CurrentCignaPolicy N/A

Chorionic Gonadotropins Preferred Specialty Management Policy

This policy governs coverage and utilization management for chorionic gonadotropin products (urine-derived and recombinant) for Cigna-administered health benefit plans, including preferred vs non-preferred product handling and exception criteria for infertility and other indications.

Policy Summary

PayerCigna

PolicyChorionic Gonadotropins Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeMaterial revision (preferred status and trial agent updates)

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionSubmit documentation of prior trial of a formulary-preferred product (e.g., evidence patient tried Pregnyl, Novarel, or Ovidrel) when requesting non-preferred chorionic gonadotropin products.

SourceLink

POLICY UPDATE CHANGES

Created criteria for National Preferred Formulary, High Performance Formulary, and Basic Formulary and updated product preferred/non-preferred status across formularies.

For National Preferred and High Performance Formularies, updated trial requirement to try Pregnyl prior to approval of non-preferred chorionic gonadotropin products.

4Products listed

1 yearApproval duration

3Formulary groups

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Coverage Criteria for Non-Preferred Chorionic Gonadotropins

Non-preferred chorionic gonadotropins are covered as medically necessary only when the following exception criteria are met. Any request that does not meet these criteria is considered not medically necessary.

ANY of the following

National Preferred and High Performance Formulary
- Cryptorchidism or hypogonadism: patient has tried Pregnyl.
  Approve for 1 year.
- Infertility or induction of ovulation AND the patient's benefit includes infertility coverage: patient has tried ONE of the following: Pregnyl or Ovidrel.
  Approve for 1 year. Note: a one-time approval may be given if the patient is at risk of missing the optimal administration timeframe to avoid disruption of the current fertility medication cycle.
- Benefit exclusion override applicable
  - Patient's benefit does NOT include infertility coverage AND benefit exclusion overrides are utilized: patient meets the standard Chorionic Gonadotropins Benefit Exclusion Overrides Policy criteria.
  - Patient has tried Pregnyl.
- Patient's benefit does NOT include infertility coverage AND benefit exclusion overrides are NOT utilized: Not reviewable (coverage denied).

ANY of the following

Basic Formulary
- Cryptorchidism or hypogonadism: patient has tried Novarel.
  Approve for 1 year.
- Infertility or induction of ovulation AND the patient's benefit includes infertility coverage: patient has tried ONE of the following: Novarel or Ovidrel.
  Approve for 1 year. Note: a one-time approval may be given if the patient is at risk of missing the optimal administration timeframe to avoid disruption of the current fertility medication cycle.
- Benefit exclusion override applicable
  - Patient's benefit does NOT include infertility coverage AND benefit exclusion overrides are utilized: patient meets the standard Chorionic Gonadotropins Benefit Exclusion Overrides Policy criteria.
  - Patient has tried Novarel.

Utilization of these products is managed based on whether a patient's benefit includes infertility coverage. If the patient's benefit includes infertility coverage, the program directs the patient to try a Preferred Product prior to approval of a Non-Preferred Product and reviews requests against the exception criteria above. If the patient's benefit does not include infertility coverage, benefit exclusion overrides may apply and the patient must meet the standard Chorionic Gonadotropins Benefit Exclusion Overrides Policy criteria and try a Preferred Product prior to approval of a Non-Preferred Product. If the patient's benefit does not include infertility coverage and benefit exclusion overrides are not utilized, coverage will be denied.

Requests for non-preferred chorionic gonadotropins that do not meet the specified exception criteria are considered not medically necessary and will be denied.

Dosing, Formulations, and Relevant Codes

Product dosing/description (not billing codes)NDC | mixed

250 mcg/0.5 mL

Ovidrel prefilled single-dose syringe concentration (recombinant hCG)

Example dosing thresholds and common regimens (hCG)

Common single-dose examples10,000 USP units (urine-derived products) or 250 mcg Ovidrel (recombinant) given 1 day after the last dose of FSH/menotropins

Lower single-dose option5,000 USP units (Novarel vial) as used for some ovulation induction regimens

TIW multi-week regimen4,000 USP units three times weekly (TIW) for 3 weeks or 6–9 months depending on indication

Alternate TIW dosing for hypogonadism500–1,000 USP units TIW for 3 weeks, then same dose twice weekly for 3 weeks

Serial small-dose course15 injections of 500–1,000 USP units over a 6-week period for selected protocols

Provider Requirements, Prior Trial, and Denial Conditions

Prior Authorization

Non-preferred product exception requirement

Requests for non-preferred chorionic gonadotropin products will only be approved when the applicable exception criteria are met; when criteria are satisfied approvals are provided for the duration noted (typically 1 year).

Step Therapy

Preferred-product trial required

A formulary-preferred product must be tried before a non-preferred chorionic gonadotropin will be approved; the specific required agent depends on the member's formulary (e.g., Pregnyl or Ovidrel for National/High Performance; Novarel or Ovidrel for Basic).

Documentation Required

Documentation of prior trial and diagnosis

hCG Formulations and Definitions

hCG formulations: urine-derived vs recombinant

Urine-derived formulations (examples)Pregnyl, Novarel, and chorionic gonadotropin for injection — highly purified, obtained from urine of pregnant females

Urine-derived route and dosing formsAdministered intramuscularly (IM); available in vials including 5,000 USP and 10,000 USP unit strengths

Recombinant formulation (example)Ovidrel (choriogonadotropin alfa) — recombinant hCG supplied as a prefilled single-dose syringe (250 mcg/0.5 mL)

Recombinant routeFor subcutaneous (SC) use only — pharmacologic activity comparable to urine-derived hCG

Clinical note on differencesUrine-derived products are IM preparations; recombinant Ovidrel is SC and available as a prefilled syringe for single-dose administration

Background and Clinical Context

Human chorionic gonadotropin (hCG) is used clinically to induce ovulation and promote final follicular maturation in assisted reproductive technologies, and can be used to support luteal function in early pregnancy. hCG is also indicated for certain male conditions such as prepubertal cryptorchidism and hypogonadotropic hypogonadism.

hCG products are available as urine-derived intramuscular preparations (for example, Pregnyl and Novarel) and as a recombinant subcutaneous formulation (Ovidrel, 250 mcg/0.5 mL). Dosing regimens vary by indication and product, including single-dose administration for final follicular maturation or multi-dose regimens for other gonadotropin protocols.

This policy’s utilization approach centers on whether the member’s benefit includes infertility coverage. When infertility coverage exists, the program encourages use of preferred products and generally requires a trial of a preferred product before approving a non-preferred product; if the benefit does not include infertility coverage, exclusions and override pathways apply as described in the policy statement.