CurrentCignaPolicy IP0512

Chemoprotective Agent - Pedmark

Defines Cigna's prior authorization and medical necessity criteria for Pedmark (sodium thiosulfate IV) to reduce cisplatin-associated ototoxicity in patients with solid tumors; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyChemoprotective Agent - Pedmark

Policy CodePolicy IP0512

Change TypeTitle updateage restriction removedtumor requirement clarifiedcoding text revised

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and document that the patient meets all medical necessity criteria (age ≥1 month, receiving cisplatin, solid localized non‑metastatic tumor, baseline sodium ≤145 mmol/L).

SourceLink

POLICY UPDATE CHANGES

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

Updated policy title from 'Sodium thiosulfate' to 'Chemoprotective Agent - Pedmark'.

Clarified tumor requirement from 'Has localized, non-metastatic solid tumor' to 'Patient has a solid tumor' with examples and retained localized, non-metastatic disease requirement.

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

≥ 1 monthminimum age for coverage

6 hoursadministration timing

≤145 mmol/Lbaseline sodium

J0208

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Coverage Criteria

Initial Coverage Criteria

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

Ototoxicity Risk Reduction criteria: A. Patient is ≥ 1 month of age; AND B. Patient is receiving cisplatin chemotherapy; AND C. Patient has a solid tumor; AND D. Patient has localized, non-metastatic disease; AND E. Patient has a baseline serum sodium level ≤ 145 mmol/L; AND F. Medication is prescribed by or in consultation with an oncologist

Dosing: Up to 20 g/m2 IV given 6 hours after each dose of cisplatin. Do not start if next cisplatin is scheduled <10 hours; do not start if serum sodium >145 mmol/L.

Pedmark (sodium thiosulfate) is covered only for the specific indication outlined in this policy: ototoxicity risk reduction associated with cisplatin in patients who meet the listed medical necessity criteria. Use of Pedmark for any other indication or clinical purpose is not medically necessary and will not be covered.

The safety and efficacy of Pedmark when administered after cisplatin infusions lasting longer than 6 hours have not been established; therefore administration in this setting is not supported. In addition, uses of Pedmark outside the specific cisplatin-associated ototoxicity indication described in this policy are considered not medically necessary.

Coding and Baseline Parameters

Considered Medically Necessary HCPCS CodesHCPCSCovered

J0208

Injection, sodium thiosulfate (Pedmark), 100 mg

inv-05: Baseline serum sodium requirement — value and limit

Baseline serum sodium≤ 145 mmol/L

Action thresholdDo not start Pedmark if serum sodium > 145 mmol/L

PurposeBaseline sodium requirement to reduce risk of hyponatremia-related contraindication to treatment

inv-06: Minimum age for coverage

Minimum age for coverage≥ 1 month

Indication age detailApplies to patients with localized, non-metastatic solid tumors receiving cisplatin

Policy change noteAge restriction updated to allow patients ≥ 1 month (requirement removed for <18 years)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Pedmark. Approval is recommended for those who meet the Criteria and Dosing for the listed indication. All approvals are provided for the duration noted below; extended approvals are allowed if the patient continues to meet Criteria and Dosing. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician.

Approval duration: 1 year for ototoxicity risk reduction when criteria are met
Prescriber requirement: must be prescribed by or in consultation with an oncologist

Note

Documentation Required

Prescriber and Clinical Documentation

Background

Pedmark (sodium thiosulfate) is indicated to reduce the risk of cisplatin-associated ototoxicity in patients aged ≥ 1 month with localized, non‑metastatic solid tumors. The product is an inorganic salt specifically approved for this chemoprotective purpose; note that efficacy has not been established when given after prolonged cisplatin infusions (> 6 hours).

Definitions & Limitations

inv-12: Limitation of use — note about infusions longer than 6 hours and effect on ototoxicity reduction

Limitation of use — infusion durationSafety and efficacy not established when Pedmark is administered following cisplatin infusions longer than 6 hours

RationaleMay not reduce ototoxicity because irreversible damage may already have occurred

Coverage implicationUse after cisplatin infusions >6 hours is considered not medically necessary

Initial Therapy Criteria

Initial Dosing

Dosing and administration requirements for initial therapy

Dosing and timing: Administer Pedmark IV over 15 minutes at recommended dose based on body surface area: 10 g/m2 for <5 kg; 15 g/m2 for 5–10 kg; 20 g/m2 for >10 kg. Dose given 6 hours after cisplatin; if cisplatin on multiple days, Pedmark must be given at least 10 hours before next cisplatin. Do not administer if next cisplatin is scheduled <10 hours or if serum sodium >145 mmol/L. Premedicate with an antiemetic; for hypersensitivity, give antihistamine and glucocorticoid before subsequent doses.Up to 20 g/m2 per dose

Administer IV over 15 minutes; observe timing relative to cisplatin as specified.

Continuation Therapy

Extended approvals are allowed if the patient continues to meet the Criteria and Dosing.

Continuation requirements: Patient continues to meet original coverage criteria and dosing, including age, tumor type and stage, receipt and timing of cisplatin, and baseline serum sodium ≤ 145 mmol/L; medication prescribed by or in consultation with an oncologist.

Approvals provided for the duration noted (up to 1 year initially); extensions allowed if criteria continue to be met.

Step Therapy Requirements

Step	Requirement	Notes
1	No step therapy requirements specified in policy	Prior authorization is required; approval recommended for patients who meet the coverage criteria and dosing. Extended approvals allowed if criteria continue to be met.

Quantity Limits

inv-16: Pedmark (sodium thiosulfate) — maximum recommended dose

Maximum recommended dose (BSA-based)Up to 20 g/m2 per dose (based on body surface area)

Pediatric dosing tiers<5 kg: 10 g/m2; 5–10 kg: 15 g/m2; >10 kg: 20 g/m2

Administration timingDose given 6 hours after each cisplatin dose; if cisplatin on multiple days, give Pedmark ≥10 hours before next cisplatin

Site of Care

Note

Specialist prescribing and administration setting guidance

Because specialized skills are required, Pedmark must be prescribed by or in consultation with a specialist (oncologist); administration is not restricted to a single site but may occur in infusion centers, hospital outpatient departments, or offices per clinical judgment.

Ensure oncology involvement for evaluation and monitoring.
Administration settings noted: infusion center, hospital outpatient, or office.