CurrentCignaPolicy N/A

Infertility - Follitropins, Clomiphene Preferred Specialty Management Policy

Defines Cigna's preferred specialty management program for follitropin products (Gonal-f family, Follistim AQ) and clomiphene (Clomid/generic), including step therapy (preferred vs non-preferred products), exception criteria for non-preferred products, and approval durations for infertility benefits.

Policy Summary

PayerCigna

PolicyInfertility - Follitropins, Clomiphene Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeAdded Step 1 Clomid; added planned oocyte/embryo preservation exception

Effective Date

Next Review Date

Key ActionDocument prior trials (e.g., clomiphene, letrozole, preferred follitropins) or alternate indication (planned oocyte/embryo preservation or spermatogenesis) when requesting exceptions and ensure the patient's benefit includes infertility coverage.

POLICY UPDATE CHANGES

Added an exception for planned oocyte preservation to Gonal-f family exception criteria.

Added 'Clomid tablets' to the policy as a Step 1 agent.

3Preferred Products (steps 1-2)

1Non-Preferred Products (step 3)

1Annual review noted

Coverage Summary

This policy defines Cigna's preferred specialty management program for follitropin products (the Gonal-f family and Follistim AQ) and clomiphene (Clomid/generic). It describes step therapy ordering (Preferred Products in Steps 1 and 2, Non-Preferred in Step 3), how utilization is governed by whether a patient’s benefit includes infertility coverage, and the exception and approval processes for non-preferred products and treatment cycles.

Drug Products Listed in Policy

Drug Products Listed in Policymixed

Clomid	clomiphene tablets (Cosette) - Step 1 Preferred
clomiphene citrate (generic)	generic clomiphene tablets - Step 1 Preferred
Gonal-f	follitropin alfa multi-dose vial - Step 2 Preferred
Gonal-f RFF	follitropin alfa RFF vial - Step 2 Preferred
Gonal-f RFF Redi-ject	follitropin alfa RFF Redi-ject pen - Step 2 Preferred
Follistim AQ	follitropin beta cartridge - Non-Preferred (Step 3)

Provider Actions & Prior Authorization

Prior Authorization

Benefit must include infertility coverage

Coverage/utilization of follitropin products and clomiphene is governed by whether the patient's benefit includes infertility coverage; if infertility coverage is not included, products are not managed by this policy.

Documentation Required

Document prior therapies and indication

For exception approvals, providers must document prior trial of specified agents (e.g., Clomid or generic clomiphene, letrozole, preferred follitropins, or prior injectable infertility cycles), or document alternate causes of infertility, planned oocyte or embryo preservation, or that the medication is being used for induction of spermatogenesis.

Document prior trial of Clomid or generic clomiphene
Document prior trial of letrozole when used for ovulatory dysfunction
Document prior injectable infertility treatment or prior cycles
Document alternate infertility cause (not ovulatory dysfunction)
Document planned oocyte or embryo preservation
Document use for induction of spermatogenesis

Billing Rule

Approval duration when cycle already started

If the patient has already started a treatment cycle with a follitropin product (preferred or non-preferred), approve for the duration needed to complete the current cycle.

Prior Authorization

Exception approvals duration

When exception criteria are met for non-preferred products, standard approvals are generally authorized for 1 year (specific criteria and indications vary by product).

Background & Evidence

The Gonal-f products and Follistim AQ are recombinant follicle-stimulating hormones indicated for the induction of ovulation and pregnancy in anovulatory infertile patients and for the development of multiple follicles for assisted reproductive technology (ART); Follistim AQ is additionally indicated for controlled ovarian stimulation in normal ovulatory women in IVF/ICSI cycles. Gonal-f (but not Gonal-f RFF) and Follistim AQ are also indicated for the induction of spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism when infertility is not due to primary testicular failure. Clomiphene citrate tablets (Clomid and generics) are indicated for the treatment of ovulatory dysfunction in women desiring pregnancy, with many guideline bodies recommending oral agents as first-line therapy for ovulatory infertility. Guideline context notes the ASRM advises gonadotropins carry more risk than oral ovulation induction and should be used by experienced clinicians, and the 2023 international PCOS guideline recommends letrozole as first-line for PCOS-related anovulatory infertility, with clomiphene and metformin as alternatives and gonadotropins as second-line or alternatives when oral agents fail.

Source	Key point
ASRM committee opinion	Gonadotropin therapy has more risks than oral ovulation induction; should be used by experienced clinicians; most women respond to oral medications
2023 International PCOS guideline	Recommends letrozole as first-line for PCOS anovulatory infertility; clomiphene and metformin are alternatives; gonadotropins are second-line or an alternative

Preferred Products: Products the program encourages use of first (Steps 1 and 2) — Step 1 includes Clomid and clomiphene citrate (generic); Step 2 includes Gonal-f, Gonal-f RFF, and Gonal-f RFF Redi-ject. Non-Preferred Product Exception Criteria: Clinical or treatment-based criteria required for coverage of non-preferred (Step 3) products — requests for Step 3 (Follistim AQ) require meeting documented exception criteria (e.g., prior trial of preferred follitropins, prior injectable cycles, alternate infertility causes, planned oocyte/embryo preservation, or use for induction of spermatogenesis) for approval.

Revision History

02/15/2023material_addition

Added an exception for planned oocyte preservation to the Gonal-f family exception criteria (allows approval when product is being used for planned oocyte preservation).

09/11/2024material_additionLatest

Exception wording expanded to include 'or embryo' (added 'or embryo' to the planned oocyte preservation exception for Gonal-f products).

02/21/2024material_addition

Added 'Clomid tablets' (clomiphene) to the policy as a Step 1 preferred agent.