Subject: Eligard 1966-A SGM P2022a

Drug

ELIGARD  (leuprolide acetate)

Policy:

I.    INDICATIONS 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A.   FDA-Approved Indication
      Palliative treatment of advanced prostate cancer 

B.   Compendial Uses
      1.   Prostate cancer
      2.   Recurrent androgen receptor positive salivary gland tumors
      3.   Gender Dysphoria (also known as gender non-conforming or transgender persons) 

All other indications are considered experimental/investigational and not medically necessary. 

II.  PRESCRIBER SPECIALTIES

For gender dysphoria, the medication must be prescribed by or in consultation with a pediatric endocrinologist that has collaborated care with a mental health care provider for members less than 18 years of age.

III. CRITERIA FOR INITIAL APPROVAL 

A.   Prostate cancer
      Authorization of 12 months may be granted for treatment of prostate cancer. 

B.   Gender dysphoria
      1.   Authorization of 12 months may be granted for pubertal hormonal suppression in an adolescent member
            when all of the following criteria are met:
            a.   The member has a diagnosis of gender dysphoria.
            b.   The member has reached Tanner stage 2 of puberty or greater.
            c.   The member’s comorbid conditions are reasonably controlled.
            d.   The member has been educated on any contraindications and side effects to therapy.
            e.   The member has been informed of fertility preservation options.
      2.   Authorization of 12 months may be granted for gender transition when all of the following criteria are met:
            a.   The member has a diagnosis of gender dysphoria.
            b.   The member will receive Eligard concomitantly with gender-affirming hormones.
            c.   The member’s comorbid conditions are reasonably controlled.
            d.   The member has been educated on any contraindications and side effects to therapy.
            e.   The member has been informed of fertility preservation options. 

C.   Salivary gland tumors
      Authorization of 12 months may be granted for treatment of recurrent salivary gland tumors as a single
      agent when the tumor is androgen receptor positive.    

IV.  CONTINUATION OF THERAPY 

A.   Authorization of 12 months may be granted for continued treatment of salivary gland tumors in
      members requesting reauthorization who are experiencing clinical benefit to therapy and who have not
      experienced an unacceptable toxicity.
B.   Authorization of 12 months may be granted for continued treatment of prostate cancer in members
      requesting reauthorization who are experiencing clinical benefit to therapy (e.g., serum testosterone less
      than 50 ng/dL) and who have not experienced an unacceptable toxicity.
C.   All members (including new members) requesting authorization for continuation of therapy for gender
      dysphoria must meet all initial authorization criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Eligard [package insert]. Fort Collins, CO: Tolmar Pharmaceuticals; April 2019.
2. The NCCN Drugs & Biologics Compendium^® © 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed February 1, 2022.
3. 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(11):3869–3903.
4. Gender Identity Research and Education Society. Guidance for GPs and other clinicians on the treatment of gender variant people. UK Department of Health. Published March 10, 2008.
5. Standards of care for the health of transsexual, transgender, and gender-nonconforming people, 7th version. ©2012 World Professional Association for Transgender Health. Available at http://www.wpath.org.
6. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. July 2020.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 01, 2022