CurrentCignaPolicy N/A

Hematology - Pyrukynd Drug Quantity Management Policy - Per Days • Pyrukynd (mitapivat tablets - Agios)

Defines retail and home delivery quantity limits for Pyrukynd (mitapivat) tablets (5 mg, 20 mg, 50 mg, and taper packs) and the exception criteria for increased quantities when co-administered with CYP3A4 inducers. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHematology - Pyrukynd Drug Quantity Management Policy - Per Days • Pyrukynd (mitapivat tablets - Agios)

Policy CodePolicy N/A

Change TypeClarified; Revised

Effective Date

Next Review Date

Key ActionIf requesting quantities above the standard limit, submit documentation that the patient is taking a concomitant CYP3A4 inducer to qualify for the exception (112 tablets/28 days retail or 336 tablets/84 days home delivery).

POLICY UPDATE CHANGES

Policy was updated to reflect the existing quantity limits when a product is obtained via home delivery.

Annual revisions with no criteria changes recorded for 2023 and 2024.

3Standard 28-day pack strengths listed

3Taper pack configurations listed

1Exception criteria types

Coverage Summary

Scope: Defines retail and home delivery quantity limits for Pyrukynd (mitapivat) tablets (5 mg, 20 mg, 50 mg, and taper packs) and the exception criteria for increased quantities when co-administered with CYP3A4 inducers. Applies to Cigna-administered health benefit plans. Coverage stance: mixed. Note: the policy distinguishes retail vs home delivery quantity limits for Pyrukynd and specifies an exception for higher quantities when the patient is taking a CYP3A4 inducer. Effective/last review dates: Last review 2025-05-02 (policy document review history also notes 05/04/2023 and 05/15/2024).

Quantity limits & exception thresholds

Retail maximum quantity (28 days)56 tablets per 28 days (for 5 mg, 20 mg, 50 mg 28-day packs)

Home delivery maximum quantity (84 days)168 tablets per 84 days (for 5 mg, 20 mg, 50 mg 28-day packs)

Taper pack annual maximum7 or 14 tablets per 365 days depending on taper pack composition (5 mg taper = 7; combined taper packs = 14)

Exception quantity for CYP3A4 inducer (retail)112 tablets per 28 days (for Pyrukynd 50 mg 28-Day Pack)

Exception quantity for CYP3A4 inducer (home delivery)336 tablets per 84 days (for Pyrukynd 50 mg 28-Day Pack)

Drug Quantity Limits & Exceptions

Quantity limits apply as listed; exceptions covered as medically necessary only when ALL of the following are met:

ALL of the following

Requested quantity does not exceed listed Retail or Home Delivery maximums for the specific strength/form
If requesting quantities above the standard limit, the request must meet one of the specified exception criteria

Exception for Pyrukynd 50 mg 28-Day Pack

Covered when ALL of the following are met:

ALL of the following

Patient is taking Pyrukynd concomitantly with a cytochrome P450 (CYP)3A4 inducer
Requested quantity is 112 tablets per 28 days at retail OR 336 tablets per 84 days at home delivery

Applicable Codes & Quantity Limits

Drug products (by strength/form) subject to quantity limitsNDC

mitapivat 5 mg tablets (28-Day Pack)	5 mg tablets x 56 tablets per 28-day pack (Retail max 56/28 days; Home Delivery max 168/84 days)
mitapivat 20 mg tablets (28-Day Pack)	20 mg tablets x 56 tablets per 28-day pack (Retail max 56/28 days; Home Delivery max 168/84 days)
mitapivat 50 mg tablets (28-Day Pack)	50 mg tablets x 56 tablets per 28-day pack (Retail max 56/28 days; Home Delivery max 168/84 days)
mitapivat 5 mg Taper Pack (7 x 5 mg blister wallet)	Retail max 7 tablets per 365 days; Home Delivery max 7 tablets per 365 days
mitapivat 5 mg and 20 mg Taper Pack (1 x 5 mg wallet and 1 x 20 mg wallet)	Retail max 14 tablets per 365 days; Home Delivery max 14 tablets per 365 days
mitapivat 20 mg and 50 mg Taper Pack (1 x 20 mg wallet and 1 x 50 mg wallet)	Retail max 14 tablets per 365 days; Home Delivery max 14 tablets per 365 days

Operational billing note: Retail maximums are applied per 28 days and home delivery maximums are applied per 84 days for the 28-day pack strengths; taper packs have annual maxima (retail and home delivery limits are reported per 365 days). This guidance complements the code table and advises using the appropriate retail vs home delivery limits when billing.

Provider Actions & Prior Authorization

Prior Authorization

Quantity limit exception request

If requesting quantities above the standard limit, submit documentation that the patient is taking a concomitant CYP3A4 inducer to qualify for the exception of 112 tablets/28 days (retail) or 336 tablets/84 days (home delivery) for the Pyrukynd 50 mg 28-day pack.

Documentation Required

Medical necessity for exceptions

Provide clinical documentation demonstrating concomitant use of a CYP3A4 inducer when requesting the exception quantity; any other exception requests must meet medical necessity criteria or will be considered not medically necessary. Specifically, documentation that the patient is taking a concomitant cytochrome P450 (CYP)3A4 inducer is required to qualify for the increased quantity for the Pyrukynd 50 mg 28-day pack.

Billing Rule

Adhere to retail vs home delivery limits

When billing, use the most appropriate codes and adhere to the applicable retail maximum per 28 days or home delivery maximum per 84 days; claims exceeding covered code/quantity will be denied as not covered.

Retail maximum (28 days) for 5 mg, 20 mg, 50 mg 28-Day Packs: 56 tablets per 28 days
Home delivery maximum (84 days) for 5 mg, 20 mg, 50 mg 28-Day Packs: 168 tablets per 84 days
Claims exceeding the covered code/quantity will be denied as not covered

Background & Dosing Notes

Background/indication and dosing: Pyrukynd (mitapivat) is indicated for treatment of hemolytic anemia due to pyruvate kinase deficiency in adults. Recommended dosing begins at 5 mg twice daily (BID) with titration to 20 mg BID and then to a maximum recommended dose of 50 mg BID, with dose increases every 4 weeks and hemoglobin assessment prior to upward titration. Monitor hemoglobin and hemolysis laboratory results (and transfusion requirements); discontinue Pyrukynd if no benefit is observed by 24 weeks. Taper schedules are recommended to avoid acute hemolysis; specific taper schedules are provided for 5 mg, 20 mg, and 50 mg BID regimens.

Definitions:

• BID — Twice daily.

• QD — Once daily.

• CYP3A4 inducer — A drug that increases activity of cytochrome P450 3A4 enzymes, potentially reducing mitapivat exposure.

Revision History

05/04/2023annual_revision

Annual revision recorded with no criteria changes.

05/15/2024annual_revision

Annual revision recorded with no criteria changes.

clarification

Policy updated to reflect existing quantity limits when a product is obtained via home delivery; no criteria changes.

05/02/2025reviewLatest

Policy review date (current policy review).