CurrentCignaPolicy N/A

Hematology - Aqvesme Prior Authorization Policy

Defines Cigna's prior authorization and medical necessity criteria for coverage of Aqvesme (mitapivat) for treatment of anemia in adults with alpha- or beta-thalassemia for prescription benefits.

Policy Summary

PayerCigna

PolicyHematology - Aqvesme Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 7, 2026

Key ActionSubmit prior authorization for Aqvesme; approvals are provided for defined durations (new starts 6 months, current recipients up to 1 year).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age for coverage

6 moinitial approval duration

1 yrrenewal approval duration

6 unitstransfusion threshold

≥50% / ≥1 g/dLtrial endpoints

Coverage Criteria for Aqvesme (mitapivat)

Alpha-Thalassemia

Covered when ONE of the following is met (A or B):

Alpha-Thalassemia coverage: A) Initial Therapy: Approve for 6 months if ALL of (i, ii, iii) are met OR B) Currently Receiving Aqvesme: Approve for 1 year if prescriber documents clinically meaningful benefit

Alpha A) Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of the following (a or b): a) Patient has a baseline hemoglobin level of ≤ 10.0 g/dL (baseline is prior to treatment or transfusion) OR b) According to the prescriber, the patient requires regular red blood cell transfusions defined by BOTH: (1) received ≥ 6 RBC units within the preceding 24 weeks; AND (2) has not had any transfusion-free period > 35 days within the preceding 24 weeks; AND iii. Medication is prescribed by or in consultation with a hematologist

Baseline is prior to treatment or transfusion.

Alpha B) Current Recipient: Prescriber attests the patient has experienced clinically meaningful benefit from Aqvesme

Policy Summary

PayerCigna

PolicyHematology - Aqvesme Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 7, 2026

Key ActionSubmit prior authorization for Aqvesme; approvals are provided for defined durations (new starts 6 months, current recipients up to 1 year).

SourceLink

On This Page

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Beta-Thalassemia

Covered when ONE of the following is met (A or B):

Beta-Thalassemia coverage: A) Initial Therapy: Approve for 6 months if ALL of (i-v) are met OR B) Currently Receiving Aqvesme: Approve for 1 year if ALL of (i-iii) are met

Beta A) Initial Therapy: i. Patient is ≥ 18 years of age; AND ii. Patient meets ONE of the following (a or b): a) Patient has a baseline hemoglobin level of ≤ 10.0 g/dL (baseline is prior to treatment or transfusion) OR b) According to the prescriber, the patient requires regular red blood cell transfusions defined by BOTH: (1) received ≥ 6 RBC units within the preceding 24 weeks; AND (2) has not had any transfusion-free period > 35 days within the preceding 24 weeks; AND iii. Patient is not currently receiving Reblozyl (luspatercept-aamt); AND iv. Patient has not received a gene therapy for transfusion-dependent beta-thalassemia in the past (e.g., Zynteglo, Casgevy); AND v. Medication is prescribed by or in consultation with a hematologist

Beta B) Current Recipient: i. Prescriber attests the patient has experienced clinically meaningful benefit from Aqvesme; AND ii. Patient is not currently receiving Reblozyl (luspatercept-aamt); AND iii. Patient has not received a gene therapy for transfusion-dependent beta-thalassemia in the past

Examples of clinically meaningful benefit: increases in hemoglobin, reduced transfusion burden, improved labs, or symptomatic improvement.

Key Clinical Definitions & Coding Thresholds

inv-05: Transfusion burden — ≥6 RBC units in preceding 24 weeks and no transfusion-free period >35 days.

Transfusion burden thresholdAt least 6 red blood cell (RBC) units received within the preceding 24 weeks and no transfusion-free period >35 days during that 24-week period

Clinical trial definition (ENERGIZE-T)Transfusion dependence defined as 6 to 20 RBC units transfused and no longer than a 6-week transfusion-free period during the 24 weeks prior to randomization

Policy useUsed to determine ‘regular red blood cell transfusions’ / transfusion-dependent status for coverage decisions

inv-06: Baseline hemoglobin — ≤10.0 g/dL.

Baseline hemoglobin thresholdBaseline hemoglobin ≤ 10.0 g/dL (baseline is prior to treatment or red blood cell transfusions)

Trial requirementA baseline hemoglobin level ≤10 g/dL was required for enrollment in pivotal trials

Policy applicationMeets one of the coverage criteria options for initial therapy in alpha- and beta-thalassemia

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Aqvesme. Approvals are provided for the durations specified by the policy. In cases where approval is authorized in months, 1 month = 30 days. Because of the specialized skills required for evaluation, diagnosis, and monitoring, Aqvesme must be prescribed by or in consultation with a physician who specializes in the condition being treated (hematologist).

Prior authorization recommended; approvals granted for specified durations (see policy).
Must be prescribed by or in consultation with a hematologist.

Denial Risk

Required Treatment Exclusions Before/With Aqvesme

Aqvesme is covered as medically necessary only when the FDA-approved/transfusion-dependent beta-thalassemia criteria in the policy are met. Before initiating or continuing Aqvesme, the following treatment exclusions must be confirmed:

Patient is not currently receiving Reblozyl (luspatercept‑aamt subcutaneous injection).
Patient has not previously received a gene therapy for transfusion‑dependent beta‑thalassemia (examples: Zynteglo, Casgevy).
For initiation: patient must meet the policy's definition of requiring regular RBC transfusions (≥6 units in the prior 24 weeks AND no transfusion‑free period >35 days in the prior 24 weeks).

Documentation Required

Prescriber Specialty Requirement

Because of the specialized evaluation and monitoring needs for patients receiving Aqvesme, the medication must be prescribed by or in consultation with a hematologist.

Prescriber specialty requirement: hematologist involvement required (prescribed by or in consultation with).

Billing Rule

Billing Codes and Claims

Claims submitted for services or drugs that are not accompanied by covered diagnosis or procedure codes referenced in the applicable coverage policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service.

Claims without covered codes under this policy will be denied as not covered.
Use the most appropriate codes as of the submission/service date.

Definitions and Clinical Response Criteria

inv-12: Regular red blood cell transfusions / transfusion-dependent — definition: at least 6 RBC units in preceding 24 weeks and no transfusion-free period >35 days.

Definition (policy)Regular red blood cell transfusions / transfusion-dependent: patient has received at least 6 RBC units within the preceding 24 weeks AND has not had any transfusion-free period >35 days within the preceding 24 weeks

Pivotal trial alignmentENERGIZE-T defined transfusion dependence as 6 to 20 RBC units transfused and no transfusion-free period longer than 6 weeks during the 24 weeks prior to randomization

Use in coverage decisionsApplied to determine eligibility for initial therapy criteria in alpha- and beta-thalassemia indications

inv-13: Clinical trial response definitions — Hemoglobin response (ENERGIZE): ≥1 g/dL increase from Week 12–24 vs baseline; transfusion response definitions.

Hemoglobin response (ENERGIZE)≥1 g/dL increase in the average hemoglobin level from Week 12 through Week 24 compared with baseline

Transfusion reduction response (ENERGIZE-T)≥50% reduction from baseline in RBC units transfused with a reduction of at least 2 units in any consecutive 12-week period through Week 48 compared with baseline

Reported trial resultsENERGIZE: 42.3% of Aqvesme patients met hemoglobin response vs 1.6% placebo; ENERGIZE-T: 30.4% met transfusion reduction response vs 12.6% placebo

OpenPayer

Hematology - Aqvesme Prior Authorization Policy

Coverage Criteria for Aqvesme (mitapivat)

Key Clinical Definitions & Coding Thresholds

Provider Requirements and Billing Guidance

Background on Aqvesme (mitapivat)

Definitions and Clinical Response Criteria