CurrentCignaPolicy IP0512

Pedmark

Cigna coverage policy for Pedmark (sodium thiosulfate IV) as a chemoprotective agent to reduce cisplatin-associated ototoxicity in patients meeting specified clinical and dosing criteria. Establishes prior authorization, medically necessary criteria, dosing limits, exclusions, and billing code guidance.

Policy Summary

PayerCigna

PolicyPedmark

Policy CodePolicy IP0512

Change TypeCriteria clarification and coding update

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age, cisplatin therapy, solid tumor diagnosis and stage, baseline serum sodium, and dosing schedule; ensure Pedmark is prescribed by or in consultation with an oncologist.

POLICY UPDATE CHANGES

Removed the requirement that patient must be <18 years of age.

Updated tumor/stage language to require 'Patient has a solid tumor' and 'Patient has localized, non-metastatic disease' with examples of solid tumors.

Updated coding description for J0208 to 'Injection, sodium thiosulfate (Pedmark), 100 mg.'

Annual Revision performed with summary: No criteria changes.

1Covered Indication (ototoxicity risk reduction)

≤145Serum sodium threshold

Up to 20 g/m2Maximum dosing

Coverage Summary

Cigna covers Pedmark (sodium thiosulfate IV) as a chemoprotective agent to reduce cisplatin-associated ototoxicity when patients meet the policy’s specified clinical and dosing criteria. Prior authorization is required for benefit coverage, and approvals are provided for up to 1 year when all criteria are met.

Surface thresholds summary

Minimum age≥ 1 month

Baseline serum sodium≤ 145 mmol/L

Time after cisplatin to Pedmark dose6 hours after each dose of cisplatin

Minimum interval before next cisplatin dosePedmark must be given at least 10 hours before the subsequent cisplatin dose; do not administer if next cisplatin < 10 hours

Maximum Pedmark doseUp to 20 g/m2 (dose tiers: <5 kg = 10 g/m2; 5–10 kg = 15 g/m2; >10 kg = 20 g/m2)

Primary billing codeJ0208

Medically Necessary Criteria (Initial and Continuation)

Medically Necessary - Ototoxicity Risk Reduction (Initial and Continuation approvals up to 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, E, and F):

Patient is ≥ 1 month of age
Patient is receiving cisplatin chemotherapy
Patient has a solid tumor
Examples include medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, anaplastic astrocytoma.
Patient has localized, non-metastatic disease

Limitations of Use and Not Medically Necessary

Limitations of Use

Situations where Pedmark is not established or may be ineffective:

Safety and efficacy not established when Pedmark is administered following cisplatin infusions longer than 6 hourscisplatin infusion > 6 hours
Pedmark may not reduce ototoxicity when administered following longer cisplatin infusions because irreversible ototoxicity may have already occurred

Not Medically Necessary

Use not covered under this policy:

Pedmark for any other use than the ototoxicity risk reduction indication described above is considered not medically necessary

Applicable Codes

Covered HCPCSHCPCSCovered

J0208

Injection, sodium thiosulfate (Pedmark), 100 mg

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Pedmark; approvals are provided for up to 1 year when the patient meets the policy criteria and dosing.

J0208

Documentation Required

Clinical documentation and specialist involvement required

Pedmark must be prescribed by or in consultation with an oncologist. Clinical documentation should support the patient’s age, receipt of cisplatin therapy, solid tumor diagnosis and disease stage (localized, non-metastatic), baseline serum sodium, and the dosing schedule.

Clinical Evidence & Guidance

Evidence includes the FDA Prescribing Information: Pedmark intravenous infusion prescribing information, Fennec Pharmaceuticals, October 2023.

Guideline endorsement: NCCN Adolescent and Young Adult Oncology Guidelines (version 2.2025) recommend Pedmark to reduce the risk of cisplatin-associated ototoxicity in eligible patients.

Background and Definitions

Pedmark is indicated to reduce the risk of ototoxicity associated with cisplatin in patients ≥ 1 month of age with localized, non-metastatic solid tumors. Efficacy has not been established when cisplatin infusions exceed 6 hours. Recommended dosing is weight/BSA-based, given as an IV infusion over 15 minutes and administered 6 hours after each dose of cisplatin (with additional timing requirements if cisplatin is given on multiple days).

Term	Definition
Pedmark
Brand name for sodium thiosulfate intravenous infusion (Fennec).
Localized, non-metastatic disease
Disease confined to primary site/region without distant metastasis (policy requires localized, non-metastatic solid tumors).

Revision History

12/15/2024coding_update

Coding description for J0208 updated from 'Injection, sodium thiosulfate, 100 mg' to 'Injection, sodium thiosulfate (Pedmark), 100 mg.'

12/15/2024annual_review

Annual revision performed with summary: No criteria changes.

10/01/2025policy_changeLatest

Removed the requirement that patient must be <18 years of age; minimum age clarified to ≥ 1 month and tumor/stage language updated to require 'Patient has a solid tumor' and 'Patient has localized, non-metastatic disease' with examples.