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    GnRH agonists for pubertal suppression

    Drugs - GnRH agonists for pubertal suppression

    September 2020

    Therapeutic area - Central Precocious Puberty, Gender dysphoria

    Central Precocious Puberty

    Drugs:

    Leuprolide acetate (Fensolvi, Lupron Depot-Ped)

    Histrelin acetate implant (Supprelin LA implant) [Endo Pharmaceuticals Inc.]

    Triptorelin(Triptodur) [Arbor Pharmaceuticals LLC.]

    Approval criteria

    • Patient has a clinical diagnosis of central precocious puberty (CPP) identified as:
      • Onset of secondary sexual characteristics earlier than 8 years in females and 9 years in males AND
      • Patient has advanced bone age (bone age at least 1 year greater than chronological age) AND
    • Patient’s clinical diagnosis should be confirmed by ONE of the following GnRH (gonadotropin-releasing hormone) stimulation test results:
      • Peak LH > 5 IU/L after GnRHa (gonadotropin-releasing hormone agonist) OR
      • Ratio of LH (peak): LH(basal) > 3 AND
    • Prescriber attests that CNS (central nervous system) abnormality has been ruled out

    Renewal criteria

    Continued coverage may be approved annually until female patient reaches 12 years of age and male patient reaches 13 years of age.

    Gender Dysphoria

    Drugs:

    Leuprolide acetate (Fensolvi, Lupron Depot, Lupron Depot-Ped)

    Histrelin acetate implant (Supprelin LA implant) [Endo Pharmaceuticals Inc.]

    Triptorelin (Triptodur) [Arbor Pharmaceuticals LLC.]

    Approval criteria

    • Patient has a clinical diagnosis of gender dysphoria as confirmed by a mental health provider AND
    • Patient has reached Tanner Stage 2 AND
    • Provider must provide documentation (chart notes, consultation notes, etc.) to substantiate all of the following:
      • Any coexisting psychological, medical, or social problems that could interfere with treatment have been addressed and are reasonably well-controlled AND
      • If the patient is 18 years of age or older, the patient has sufficient mental capacity to estimate the consequences of treatment, weigh benefits and risks AND
      • The patient has been informed of effects and side effects of treatment (including potential loss of fertility and options to preserve fertility) AND
      • The patient has given informed consent and, if under 18 years of age, parent(s) or guardian(s) have consented to treatment AND
      • If under 18 years of age, a pediatric endocrinologist or other clinician experienced in pubertal suppression agrees with the indication for GnRH analog treatment and that there are no medical contraindications AND
    • The patient is NOT concurrently on any of the following GnRH analogs:
      • Leuprolide acetate (e.g., Eligard, Lupron Depot, Lupron Depot-Ped)
      • Trelstar
      • Vantas
      • Zoladex

    Renewal criteria

    Continued coverage may be approved annually:

    • For transgender females: until gonadectomy
    • For transgender males: until 50 years old or as determined by provider

    Billing for GnRH agonists

    GnRH agonists, prescribed for any indication, must be billed as a medical claim.

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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