CurrentCentenePolicy CP.PMN.243

Progesterone (Crinone, Endometrin)

Governs prior authorization requirements and medical necessity criteria for Crinone (4%, 8%) and Endometrin vaginal progesterone products for Centene lines of business, affecting providers requesting coverage for ART, secondary amenorrhea, and prevention of preterm birth.

Policy Summary

PayerCentene

PolicyProgesterone (Crinone, Endometrin)

Policy CodePolicy CP.PMN.243

Change TypeNo material clinical or coverage changes

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) demonstrating that the member meets all approval criteria and obtain prior authorization for Crinone or Endometrin.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3covered indications

180 mg/dayCrinone 8% ART max

300 mg/dayEndometrin ART max

6 w/6 mapproval durations

notedMedicaid precedence

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Coverage Criteria

Initial Approval — Assisted Reproductive Technology (ART) Treatment

Covered when ALL of the following are met

ART initial criteria: 1. Member must have infertility coverage (optional pharmacy benefit); 2. Age ≥ 18 years; 3. Request is for Crinone 8% or Endometrin; 4. Prescribed as supplementation or replacement of progesterone as part of ART treatment for infertile women; 5. Dose does not exceed one of the following: a) Crinone 8%: 180 mg per day for up to 12 weeks; b) Endometrin: 300 mg per day for up to 10 weeks.

Initial Approval — Secondary Amenorrhea

Covered when ALL of the following are met

Secondary amenorrhea initial criteria: 1. Diagnosis of secondary amenorrhea; 2. Age ≥ 18 years; 3. Request is for Crinone 4% or 8%; 4. Failure of a progestin product (e.g., medroxyprogesterone, norethindrone), unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed one of the following: a) Crinone 4%: 45 mg every other day for up to 6 doses; b) Crinone 8%: 90 mg every other day for up to 6 doses.

For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.

Initial Approval — Prevention of Preterm Birth (off-label)

Covered when ALL of the following are met

Prevention of preterm birth initial criteria: 1. Prescribed for prevention of preterm birth; 2. Age ≥ 18 years; 3. Request is for Crinone 8% or Endometrin; 4. Gestational age is ≥ 16 weeks; 5. Member has a short cervix defined as cervical length ≤ 25 mm; 6. Dose does not exceed one of the following: a) Crinone 8%: 90 mg per day; b) Endometrin: 200 mg per day.

Approval duration: 6 months.

Continuation / Renewal Criteria (All Indications in Section I)

Covered when ALL of the following are met

Continuation criteria: 1. Member meets one of the following: a) Currently receiving medication via Centene benefit or previously met initial approval criteria; b) Currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Member meets one of the following: a) For ART: i. Member must have infertility coverage; ii. Member has not yet received more than 12 weeks of therapy (Crinone 8%) or 10 weeks of therapy (Endometrin); b) For secondary amenorrhea: member has not yet received 6 doses of Crinone 4% or 8%; c) For prevention of preterm birth: week 37 (through 36 weeks, 6 days) of gestation or delivery has not yet been reached; 4. If request is for a dose increase, the new dose does not exceed the indication-specific maximums: a) ART: Crinone 8%: 180 mg/day for up to 12 weeks; Endometrin: 300 mg/day for up to 10 weeks; b) Secondary amenorrhea: Crinone 4%: 45 mg every other day for up to 6 doses; Crinone 8%: 90 mg every other day for up to 6 doses; c) Prevention of preterm birth: Crinone 8%: 90 mg/day; Endometrin: 200 mg/day.

Uses not listed under Section I (Diagnoses/Indications for which coverage is NOT authorized) require follow-up under the plan's formulary/off-label pathways. If the drug has recently undergone a label change within the last 6 months that is not reflected in this policy, refer to the applicable no-coverage or non-formulary policy for the member's line of business (commercial, health insurance marketplace, or Medicaid). If the requested use is not described under Section I and no recent label change applies, the request should be evaluated according to the applicable off-label use policy for the member's line of business.

This clinical policy is the property of the Health Plan and is protected by copyright. Unauthorized copying, use, modification, distribution, display, storage, transmission, or publication of this policy or any information contained herein is strictly prohibited without the prior written permission of Centene Corporation. Providers, members, and their representatives are bound to the terms and conditions expressed in this policy through the terms of their contracts; where no contract exists, providing services or submitting claims constitutes agreement to be bound.

Requests for indications that are not listed in Section I will be evaluated by following the referenced policies. If the request involves a recent label change (within the last 6 months), route the request to the appropriate no-coverage or non-formulary policy for the member's line of business. For all other off-label or non-listed indications, evaluate the request under the applicable off-label use policy for the relevant line of business (commercial, health insurance marketplace, or Medicaid).

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Crinone (4%, 8%) and Endometrin require prior authorization. Provider must demonstrate criteria are met and submit supporting clinical documentation.

Affected products: Crinone 4%, Crinone 8%, Endometrin (vaginal insert)
Pharmacy benefit coverage required for infertility/fertility preservation per plan and state-specific restrictions may apply

Documentation Required

Documentation Requirement

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Failure to submit required documentation may result in denial of the request.

Acceptable documentation: office chart notes, lab results, operative reports, medication history, prior authorization forms
Documentation must demonstrate criteria such as diagnosis, prior medication trials, age, dose limits, and any contraindications

Step Therapy

Step Therapy — Secondary Amenorrhea

Step therapy for secondary amenorrhea: request for Crinone 4% or 8% requires failure of an oral progestin (e.g., medroxyprogesterone, norethindrone) unless contraindicated or clinically significant adverse effects are experienced. Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 effective 1/1/2026.

Indication: Secondary amenorrhea
Requirement: Failure of an oral progestin unless contraindicated
Exception: Illinois HIM — step therapy does not apply as of 1/1/2026 per IL HB 5395
Dose limits: Crinone 4% — 45 mg every other day for up to 6 doses; Crinone 8% — 90 mg every other day for up to 6 doses

Note

Provider Contractual Terms

Providers are independent contractors and not agents or employees of the Health Plan. Providers, members, and their representatives are bound to the terms and conditions herein by their contracts; where no contract exists, providing services or submitting claims constitutes agreement to be bound.

Providers exercise independent clinical judgment and the Health Plan has no control over their practice
Contractual binding: terms apply via existing contracts or by submission of services/claims when no contract exists

Denial Risk

Unauthorized Copying/Use/Distribution

This clinical policy is the property of the Health Plan. Unauthorized copying, use, or distribution of this clinical policy or any information contained herein is strictly prohibited.

Unauthorized reproduction or distribution may result in enforcement actions per Health Plan policy

Definitions

inv-18: Secondary amenorrhea — absence of menses addressed by Crinone per FDA labeling

DefinitionSecondary amenorrhea — absence of menses addressed by Crinone per FDA labeling

FDA indication (Crinone 4%)Crinone 4% is indicated for the treatment of secondary amenorrhea

FDA indication (Crinone 8%)Crinone 8% is indicated for treatment of secondary amenorrhea in women who have failed to respond to Crinone 4%

inv-19: Short cervix — defined in policy as cervical length ≤ 25 mm for prevention of preterm birth criteria

Policy definitionShort cervix defined as cervical length ≤ 25 mm

Use in criteriaRequired for coverage under the 'Prevention of Preterm Birth' initial approval criteria

Related requirementGestational age must be ≥ 16 weeks when used for prevention of preterm birth

inv-20: Provider status — providers are independent contractors exercising independent judgment

Provider relationship to Health PlanProviders are independent contractors who exercise independent judgment and are not agents or employees of the Health Plan

ImplicationHealth Plan has no control or right of control over providers referenced in this clinical policy

Contractual noteProviders, members, and their representatives are bound to the policy terms through their contracts or by providing services/submitting claims

inv-21: Medicaid precedence — state Medicaid coverage provisions take precedence over this clinical policy when conflicts exist

Medicaid precedence statementFor Medicaid members, state Medicaid coverage provisions take precedence over this clinical policy when conflicts exist

Action for providersRefer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy

ScopeThis precedence applies only to Medicaid members and supersedes conflicting provisions in this clinical policy

OpenPayer

Progesterone (Crinone, Endometrin)

Coverage Criteria

Coding and Clinical Thresholds

Provider Actions & Requirements

Background

Definitions