BlueCross BlueShield of Tennessee Medical Policy Manual

Leuprolide Suspension (Lupron Depot-Ped®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

1. 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.

1. FDA-Approved Indication

Lupron Depot-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).

2. Compendial Use

Gender dysphoria (also known as transgender and gender diverse (TGD) persons)

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

2. 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.

3. 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.

4. CRITERIA FOR INITIAL APPROVAL

1. 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:
   1. 1. 1. 1. Member has been evaluated for intracranial tumors (e.g., lab tests, computed tomography [CT] scan, magnetic resonance imaging [MRI]).
            2. 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.
            3. The assessment of bone age versus chronological age supports the diagnosis of CPP.
            4. 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: 

1. Member has been evaluated for intercranial tumors (e.g., lab tests, CT scan, MRI).
2. 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.
3. The assessment of bone age versus chronological age supports the diagnosis of CPP.
4. The member was less than 9 years of age at the onset of secondary sexual characteristics.

2. Gender dysphoria

*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law

1. Authorization of 12 months may be granted for pubertal hormonal suppression in an adolescent member when all of the following criteria are met:

1. The member has a diagnosis of gender dysphoria.
2. The member is able to make an informed decision to engage in treatment.
3. The member has reached Tanner stage 2 of puberty or greater.
4. The member’s comorbid conditions are reasonably controlled.
5. The member has been educated on any contraindications and side effects to therapy.
6. 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:

1. The member has a diagnosis of gender dysphoria.
2. The member is able to make an informed decision to engage in treatment.
3. The member will receive the requested medication concomitantly with gender-affirming hormones.
4. The member’s comorbid conditions are reasonably controlled.
5. The member has been educated on any contraindications and side effects to therapy.
6. The member has been informed of fertility preservation options.

5. CONTINUATION OF THERAPY  

1. 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:
   1. The member is currently receiving the requested medication through a paid pharmacy or medical benefit.
   2. 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:
   1. The member is currently receiving the requested medication through a paid pharmacy or medical benefit.
   2. The member is not experiencing treatment failure (e.g., clinical pubertal progression, lack of growth deceleration, continued excessive bone age advancement).

2. Gender dysphoria

*Individual is age 18 or older or the individual is less than age 18 as permissive under applicable law 

1. 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:
      1. 1. 1. The member has a diagnosis of gender dysphoria.
            2. The member is able to make an informed decision to engage in treatment.
            3. The member has previously reached Tanner stage 2 of puberty or greater.
            4. The member’s comorbid conditions are reasonably controlled.
            5. The member has been educated on any contraindications and side effects to therapy.
            6. 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:

1. The member has a diagnosis of gender dysphoria.
2. The member is able to make an informed decision to engage in treatment.
3. The member will receive the requested medication concomitantly with gender-affirming hormones.
4. The member’s comorbid conditions are reasonably controlled.
5. The member has been educated on any contraindications and side effects to therapy.
6. Before the start of therapy, the member has been informed of fertility preservation options.

6. OTHER

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

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Lupron Depot-PED [package insert]. North Chicago, IL: AbbVie Inc.; April 2023.
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. Pediatrics. 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. Coleman E, Radix AE, Brown GR, et al. Standards of care for the health of transgender, and gender diverse people, version 8. ©2022 ;23 (Suppl 1): S1-S259. doi: 10.1080/26895269.2022.2100644        
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.

ORIGINAL EFFECTIVE DATE: 5/1/2004

MOST RECENT REVIEW DATE: 11/12/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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