CurrentCignaPolicy N/A

Infertility - Vaginal Progesterone Preferred Specialty Management Policy

A Cigna Preferred Specialty Management program that designates Crinone 8% gel and Endometrin as preferred vaginal progesterone products for ART-related infertility coverage, directs use of the preferred product first, and defines exception criteria for non-preferred product approval. Documentation requirements and approval durations are specified.

Policy Summary

PayerCigna

PolicyInfertility - Vaginal Progesterone Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeDocumentation & criteria updates

Effective Date

Next Review Date

Key ActionProviders should direct patients to try the preferred product (Crinone 8% gel) prior to approval of a non-preferred product; requests for non-preferred products are reviewed using exception criteria.

POLICY UPDATE CHANGES

Added documentation requirement for the trial of Crinone 8% gel.

Added a note under continuation criterion to approve for 9 months or the given timeframe to complete the current course of therapy.

Removed the phrase 'and according to the prescriber, has experienced inadequate efficacy OR significant intolerance with' to match automation.

New Policy creation and review date entries for 03/27/2024 and 04/03/2024.

2Preferred Products Listed

1Non-Preferred Product (with exception criteria)

9 monthsMax continuation approval duration specified

Program overview and intent

This Preferred Specialty Management program designates Crinone 8% gel and Endometrin as preferred vaginal progesterone products for Assisted Reproductive Technology (ART)-related progesterone supplementation in infertile women and directs use of the preferred product before approval of a non-preferred product.

The program applies to health benefit plans administered by Cigna companies and utilization may vary by line of business and customer benefit plan documents; some vaginal progesterone products are managed based on whether the patient’s benefit includes infertility coverage. Documentation requirements and approval durations are specified in the criteria.

General Coverage / Program Intent

This Preferred Specialty Management program directs use of the Preferred Product prior to approval of a Non-Preferred Product; approvals are provided for specified durations. Documentation requirement and applicability are summarized below.

General applicability: Program applies to health benefit plans administered by Cigna companies; applicability may vary by line of business and customer benefit plan documents.

See plan documents for exceptions

Benefit scope: Utilization of some vaginal progesterone products is managed based on whether the patient's benefit includes infertility coverage.

Documentation overview: Documentation is required for use of Crinone 8% gel; acceptable documentation may include chart notes, prescription claims records, prescription receipts, and/or other information.

Documentation needed to support exception A for non-preferred product approval

Preferred products (codes / names)

Preferred Products (drug names)mixedCovered

Crinone 8% gel	Progesterone 8% vaginal gel (Allergan)
Endometrin	Progesterone vaginal insert (Ferring)

Crinone 4% gel is not part of this preferred specialty management program because it is indicated for secondary amenorrhea and not for ART; coverage of related products may depend on whether the patient’s benefit includes infertility coverage.

Exception criteria for non-preferred product (Endometrin)

Non-Covered / Not Medically Necessary

Any other exception not meeting the above criteria is considered not medically necessary.

Not medically necessary - other requests: Any request for the non-preferred product(s) that does not meet the specified exception criteria is considered not medically necessary

What providers must do

Step Therapy

Step to preferred product before non-preferred approval

Providers should direct patients to try the preferred product (Crinone 8% gel) prior to approval of a non-preferred product; requests for non-preferred products are reviewed using exception criteria.

Scope: program directs use of the preferred product first (Crinone 8% gel) before non-preferred approval

Documentation Required

Documentation required for Crinone 8% trial

Documentation that the patient tried Crinone 8% gel must be supplied to support approval of a non-preferred product under the exception for prior trial.

Chart notes
Prescription claims records
Prescription receipts

Evidence and references

A randomized study reported that Endometrin was non-inferior to Crinone 8% gel for ongoing pregnancy rates in patients <35 years of age or with follicle stimulating hormone <10 IU/L.

Evidence:

- Doody KJ et al., Fertil Steril. 2009;91(4):1012-1017 - Endometrin non-inferiority trial

- Crinone prescribing information (Allergan; June 2017)

- Endometrin prescribing information (Ferring; January 2018)

Reference	Source/Date
Crinone prescribing information	Allergan; June 2017
Endometrin prescribing information	Ferring; January 2018
Clinical trial (Doody KJ et al., Fertil Steril.)	2009;91(4):1012-1017

Policy update changes

03/27/2024added

Added documentation requirement for the trial of Crinone 8% gel; acceptable documentation may include chart notes, prescription claims records, prescription receipts, and/or other information.

04/03/2024removed

Removed the alternative exception phrase 'and according to the prescriber, has experienced inadequate efficacy OR significant intolerance with' to match automation.

03/19/2025addedLatest