Subject: Fensolvi 3864-A SGM P2022a
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FENSOLVI
(leuprolide acetate)
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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 pediatric endocrinologist that has collaborated care with a mental health care provider for members 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.
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 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
All members (including new members) requesting authorization for continuation of therapy must
meet all initial authorization criteria.
Place of Service:
Outpatient
The above policy is based on the following references:
- Fensolvi [package insert]. Fort Collins, CO: Tolmar, Inc.; May 2020.
- Kletter GB, Klein KO, Wong YY. A pediatrician’s guide to central precocious puberty. Clin Pediatr. 2015;54:414-424.
- 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.
- 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.
- 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.
- Kaplowitz P, Bloch C, the Section on Endocrinology. Evaluation and referral of children with signs of early puberty. 2016;137:e20153732.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical May 15, 2013.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. March 18, 2019.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. September 09, 2019.
- 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.
- 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.
- 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.
- Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. July 2020.
- 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.
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
