CurrentCignaPolicy N/A

PREFERRED SPECIALTY MANAGEMENT POLICY - Infertility - Gonadotropin-Releasing Hormone Antagonists Preferred Specialty Management Policy

Defines Cigna's preferred specialty management program for GnRH antagonists (Cetrotide/cetrorelix, Ganirelix, Fyremadel) when infertility coverage is included or excluded, including exception criteria for non-preferred products and handling when benefits do not include infertility coverage.

Policy Summary

PayerCigna

PolicyPREFERRED SPECIALTY MANAGEMENT POLICY - Infertility - Gonadotropin-Releasing Hormone Antagonists Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAnnual revision (added generic Cetrotide); administrative clarifications

Effective DateN/A

Next Review DateSep 17, 2025

Key ActionWhen patient's benefit includes infertility coverage, document trial of a Preferred Product (cetrotide/cetrorelix or Fyremadel) prior to approval of a Non-Preferred product (ganirelix); approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Added the generic of Cetrotide subcutaneous injection as a Preferred Product.

Annual revisions on 09/06/2023 and 09/11/2024 noted as 'No criteria changes.'

3Products referenced

1 yearApproval duration

Coverage Summary

Cetrotide, Ganirelix, and Fyremadel are GnRH antagonists indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation. The policy describes these products (Cetrotide/cetrorelix, Ganirelix, Fyremadel) and their mechanism as synthetic decapeptide GnRH antagonists that competitively block pituitary receptors to control LH and FSH release.

The policy directs use of Preferred Products when a patient's benefit includes infertility coverage and defines exception criteria for approval of Non-Preferred Products. Coverage stance is mixed, and when exception criteria are met approvals are typically provided for 1 year.

Products referenced3

Typical approval duration1 year

Last review2024-09-11

Next review2025-09-17

Medical-Necessity Criteria

General Policy Statement

Utilization is managed based on whether a patient's benefit includes infertility coverage and a Preferred Product must be tried prior to approval of a Non-Preferred Product; approvals provided for durations noted below.

ANY of the following

If the patient's benefit includes infertility coverage, the Preferred Specialty Management program directs the patient to try one Preferred Product prior to approval of a Non-Preferred Product. Requests for a Non-Preferred Product will be reviewed using the exception criteria.
If the patient's benefit does NOT include infertility coverage, benefit exclusion overrides may be in place for indications other than infertility and the Preferred Specialty Management program requires meeting the standard Infertility - Gonadotropin-Releasing Hormone Antagonists Benefit Exclusion Overrides Policy criteria and trying a Preferred Product prior to approval of a Non-Preferred Product (when clinically appropriate).
If the patient's benefit does NOT include infertility coverage and benefit exclusion overrides are NOT utilized, coverage is not reviewable.

Non-Preferred Product Exception Criteria - Ganirelix (brand and generic)

Non-preferred product is covered as medically necessary when the following exception criteria are met. Any other exception is considered not medically necessary.

ANY of the following

Scenario 1 (benefit includes infertility coverage)
- Patient's benefit includes infertility coverage
- Patient has tried one of cetrorelix acetate subcutaneous injection (Cetrotide, generics) or Fyremadel
- Approve for 1 year
Scenario 2 (benefit does NOT include infertility coverage; exclusion overrides utilized)
- Patient's benefit does NOT include infertility coverage

Coding

Products referencedmixed

Cetrotide	cetrorelix acetate subcutaneous injection (brand and generics) - Preferred Product
Ganirelix	ganirelix acetate subcutaneous injection (brand and generics) - Non-Preferred Product per policy; exception criteria required
Fyremadel	ganirelix acetate subcutaneous injection (Fyremadel, generic only) - Preferred Product

Provider Actions / Prior Authorization

Prior Authorization

Try Preferred Product before Non-Preferred

When the patient's benefit includes infertility coverage, the Preferred Specialty Management program requires documentation that the patient tried a Preferred Product (cetrorelix/Cetrotide or Fyremadel) prior to approving a Non-Preferred product (ganirelix). Approvals are provided for 1 year when exception criteria are met.

Prior Authorization

Benefit Exclusion Overrides requirement

If the patient's benefit does NOT include infertility coverage and benefit exclusion overrides are utilized, the provider must document that the patient meets the standard Infertility - Gonadotropin-Releasing Hormone Antagonists Benefit Exclusion Overrides Policy criteria in order to be eligible for approval.

Documentation Required

Document prior product trials

Providers must document prior use or trial of the specified Preferred Products (cetrorelix acetate/Cetrotide or Fyremadel) when claiming the exception criteria to support approval of a non-preferred product.

Background

Cetrotide, Ganirelix, and Fyremadel are indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. The source states that these agents are synthetic decapeptides and GnRH antagonists used to prevent premature luteinizing hormone surges during controlled ovarian stimulation.

Prescribing information references are provided for each product: Cetrotide PI Jun 2024, Ganirelix PI Feb 2024, and Fyremadel PI Nov 2024.

Preferred Product: A product designated by the Preferred Specialty Management program as the first-line product to be tried for patients with infertility coverage (examples: Cetrotide/cetrorelix and Fyremadel).

Non-Preferred Product: A product requiring exception criteria for approval (example: Ganirelix brand and generic per this policy).

Revision History

09/06/2023administrative_review

Annual Revision — No criteria changes.

09/11/2024administrative_reviewLatest

Annual Revision — No criteria changes.

09/11/2024material_changeLatest

Added the generic of Cetrotide subcutaneous injection as a Preferred Product.

Policy Summary

PayerCigna

PolicyPREFERRED SPECIALTY MANAGEMENT POLICY - Infertility - Gonadotropin-Releasing Hormone Antagonists Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAnnual revision (added generic Cetrotide); administrative clarifications

Effective DateN/A

Next Review DateSep 17, 2025

SourceLink

On This Page

Benefit exclusion overrides ARE utilized

ALL of the following

2A: The patient meets the standard Infertility - Gonadotropin-Releasing Hormone Antagonists Benefit Exclusion Overrides Policy criteria
2B: The patient has tried one of cetrorelix acetate subcutaneous injection (Cetrotide, generics) or Fyremadel

Scenario 3 (benefit does NOT include infertility coverage; exclusion overrides utilized but Preferred Product not tried)

Patient has met exception criterion 2A (meets standard Benefit Exclusion Overrides Policy criteria)
Patient has NOT tried a Preferred Product
Approve cetrorelix acetate subcutaneous injection (Cetrotide, generics) or Fyremadel for 1 year

Scenario 4 (benefit does NOT include infertility coverage; exclusion overrides NOT utilized)

Patient's benefit does NOT include infertility coverage
Benefit exclusion overrides are NOT utilized
Coverage is not reviewable