Subject: Triptodur 2504-A SGM P2022a

Drug

TRIPTODUR  (triptorelin)

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

B.   Compendial Uses
      1.   Gender dysphoria (also known as gender non-conforming or transgender persons)
      2.   Preservation of ovarian function
      3.   Prevention of recurrent menstrual related attacks in acute porphyria 

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.
            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 Triptodur 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.   Preservation of ovarian function
      Authorization of 3 months may be granted for preservation of ovarian function when the member
      is premenopausal and undergoing chemotherapy.

D.  Prevention of recurrent menstrual related attacks in acute porphyria
     Authorization of 12 months may be granted for prevention of recurrent menstrual related attacks
     in members with acute porphyria when the requested medication is prescribed by or in consultation
     with a physician experienced in the management of porphyrias.  

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. 

C.   All other indications
      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:

1. Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; October 2018.
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. 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. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. March 18, 2019.
11. Moore HCF, Unger JM, Phillips K-A, et al. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med. 2015;372:923-32. doi:10.1056/NEJMoa1413204.
12. Clowse MEB, Behera MA, Anders CK, et al. Ovarian preservation by GnRH agonists during chemotherapy: a meta-analysis. J Womens Health (Larchmt). 2009 Mar;18(3):311–319. doi:10.1089/jwh.2008.0857
13. Stein P, Badminton M, Barth J, Rees D, Stewart MF; British and Irish Porphyria Network. Best practice guidelines on clinical management of acute attacks of porphyria and their complications. Ann Clin Biochem. 2013 May;50(Pt 3):217-23.
14. Innala, E, Bäckström, T, Bixo, M, Andersson, C. Evaluation of gonadotrophin-releasing hormone agonist treatment for prevention of menstrual-related attacks in acute porphyria. Acta Obstet Gynecol.2010;89:95–100.
15. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Pediatric Endocrinology Clinical Programs. September 09, 2019.
16. Clinical Consult: CVS Caremark Clinical Programs Review. Focus on Gender Dysphoria Clinical Programs. July 2020.
17. Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics, Inc. Updated periodically. Available at: https://www.micromedexsolutions.com [available with subscription]. Accessed January 16, 2022.
18. 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