CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cetrotide Fyremadel Ganirelix 1912 A 1913 A Sgm P2022

Covers Cetrotide (cetrorelix acetate), Fyremadel (ganirelix acetate) and ganirelix when used to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation, ovulation induction, or assisted reproductive technology (ART), subject to approval criteria and exclusions. All other indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCetrotide Fyremadel Ganirelix 1912 A 1913 A Sgm P2022

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization may be granted for up to 12 months for inhibition of premature LH surges; obtain a medical authorization number and confirmation of approved procedure(s) when medical benefit alignment applies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy remains current with prior criteria and coverage positions.

1Covered Indication (LH surge inhibition)

All othersNot covered (experimental)

Coverage Summary

Covers Cetrotide (cetrorelix acetate), Fyremadel (ganirelix acetate) and ganirelix when used to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation, ovulation induction, or assisted reproductive technology (ART). All other indications are considered experimental/investigational and not medically necessary. Authorization may be granted for up to 12 months for inhibition of premature LH surges. When the drug is requested for a procedure approved under a member's medical benefit plan, Specialty Guideline Management coverage review will be bypassed and a medical authorization number and confirmation of the approved procedure(s) are required.

Initial Therapy Criteria

Medically Necessary / Initial Authorization

Covered when ALL of the following are met:

Medically Necessary / Initial Authorization - all criteria

Patient population: Patient is a woman undergoing controlled ovarian stimulation, ovulation induction, or assisted reproductive technology (ART)
Requested drug: Drug requested is Cetrotide, Fyremadel, or ganirelix for the inhibition of premature luteinizing hormone (LH) surges
Exclusions: Member has no exclusions to the prescribed therapy

Unproven / Exclusions

Exclusions / Not Medically Necessary

Not covered when ANY of the following apply:

Exclusions / Not Medically Necessary - any criteria: Use for indications other than inhibition of premature LH surges (including indications not FDA-approved or compendial) — considered experimental/investigational and not medically necessary

Medical Benefit Alignment / Bypass Conditions

Medical Benefit Alignment Exception

Bypass condition:

Medical Benefit Alignment Exception - bypass: If the drug is requested for a procedure that has been approved under a member's medical benefit plan, Specialty Guideline Management coverage review will be bypassed; member exempt from Sections III and IV but a medical authorization number and confirmation of the approved procedure(s) are required

Note: Some plans may opt-out of medical benefit alignment; those members must meet Sections III and IV requirements

Prior Authorization

Authorization required

Authorization may be granted for up to 12 months for inhibition of premature LH surges; when medical benefit alignment applies, Specialty Guideline Management coverage review will be bypassed and a medical authorization number and confirmation of the approved procedure(s) are required.

Up to 12 months authorization
Medical authorization number required when bypass applies

Documentation Required

Documentation of indication

Providers must document that the patient is undergoing controlled ovarian stimulation, ovulation induction, or assisted reproductive technology (ART) and that the member has no exclusions to the prescribed therapy.

Denial Risk

Denial for non-covered indications

Requests for use outside of the FDA-approved indication for inhibition of premature LH surges (including non‑FDA or non‑compendial uses) will be considered experimental/investigational and are not medically necessary — risk of denial.

Background

GnRH antagonists Cetrotide, Fyremadel, and ganirelix are indicated to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation. Authorization of up to 12 months may be granted for members undergoing ovulation induction or assisted reproductive technology (ART). If the drug is requested for a procedure approved under a member's medical benefit plan, Specialty Guideline Management coverage review will be bypassed; a medical authorization number and confirmation of the approved procedure(s) are required.