Subject: Triptodur opt-out 2190-A SGM P2023
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. Preservation of ovarian function
2. 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,
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. 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. Preservation of ovarian function
Authorization of 3 months may be granted for preservation
of ovarian function when the member is premenopausal and
undergoing chemotherapy.
C. 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.
IV. 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. 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:
- Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; April 2022.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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 Gynecol2010;89:95–100.
- 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.
June 11, 2023
