Currentmoda_health_plan_incPolicy IC-0679

Pedmark (sodium thiosulfate) (Intravenous) coverage for cisplatin ototoxicity prevention in pediatrics

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Defines prior authorization, dosing limits, and medical necessity criteria for intravenous Pedmark (sodium thiosulfate) to reduce cisplatin-induced ototoxicity, primarily for pediatric members receiving cisplatin. Applies to coverage and utilization management by Moda Health Plan Inc.

Policy Summary

Payermoda_health_plan_inc

PolicyPedmark (sodium thiosulfate) (Intravenous) coverage for cisplatin ototoxicity prevention in pediatrics

Policy CodePolicy IC-0679

Change TypeNo material change

Effective Date

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionObtain prior authorization (initial validity 12 weeks) and document billing using HCPCS J0208 with appropriate diagnosis codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wksPrior auth validity

500Max units /14 days

J0208HCPCS

1 mo–<18 yr

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Currentmoda_health_plan_incPolicy IC-0679

Pedmark (sodium thiosulfate) (Intravenous) coverage for cisplatin ototoxicity prevention in pediatrics

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Policy Summary

Payermoda_health_plan_inc

PolicyPedmark (sodium thiosulfate) (Intravenous) coverage for cisplatin ototoxicity prevention in pediatrics

Policy CodePolicy IC-0679

Change TypeNo material change

Effective Date

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionObtain prior authorization (initial validity 12 weeks) and document billing using HCPCS J0208 with appropriate diagnosis codes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wksPrior auth validity

500Max units /14 days

J0208HCPCS

1 mo–<18 yr

Coverage and Clinical Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Universal and indication-specific criteria: Member does not have a serum sodium level greater than 145 mmol/L; AND member is at least 1 month and less than 18 years of age; AND member has a localized, non-metastatic solid tumor; AND member 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; AND alternative sodium thiosulfate formulations (12.5 g/50 mL) may be used only when Pedmark is not obtainable as confirmed by the FDA Drug Shortage website.<= 145 mmol/L

FDA-approved pediatric indication; orphan drug status noted

inv-02: Renewal Therapy — Renewal is provided when ALL of the following are met:

Renewal is provided when ALL of the following are met:

Renewal requirements: Member continues to meet the universal and indication-specific relevant criteria (including concomitant therapy and performance status as applicable); AND absence of unacceptable toxicity from the drug (examples: hypersensitivity reactions, hypernatremia, hypokalemia, severe nausea/vomiting); AND member continues to require chemoprotective treatment to counteract cisplatin ototoxicity.

Authorization may be renewed every 12 weeks (84 days)

Any use of Pedmark (sodium thiosulfate) outside the policy’s specified pediatric indication is permitted only under a documented supply limitation for the Pedmark product. Specifically, alternative sodium thiosulfate formulations (12.5 g/50 mL) may be used only when Pedmark is not obtainable as confirmed on the FDA Drug Shortage website (http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm).

Pedmark is approved for prevention of cisplatin-induced ototoxicity only in pediatric patients aged 1 month to <18 years with localized, non‑metastatic solid tumors who are receiving cisplatin infusions 1 to 6 hours in duration. Use outside this pediatric age range (age <1 month or ≥18 years), for metastatic disease, or when the cisplatin infusion timing criteria are not met is not covered.

Timing and infusion considerations: Pedmark must be administered as an intravenous infusion over 15 minutes and given 6 hours after completion of each cisplatin infusion. For multiday cisplatin regimens, Pedmark should be given after each cisplatin dose and only if the next cisplatin infusion is scheduled to begin at least 10 hours after Pedmark administration; do not administer Pedmark if the next cisplatin infusion is scheduled to start in less than 10 hours.

Initial Therapy Requirements

inv-14: Initial Therapy — Initial approval criteria for Pedmark (structured medical necessity criteria).

Initial approval criteria for Pedmark (sodium thiosulfate):

Initial therapy nodes: Member is at least 1 month and less than 18 years of age; AND member has a localized, non-metastatic solid tumor; AND member 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; AND serum sodium ≤ 145 mmol/L; AND Pedmark will be administered as an intravenous infusion over 15 minutes, approximately 6 hours after completion of cisplatin per product labeling with pediatric weight/surface-area–based dosing.<= 145 mmol/L

Dosing and timing per product labeling; do not administer if next cisplatin infusion is scheduled in <10 hours

Continuation / Renewal Requirements

inv-15: Continuation Therapy — Continuation/renewal requirements and conditions.

Continuation/renewal requirements and conditions:

Continuation criteria: Member continues to meet the universal and indication-specific criteria; AND absence of unacceptable toxicity from the drug; AND member continues to require chemoprotective treatment to counteract cisplatin ototoxicity; AND prior authorization may be renewed every 12 weeks (84 days) to correspond with anticipated cisplatin administration.

Examples of unacceptable toxicity include hypersensitivity, hypernatremia, hypokalemia, severe nausea/vomiting.

Billing and Diagnosis Codes

Covered HCPCS CodeHCPCSCovered

J0208

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

Covered Diagnosis CodesICD-10Covered

H91.01	Ototoxic hearing loss, right ear
H91.02	Ototoxic hearing loss, left ear
H91.03	Ototoxic hearing loss, bilateral
H91.09	Ototoxic hearing loss, unspecified

Serum sodium — threshold for coverage

Serum sodium thresholdMember must not have a serum sodium level greater than 145 mmol/L (145 mEq/L)

Clinical implicationSerum sodium >145 mmol/L (hypernatremia) is a contraindicating finding and may trigger denial

Source guidance locationUniversal criteria for initial therapy

Prior Auth, Documentation, and Billing Actions

Prior Authorization

Prior authorization valid for 12 weeks; renew every 12 weeks

Initial prior authorization is valid for 12 weeks (84 days) to correspond with anticipated cisplatin administration; prior authorizations may be renewed every 12 weeks (84 days) thereafter to correspond with anticipated cisplatin administration.

Step Therapy

Alternative formulation allowed only with FDA drug‑shortage confirmation

Use of alternative sodium thiosulfate (12.5 g/50 mL) is permitted only when Pedmark is not obtainable as confirmed by the FDA Drug Shortage website (http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm).

Key Definitions and Dosing Timing

Pedmark dosing timing

Timing relative to cisplatinAdminister Pedmark as an IV infusion 6 hours after completion of each cisplatin infusion

Infusion durationAdminister Pedmark as an intravenous infusion over 15 minutes following cisplatin

Multiday cisplatin regimensFor multiday cisplatin regimens, give Pedmark 6 hours after each cisplatin infusion and at least 10 hours before the next cisplatin infusion; do not give if next cisplatin is scheduled in <10 hours

Step Therapy and Alternative Sourcing

Step	Requirement	Notes
1	Alternative sodium thiosulfate formulation (12.5 g/50 mL) may be used only when Pedmark is not obtainable.	Obtainability must be confirmed via the FDA Drug Shortage website: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

Quantity and Billing Limits

Pedmark (sodium thiosulfate) — quantity limit

Maximum billable units500 billable units (50 g) every 14 days

Unit definition1 billable unit = 100 mg (HCPCS unit) — 500 units = 50 g

Indication scope for limitLimit applied for cisplatin-induced ototoxicity prevention

Administration Setting

Note

Infusion center administration timing and method

Administer Pedmark as an intravenous infusion over 15 minutes following cisplatin; dosing and timing must follow the chemotherapy schedule (administer 6 hours after completion of cisplatin infusions that are 1–6 hours in duration, and do not give if the next cisplatin infusion is scheduled in less than 10 hours).

Background

Pedmark (sodium thiosulfate) is indicated to reduce the risk of cisplatin‑induced ototoxicity in pediatric patients with localized, non‑metastatic solid tumors. The policy limits use to members who are at least 1 month and less than 18 years of age and who are receiving cisplatin infusions of 1 to 6 hours duration. Pedmark is given after cisplatin to provide otoprotection while minimizing interference with cisplatin activity.