CurrentMass General Brigham Health PlanPolicy N/A

Follistim AQ (follitropin beta)

Pharmacy benefit prior authorization policy for Follistim AQ (follitropin beta), Gonal-F (follitropin alfa), and Gonal-F RFF for ovulation induction/follicle stimulation as part of ART and treatment of hypogonadotropic hypogonadism. Applies to commercial/exchange members; product designated specialty and must be filled at contracted specialty pharmacy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFollistim AQ (follitropin beta)

Policy CodePolicy N/A

Change TypeReview update

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization is required for Follistim AQ, Gonal-F, and Gonal-F RFF under the pharmacy benefit for commercial/exchange members; authorization may be granted only if clinical criteria documented.

SourceLink

POLICY UPDATE CHANGES

Removed Bravelle as product is no longer available and added Gonal-F RFF as a preferred agent along with Gonal-F.

12 monthsAuthorization duration

Commercial/ExchangePlan applicability

SpecialtyDispensing requirement

Coverage Summary

This policy is a pharmacy benefit prior authorization for Follistim AQ (follitropin beta), Gonal-F (follitropin alfa), and Gonal-F RFF (follitropin alfa) for ovulation induction/follicle stimulation as part of assisted reproductive technology (ART) programs and for treatment of hypogonadotropic hypogonadism. It applies to Commercial/Exchange members. These products are designated specialty and must be filled at a contracted specialty pharmacy.

Initial Therapy Criteria — Ovulation Induction / ART

Ovulation induction or follicle stimulation (ART)

Authorization may be granted when ANY of the following criteria is met, and documentation is provided:

ANY of the following

Member has completed three or more previous cycles of clomiphene.
Member has a risk factor for poor ovarian response to clomiphene.
Member has contraindication or exclusion to clomiphene.
Member is 37 years of age or older.

Initial Therapy Criteria — Hypogonadotropic Hypogonadism

Hypogonadotropic hypogonadism

Authorization may be granted when ALL the following criteria are met, and documentation is provided:

ALL of the following

Member has low pretreatment testosterone levels.
Member has low or low-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) levels.

Follistim AQ — Additional Coverage Criteria

Follistim AQ (follitropin beta) - additional criteria

Authorization for Follistim AQ may be granted when ANY of the following criteria is met in addition to the criteria above, and documentation is provided:

ANY of the following

Member has a contraindication to Gonal-F or Gonal-F RFF or any of its drug components.
Member is intolerant to or had a confirmed adverse event with Gonal-F or Gonal-F RFF.

Note: Coverage of Follistim AQ requires the additional restriction that the member has a contraindication or intolerance/adverse event to Gonal-F or Gonal-F RFF (or any of their components), in addition to meeting the applicable initial authorization criteria.

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required for Follistim AQ, Gonal-F, and Gonal-F RFF under the pharmacy benefit for commercial/exchange members; authorization may be granted only if the applicable clinical criteria are documented.

Documentation Required

Documentation of clinical criteria

Provider must supply documentation supporting the selected criterion.

Prior clomiphene cycles (e.g., three or more previous cycles).
Risk factors for poor ovarian response to clomiphene.
Contraindication to or intolerance/adverse event with clomiphene or, for Follistim AQ, contraindication/intolerance to Gonal-F or Gonal-F RFF.
Member age (e.g., 37 years or older).
Pretreatment laboratory values (testosterone and FSH/LH levels).

Billing Rule

Specialty pharmacy dispensing

This medication is designated specialty and must be dispensed through a contracted specialty pharmacy.

Must be filled at a contracted specialty pharmacy (contact information provided in the policy).

Benefit / Program applicability: Prior authorization under the Pharmacy Benefit for Commercial/Exchange members. (No specific billing or product codes provided.)

Background & Definitions

Background: This policy governs prior authorization for injectable follicle-stimulating hormones used for ovulation induction/follicle stimulation within ART and for hypogonadotropic hypogonadism. In addition, Follistim AQ has a specific additional restriction: authorization for Follistim AQ is allowed only when the member has an intolerance to or contraindication to Gonal-F products (Gonal-F or Gonal-F RFF) or their components.

Definitions: ART — Assisted reproductive technology.

Revision History

2023-11-15reviewed

Policy reviewed and updated at Nov P&T meeting; removed Bravelle as product is no longer available and added Gonal-F RFF as a preferred agent along with Gonal-F.

2024-01-01revisedLatest

Effective date for removal of Bravelle and addition of Gonal-F RFF as a preferred agent along with Gonal-F.