ph-0131
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Trelstar® (triptorelin)

Policy Number: PH-0131

Intramuscular

 

Last Review Date: 04/06/2021

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

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 medication 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]:

  • 3.75 mg injection − 1 injection every 28 days
  • 11.25 mg injection – 1 injection every 84 days
  • 22.5 mg injection – 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 18 years or older

Central Precocious Puberty (CPP) 5,6,7,9,10,11

  • Patient is less than 13 years old; AND
  • Onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys associated with pubertal pituitary gonadotropin activation; AND
  • Diagnosis is confirmed by a pubertal gonadal sex steroid levels and a pubertal  LH response to stimulation by native 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

Endometriosis 3,4

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

Uterine leiomyomata (fibroids) 8

  • Patient is 18 years or older; 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)

  1. Renewal Criteria

Coverage can 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

CPP 5,6,7,9,10,11

  • Disease response as indicated by lack of progression or stabilization of secondary sexual characteristics, decrease in growth velocity and bone age advancement, and improvement in final height prediction

     Endometriosis/Uterine leiomyomata (fibroids)

  • 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

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:

  • Trelstar 3.75mg powder for injection with Mixject delivery system: 00023-5902-xx
  • Trelstar 11.25mg powder for injection with Mixject delivery system : 00023-5904-xx
  • Trelstar 22.5mg powder for injection with Mixject delivery system: 00023-5906-xx
  1. References
  1. Trelstar [package insert].  Madison, NJ; Allergan USA, Inc; May 2020.  Accessed March 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for triptorelin.  National Comprehensive Cancer Network, 2021.  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 2021.
  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. 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 March 2021.
  13. 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 04/24/2020 with effective date 05/01/2020. Accessed March 2021.
  14. Novitas Solutions, Inc.  Local Coverage Article: Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (A56776).  Centers for Medicare & Medicaid Services, Inc.  Updated on 11/08/2019 with effective date 11/14/2019.  Accessed March 2021.

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

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: http://www.cms.gov/medicare-coverage-database/search/advanced-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/search/document-id-search-results.aspx?DocID=A57655&bc=gAAAAAAAAAAA&   

Jurisdiction(s): 6, K

NCD/LCD Document (s): A52453

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A52453&bc=gAAAAAAAAAAAAA%3d%3d&

Jurisdiction(s):  H

NCD/LCD Document (s): A56776

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56776&bc=gAAAAAAAAAAA

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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