ph-0131
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Trelstar® (triptorelin)

Policy Number: PH-0131

Intramuscular

 

Last Review Date: 03/01/2022

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

Precertification requirements do not apply for this policy. Pre-payment claim edits are applied to diagnosis criteria within this policy.

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.

  1. Length of Authorization
  • Endometriosis/Uterine Leiomyomata (fibroids): Coverage will be provided for 6 months and is NOT eligible for renewal
  • All other indications: Coverage will be provided for 12 months and may be renewed
  1. 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

   All Other Indications: 1 unit every 28 days

  1. 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) ‡ 5,6,7,9,10,11

  • 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) 7-9

  • 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
    • Puberty has started in the adolescent (e.g., Tanner stage ≥G2/B2); AND
    • There are no medical contraindications to treatment

** Definition of a qualified mental health professional 8

  • A master’s degree or its equivalent in a clinical behavioral science field. This degree or a more advanced one should be granted by an institution accredited by the appropriate national or regional accrediting board. The mental health professional should also have documented credentials from the relevant licensing board or equivalent; AND
  • Competence in using the Diagnostic Statistical Manual of Mental Disorders and/or the International Classification of Diseases for diagnostic purposes; AND
  • Ability to recognize and diagnose co-existing mental health concerns and to distinguish these from gender dysphoria; AND
  • Knowledgeable about gender nonconforming identities and expressions, and the assessment and treatment of gender dysphoria; AND
  • Continuing education in the assessment and treatment of gender dysphoria. This may include attending relevant professional meetings, workshops, or seminars; obtaining supervision from a mental health professional with relevant experience; or participating in research related to gender nonconformity and gender dysphoria.

§ DSM-V Criteria for Gender Dysphoria 7,9

  • A marked incongruence between one’s experienced/expressed gender and natal gender of at least 6mo in duration, as manifested by at least TWO of the following:
    • A marked incongruence between one’s experienced/expressed gender and primary and/or secondary sex characteristics (or in young adolescents, the anticipated secondary sex characteristics)
    • A strong desire to be rid of one’s primary and/or secondary sex characteristics because of a marked incongruence with one’s experienced/expressed gender (or in young adolescents, a desire to prevent the development of the anticipated secondary sex characteristics)
    • A strong desire for the primary and/or secondary sex characteristics of the other gender
    • A strong desire to be of the other gender (or some alternative gender different from one’s designated gender)
    • A strong desire to be treated as the other gender (or some alternative gender different from one’s designated gender)
    • A strong conviction that one has the typical feelings and reactions of the other gender (or some alternative gender different from one’s designated gender); AND
  • The condition is associated with clinically significant distress or impairment in social, occupational, or other important areas of functioning; AND
  • Specify one of the following:
    • The condition exists with a disorder of sex development; OR
    • The condition is posttransitional, in that the individual has transitioned to full-time living in the desired gender (with or without legalization of gender change) and has undergone (or is preparing to have) at least one sex-related medical procedure or treatment regimen—namely, regular sex hormone treatment or gender reassignment surgery confirming the desired gender (e.g., penectomy, vaginoplasty in natal males; mastectomy or phalloplasty in natal females).

    

        Endometriosis ‡ 3,4

  • Patient is at least 18 years of age; AND
  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment)

  Uterine Leiomyomata (fibroids) ‡ 8

  • Patient is at least 18 years of age; AND
  • Documentation patient’s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND
  • Documentation patient is receiving iron therapy

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

  1. Renewal Criteria

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, urinary tract obstruction, severe QT/QTc interval prolongation, severe hyperglycemia/diabetes, cardiovascular toxicity, metastatic vertebral lesions, spinal cord compression 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) 5,6,7,9,10,11

  • 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 12-14

  • 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.
  1. 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

  1. Billing Code/Availability Information

HCPCS Code:

  • J3315 – Injection, triptorelin 3.75 mg: 1 billable unit = 3.75 mg

NDC(s):

  • Trelstar 3.75mg for injection with MIXJECT single-dose delivery system: 00023-5902-xx
  • Trelstar 11.25mg for injection with MIXJECT single-dose delivery system: 00023-5904-xx
  • Trelstar 22.5mg for injection with MIXJECT single-dose delivery system: 00023-5906-xx
  1. References
  1. Trelstar [package insert]. Ewing, NJ; Verity Pharmaceuticals, Inc; December 2021. Accessed February 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for triptorelin. National Comprehensive Cancer Network, 2022. 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 February 2022.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Fuqua JS. Treatment and Outcomes of Precocious Puberty: An Update. The Journal of Clinical Endocrinology & Metabolism 2013 98:6, 2198-2207
  8. van Leusden HAIM: Symptom-free interval after triptorelin treatment of uterine fibroids: long-term results. Gynecol Endocrinol 1992; 6:189-198.
  9. 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/.
  10. 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.
  11. Carel JC, Eugster E, 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.
  12. 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.
  13. 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.
  14. 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
  15. 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
  16. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A57655). Centers for Medicare & Medicaid Services, Inc. Updated on 11/21/2019 with effective date 10/03/2018.  Accessed February 2022.
  17. 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 12/22/2021 with effective date 01/01/2022. Accessed February 2022.
  18. Novitas Solutions, Inc.  Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776). Centers for Medicare & Medicaid Services, Inc. Updated on 10/08/2021 with effective date 10/01/2021. Accessed February 2022.

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

N80.0

Endometriosis of uterus

N80.1

Endometriosis of ovary

N80.2

Endometriosis of fallopian tube

N80.3

Endometriosis of pelvic peritoneum

N80.8

Other endometriosis

N80.9

Endometriosis, unspecified

Z85.46

Personal history of malignant neoplasm of prostate

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

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 Determination (NCD), Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): N

NCD/LCD Document (s): A57655

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a57655&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a52453&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

Jurisdiction(s): H

NCD/LCD Document (s): A56776

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56776&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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
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