CurrentCignaPolicy N/A

Chorionic Gonadotropins Drug Quantity Management Policy - Per Rx

Defines drug quantity limits and coverage criteria for urine-derived chorionic gonadotropin products (Pregnyl, Novarel, and generic urine-derived hCG) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyChorionic Gonadotropins Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionRequest authorization for up to a 1-year approval; if requested quantity exceeds the Drug Quantity Management limits, provide clinical justification per product- and indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 / 9Pregnyl max per Rx

6 / 18Novarel max per Rx

30,000 U30-day qty equiv

1 yrApproval duration

Coverage Criteria

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Pregnyl or generic 10,000 unit vials

Prepubertal cryptorchidism: Patient has prepubertal cryptorchidism not due to an anatomical obstruction
Approve requested quantity up to 4 vials per dispensing at retail or up to 12 vials per dispensing at home delivery.
Hypogonadotropic hypogonadism: Patient has hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency)
Approve requested quantity up to 6 vials per dispensing at retail or up to 18 vials per dispensing at home delivery.
Induction of ovulation: Indication is induction of ovulation and pregnancy
No overrides recommended; standard quantity limits apply.

Novarel 5,000 unit vials

Prepubertal cryptorchidism: Patient has prepubertal cryptorchidism not due to an anatomical obstruction
Approve requested quantity up to 8 vials per dispensing at retail or up to 24 vials per dispensing at home delivery.
Hypogonadotropic hypogonadism: Patient has hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency)
Approve requested quantity up to 12 vials per dispensing at retail or up to 36 vials per dispensing at home delivery.
Induction of ovulation: Indication is induction of ovulation and pregnancy
No overrides recommended; standard quantity limits apply.

Initial Therapy Criteria

Label dosing examples

Dosing examples from product labeling by indication (IM administration):

Prepubertal cryptorchidism dosing options: Examples include: 4,000 USP units three times weekly for 3 weeks; 5,000 USP units every second day for four injections; 15 injections of 500–1,000 USP units over 6 weeks; 500 USP units three times weekly for 4–6 weeks (if unsuccessful, repeat a series one month later using 1,000 USP units per injection).

Used to justify quantity limits.

Hypogonadotropic hypogonadism dosing options: Examples include: 500–1,000 USP units three times weekly for 3 weeks then the same dose twice weekly for 3 weeks; or 4,000 USP units three times weekly for 6–9 months followed by 2,000 USP units three times weekly for an additional 3 months.

Used to justify quantity limits.

Ovulation induction (OI) dosing: Example: 5,000–10,000 USP units one day following the last menotropin dose (10,000 USP units recommended in labeling).

Used to justify quantity limits.

Quantity Limits by Product

Pregnyl (10,000 unit vial) — Quantity limits and clinical overrides

Retail maximum per Rx3 vials per Rx (10,000 unit vial)

Home delivery maximum per Rx9 vials per Rx (10,000 unit vial)

Clinical override — prepubertal cryptorchidismApprove up to 4 vials per dispensing at retail and up to 12 vials per dispensing at home delivery

Clinical override — hypogonadotropic hypogonadismApprove up to 6 vials per dispensing at retail and up to 18 vials per dispensing at home delivery

Chorionic gonadotropin injection [urine-derived] (10,000 unit vial) — Quantity limits and clinical overrides

Retail maximum per Rx3 vials per Rx (10,000 unit vial)

Home delivery maximum per Rx9 vials per Rx (10,000 unit vial)

Clinical override — prepubertal cryptorchidismApprove up to 4 vials per dispensing at retail and up to 12 vials per dispensing at home delivery

Clinical override — hypogonadotropic hypogonadismApprove up to 6 vials per dispensing at retail and up to 18 vials per dispensing at home delivery

Novarel (5,000 unit vial) — Quantity limits and clinical overrides

Retail maximum per Rx6 vials per Rx (5,000 unit vial)

Home delivery maximum per Rx18 vials per Rx (5,000 unit vial)

Clinical override — prepubertal cryptorchidismApprove up to 8 vials per dispensing at retail and up to 24 vials per dispensing at home delivery

Clinical override — hypogonadotropic hypogonadismApprove up to 12 vials per dispensing at retail and up to 36 vials per dispensing at home delivery

Provider Actions & Authorization

Documentation Required

Documentation & decision context

Coverage determinations require consideration of the applicable benefit plan terms, any relevant laws or regulations, and collateral source materials (including coverage policies). Each request must be reviewed on its own merits; medical directors may exercise clinical judgment and discretion when making individual determinations. In the event of a conflict, the member’s benefit plan document controls.

Prior Authorization

Quantity limits and authorization

Approvals are provided for 1 year in duration unless otherwise noted. If the Drug Quantity Management rule is not met for the requested medication at the point of sale, coverage will be determined by the clinical criteria in this policy.

All approvals default to a 1-year authorization period.

Step Therapy

Step therapy

No step therapy requirements are specified in this policy.

Denial Risk

Denial trigger

If the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the clinical criteria below; exceptions described in the policy may apply. Providers should ensure documentation supports the medical necessity criteria and be aware that failure to meet Drug Quantity Management limits may trigger a denial unless criteria or exceptions are satisfied.

If DQM rule not met at POS, adjudication follows clinical criteria in the policy.
Exceptions are described in the Criteria section for specific diagnoses (prepubertal cryptorchidism, hypogonadotropic hypogonadism).

Definitions

Chorionic gonadotropin (hCG) — Indications and definitions

Indications (covered)Prepubertal cryptorchidism not due to anatomical obstruction; selected male hypogonadotropic hypogonadism (secondary to pituitary deficiency); induction of ovulation and pregnancy in appropriately pretreated anovulatory infertile women

Formulation/administrationUrine-derived human chorionic gonadotropin (hCG); intramuscular administration per product labeling

Products addressed by policyPregnyl (10,000 unit vial), Novarel (5,000 unit vial), and generic urine-derived chorionic gonadotropin (10,000 unit vial)

Excluded related productOvidrel (choriogonadotropin alfa, recombinant) is noted but not targeted by this quantity management policy

Background

Urine-derived human chorionic gonadotropin (hCG) products — including Pregnyl, Novarel, and generic urine-derived hCG — are indicated for prepubertal cryptorchidism, select cases of hypogonadotropic hypogonadism, and for induction of ovulation in appropriately pretreated anovulatory infertile women. These products are for intramuscular (IM) administration only, and dosing regimens vary by indication. Although hCG is used in assisted reproductive technology settings, the urine-derived products in this policy are not indicated for ART programs in labeling. Ovidrel (recombinant choriogonadotropin alfa) is a related product but explicitly excluded from this quantity management policy.

Policy Summary

PayerCigna

PolicyChorionic Gonadotropins Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 9, 2024

SourceLink

On This Page

OpenPayer

Chorionic Gonadotropins Drug Quantity Management Policy - Per Rx

Coverage Criteria

Initial Therapy Criteria

Quantity Limits by Product

Provider Actions & Authorization

Site of Care

Definitions

Background