 mg every 8 weeks for weight ≥30 to <40 kg, 3,000 mg every 8 weeks for weight ≥40 to <60 kg, 3,300 mg every 8 weeks for weight ≥60 to <100 kg, or 3,600 mg every 8 weeks for weight ≥100 kg.
Switching from Soliris: If switching therapy from Soliris, the loading dose is administered 2 weeks after the last Soliris infusion.
Loading Day 1: 900 mg; maintenance Day 15 and every 8 weeks: 2,100 mg
Weight ≥30 to <40 kgLoading Day 1: 1,200 mg; maintenance Day 15 and every 8 weeks: 2,700 mg
Weight ≥40 to <60 kgLoading Day 1: 2,400 mg; maintenance Day 15 and every 8 weeks: 3,000 mg
Weight ≥60 to <100 kgLoading Day 1: 2,700 mg; maintenance Day 15 and every 8 weeks: 3,300 mg
Weight ≥100 kgLoading Day 1: 3,000 mg; maintenance Day 15 and every 8 weeks: 3,600 mg