Subject: Eligard 1966-A SGM P2022b

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 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 patients 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 has reached Tanner stage 2 of puberty
                             or greater.
                      iii.   The member’s comorbid conditions are reasonably
                             controlled.
                      iv.   The member has been educated on any
                             contraindications and side effects to therapy.
                      v.    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 will receive Eligard concomitantly with
                             gender-affirming hormones.
                      iii.    The member’s comorbid conditions are reasonably
                              controlled.
                      iv.    The member has been educated on any
                              contraindications and side effects to therapy.
                      v.     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
                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 has previously reached Tanner stage 2 of
                       puberty or greater.
                iii.   The member’s comorbid conditions are reasonably
                       controlled.
                iv.   The member has been educated on any
                       contraindications and side effects to therapy.
                v.    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 will receive Eligard concomitantly with
                       gender-affirming hormones.
                iii.   The member’s comorbid conditions are reasonably
                       controlled.
                iv.   The member has been educated on any
                       contraindications and side effects to therapy.
                v.    Before the start of therapy, the member has been informed of fertility preservation options.

 

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.
7. Mahfouda S, Moore JK, Siafarikas A, et al. Puberty Suppression in Transgender Children and Adolescents. Lancet Diabetes Endocrinol. 2017; 5: 816-26.
8. 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.
9. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. September 2022.

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.

December 11, 2022