Subject: Fensolvi 3864-A SGM P2022b

Drug

FENSOLVI  (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
                 Fensolvi is indicated for the treatment of pediatric patients
                 2 years of age and older with central precocious puberty
                 (CPP).

            B.  Compendial Use
                 Gender dysphoria (also known as gender non-conforming
                 or transgender persons)

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

 

     II.  DOCUMENTATION

           Submission of the following information is necessary to initiate
           the prior authorization review: For central precocious puberty, a
           pubertal response to a gonadotropin releasing hormone (GnRH)
           agonist test or a pubertal level of a third-generation luteinizing
           hormone (LH) assay

 
   III.  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.

 
    IV.  CRITERIA FOR INITIAL APPROVAL

           A.  Central precocious puberty (CPP)
                1.  Authorization of 12 months may be granted for
                     treatment of CPP in a female member when all of the
                     following criteria are met:
                     i.    Intracranial tumor has been evaluated by
                           appropriate lab tests and diagnostic imaging, such
                           as computed tomography (CT scan), magnetic
                           resonance imaging (MRI), or ultrasound.
                     ii.   The diagnosis of CPP has been confirmed by a
                           pubertal response to a gonadotropin releasing
                           hormone (GnRH) agonist test or a pubertal level of a
                           third-generation luteinizing hormone (LH) assay.
                     iii.   The assessment of bone age versus chronological
                            age supports the diagnosis of CPP.
                     iv.   The member was less than 8 years of age at the
                            onset of secondary sexual characteristics.
                 2.  Authorization of 12 months may be granted for
                      treatment of CPP in a male member when all of the
                      following criteria are met:
                      i.      Intracranial tumor has been evaluated by
                              appropriate lab tests and diagnostic imaging, such
                              as CT scan, MRI, or ultrasound.
                      ii.     The diagnosis of CPP has been confirmed by a
                              pubertal response to a GnRH agonist test or a
                              pubertal level of a third generation LH assay.
                      iii.    The assessment of bone age versus chronological
                              age supports the diagnosis of CPP.
                      iv.    The member was less than 9 years of age at the
                              onset of secondary sexual characteristics.

            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 Fensolvi 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.

 
       V.  CONTINUATION OF THERAPY

            A.  Central precocious puberty (CPP)
                 1.  Authorization of up to 12 months may be granted for
                      continuation of therapy for CPP in a female member if
                      the member is currently less than 12 years of age and
                      the member meets both of the following:
                      i.     The member is currently receiving the requested
                             medication through a paid pharmacy or medical
                             benefit.
                      ii.    The member is not experiencing treatment failure
                             such as clinical pubertal progression, lack of growth
                             deceleration, and continued excessive bone age
                             advancement.
                 2.  Authorization of up to 12 months may be granted for
                      continuation of therapy for CPP in a male member if the
                      member is currently less than 13 years of age and the
                      member meets both of the following:
                      i.    The member is currently receiving the requested
                            medication through a paid pharmacy or medical
                            benefit.
                     ii.    The member is not experiencing treatment failure
                            such as clinical pubertal progression, lack of growth
                            deceleration, and continued excessive bone age
                            advancement.

            B.  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 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 Fensolvi 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. Fensolvi [package insert]. Fort Collins, CO: Tolmar, Inc.; May 2020.
2. Kletter GB, Klein KO, Wong YY. A pediatrician’s guide to central precocious puberty. Clin Pediatr. 2015;54:414-424.
3. Carel J, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123:e752-e762.
4. Bangalor Krishna K, Fuqua JS, Rogol AD, et al. Use of gonadotropin-releasing hormone analogs in children: Update by an international consortium. Horm Res Paediatr. 2019;91(6):357-372.
5. Houk CP, Kunselman AR, Lee PA. Adequacy of a single unstimulated luteinizing hormone level to diagnose central precocious puberty in girls. Pediatrics. 2009;123:e1059-e1063.
6. Kaplowitz P, Bloch C, the Section on Endocrinology. Evaluation and referral of children with signs of early puberty. 2016;137:e20153732.
7. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical May 15, 2013.
8. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. March 18, 2019.
9. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. September 09, 2019.
10. 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.
11. 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.
12. 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.
13. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. July 2020.
14. Cheuiche AV, da Silveira LG, de Paula LCP, Lucena IRS, Silveiro SP. Diagnosis and management of precocious sexual maturation: an updated review. Eur J Pediatr. 2021;180(10):3073-3087.
15. Mahfouda S, Moore JK, Siafarikas A, et al. Puberty Suppression in Transgender Children and Adolescents. Lancet Diabetes Endocrinol. 2017; 5: 816-26.
16. 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.
17. 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