Subject: Eligard 1966-A, 6043-A SGM P2023a

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 transgender and
               gender diverse (TGD) 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 provider specialized in the care of
          transgender youth (e.g., pediatric endocrinologist, family or
          internal medicine physician, obstetrician-gynecologist) that has
          collaborated care with a mental health 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:
                    i.     The member has a diagnosis of gender dysphoria.
                    ii.    The member is able to make an informed decision to
                           engage in treatment.
                    iii.   The member has reached Tanner stage 2 of puberty
                           or greater.
                    iv.   The member’s comorbid conditions are reasonably
                           controlled.
                    v.    The member has been educated on any
                           contraindications and side effects to therapy.
                    vi.   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:
                    i.     The member has a diagnosis of gender dysphoria.
                    ii.    The member is able to make an informed decision to
                           engage in treatment.
                    iii.   The member will receive the requested medication
                           concomitantly with gender-affirming hormones.
                    iv.   The member’s comorbid conditions are reasonably
                           controlled.
                    v.    The member has been educated on any
                           contraindications and side effects to therapy.
                    vi.   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.  Salivary gland tumors
               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.  Prostate cancer
               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.  Gender Dysphoria
               1.  Authorization of 12 months may be granted for continued
                    treatment for pubertal hormonal suppression in
                    adolescent members requesting reauthorization when all
                    of the following criteria are met:
                    i.     The member has a diagnosis of gender dysphoria.
                    ii.    The member is able to make an informed decision to
                           engage in treatment.
                    iii.   The member has previously reached Tanner stage 2
                           of puberty or greater.
                    iv.   The member’s comorbid conditions are reasonably
                           controlled.
                    v.    The member has been educated on any
                           contraindications and side effects to therapy.
                    vi.   Before the start of therapy, the member has been
                           informed of fertility preservation options.
               2.  Authorization of 12 months may be granted for continued
                    treatment for gender transition in members requesting
                    reauthorization when all of the following criteria are met:
                    i.     The member has a diagnosis of gender dysphoria.
                    ii.    The member is able to make an informed decision to
                           engage in treatment.
                    iii.   The member will receive the requested medication
                           concomitantly with gender-affirming hormones.
                    iv.   The member’s comorbid conditions are reasonably
                          controlled.
                    v.    The member has been educated on any
                           contraindications and side effects to therapy.
                    vi.   Before the start of therapy, the member has been
                           informed of fertility preservation options.

     V.  OTHER

          Per state regulatory guidelines around gender dysphoria, age
          restrictions may apply.

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^® © 2023 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed February 15, 2023.
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, 8th version. ©2022 World Professional Association for Transgender Health. Available at http://www.wpath.org.
6. Mahfouda S, Moore JK, Siafarikas A, et al. Puberty Suppression in Transgender Children and Adolescents. Lancet Diabetes Endocrinol. 2017; 5: 816-26.
7. Health Care for Transgender and Gender Diverse Individuals. ©2021 The American College of Obstetricians and Gynecologists. Available at: https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2021/03/health-care-for-transgender-and-gender-diverse-individuals.

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.

September 27, 2023