Subject: Fensolvi 3864-A SGM P2023

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,
          laboratory report or medical record of 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 (e.g.,
                           computed tomography [CT] scan, magnetic
                           resonance imaging [MRI]).
                    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, (e.g.,
                            CT scan, MRI).
                     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
                           (e.g., clinical pubertal progression, lack of growth
                           deceleration, 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
                           (e.g., clinical pubertal progression, lack of growth
                           deceleration, 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.; April 2022.
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. Bangalore 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. 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.
8. 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.
9. 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.
10. 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.
11. Mahfouda S, Moore JK, Siafarikas A, et al. Puberty Suppression in Transgender Children and Adolescents. Lancet Diabetes Endocrinol. 2017; 5: 816-26.
12. 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.

June 11, 2023