CurrentAvMedPolicy N/A

Aqvesme (mitapivat) prior authorization and step-edit request

Form and clinical criteria used by AvMed to authorize initial and continued coverage of Aqvesme (mitapivat) for treatment of alpha- or beta-thalassemia in members; applies to prescribers and pharmacy prior authorization reviewers.

Policy Summary

PayerAvMed

PolicyAqvesme (mitapivat) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form signed by the prescribing physician with required clinical documentation for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 more-authorization duration

100 mg BIDrecommended dosage

56 tabsquantity limits

≥18minimum age

Coverage Criteria for Aqvesme (mitapivat)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization (6 months):

Initial Authorization requirements

Thalassemia diagnosis
- Alpha-thalassemia criteria: Diagnosis of alpha-thalassemia with submission of medical history and chart notes containing hematological findings, electrophoresis analysis, and/or molecular analysis where available; baseline hemoglobin ≤10.0 g/dL OR >10.0 g/dL if transfusion-dependent; if transfusion-dependent, documentation of ≥6 RBC units transfused in prior 24 weeks.
- Beta-thalassemia criteria: Diagnosis of beta-thalassemia (including β+, β0, Hb E/β-thalassemia, or non-deletional Hb H) with submission of medical history and chart notes containing hematological findings, electrophoresis analysis, and/or molecular analysis where available; baseline hemoglobin ≤10.0 g/dL OR >10.0 g/dL if transfusion-dependent; if transfusion-dependent, documentation of ≥6 RBC units transfused in prior 24 weeks.

Policy Summary

PayerAvMed

PolicyAqvesme (mitapivat) prior authorization and step-edit request

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form signed by the prescribing physician with required clinical documentation for approval.

SourceLink

On This Page

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inv-02: Continuation Therapy

Reauthorization (12 months) — Covered when ALL of the following are met:

Reauthorization requirements: Member continues to meet the initial diagnosis and therapy preclusions; provider has continued to monitor liver function (ALT, AST, alkaline phosphatase, and total bilirubin with fractionation) and member does NOT have liver cirrhosis or hepatic injury (submit lab documentation); member has experienced clinically meaningful benefit defined as: for transfusion-dependent members, no increase in transfusion requirements from pretreatment baseline or the last authorization review (submit most recent transfusion records); for non-transfusion-dependent members, stabilization or improvement in hemoglobin level (submit lab documentation).

Coverage for Aqvesme (mitapivat) is available with prior authorization when clinical criteria are satisfied. Initial approvals are for 6 months and reauthorizations for 12 months. The policy requires documentation that the member is ≥18 years of age, that the prescribing provider is a hematologist (or has consulted one) or a specialist in treating alpha- or beta-thalassemia, and that the member does not have specified hepatobiliary conditions (including cirrhosis/severe fibrosis, symptomatic cholelithiasis/cholecystitis, drug-induced cholestatic hepatitis, or AST/ALT >2.5× ULN unless attributable to hemolysis or hepatic iron deposition).

The drug will not be approved if used concurrently with Pyrukynd (mitapivat) or Reblozyl (luspatercept-aamt) or if the member has a history of prior gene therapy (e.g., Casgevy, Zynteglo). For disease-specific eligibility, members must have either alpha- or beta-thalassemia meeting the policy hemoglobin and transfusion criteria, including a documented baseline hemoglobin of ≤ 10.0 g/dL (or >10.0 g/dL only if transfusion-dependent) and, for transfusion-dependent members, documentation of at least 6 RBC units transfused in the prior 24 weeks.

Coding and Clinical Thresholds

No codes provided on formmixed

No codes listed

inv-05: Baseline hemoglobin — threshold value (≤ 10.0 g/dL or >10.0 if transfusion-dependent)

Baseline hemoglobin threshold≤ 10.0 g/dL (or >10.0 g/dL if transfusion-dependent) — laboratory documentation required

Context for transfusion-dependent membersIf transfusion-dependent, hemoglobin may be >10.0 g/dL but documentation of transfusion dependence is required

Documentation requirementSubmit laboratory documentation of baseline hemoglobin level with prior authorization request

inv-06: Transfusion requirement threshold — ≥ 6 RBC units in prior 24 weeks

Transfusion threshold≥ 6 red blood cell (RBC) units transfused within the prior 24 weeks

Evidence requiredSubmit most recent chart notes, procedural notes, or therapy orders detailing current and past transfusion requirements

Pretreatment reportingForm asks: 'Please Provide Pretreatment Transfusion Requirements: _____ units' to document number of units

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The prescribing physician must sign and clearly print their name on the request form (preprinted stamps are not valid). All clinical criteria must be met for approval. Incomplete, incorrect, or illegible submissions (including missing phone/fax) may delay processing or result in denial.

Fax completed form to 1-305-671-0200
Prescribing physician signature required (no preprinted stamps)
Ensure phone and fax numbers are correct on the form

Step Therapy

Step-Edit / Prior Therapy Verification

Step-edit / prior-therapy verification applies. Use of samples to initiate therapy does not satisfy step-edit or prior authorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Samples do NOT meet initiation criteria
Prior therapies verified via pharmacy claims or submitted chart notes

Documentation Required

Required Supporting Documentation

Supporting documentation is required for all checked clinical criteria. Submit medical history, chart notes, hematological findings, electrophoresis and/or molecular analysis where available, and relevant laboratory results (including baseline and ongoing hemoglobin and liver function tests). For transfusion-dependent members, provide documentation of transfusion units and dates.

Medical history and chart notes with hematological findings
Electrophoresis and/or molecular analysis where available
Laboratory documentation: hemoglobin values, ALT, AST, alkaline phosphatase, total bilirubin with fractionation
Transfusion records: number of RBC units in preceding 24 weeks and current transfusion requirements

Denial Risk

Incomplete or Illegible Submission May Delay or Result in Denial

Incomplete or illegible information or missing documentation may delay review or lead to denial. Ensure all required fields on the drug information and authorization form are complete (drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code if applicable, weight and date obtained, recommended dosage, and quantity).

Complete Drug Information section: name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code (if applicable), weight and date obtained
Provide recommended dosage and quantity limits (e.g., 100 mg twice daily; 28-day supply details)
Missing lab results, diagnostics, or chart notes may result in denial

Background

Mitapivat (Aqvesme) is an oral small-molecule activator of pyruvate kinase requested for treatment of alpha- or beta-thalassemia. The policy frames use for adults (≥18 years) with documented thalassemia meeting hemoglobin and transfusion thresholds and excludes use in patients with other hemoglobinopathies such as homozygous or heterozygous Sickle Hemoglobin (HbS) or Hemoglobin C (HbC).

Because of hepatobiliary safety concerns, the policy requires baseline and ongoing liver function monitoring (ALT, AST, alkaline phosphatase, total bilirubin) and excludes members with significant liver disease or elevated transaminases beyond specified limits unless explained by hemolysis or hepatic iron deposition. The medication is dispensed through specialty pharmacy and must be authorized using the prescriber-signed prior authorization form; samples do not meet initiation criteria.

Initial Authorization (6 months)

inv-13: Initial Authorization

Covered when ALL of the following are met for initial authorization (6 months):

Initial therapy

Thalassemia diagnosis
- Alpha-thalassemia: Diagnosis of alpha-thalassemia with submitted medical history, chart notes with hematological findings, electrophoresis and/or molecular analysis where available; baseline hemoglobin ≤10.0 g/dL OR >10.0 g/dL if transfusion-dependent; if transfusion-dependent, ≥6 RBC units transfused in prior 24 weeks.
- Beta-thalassemia: Diagnosis of beta-thalassemia (including β+, β0, Hb E/β-thalassemia, or non-deletional Hb H) with submitted medical history, chart notes with hematological findings, electrophoresis and/or molecular analysis where available; baseline hemoglobin ≤10.0 g/dL OR >10.0 g/dL if transfusion-dependent; if transfusion-dependent, ≥6 RBC units transfused in prior 24 weeks.

Reauthorization / Continuation Criteria

inv-14: Reauthorization

Reauthorization (12 months) — Covered when ALL of the following are met:

Reauthorization: Member continues to meet the diagnosis and therapy preclusions listed for initial authorization; liver function monitoring (ALT, AST, alkaline phosphatase, total bilirubin with fractionation) has been performed and member does not have liver cirrhosis or hepatic injury (submit lab documentation); member demonstrates clinically meaningful benefit: transfusion-dependent members have not experienced an increase in transfusion requirements from pretreatment baseline or last authorization review; non–transfusion-dependent members have stabilization or improvement in hemoglobin level.

OpenPayer

Aqvesme (mitapivat) prior authorization and step-edit request

Coverage Criteria for Aqvesme (mitapivat)

Coding and Clinical Thresholds

Provider Actions and Documentation Requirements

Background

Definitions

Initial Authorization (6 months)

Reauthorization / Continuation Criteria

Step Therapy and Prior Treatment Verification

Quantity Limits and Dosing

Site of Care and Specialty Pharmacy