CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pedmark (sodium thiosulfate) — Ototoxicity Prophylaxis with Cisplatin

Defines accepted indications, coverage criteria, dosing limits, and authorization process for Pedmark (sodium thiosulfate) for pediatric ototoxicity prophylaxis with cisplatin and related continuation requests; applies to medication requests processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPedmark (sodium thiosulfate) — Ototoxicity Prophylaxis with Cisplatin

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNovember 29, 2024

Next Review DateNovember 13, 2024

Key ActionSubmit medication requests to Evolent for Utilization Management review and final approval by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Nov 29, 2024effective date

1 mo–18 yrage range

6–10 hrsseparation time

10/15/20 gm/m2single dose max

Coverage Criteria — Pedmark (sodium thiosulfate)

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Ototoxicity prophylaxis with cisplatin

Covered when ALL of the following are met

Pediatric ototoxicity prophylaxis criteria

Timing requirement: Pedmark will be given separated from cisplatin by at least 6-10 hours>=6 hours separation and <=10 hours suggested; not to be used with cisplatin continuous infusions given over 6-24 hours
Separation required to avoid decreased cisplatin efficacy

Initial therapy (ototoxicity prophylaxis)

Initial coverage for ototoxicity prophylaxis when supported by evidence

Initial therapy criteria: Pediatric patient 1 month-18 years with localized, non-metastatic solid tumor AND planned cisplatin therapy AND Pedmark administered 6-10 hours after cisplatin (not with continuous infusions over 6-24 hours)age 1 month-18 years; 6-10 hour separation

Supported by FDA labeling and clinical trial evidence references

Continuation requests exemption

Continuation requests exempt from full review when ALL of the following are met

Continuation exemption: Requested medication was used within the last year AND member has not experienced disease progression or intolerance AND no additional medications are being added to the requestused within 1 year

Continuation requests meeting these conditions are exempt from policy review

Investigational or off‑label uses of Pedmark (sodium thiosulfate) that do not meet the policy’s evidence standards are excluded from coverage. Specifically, requests will be excluded when dosing exceeds the policy’s single‑dose maximums or when the proposed indication lacks sufficient supporting evidence as defined in the policy. Examples of insufficient evidence include reliance on uncontrolled case reports or meeting abstracts without full peer‑reviewed publications, or clinical evidence that does not adequately represent the patient population, tumor type, or treatment regimen under consideration. Uses that are not generally accepted by the medical community and are unsupported by CMS‑recognized compendia or acceptable peer‑reviewed literature are considered investigational and will be denied.

Use of Pedmark for indications or in clinical contexts that do not meet the policy’s defined evidence requirements is considered not appropriate. The policy requires supporting evidence from CMS‑recognized compendia or acceptable peer‑reviewed literature; evidence will be evaluated for adequacy based on factors including whether the patient and cancer characteristics are represented, whether the chemotherapy or other oncologic regimen is represented, whether outcomes are clinically meaningful, and whether study design is appropriate. Abstracts without full publication, case reports, or other anecdotal data are specifically identified as inadequate. Requests relying on such limited evidence should be considered not medically necessary.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Evolent UM processes all medication requests from network ordering providers. Prior authorization is required for Pedmark (sodium thiosulfate) and requests must be submitted to Evolent's Utilization Management for review. Final approval authority resides with the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Submit prior authorization requests to Evolent Utilization Management.
Final approval granted by the Utilization Management Committee.

Note

Continuation Request Exemption

Continuation (renewal) requests for a previously used, not-approvable medication may be exempt from this policy when ALL of the following are met: the medication was used within the last year; the member has no disease progression and no intolerance to the medication; and no additional medications are being added to the continuation request.

Continuation requests exempt if: used within last year; no disease progression or intolerance; no additional medications added.

Documentation Required

Required Supporting Documentation

Requests must be supported by at least one of the following sources of evidence: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Supporting documentation should demonstrate that the indication, patient clinical characteristics, and the oncologic regimen match the evidence base. Abstracts without a full peer-reviewed article, case reports, or insufficient peer-reviewed evidence are not acceptable alone.

Acceptable sources: FDA label; CMS-recognized compendia; NCCN or ASCO guidelines; peer-reviewed literature meeting CMS standards.
Documentation should show patient and regimen are represented in the evidence and that outcomes are clinically meaningful.

Denial Risk

Denial Triggers

Requests may be denied if dosing exceeds the single-dose limits for Pedmark (sodium thiosulfate): 10 g/m2 for weight <5 kg, 15 g/m2 for 5–10 kg, or 20 g/m2 for >10 kg. Requests for investigational or off‑label indications lacking sufficient evidence (per criteria in this policy) may also be denied.

Single-dose dosing limits: 10 g/m2 (<5 kg); 15 g/m2 (5–10 kg); 20 g/m2 (>10 kg).
Investigational/off-label uses without adequate CMS compendia or acceptable peer‑reviewed evidence are denial triggers.

Background

Pedmark (sodium thiosulfate) is used as an otoprotective agent to reduce the risk of cisplatin‑induced hearing loss in pediatric patients. The policy defines the covered indication as pediatric members aged 1 month to 18 years with localized, non‑metastatic solid tumors who will receive cisplatin therapy. Administration timing is critical: Pedmark should be given separated from cisplatin by at least 6–10 hours to avoid reducing cisplatin efficacy. The policy references pivotal trials and prescribing information as the evidentiary basis and also notes exclusion for dosing that exceeds established single‑dose limits.

Revision History

2024-11-29policy_effectiveLatest

Policy approved by the Utilization Management Committee and made effective; Pedmark (sodium thiosulfate) drug policy effective date set to November 29, 2024.

2024-11-13committee_approval

Policy reviewed and approved by the Evolent Specialty Services Clinical Guideline Review Committee on November 13, 2024.

2023-11-08committee_review

Policy reviewed by the Utilization Management Committee on November 8, 2023.

2022-11-09committee_review

Policy reviewed by the Utilization Management Committee on November 9, 2022.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPedmark (sodium thiosulfate) — Ototoxicity Prophylaxis with Cisplatin

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateNovember 29, 2024

Next Review DateNovember 13, 2024

Key ActionSubmit medication requests to Evolent for Utilization Management review and final approval by the Utilization Management Committee.

SourceLink

On This Page

OpenPayer

Pedmark (sodium thiosulfate) — Ototoxicity Prophylaxis with Cisplatin

Coverage Criteria — Pedmark (sodium thiosulfate)

Coding and Quantity Limits

Provider Actions, Prior Authorization, and Documentation

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Site of Care

Background

Revision History