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Asset Publisher
Trelstar® (triptorelin)
Policy Number: PH-0131
Intramuscular
Last Review Date: 04/04/2024
Date of Origin: 11/28/2011
Dates Reviewed: 12/2011, 03/2012, 06/19/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 3/2015, 05/2015, 8/2015, 11/2015, 2/2016, 5/2016, 8/2016, 11/2016, 02/2017, 5/2017, 8/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 03/2022, 10/2022, 04/2023, 04/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
- Endometriosis/Uterine Leiomyomata (fibroids): Coverage will be provided for 6 months and may NOT be renewed.
- All other indications: Coverage will be provided for 12 months and may be renewed
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- Trelstar 3.75 mg injection single-dose delivery system − 1 injection every 28 days
- Trelstar 11.25 mg injection single-dose delivery system – 1 injection every 84 days
- Trelstar 22.5 mg injection single-dose delivery system – 1 injection every 168 days
B. Max Units (per dose and over time) [HCPCS Unit]:
Prostate Cancer: 6 units every 168 days
Gender Dysphora: 1 unit at weeks 0, 2, and 4 and every 28 days thereafter
All Other Indications: 1 unit every 28 days
- Initial Approval Criteria
Coverage is provided in the following conditions:
Prostate Cancer † 1,2
- Patient is at least 18 years of age
Central Precocious Puberty (CPP) ‡ 9-12,16
- Patient is less than 13 years of age; AND
- Onset of secondary sexual characteristics earlier than age 8 for females and 9 for males associated with pubertal pituitary gonadotropin activation; AND
- Diagnosis is confirmed by pubertal gonadal sex steroid levels and a pubertal luteinizing hormone (LH) response to stimulation by native gonadotropin-releasing hormone (GnRH); AND
- Bone age advanced greater than 2 standard deviations (SD) beyond chronological age; AND
- Tumor has been ruled out by lab tests such as diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), and human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor); AND
- Will not be used in combination with growth hormone
Gender Dysphoria (formerly Gender Identity Disorder) ‡ 13,17,18
- Patient has experienced puberty development to at least Tanner stage 2; AND
- Patient has a diagnosis of gender dysphoria as confirmed by a qualified mental health professional (MHP)** OR the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Criteria §; AND
- A qualified MHP** has confirmed all of the following:
- Patient has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria (whether suppressed or expressed); AND
- Gender dysphoria worsened with the onset of puberty; AND
- Any coexisting psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment; AND
- Patient has sufficient mental capacity to give informed consent to this (reversible) treatment; AND
- Patient has been informed of the effects and side effects of treatment (including potential loss of fertility if the individual subsequently continues with sex hormone treatment) and options to preserve fertility; AND
- Patient has given informed consent and (particularly when the adolescent has not reached the age of legal medical consent, depending on applicable legislation) the parents or other caretakers or guardians have consented to the treatment and are involved in supporting the adolescent throughout the treatment process; AND
- A pediatric endocrinologist or other clinician experienced in pubertal assessment has confirmed all of the following:
- Agreement in the indication for treatment; AND
- There are no medical contraindications to treatment
** Definition of a qualified mental health professional 18 |
|
§ DSM-V Criteria for Gender Dysphoria 13,17 |
|
Endometriosis ‡ 3,4
- Patient is at least 18 years of age; AND
- Patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment).
Uterine Leiomyomata (fibroids) ‡ 8,19
- Patient is at least 18 years of age; AND
- Patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
- Patient is receiving iron therapy
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage may be renewed based upon the following criteria:
- Patient continues to meet the indication-specific relevant criteria identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions, tumor flare, severe QT/QTc interval prolongation, metabolic syndrome (hyperglycemia, diabetes mellitus, hyperlipidemia), cardiovascular diseases (e.g., myocardial infarction, stroke, etc.) etc.; AND
Prostate Cancer 1,2
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Central Precocious Puberty (CPP) 9-12,16
- Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in height velocity, and a decrease in the ratio of bone age to chronological age (BA:CA), and improvement in final height prediction
Gender Dysphoria 13,17
- Patient has shown a beneficial response to treatment as evidenced by routine monitoring of clinical pubertal development and applicable laboratory parameters
Endometriosis/Uterine Leiomyomata (fibroids) 8
- Coverage may not be renewed.
- Dosage/Administration
Indication |
Dose |
Prostate Cancer |
3.75 mg intramuscularly (IM) once every 4 weeks, 11.25 mg IM once every 12 weeks, or 22.5 mg IM once every 24 weeks |
Gender Dysphoria |
3.75 mg intramuscularly (IM) at weeks 0, 2, 4 and every 4 weeks thereafter |
All other indications |
3.75 mg intramuscularly (IM) every 4 weeks |
- Billing Code/Availability Information
HCPCS Code:
- J3315 – Injection, triptorelin pamoate, 3.75 mg; 1 billable unit = 3.75 mg
NDC(s):
- Trelstar 3.75mg for injection with MIXJECT single-dose delivery system: 74676-5902-xx
- Trelstar 11.25mg for injection with MIXJECT single-dose delivery system: 74676-5904-xx
- Trelstar 22.5mg for injection with MIXJECT single-dose delivery system: 74676-5906-xx
- References
- Trelstar [package insert]. Ewing, NJ; Verity Pharmaceuticals, Inc; November 2023. Accessed March 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for triptorelin. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2024.
- Bergqvist A, Bergh T, Hogström L, et al. Effects of triptorelin versus placebo on the symptoms of endometriosis. Fertil Steril. 1998 Apr;69(4):702-8.
- Donnez J, Dewart PJ, Hedon B, et al. Equivalence of the 3-month and 28-day formulations of triptorelin with regard to achievement and maintenance of medical castration in women with endometriosis. Fertil Steril. 2004 Feb;81(2):297-304.
- Swaenepoel C, Chaussain JL, & Roger M: Long-term results of long-acting luteinizing-hormone-releasing hormone agonist in central precocious puberty. Horm Res 1991; 36:126-130.
- Oostdijk W, Hummelink R, Odink RJH, et al: Treatment of children with central precocious puberty by a slow-release gonadotropin-releasing hormone agonist. Eur J Pediatr 1990; 149:308-313.
- Fuqua JS. Treatment and Outcomes of Precocious Puberty: An Update. The Journal of Clinical Endocrinology & Metabolism 2013 98:6, 2198-2207
- van Leusden HAIM: Symptom-free interval after triptorelin treatment of uterine fibroids: long-term results. Gynecol Endocrinol 1992; 6:189-198.
- Beccuti G, Ghizzoni L. Normal and Abnormal Puberty. Endotext. De Groot LJ, Chrousos G, Dungan K, et al., editors, South Dartmouth (MA): MDText.com, Inc.; 2000-. Accessed at: https://www.ncbi.nlm.nih.gov/books/NBK279024/.
- Brito VN, Spinola-Castro AM, Kochi C, et al. Central precocious puberty: revisiting the diagnosis and therapeutic management. Arch Endocrinol Metab. 2016 Apr;60(2):163-72.
- Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009 Apr;123(4):e752-62. doi: 10.1542/peds.2008-1783. Epub 2009 Mar 30.
- Kaplowitz P, Bloch C; Section on Endocrinology, American Academy of Pediatrics. Evaluation and Referral of Children With Signs of Early Puberty. Pediatrics. 2016 Jan;137(1). Doi: 10.1542/peds.2015-3732. Epub 2015 Dec 14.
- 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; 102:3869.
- The World Professional Association for Transgender Health (WPATH), Standards of Care for the Health of Transsexual, and Gender Nonconforming People. Seventh Version. July 2012. Available at: https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341
- Schagen SE, Cohen-Kettenis PT, Delemarre-van de Waal HA, et al; Efficacy and safety of gonadotropin-releasing hormone agonist treatment to suppress puberty in gender dysphoric adolescents. J Sex Med 2016; 13(7):1125-1132.
- Krishna KB, Fuqua JS, Rogol AD, et al. Use of Gonadotropin-Releasing Hormone Analogs in Children: Update by an International Consortium Horm Res Paediatr 2019;91:357–372.
- American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association Publishing.
- Coleman E, Radix AE, Bouman WP, et al. Standards of Care for the Health of Transgender and Gender Diverse People, Version 8. Int J Transgend Health. 2022 Sep 6;23(Suppl 1):S1-S259. doi: 10.1080/26895269.2022.2100644.
- Stewart EA, Laughlin-Tommaso SK. (2023) Uterine fibroids (leiomyomas): Epidemiology, clinical features, diagnosis, and natural history. In: Barbieri R, Chakrabarti A (Eds). UpToDate. Last update: Nov 03, 2023. Accessed March 5, 2024. Available from: https://www.uptodate.com/contents/uterine-fibroids-leiomyomas-epidemiology-clinical-features-diagnosis-and-natural-history.
- National Government Services, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A52453). Centers for Medicare & Medicaid Services, Inc. Updated on 11/20/2023 with effective date 01/01/2023. Accessed March 2024.
- Palmetto GBA. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A59160). Centers for Medicare & Medicaid Services, Inc. Updated on 02/07/2024 with effective date 03/15/2024. Accessed March 2024.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C61 |
Malignant neoplasm of prostate |
D25.0 |
Submucous leiomyoma of uterus |
D25.1 |
Intramural leiomyoma of uterus |
D25.2 |
Subserosal leiomyoma of uterus |
D25.9 |
Leiomyoma of uterus, unspecified |
E30.1 |
Precocious puberty |
E30.8 |
Other disorders of puberty |
F64.0 |
Transsexualism |
F64.1 |
Dual role transvestism |
F64.2 |
Gender identity disorder of childhood |
F64.8 |
Other gender identity disorders |
F64.9 |
Gender identity disorder, unspecified |
N80.00 |
Endometriosis of the uterus, unspecified |
N80.01 |
Superficial endometriosis of the uterus |
N80.02 |
Deep endometriosis of the uterus |
N80.03 |
Adenomyosis of the uterus |
N80.101 |
Endometriosis of right ovary, unspecified depth |
N80.102 |
Endometriosis of left ovary, unspecified depth |
N80.103 |
Endometriosis of bilateral ovaries, unspecified depth |
N80.109 |
Endometriosis of ovary, unspecified side, unspecified depth |
N80.111 |
Superficial endometriosis of right ovary |
N80.112 |
Superficial endometriosis of left ovary |
N80.113 |
Superficial endometriosis of bilateral ovaries |
N80.119 |
Superficial endometriosis of ovary, unspecified ovary |
N80.121 |
Deep endometriosis of right ovary |
N80.122 |
Deep endometriosis of left ovary |
N80.123 |
Deep endometriosis of bilateral ovaries |
N80.129 |
Deep endometriosis of ovary, unspecified ovary |
N80.201 |
Endometriosis of right fallopian tube, unspecified depth |
N80.202 |
Endometriosis of left fallopian tube, unspecified depth |
N80.203 |
Endometriosis of bilateral fallopian tubes, unspecified depth |
N80.209 |
Endometriosis of unspecified fallopian tube, unspecified depth |
N80.211 |
Superficial endometriosis of right fallopian tube |
N80.212 |
Superficial endometriosis of left fallopian tube |
N80.213 |
Superficial endometriosis of bilateral fallopian tubes |
N80.219 |
Superficial endometriosis of unspecified fallopian tube |
N80.221 |
Deep endometriosis of right fallopian tube |
N80.222 |
Deep endometriosis of left fallopian tube |
N80.223 |
Deep endometriosis of bilateral fallopian tubes |
N80.229 |
Deep endometriosis of unspecified fallopian tube |
N80.30 |
Endometriosis of pelvic peritoneum, unspecified |
N80.311 |
Superficial endometriosis of the anterior cul-de-sac |
N80.312 |
Deep endometriosis of the anterior cul-de-sac |
N80.319 |
Endometriosis of the anterior cul-de-sac, unspecified depth |
N80.321 |
Superficial endometriosis of the posterior cul-de-sac |
N80.322 |
Deep endometriosis of the posterior cul-de-sac |
N80.329 |
Endometriosis of the posterior cul-de-sac, unspecified depth |
N80.331 |
Superficial endometriosis of the right pelvic sidewall |
N80.332 |
Superficial endometriosis of the left pelvic sidewall |
N80.333 |
Superficial endometriosis of bilateral pelvic sidewall |
N80.339 |
Superficial endometriosis of pelvic sidewall, unspecified side |
N80.341 |
Deep endometriosis of the right pelvic sidewall |
N80.342 |
Deep endometriosis of the left pelvic sidewall |
N80.343 |
Deep endometriosis of the bilateral pelvic sidewall |
N80.349 |
Deep endometriosis of the pelvic sidewall, unspecified side |
N80.351 |
Endometriosis of the right pelvic sidewall, unspecified depth |
N80.352 |
Endometriosis of the left pelvic sidewall, unspecified depth |
N80.353 |
Endometriosis of bilateral pelvic sidewall, unspecified depth |
N80.359 |
Endometriosis of pelvic sidewall, unspecified side, unspecified depth |
N80.361 |
Superficial endometriosis of the right pelvic brim |
N80.362 |
Superficial endometriosis of the left pelvic brim |
N80.363 |
Superficial endometriosis of bilateral pelvic brim |
N80.369 |
Superficial endometriosis of the pelvic brim, unspecified side |
N80.371 |
Deep endometriosis of the right pelvic brim |
N80.372 |
Deep endometriosis of the left pelvic brim |
N80.373 |
Deep endometriosis of bilateral pelvic brim |
N80.379 |
Deep endometriosis of the pelvic brim, unspecified side |
N80.381 |
Endometriosis of the right pelvic brim, unspecified depth |
N80.382 |
Endometriosis of the left pelvic brim, unspecified depth |
N80.383 |
Endometriosis of bilateral pelvic brim, unspecified depth |
N80.389 |
Endometriosis of the pelvic brim, unspecified side, unspecified depth |
N80.3A1 |
Superficial endometriosis of the right uterosacral ligament |
N80.3A2 |
Superficial endometriosis of the left uterosacral ligament |
N80.3A3 |
Superficial endometriosis of the bilateral uterosacral ligament(s) |
N80.3A9 |
Superficial endometriosis of the uterosacral ligament(s), unspecified side |
N80.3B1 |
Deep endometriosis of the right uterosacral ligament |
N80.3B2 |
Deep endometriosis of the left uterosacral ligament |
N80.3B3 |
Deep endometriosis of bilateral uterosacral ligament(s) |
N80.3B9 |
Deep endometriosis of the uterosacral ligament(s), unspecified side |
N80.3C1 |
Endometriosis of the right uterosacral ligament, unspecified depth |
N80.3C2 |
Endometriosis of the left uterosacral ligament, unspecified depth |
N80.3C3 |
Endometriosis of bilateral uterosacral ligament(s), unspecified depth |
N80.3C9 |
Endometriosis of the uterosacral ligament(s), unspecified side, unspecified depth |
N80.391 |
Superficial endometriosis of the pelvic peritoneum, other specified sites |
N80.392 |
Deep endometriosis of the pelvic peritoneum, other specified sites |
N80.399 |
Endometriosis of the pelvic peritoneum, other specified sites, unspecified depth |
N80.40 |
Endometriosis of rectovaginal septum, unspecified involvement of vagina |
N80.41 |
Endometriosis of rectovaginal septum without involvement of vagina |
N80.42 |
Endometriosis of rectovaginal septum with involvement of vagina |
N80.50 |
Endometriosis of intestine, unspecified |
N80.511 |
Superficial endometriosis of the rectum |
N80.512 |
Deep endometriosis of the rectum |
N80.519 |
Endometriosis of the rectum, unspecified depth |
N80.521 |
Superficial endometriosis of the sigmoid colon |
N80.522 |
Deep endometriosis of the sigmoid colon |
N80.529 |
Endometriosis of the sigmoid colon, unspecified depth |
N80.531 |
Superficial endometriosis of the cecum |
N80.532 |
Deep endometriosis of the cecum |
N80.539 |
Endometriosis of the cecum, unspecified depth |
N80.541 |
Superficial endometriosis of the appendix |
N80.542 |
Deep endometriosis of the appendix |
N80.549 |
Endometriosis of the appendix, unspecified depth |
N80.551 |
Superficial endometriosis of other parts of the colon |
N80.552 |
Deep endometriosis of other parts of the colon |
N80.559 |
Endometriosis of other parts of the colon, unspecified depth |
N80.561 |
Superficial endometriosis of the small intestine |
N80.562 |
Deep endometriosis of the small intestine |
N80.569 |
Endometriosis of the small intestine, unspecified depth |
N80.A0 |
Endometriosis in cutaneous scar |
N80.A1 |
Endometriosis of bladder, unspecified depth |
N80.A2 |
Superficial endometriosis of bladder |
N80.A41 |
Deep endometriosis of bladder |
N80.A42 |
Superficial endometriosis of right ureter |
N80.A43 |
Superficial endometriosis of left ureter |
N80.A49 |
Superficial endometriosis of bilateral ureters |
N80.A51 |
Superficial endometriosis of unspecified ureter |
N80.A52 |
Deep endometriosis of right ureter |
N80.A53 |
Deep endometriosis of left ureter |
N80.A59 |
Deep endometriosis of bilateral ureters |
N80.A61 |
Deep endometriosis of unspecified ureter |
N80.A62 |
Endometriosis of right ureter, unspecified depth |
N80.A63 |
Endometriosis of left ureter, unspecified depth |
N80.A69 |
Endometriosis of bilateral ureters, unspecified depth |
N80.B1 |
Endometriosis of unspecified ureter, unspecified depth |
N80.B2 |
Endometriosis of pleura |
N80.B31 |
Endometriosis of lung |
N80.B32 |
Superficial endometriosis of diaphragm |
N80.B39 |
Deep endometriosis of diaphragm |
N80.B4 |
Endometriosis of diaphragm, unspecified depth |
N80.B5 |
Endometriosis of the pericardial space |
N80.B6 |
Endometriosis of the mediastinal space |
N80.C0 |
Endometriosis of cardiothoracic space |
N80.C10 |
Endometriosis of the abdomen, unspecified |
N80.C11 |
Endometriosis of the anterior abdominal wall, subcutaneous tissue |
N80.C19 |
Endometriosis of the anterior abdominal wall, fascia and muscular layers |
N80.C2 |
Endometriosis of the anterior abdominal wall, unspecified depth |
N80.C3 |
Endometriosis of the umbilicus |
N80.C4 |
Endometriosis of the inguinal canal |
N80.C9 |
Endometriosis of extra-pelvic abdominal peritoneum |
N80.D0 |
Endometriosis of other site of abdomen |
N80.D1 |
Endometriosis of the pelvic nerves, unspecified |
N80.D2 |
Endometriosis of the sacral splanchnic nerves |
N80.D3 |
Endometriosis of the sacral nerve roots |
N80.D4 |
Endometriosis of the obturator nerve |
N80.D5 |
Endometriosis of the sciatic nerve |
N80.D6 |
Endometriosis of the pudendal nerve |
N80.D9 |
Endometriosis of the femoral nerve |
N80.9 |
Endometriosis, unspecified |
Z85.46 |
Personal history of malignant neoplasm of prostate |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes |
||
Jurisdiction |
NCD/LCA/LCD Document (s) |
Contractor |
6, K |
A52453 |
National Government Services, Inc |
J, M |
A59160 |
Palmetto GBA |
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |
TRELSTAR® (triptorelin) Prior Auth Criteria |
|