CurrentCignaPolicy IP0370

Hydroxyprogesterone Caproate (Makena) — Drug and Biologic Coverage Policy

This policy governs coverage and coding for hydroxyprogesterone caproate (Makena) for Cigna-administered health benefit plans; it informs providers about the product's regulatory status and coverage stance.

Policy Summary

PayerCigna

PolicyHydroxyprogesterone Caproate (Makena) — Drug and Biologic Coverage Policy

Policy CodePolicy IP0370

Change TypeRoutine review — no material changes

Effective DateMar 15, 2024

Next Review DateMar 15, 2025

Key ActionNote that hydroxyprogesterone caproate (Makena) is considered experimental/investigational and may be denied due to FDA approval withdrawal.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1726listed HCPCS code for Makena (10 mg injection)

Apr 6, 2023FDA approval withdrawal date

singleton pregnancyoriginal indicated population

Coverage Determination

Coverage stance

Policy statement regarding coverage status

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Makena (hydroxyprogesterone caproate) and its generics are unapproved products following FDA withdrawal of approval effective April 6, 2023. Because approval was withdrawn, these products cannot lawfully be distributed in interstate commerce and are not recognized as approved therapeutic options under this policy.

Consistent with the policy's coverage stance, use of Makena and its generics is considered experimental, investigational, or unproven for any indication due to insufficient evidence establishing safety, efficacy, and improved health outcomes.

Provider Actions and Requirements

Prior Authorization

Prior Authorization / Coding Note

Prior authorization may be required per the member's benefit plan. Note that J1726 (Injection, hydroxyprogesterone caproate, (Makena), 10 mg) is listed in coding references; coverage follows policy criteria and the applicable benefit plan.

J1726 — Injection, hydroxyprogesterone caproate, (Makena), 10 mg
Effective April 6, 2023: FDA withdrew approval for Makena; Makena and generics are unapproved and cannot be lawfully distributed in interstate commerce

Step Therapy

No step therapy provisions are specified in this policy. Providers should not assume any step therapy requirements apply for hydroxyprogesterone caproate under this policy; review the member's specific benefit plan for any product-specific management rules.

Documentation Required

Documentation Requirements

Document clinical rationale and supporting records. Coverage determinations require consideration of the applicable benefit plan, any relevant laws/regulations, and collateral materials (including this Coverage Policy). Include documentation that demonstrates how requested services meet policy criteria when submitting authorization requests.

Verify member's benefit plan terms and any applicable state/federal mandates
Attach relevant clinical records when requesting prior authorization

Denial Risk

Denial risk: Makena and its generics are considered experimental/investigational/unapproved following FDA withdrawal of approval and may be denied as not medically necessary or not covered under applicable plans. Expect increased likelihood of coverage denial when requests do not meet policy and benefit plan criteria.

FDA withdrawal of approval (effective April 6, 2023) increases denial risk
Policy classifies use as experimental/investigational/unproven

Definitions

Makena (hydroxyprogesterone caproate) — definition

Generic namehydroxyprogesterone caproate

Brand name (former)Makena

Drug class / formulationInjectable progestin (intramuscular injection)

Original indicated populationWomen with a singleton pregnancy and a history of singleton spontaneous preterm birth to reduce risk of recurrent preterm birth

Regulatory statusFDA approval withdrawn April 6, 2023; Makena and generics are unapproved and cannot be lawfully distributed in interstate commerce

Effect on effectiveness claimEffectiveness was based on reduced proportion of deliveries before 37 weeks of gestation

Site of Care

Note

Site of care — office: no rules specified; distribution affected by withdrawal

No site-of-care restrictions are specified for office administration; however, FDA withdrawal of Makena has limited supply and affects distribution.

There are no policy site-of-care rules listed for office setting.
Distribution and availability are impacted by the April 6, 2023 withdrawal.