Trelstar Depot (triptorelin)

Transcription

1 Dates Reviewed: 12/13/2011, 03/2012, 06/19/2012, 09/06/2012, 12/06/2012, 03/07/2013, 06/06/2013, Date of Origin: 11/28/ /05/2013, 12/05/2013, 03/25/2014 Prior Auth Available: Post-service edit: The medical necessity criteria were developed by ICORE Healthcare for the purpose of making clinical review determinations for requests for medications commonly used in various diseases. The clinical disciplines of oncology, hematology, rheumatology, neurology, internal medicine, pharmacy and nursing were consulted as part of the criteria development. The development followed an extensive literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual drug. The indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network (NCCN) guidelines and/or other published peer reviewed research literature. I. Medication Description: Gonadotropin-Releasing Hormone Analog: Triptorelin is a potent inhibitor of gonadotropin secretion when given continuously and in therapeutic doses. Following the first administration, there is a transient surge in circulating levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, and estradiol. After chronic and continuous administration, usually 2 to 4 weeks after initiation of therapy, a sustained decrease in LH and FSH secretion and marked reduction of testicular and ovarian steroidogenesis is observed. In men, a reduction of serum testosterone concentration to a level typically seen in surgically castrated men is obtained. Consequently, tissues and functions that depend on these hormones for maintenance become quiescent. These effects are usually reversible after cessation of therapy. Triptorelin long-acting injection: Following a single IM injection of triptorelin long-acting injection to men with advanced prostate cancer, serum testosterone levels first increased, peaking on days 2 to 3, and thereafter declined to low levels by weeks 3 to 4. II. III. Length of Authorization: o Endometriosis/Uterine leiomyomata (fibroids): Coverage will be provided for 6 months and medication is NOT eligible for renewal o All other indications: Coverage will be provided for 6 months and may be renewed Review Criteria: Coverage is provided in the following conditions: Prostate cancer Central Precocious Puberty (CPP) o Patient is less than 13 years old; AND o Onset of secondary sexual characteristics earlier than age 8 for girls and 9 for boys associated with pubertal pituitary gonadotropin activation; AND o Diagnosis is confirmed by a pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH; AND o Bone age advanced 1 year beyond chronological age; AND o Tumor has been ruled out by lab tests, CT, MRI, or ultrasound Page 1 of 6

2 Endometriosis o Patient older than 18; AND o Documentation patient s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment) Uterine leiomyomata (fibroids) o Patient older than 18; AND o Documentation patient s diagnosis has been confirmed by a workup/evaluation (versus presumptive treatment); AND o Documentation patient is receiving iron therapy FDA Approved Indication(s) IV. Renewal Criteria: Coverage can be renewed based upon the following criteria: (Oncology Indications) o Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND o Absence of unacceptable toxicity from the drug CPP o Patient continues to meet criteria identified in section III; AND o Disease response as indicated by lack of progression of secondary sexual characteristics; AND o Absence of unacceptable toxicity from the drug V. Dosage/Administration: Indication Prostate Cancer All other indications Dose 3.75 mg intramuscularly (IM) once every 4 weeks, mg IM once every 12 weeks, or 22.5 mg IM once every 24 weeks 3.75mg every 4 weeks VI. Billing/Code Information : Jcode: J3315 Trelstar Depot (Watson) 3.75 mg, mg, 22.5 mg Injection: 1 billable unit = 3.75 mg Max Units (per dose and over time): Male 6 units every 168 days Female 1 unit every 28 days Quantity Limitations: 3.75 mg injection - 1 injection every 28 days 11.25mg injection 1 injection every 84 days 22.5 mg injection - 1 injection every 168 days Page 2 of 6

3 Covered Diagnosis: ICD-9 Codes Diagnosis Submucous leiomyoma of uterus Intramural leiomyoma of uterus Subserous leiomyoma of uterus Leiomyoma of uterus, unspecified Precocious sexual development and puberty, not elsewhere classified 185 Malignant neoplasm of prostate Endometriosis of uterus Endometriosis of ovary Endometriosis of fallopian tube Endometriosis of pelvic peritoneum Endometriosis of other specified sites Endometriosis, site unspecified V10.46 Personal history of malignant neoplasm of prostate VII. Centers for Medicare and Medicaid Services (CMS): Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub ), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 9 (N) ICD-9 Codes NCD/LCD Document (s): L29215; L29360 Diagnosis CARCINOMA IN SITU OF PROSTATE Jurisdiction(s): 6, K ICD-9 Codes NCD/LCD Document (s): A49923 Diagnosis 185* MALIGNANT NEOPLASM OF PROSTATE SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRA- ABDOMINAL LYMPH NODES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF INGUINAL REGION AND LOWER LIMB SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF MULTIPLE SITES SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH Page 3 of 6

4 NODES SITE UNSPECIFIED SECONDARY MALIGNANT NEOPLASM OF LUNG SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM MALIGNANT NEOPLASM OF LIVER SECONDARY SECONDARY MALIGNANT NEOPLASM OF SKIN SECONDARY MALIGNANT NEOPLASM OF BRAIN AND SPINAL CORD SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW 233.4* CARCINOMA IN SITU OF PROSTATE V10.46* PERSONAL HISTORY OF MALIGNANT NEOPLASM OF PROSTATE *Secodary codes must be billed with 185, 233.4, or V10.46 Jurisdiction(s): H NCD/LCD Document (s): L32610 ICD-9 Codes Diagnosis SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW Jurisdiction(s): 12 (L) NCD/LCD Document (s): L27500 ICD-9 Codes Diagnosis SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW Jurisdiction(s): 5, 8 NCD/LCD Document (s): L30479 ICD-9 Codes Diagnosis VIII. Criteria Exclusions: o Treatment for diagnoses not FDA approved o All indications not described in Section III Review criteria are not covered and may be considered experimental or investigational. IX. Black Box Warnings/Contraindications: Black Box Warnings N/A Page 4 of 6

5 Contraindications o Hypersensitivity to triptorelin, GnRH, GnRH agonists analogs, or any component of the formulation o Pregnancy X. References: 1. Trelstar [package insert]. Parsippany, NJ; Watson Pharma, Inc; March Accessed February Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium ) for Triptorelin. National Comprehensive Cancer Network, 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 Bergqvist A, Bergh T, Hogström L, et al. Effects of triptorelin versus placebo on the symptoms of endometriosis. Fertil Steril Apr;69(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 Feb;81(2): 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: Oostdijk W, Hummelink R, Odink RJH, et al: Treatment of children with central precocious puberty by a slowrelease gonadotropin-releasing hormone agonist. Eur J Pediatr 1990; 149: van Leusden HAIM: Symptom-free interval after triptorelin treatment of uterine fibroids: long-term results. Gynecol Endocrinol 1992; 6: First Coast Service Options, Inc. Local Coverage Determination (LCD): Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (L29215; L29360). Centers for Medicare & Medicaid Services, Inc. Updated on 10/29/2010 with effective date 05/07/2010. Accessed February National Government Services, Inc. Local Coverage Article for Luteinizing Hormone-Releasing Hormone (LHRH) Analogs Related to LCD L25820 (A49923). Centers for Medicare & Medicaid Services, Inc. Updated on 08/27/2013 with effective date of 10/25/2013. Accessed February Novitas Solutions, Inc. Local Coverage Determination (LCD): Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (L32610). Centers for Medicare & Medicaid Services, Inc. Updated on 11/05/2012 with effective date 11/19/2012. Accessed February Novitas Solutions, Inc. Local Coverage Determination (LCD): Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (L27500). Centers for Medicare & Medicaid Services, Inc. Updated on 04/04/2012 with effective date 04/02/2012. Accessed February Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD): Luteinizing Hormone-Releasing Hormone (LHRH) Analogs (L30479). Centers for Medicare & Medicaid Services, Inc. Updated on 08/26/2013 with effective date 09/07/2013. Accessed February XI. Appendix: Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI Noridian Administrative Services (NAS) F AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Administrative Services (NAS) 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) Page 5 of 6

6 H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC Page 6 of 6