PEDMARK (sodium thiosulfate)

PEDMARK (sodium thiosulfate)

Medical Administration – intravenous

Diagnosis considered for coverage:

• Indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors
• Limitations of Use: 
  • The safety and efficacy of Pedmark have not been established when administered following cisplatin infusions longer than 6 hours. Pedmark may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred

Coverage Criteria:

For diagnosis of ototoxicity associated with cisplatin:

• Dose does not exceed FDA label maximum dose based on the surface area according to actual body weight; AND
• Patient is 1 month of age or older; AND
• Patient has a diagnosis of solid tumors; AND
• Disease is both of the following: 
  • Localized
  • Non-metastatic; AND
• Used for the prevention of ototoxicity due to cisplatin-based chemotherapy: AND
• Prescribed by or in consultation with an oncologist

Coverage Duration: 

• 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• The recommended dose of Pedmark is based on surface area according to actual body weight
  • Less than 5 kg: 10 g/m2 
  • 5 to 10 kg: 15 g/m2
  • Greater than 10 kg: 20 g/m2
• Administration: 
  • STS should be administered as an IV infusion over 15 minutes, following cisplatin infusion that are 1 to 6 hours in duration.
  • STS should be administered 6 hours after completion of each cisplatin infusion and at least 10 hours before the next cisplatin infusion. It should not be administered if the next cisplatin infusion is scheduled to begin in less than 10 hours to avoid interference with the antitumor activity of cisplatin.
  • STS has not been studied for use after cisplatin infusion longer than 6 hours.
• Monitor serum sodium and potassium at baseline and as clinically indicated; STS should not be administered in patients with serum sodium greater than 145 mmol/L

Policy Updates:

• 6/1/2023 – New policy approved by P&T

References:

• Pedmark Prescribing Information. Fennec Pharmaceuticals, Inc. Hoboken, NJ. September 2022. 
• Clinical Consult - Pediatric Hematology/Oncology specialist. November 15, 2022.