CurrentUnitedHealthcarePolicy 2025 P 1387-4

Pyrukynd (mitapivat) prior authorization

Prior authorization policy for Pyrukynd (mitapivat) for treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, covering initial authorization, reauthorization, authorization lengths, and automated approval allowances. Applies to UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyPyrukynd (mitapivat) prior authorization

Policy CodePolicy 2025 P 1387-4

Change TypeRevised (annual review — no changes)

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization required; initial approval requires both diagnosis of PK deficiency and use for hemolytic anemia; initial authorization duration 12 months.

POLICY UPDATE CHANGES

Effective date set to 8/1/2025 per header; annual review 5/2025 indicated no changes to coverage criteria.

12 moInitial authorization duration

12 moReauth if positive response

4 wkReauth if no documented response

1Program Number

Coverage Summary

Pyrukynd (mitapivat) is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Coverage is covered_with_criteria and is subject to prior authorization per this policy. Initial authorization requires documentation of PK deficiency and use for hemolytic anemia and will be issued for 12 months. State mandates and member-specific benefit plans may affect coverage criteria.

Initial Authorization Criteria

Initial Authorization

Pyrukynd will be approved based on both of the following criteria:

ALL of the following

Diagnosis of pyruvate kinase (PK) deficiency
Used for the treatment of hemolytic anemia
Authorization will be issued for 12 months

Authorization and Program Stats

Initial authorization duration12 months

Program Number1

Reauthorization / Continuation Criteria

Reauthorization

Pyrukynd will be approved based on one of the following criteria:

ANY of the following

Documentation of positive clinical response to Pyrukynd therapy
Authorization issued for 12 months if met
Documentation does not provide evidence of positive clinical response to Pyrukynd therapy; allow for dose titration with discontinuation of therapy
Authorization issued for 4 weeks if met

Positive clinical response: Not explicitly defined in the document; documentation of clinical benefit from therapy is required for 12-month reauthorization.

Additional Clinical Rules / Automated Approval

Additional Clinical Rules

Automated approval allowances

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic

Use of automated approval and re-approval processes varies by program and/or therapeutic class

Provider Actions

Prior Authorization

Prior authorization required for Pyrukynd

Prior authorization is required for Pyrukynd (mitapivat). Initial approval requires both a diagnosis of pyruvate kinase (PK) deficiency and use for the treatment of hemolytic anemia. Initial authorization will be issued for 12 months.

Prior Authorization

Reauthorization requirements and durations

Reauthorization is approved via one of two paths: documentation of a positive clinical response to Pyrukynd, which yields authorization for 12 months; or documentation that does not show a positive clinical response, which allows a 4-week authorization to permit dose titration with discontinuation of therapy.

Documentation Required

Evidence sources may be accepted

For reauthorization decisions, documentation of clinical response (or lack of response) must be provided. UnitedHealthcare may also approve initial and reauthorization solely based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Background

Pyrukynd (mitapivat) is a pyruvate kinase activator indicated for treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. State mandates and member-specific benefit plans may impact coverage criteria and other utilization management programs or federal requirements may also apply.

Revision History

5/2023prior_history_note_update

Prior history notes updates: Added state mandate footnote (5/2023)

5/2025criteria_update_and_annual_reviewLatest

Updated initial criteria approval to 12 months (5/2025); annual review 5/2025 indicated no changes to coverage criteria. Effective date set to 8/1/2025 per header; annual review 5/2025 indicated no changes to coverage criteria.

8/1/2025effective_dateLatest

Effective date set to 8/1/2025 per header