CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug Policy: Pedmark (sodium thiosulfate) — Ototoxicity Prophylaxis

Defines coverage, usage criteria, exclusions, and utilization management processes for Pedmark (sodium thiosulfate) to reduce cisplatin-related ototoxicity in pediatric cancer patients and other FDA/compendia-supported indications; applies to medication requests processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPedmark (sodium thiosulfate) drug policy — ototoxicity prophylaxis

Policy CodePolicy N/A

Change TypeMinor revision — no material clinical changes

Effective DateNovember 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests with indication and supporting evidence per FDA labeling or CMS-recognized compendia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11/29/24effective date

11/13/24committee approval

pediatric <18primary population

single-dose limitsdose thresholds

Coverage Criteria

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inv-01: Ototoxicity prophylaxis (initial therapy)

Covered when ALL of the following are met:

Pediatric ototoxicity prophylaxis criteria: Patient is a pediatric member (up to 18 years of age); Diagnosis is a localized, non-metastatic solid tumor for which cisplatin is planned; Pedmark (sodium thiosulfate) will be administered separated from the cisplatin infusion by at least 6–10 hours; Pedmark is not used with cisplatin delivered as a continuous infusion over 6–24 hours.

From policy section B Ototoxicity Prophylaxis with Cisplatin

inv-02: Continuation therapy

Continuation therapy covered when ALL are met:

Continuation criteria: Medication was used within the last year; The member has not experienced disease progression and/or has not had intolerance to the requested medication; No additional medication(s) are being added to the continuation request.

Continuation requests exemption from investigational rules

Coverage excludes dosing that exceeds the policys single-dose maximums. Specifically, requests where a single Pedmark (sodium thiosulfate) dose is greater than 10 g/m2 for weight < 5 kg, 15 g/m2 for weight 5–10 kg, or 20 g/m2 for weight > 10 kg will not be approved.

Uses of Pedmark that are considered investigational or off-label and lack adequate supporting evidence are excluded. The policy defines insufficient evidence as situations where the patient or cancer characteristics, the chemotherapy/biologic/immune/targeted or other oncologic regimen, or clinically meaningful outcomes are not adequately represented in published studies; where experimental design is inappropriate to answer the clinical question; or where evidence is limited to uncontrolled case reports or meeting abstracts without a full peer-reviewed publication. Such indications not supported by CMS-recognized compendia or acceptable peer-reviewed literature are not approvable.

Initial Therapy — Ototoxicity Prophylaxis

inv-12: Initial therapy — ototoxicity prophylaxis (pediatric patients receiving cisplatin with timing separation)

Covered when ALL of the following are met for pediatric patients receiving cisplatin:

Initial therapy — ototoxicity prophylaxis (pediatric cisplatin timing): Patient is a pediatric member (up to 18 years of age); Patient has a localized, non-metastatic solid tumor and cisplatin is planned; Pedmark (sodium thiosulfate) administration is separated from cisplatin infusion by at least 6–10 hours; Pedmark is not administered when cisplatin is given as a continuous infusion over 6–24 hours.

Section B Ototoxicity Prophylaxis with Cisplatin

Continuation Requests

inv-13: Continuation requests — may be approved if the following all apply

Continuation requests may be approved if ALL of the following apply:

Continuation therapy approval conditions: Medication was used within the last year; There is no disease progression and the member has not had intolerance to the medication; No additional medications are being added to the continuation request.

See continuation request rules

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Pedmark (sodium thiosulfate) requests. Pedmark is authorized when used for ototoxicity prophylaxis in pediatric patients receiving cisplatin per the criteria in this policy. Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Pedmark (sodium thiosulfate) use must follow separation from cisplatin infusion by at least 6-10 hours; not authorized with continuous cisplatin infusions given over 6-24 hours.
Prior authorization requests should document indication, patient age, tumor localization (non-metastatic solid tumor), scheduled cisplatin therapy, and planned timing between cisplatin and Pedmark doses.

Note

Continuation Request Rules

Continuation (renewal) requests are allowed when the requested medication was used within the last year, the member has not experienced disease progression and/or intolerance to the medication, and no additional medications are being added to the continuation request. Continuation requests for medications deemed not-approvable by this policy remain subject to exclusion criteria.

Used within the last 12 months
No disease progression and no intolerance to the requested medication
No additional medications added to the continuation request

Documentation Required

Supporting Evidence Required

Providers must supply supporting evidence consistent with FDA labeling or CMS-recognized compendia (e.g., NCCN) or peer-reviewed literature that meets CMS standards. Documentation should demonstrate that the patient population, cancer characteristics, and concomitant therapy match the evidence, and that reported study outcomes are clinically meaningful. Case reports or abstracts without full peer-reviewed articles generally do not provide adequate supportive evidence.

Cite FDA prescribing information when applicable (Pedmark prescribing information).
If relying on literature, include full peer‑reviewed articles or CMS‑recognized compendia (NCCN, ASCO, AHFS, Clinical Pharmacology, Micromedex).
Ensure the evidence represents the clinical characteristics and chemotherapy regimen of the patient and reports clinically meaningful outcomes.

Denial Risk

Denial Triggers

Requests may be denied for dosing that exceeds single-dose limits or for investigational/off-label uses lacking sufficient evidence or general medical acceptance.

Single-dose limits: 10 g/m2 (weight <5 kg), 15 g/m2 (5–10 kg), 20 g/m2 (greater than 10 kg) — requests exceeding these limits may be denied.
Investigational or off-label uses without support from CMS-recognized compendia or acceptable peer-reviewed literature may be denied.

Coding & Dose Limits

Single dose limits — Pedmark (sodium thiosulfate)

Weight < 5 kgSingle-dose maximum 10 g/m2

Weight 5–10 kgSingle-dose maximum 15 g/m2

Weight > 10 kgSingle-dose maximum 20 g/m2

Quantity & Dosing Limits

Pedmark (sodium thiosulfate) — single-dose maximum by weight

< 5 kgMaximum single dose: 10 g/m2

5–10 kgMaximum single dose: 15 g/m2

> 10 kgMaximum single dose: 20 g/m2

Step Therapy / Renewal Rules

Step/Tier	Requirement	Notes
Continuation (renewal) rule	Medication was used within the last year	Requests for continuation are eligible only if the medication was used within the past 12 months per policy	No disease progression or intolerance	Member must have no documented disease progression and no intolerance to the medication	No new medications added	Additional medication(s) are not being added to the continuation request; adding new agents may require a new prior authorization

Definitions

Ototoxicity prophylaxis definition — Pedmark use

DefinitionUse of Pedmark (sodium thiosulfate) to reduce the risk of cisplatin-induced ototoxicity in pediatric members (up to 18 years) with localized, non-metastatic solid tumors receiving cisplatin.

Timing requirementPedmark must be administered separated from cisplatin infusion by at least 6–10 hours to avoid decreasing cisplatin efficacy.

Not with continuous infusionPedmark may not be used with cisplatin given as a continuous infusion over 6–24 hours.

Background

Pedmark (sodium thiosulfate) is described in this policy as an agent used to reduce cisplatin-related ototoxicity in pediatric oncology. The policys coverage framework focuses on its use for ototoxicity prophylaxis in pediatric patients (generally those <= 18 years) receiving cisplatin, with authorization and dosing limits and evidence standards applied to ensure use aligns with published, peer-reviewed evidence and compendia guidance.

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