CurrentUnitedHealthcarePolicy 2025 P 3125-7

Step therapy program for Cetrotide (cetrorelix acetate)

Defines a step therapy program requiring trial of ganirelix acetate (Organon Global, Inc. formulations) before coverage of Cetrotide (cetrorelix acetate) for members undergoing ovarian stimulation; includes authorization duration, exceptions, and program notes. Effective for UnitedHealthcare clinical pharmacy programs.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy program for Cetrotide (cetrorelix acetate)

Policy CodePolicy 2025 P 3125-7

Change TypeAnnual review (administrative updates)

Effective DateNov 1, 2025

Next Review Date

Key ActionPrior authorization required: members must have history of failure, contraindication, or intolerance to ganirelix acetate (Organon Global Inc. formulations) before Cetrotide will be approved; authorization will be issued for 2 months.

POLICY UPDATE CHANGES

8/2019: New step therapy program established.

8/2022 annual review: Added Organon Global ganirelix acetate generic as a preferred product; updated exclusion statements and references.

8/2023 annual review: Updated references.

8/2024 annual review: Updated background and references.

Annual review 8/2025: Removed reference to Merck & Co., Inc. formulation and updated references.

1Primary Step Requirement

2 monthsAuthorization Duration

2019-2025P&T Review Years

Summary of Changes & Impact

Background: Step therapy encourages use of lower cost alternatives and this program requires trial of ganirelix acetate (Organon Global, Inc. formulations) before coverage of Cetrotide (cetrorelix acetate). Cetrotide and ganirelix acetate are GnRH antagonists indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing ovarian stimulation. Program updates through 8/2025 are administrative/content changes to references and manufacturer references (including removal of a Merck formulation reference) and clarification of the program preference; there is no change to coverage criteria. Scope: defines a step therapy program requiring trial of ganirelix acetate before Cetrotide for members undergoing ovarian stimulation, includes authorization duration, exceptions, and program notes.

Key Policy Statistics

Primary Step Requirement1

Authorization Duration2 months

P&T Review Years2019-2025

Effective Date2025-11-01

Last Review2025-08-01

Coverage Criteria

Step Therapy Coverage Criteria for Cetrotide (cetrorelix acetate)

Cetrotide will be approved when ALL of the following are met:

ALL of the following

History of failure, contraindication, or intolerance to ganirelix acetate (Organon Global Inc. formulations)

Referenced Codes & Diagnosis

Referenced diagnosis codingICD-10

No codes listed

Actions Required by Providers

Step Therapy

Step therapy requirement

Prior authorization required: members must have history of failure, contraindication, or intolerance to ganirelix acetate (Organon Global Inc. formulations) before Cetrotide will be approved; authorization will be issued for 2 months.

Authorization duration: 2 months
Required prior trial: Organon ganirelix acetate formulations

Documentation Required

Support for exception

Provider must document history of failure, contraindication, or intolerance to ganirelix acetate to meet coverage criteria; UnitedHealthcare may also approve based on previous claim/medication history, diagnosis codes, and/or claim logic.

Prior medication/claim history may be accepted as evidence

Background, Definitions & Evidence

Purpose: Step therapy programs are utilized to encourage use of lower cost alternatives for certain therapeutic classes. Cetrotide (cetrorelix acetate) and ganirelix acetate are synthetic decapeptides with gonadotropin-releasing hormone (GnRH) antagonist activity indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing ovarian stimulation. Note: Infertility is typically excluded from coverage; refer to plan specifics to determine exclusion status.

Step therapy: A utilization management program requiring trial of a preferred/less costly medication before coverage of an alternative.

Reference	Source
Package insert - Cetrotide	EMD Serono, Inc.; June 2024
Package insert - Ganirelix	Organon Global Inc.; February 2024

Policy Update Changes

8/2019added

New step therapy program established requiring trial of ganirelix acetate before coverage of Cetrotide. (Material change)

8/2022revised

Program preference clarified: added Organon Global ganirelix acetate as a preferred product; updated exclusion statements and references. (Non-material)

8/2023revised

Annual review: updated references. (Non-material)

Effective Dates & Administrative Notes

Policy Dates & Metadata

Effective Date2025-11-01

Last Review2025-08-01

Next Review

Policy Number2025 P 3125-7

StatusCURRENT

Scope summaryDefines a step therapy program requiring trial of ganirelix acetate (Organon Global, Inc. formulations) before coverage of Cetrotide (cetrorelix acetate) for members undergoing ovarian stimulation; includes authorization duration, exceptions, and program notes. Effective for UnitedHealthcare clinical pharmacy programs.