Background

Supprelin LA is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of children with central precocious puberty (CPP).

Triptour is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Fensolvi is a gonadotropin releasing hormone (GnRH) agnoist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

Lupron Depot is a gonadotropin releasing hormone (GnRH) agonist indicated for treatment of advanced prostatic cancer.

Lupon Depo-Ped is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.

Policy

Eligard

Fensolvi

Lupron Depot

Lupron Depot-PED

Generic leuprolide acetate

Supprelin LA, Trelstar

Triptodur

Coverage of Gonadotropin-Releasing Hormone Agonist is provided when the criteria below are met and there has been a trial and failure of preferred therapy, (if applicable). 

Treatment with Gonadotropin-Releasing Hormone Agonist is considered MEDICALLY NECESSARY when the following criteria are met:

Endometriosis (Lupron depot only)

1. Diagnosis of endometriosis
2. One of the following:
   1. History of inadequate pain control response following a trial of at least 6 months, or history of intolerance or contraindication to one of the following:
      • Danazol
      • Combination (estrogen/progestin) oral contraceptive
      • Progestins
   2. Patient has had surgical ablation to prevent recurrence

Continuation of Gonadotropin-Releasing Hormone Agonist is considered MEDICALLY NECESSARY when the following criteria are met for endometriosis:

1. Recurrence of symptoms following a trial of at least 6 months with leuprolide acetate
2. Used in combination with one of the following:
   • Norethindrone 5 mg daily
   • Other “add-back” sex-hormones (e.g., estrogen, medroxyprogesterone)
   • Other bone-sparing agents (e.g., bisphosphonates)

Uterine Leiomyomata (Fibroids) — For the reduction of the size of fibroids [off-label] (Lupron depot only)

• For use prior to surgery to reduce the size of fibroids to facilitate a surgical procedure (e.g., myomectomy, hysterectomy)

Uterine Leiomyomata (Fibroids) — Anemia (Lupron depot only)

1. For the treatment of anemia
2. Anemia is caused by uterine leiomyomata (fibroids)
3. Patient has tried and had an inadequate response to at least 1 month of monotherapy with iron
4. Used in combination with iron therapy
5. For use prior to surgery

Central Precocious Puberty (CPP) Fensolvi, Lupron Depot-Ped, Supprelin LA, Triptodur only.

1. Diagnosis of central precocious puberty (idiopathic or neurogenic)
2. Early onset of secondary sexual characteristics in one of the following:

• Females less than 8 years of age
• Males less than 9 years of age

3. Advanced bone age of at least one year compared with chronological age
4. One of the following:
   • Both of the following:
     1. Patient has undergone gonadotropin-releasing hormone agonist (GnRHa) testing
     2. Peak luteinizing hormone (LH) level above pre-pubertal range
   • Patient has a random LH level in the pubertal range
5. One of the following:
   • Patient had one of the following diagnostic evaluations to rule out tumors, when suspected:
     1. Diagnostic imaging of the brain (MRI or CT scan) (in patients with symptoms suggestive of a brain tumor or in those 6 years of age or younger)
     2. Pelvic/testicular/adrenal ultrasound (if steroid levels suggest suspicion)
     3. Adrenal steroids to rule out congenital adrenal hyperplasia (when pubarche precedes thelarche or gonadarche
   • Patient has no suspected tumors
   • Prescribed by or in consultation with an endocrinologist

Continuation of Gonadotropin-Releasing Hormone Agonist is considered MEDICALLY NECESSARY when the following criteria are met for Central Precocious Puberty (CPP):

1. Patient demonstrates positive clinical response to therapy (e.g., lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, a decrease in the ratio of bone age to chronological age, improvement in final height prediction, LH levels have been suppressed to pre-pubertal levels)
2. Patient is currently younger than the appropriate time point for the onset of puberty (e.g., females younger than 11 years of age, males younger than 12 years of age)
3. Prescribed by or in consultation with an endocrinologist

Treatment of Infertility (off-label) *Please refer to contact resources to confirm whether benefit exclusions should be reviewed for medical necessity. (Generic leuprolide acetate)

1. Diagnosis of infertility
2. Used as part of an assisted reproductive technology (ART) protocol

Gender Dysphoria/Gender Incongruence (off-label) *Please refer to contact resources to confirm whether benefit exclusions should be reviewed for medical necessity. (Eligard, Fensolvi, Lupron Depot, Lupron Depot-PED, Generic leuprolide acetate, Supprelin LA, Trelstar, Triptodur)

1. Using gonadotropin for suppression of puberty
2. Diagnosis of gender dysphoria/gender incongruence

Cancer Indications

The drug is being used as indicated by the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B.

References

1. 1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pacriteria/gnrh-agonists-for-pubertal-suppression.jsp  Lupron Depot package insert, AbbVie Inc., North Chicago, IL 60064
2. 2.Lupron Depot-Ped package insert, Abbott Laboratories, North Chicago, IL 60064
3. 3.Triptodur package insert, Arbor Pharmaceuticals, LLC, Atlanta, GA 30328
4. 4.Fensolvi package insert, Tolmar, Inc., Fort Collins, CO 80526
5. 5.Supprelin LA package insert, Endo Pharmaceuticals Solutions Inc., Chadds Ford, PA 19317

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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