Last Review Date: 03/05/2024

Date of Origin:  10/24/2022

Dates Reviewed:  11/2022, 03/2023, 03/2024

1. Length of Authorization

Coverage will be provided for 12 weeks (84 days) unless otherwise specified to correspond with the anticipated duration of cisplatin administration. Coverage may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Pedmark 12.5 gm/100 mL single-dose vial for injection: 4 vials per 14 days

B. Max Units (per dose and over time) [HCPCS Unit]:

    Cisplatin induced ototoxicity prevention

• 500 billable units (50 gm) every 14 days

3. Initial Approval Criteria

Coverage is provided in the following conditions:

Universal Criteria ¹

• Patient does not have a serum sodium level greater than 145 mmol/L (145 mEq/L); AND

Reduction of ototoxicity risk associated with cisplatin † Φ ^1-4

• Patient is at least 1 month of age and less than 18 years of age; AND
• Patient has a localized, non-metastatic solid tumor; AND
• Patient is receiving cisplatin infusions that are 1 to 6 hours in duration and the next cisplatin infusion is scheduled to be in more than 10 hours

Note: Any other use of Pedmark will be allowed ONLY when:

• Sodium thiosulfate (12.5 g/50 mL) is not obtainable as confirmed by the FDA Drug shortage website located at: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Φ Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria: 

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions, hypernatremia, hypokalemia, severe nausea/vomiting, etc.; AND
• Patient continues to require chemoprotective treatment to counteract cisplatin ototoxicity

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J0208 – Injection, sodium thiosulfate (pedmark), 100 mg; 1 billable unit = 100 mg

NDC(s):

• Pedmark 12.5 gm/100 mL single-dose vial solution for injection: 73077-0010-xx

7. References

1. Pedmark [package insert]. East Windsor, NJ; Fennec Pharmaceuticals, Inc.; September 2022. Accessed January 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) sodium thiosulfate. 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 January 2024.
3. Freyer DR, Chen L, Krailo MD, et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jan;18(1):63-74. doi: 10.1016/S1470-2045(16)30625-8. Epub 2016 Dec 1. Erratum in: Lancet Oncol. 2017 Jun;18(6):e301.
4. Brock PR, Maibach R, Childs M, et al. Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss. N Engl J Med. 2018 Jun 21;378(25):2376-2385. doi: 10.1056/NEJMoa1801109. PMID: 29924955; PMCID: PMC6117111.
5. Chen CH, Huang CY, Lin HH, et al. Association of Sodium Thiosulfate With Risk of Ototoxic Effects From Platinum-Based Chemotherapy: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Aug 2;4(8):e2118895. doi: 10.1001/jamanetworkopen.2021.18895. PMID: 34338793; PMCID: PMC8329743.
6. Romano A, et al. Assessment and management of platinum-related ototoxicity in children treated for cancer. Cancers (Basel). 2020;12(5):1266. doi: 10.3390/cancers12051266
7. National Cancer Institute. Sodium thiosulfate prevents cisplatin-induced hearing loss in some children. July 13, 2018. Accessed January 29, 2024. https://www.cancer.gov/news-events/cancer-currents-blog/2018/cisplatin-hearing-loss-sodium-thiosulfate.
8. Freyer, DR, et al. Prevention of cisplatin-induced ototoxicity in children and adolescents with cancer: a clinical practice guideline. Lancet Child Adolesc Health. 2020;4(2):141−150. doi:10.1016/S2352-4642(19)30336-0
9. Abel D. Coding and Reimbursement for Cochleotoxicity and Vestibulotoxicity Services. Semin Hear. 2019 May;40(2):188-196. doi: 10.1055/s-0039-1684047. Epub 2019 Apr 26. PMID: 31036995; PMCID: PMC6486367.

Appendix 1 – Covered Diagnosis Codes

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 (applicable to existing NCD/LCD): N/A