Policy: Gonadotropin Releasing Hormone Analogs
Policy Number: PHARMACY 042.35 T2
Last Update: 2021-10-01
Issued in: New York

Youth Services:

Gender Dysphoria in Adolescents:

GnRH analogs may be covered for the treatment of Gender Dysphoria when ALL of the following criteria are met:

For initial therapy, submission of medical records (e.g., chart notes, laboratory values) documenting all the following:

• Diagnosis of gender dysphoria, according to the current DSM (i.e., DSM-5) criteria, by a mental health professional with expertise in child and adolescent psychiatry; and
• Medication is prescribed by or in consultation with a pediatric endocrinologist or by a physician working in a multidisciplinary clinic for transgender youth; and
• Patient has experienced puberty development to at least Tanner stage 2 (stage 2 through 4); and
• One of the following laboratory tests, based upon the laboratory reference range, confirming:
  • Pubertal levels of estradiol in females; or
  • Pubertal levels of testosterone in males; or
  • Pubertal basal level of luteinizing hormone (based on laboratory reference ranges); or
  • A pubertal luteinizing hormone response to a GnRH stimulation test; and
  • A letter from the prescriber and/or formal documentation stating all of the following:
    • Patient has experienced pubertal changes that have resulted in an increase of their gender dysphoria that has significantly impaired psychological or social functioning; and
    • Coexisting psychiatric and medical comorbidities or social problems, that may interfere with the diagnostic
    • procedures or treatment, have been addressed or removed; and
    • Both of the following:
      • Current enrollment, attendance, and active participation in psychological and social support treatment program; and
      • Patient will continue enrollment, attendance and active participation in psychological and social support throughout the course of treatment; and
    • Patient demonstrates knowledge and understanding of the expected outcomes of treatment and related transgender therapies; and
    • Initial authorization will be for no longer than 12 months.

For continuation therapy, submission of medical records (e.g., chart notes, laboratory values) documenting all the following:

• Documentation of LH suppression using a GnRH stimulation test
• Documented diagnosis of gender dysphoria, according to the current DSM (i.e., DSM-5) criteria, by a mental health professional with expertise in child and adolescent psychiatry; and
• Medication is prescribed by or in consultation with a pediatric endocrinologist or by a physician working in a multidisciplinary clinic for transgender youth; and
• A letter from the prescriber and/or formal documentation stating all of the following:
  • Patient continues to meet their individual goals of therapy for gender dysphoria; and
  • Patient continues to have a strong affinity for the desired (opposite of natal) gender; and
  • Discontinuation of treatment and subsequent pubertal development would interfere with or impair psychological functioning and well-being; and
  • Coexisting psychiatric and medical comorbidities or social problems that may interfere with treatment continue to be addressed or removed; and
  • Both of the following:
    • Current enrollment, attendance, and active participation in psychological and social support treatment program; and
    • Patient will continue enrollment, attendance and active participation in psychological and social support throughout the course of treatment and
• Patient demonstrates knowledge and understanding of the expected outcomes of treatment and related transgender therapies; and
• Reauthorization will be for no longer than 12 months.

Note: Clinical evidence supporting the use of GnRH analogs for the treatment of gender dysphoria is limited and lacks long-term safety data. Statistically robust randomized controlled trials are needed to address the issue of whether the benefits outweigh the clinical risk in its use.