Illinois Insurance Coverage for Hormonal Therapy Medication

This coverage policy complies with Illinois Insurance Code Section 356z.60 regarding coverage for hormonal therapy medication used to treat gender dysphoria. Hormone therapy is used to induce physical changes in alignment with a person's gender identity as part of medically necessary gender- affirming care. Coverage will be provided for hormonal therapy medications approved by the FDA for gender dysphoria, including off-label use as required by Illinois Insurance Code Section 356z.60.

Table 1: Common Hormonal Medications Used for Gender Affirming Therapy

• Testosterone
• Testosterone cypionate - Depo-Testosterone - Injectable
• Testosterone enanthate - Delatestryl - Injectable
• Testosterone undecanoate - Aveed - Injectable
• Testosterone gel - Androgel, Fortesta, Testim - Transdermal
• Testosterone patch - Androderm - Transdermal
• Estrogens
• Estradiol - Estrace, Estraderm, Elestrin - Oral, Patch, Gel
• Ethinyl estradiol - Estinyl - Oral
• Conjugated estrogens - Premarin - Oral
• Anti-androgens
• Spironolactone - Aldactone - Oral
• Cyproterone acetate - Androcur - Oral
• Gonadotropin releasing hormone (GnRH) agonists - Lupron, Zoladex - Injectable, Implant
• 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) - Propecia, Proscar - Oral

Definitions

• FDA refers to the U.S. Food & Drug Administration, a federal agency responsible for the safety and efficacy of drugs, medical devices, and more.
• Formulary means a list of medications available to members with or without Prior Authorization.
• Hormonal therapy medication means medications administered to alter physical characteristics as part of gender-affirming medical treatment. This includes medications to feminize or masculinize features and suppress endogenous sex hormone secretion.
• Off-label use refers to the use of a drug or medical device for a purpose or in a manner that is not included in the approved product labeling. This includes:
  1. Using an approved drug or device for a different indication, age group, dosage, or route of administration than what is specified in the FDA-approved labeling
  2. Prescribing a medication at a different dose than the dose specified in the approved labeling
  3. Prescribing a medication for longer than the approved duration
• Therapeutic Equivalent Version refers to different products that are expected to have the same clinical effect and safety profile when given in equivalent doses.

Coverage Criteria

The requested hormonal therapy medication will be covered at $0 member cost share when the following criteria are met:

1. The medication is U.S. FDA-approved or prescribed off-label for gender dysphoria; AND
2. The requested medication is EITHER:
   • on the Plan's Formulary; or
   • the attending provider deems it medically necessary; AND
3. The attending provider provides documentation supporting the medical necessity of the requested medication.

If the above criteria are met, the requested product will be authorized at $0 cost share for up to 12 months or the duration deemed medically necessary by the attending provider, whichever is greater.

References

1. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine treatment of gender- dysphoric/gender incongruent persons: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2017;102:3869-903.
2. "Illinois General Assembly - Illinois Compiled Statutes." www.ilga.gov, www.ilga.gov/legislation/ilcs/fulltext.asp?DocName=021500050K356z.60. Accessed 14 Nov. 2023.
3. Coleman, E., Radix, A. E., Bouman, W.P., Brown, G.R., de Vries, A. L. C., Deutsch, M. B., Ettner, R., Fraser, L., Goodman, M., Green, J., Hancock, A. B., Johnson, T. W., Karasic, D. H., Knudson, G. A., Leibowitz, S. F., Meyer-Bahlburg, H. F.L., Monstrey, S. J., Motmans, J., Nahata, L., ... Arcelus, J. (2022). Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. International Journal of Transgender Health, 23(S1), S1-S260. https://doi.org/10.1080/26895269.2022.2100644
4. Deutsch MB. Guidelines for the primary and gender-affirming care of transgender and gender nonbinary people. University of California, San Francisco. June 17, 2016. https://transcare.ucsf.edu/guidelines.
5. Klein DA, Paradise SL, Goodwin ET. Caring for transgender and gender-diverse persons: what clinicians should know. Am Fam Physician 2018;98:645-53.
6. Rainbow Health. Guidelines for gender-affirming primary care with trans and non-binary patients.2019. https://www.rainbowhealthontario.ca/wp-content/uploads/woocommerce_uploads/2019/12/Guidelines-FINAL-Dec-2019-iw2oti.pdf.