CurrentCareSourcePolicy N/A

Chemoprotective Agent Pedmark (sodium thiosulfate) Utilization Management Medical Policy

Defines prior authorization and medical necessity criteria for Pedmark (sodium thiosulfate IV) to reduce cisplatin-associated ototoxicity in pediatric patients with localized, non‑metastatic solid tumors; applies to providers seeking medical benefit coverage from the payer.

Policy Summary

PayerCareSource

PolicyChemoprotective Agent Pedmark (sodium thiosulfate) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 18, 2024

Key ActionObtain prior authorization and ensure Pedmark is prescribed by or in consultation with an oncologist, with dosing per policy (administer IV 6 hours after each cisplatin dose).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 mo–18 yrage range specified for indication

6 hoursinterval after cisplatin

<145baseline serum sodium

up to 20 g/m2max recommended dose

localized, non‑metastaticdisease setting

Recommended Authorization / Coverage Criteria

FDA-Approved Indication / Recommended Authorization Criteria

Covered when ALL of the following are met:

Main eligibility: Patient is between 1 month and 18 years of age; patient has a localized, non-metastatic solid tumor (examples: medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, anaplastic astrocytoma); patient is receiving cisplatin chemotherapy; baseline serum sodium < 145 mmol/L; medication is prescribed by or in consultation with an oncologist; dosing follows policy (administered IV up to 20 g/m2 given 6 hours after each dose of cisplatin).see child nodes

Examples of solid tumors include medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, anaplastic astrocytoma.

Do not initiate Pedmark if the next scheduled dose of cisplatin will begin in 10 hours. Pedmark dosing should be timed relative to cisplatin: the policy specifies administration of Pedmark as an intravenous infusion 6 hours after each cisplatin dose, and when cisplatin is given on multiple days, Pedmark must be given at least 10 hours before the subsequent cisplatin dose. Also note the policy limitation that safety and efficacy have not been established when Pedmark is administered following cisplatin infusions lasting longer than 6 hours.

Coverage is not recommended for indications or circumstances that are not explicitly listed in the Recommended Authorization Criteria. Requests that do not meet the policy criteria may be denied and will be reviewed only if submitted with supporting clinical documentation.

Policy Summary

PayerCareSource

PolicyChemoprotective Agent Pedmark (sodium thiosulfate) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateSep 18, 2024

Key ActionObtain prior authorization and ensure Pedmark is prescribed by or in consultation with an oncologist, with dosing per policy (administer IV 6 hours after each cisplatin dose).

SourceLink

On This Page

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Administration, Dosing, and Regimen Limitations

Regimen	Dose / timing	Coverage status
Pedmark (sodium thiosulfate) IV infusion for ototoxicity prevention during cisplatin chemotherapy in eligible pediatric patients	Administer intravenous infusion over 15 minutes based on body surface area (per policy), up to 20 g/m2; give 6 hours after each cisplatin dose; if cisplatin is given on multiple days, give at least 10 hours before the subsequent cisplatin dose; do not administer if the next cisplatin dose is scheduled to begin in <10 hours; baseline serum sodium must be < 145 mmol/L	Covered with criteria

Key Clinical Parameters and Timing

Serum sodium requirement (baseline)

Baseline serum sodium requirementSerum sodium < 145 mmol/L

Source phrasingPatient has a baseline serum sodium level < 145 mmol/L

Clinical noteDo not start Pedmark if serum sodium is > 145 mmol/L per dosing guidance

Timing after cisplatin

Primary timingAdminister Pedmark 6 hours after administration of cisplatin

Multiple-day cisplatin regimensIf cisplatin is administered on multiple days, give Pedmark at least 10 hours before the subsequent cisplatin dose

Do not give when next cisplatin is imminentDo not administer Pedmark if the next dose of cisplatin is scheduled to begin in less than 10 hours

Dosing route and infusion timeAdministered as an intravenous infusion (recommended infusion over 15 minutes)

Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Pedmark medical benefit coverage. Approval is recommended only for patients who meet the policy's specified criteria and dosing. Requests for doses outside the established dosing in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Pedmark, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required before initiation
Off‑label or off‑dosing requests require clinician review (Medical Director or Pharmacist)
Approvals issued for specified duration per policy

Step Therapy

No step therapy requirements are specified for Pedmark in this policy.

Documentation Required

Prescriber and Documentation Requirements

Pedmark must be prescribed by or in consultation with an oncologist (physician who specializes in the condition being treated). Documentation must be submitted to support the oncologist involvement. For any dosing requests that deviate from the dosing outlined in the policy, submit clinical justification and supporting documentation; these requests will be reviewed on a case‑by‑case basis and may require additional clinical review.

Medication prescribed by or in consultation with an oncologist is required
Provide documentation of oncologist consultation with authorization request
For off‑policy dosing, include clinical rationale and supporting records

Denial Risk

Denial Risk for Off‑Criteria Use

Coverage is not recommended when the patient does not meet the policy's Recommended Authorization Criteria (including indication, cisplatin use, localized non‑metastatic disease, baseline serum sodium < 145 mmol/L, and dosing/timing requirements). Requests that do not meet criteria are at high risk for denial.

Non‑adherence to listed clinical criteria or dosing/timing increases denial risk
Coverage not recommended for indications or circumstances outside the policy criteria

Limitations of Use and Definitions

Limitation_of_use

Limitation on infusion durationSafety and efficacy have not been established when Pedmark is administered following cisplatin infusions longer than 6 hours

ImplicationPedmark may not reduce ototoxicity that has already occurred if given after prolonged cisplatin infusions

Coverage recommendationPedmark not recommended when administered following cisplatin infusions longer than 6 hours

Clinical Background

Pedmark (sodium thiosulfate) is indicated to reduce the risk of cisplatin‑associated ototoxicity in pediatric patients 1 month to 18 years of age with localized, non‑metastatic solid tumors (examples include medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, and anaplastic astrocytoma). The agent is administered as an intravenous infusion and is dosed by body surface area, with approvals provided for doses up to 20 g/m2. The clinical rationale is chemoprotective: Pedmark is given after cisplatin to reduce hearing loss risk, but its benefit has not been established when given following prolonged cisplatin infusions (>6 hours) or after ototoxicity has already occurred.