CurrentCignaPolicy N/A

Pedmark (sodium thiosulfate) prior authorization

Prior authorization form and requirements for coverage of Pedmark (sodium thiosulfate) for ototoxicity risk reduction in patients receiving cisplatin; intended for providers submitting PA requests to Cigna Pharmacy Services.

Policy Summary

PayerCigna

PolicyPedmark (sodium thiosulfate) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with required patient and prescriber identifiers, clinical details (cisplatin use, tumor type, baseline serum sodium), dose and duration, and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

Accredonationally preferred specialty pharmacy

855-840-1678fax number to submit completed form

800-882-4462phone for urgent requests

Coverage Criteria for Pedmark (sodium thiosulfate)

Initial Therapy / Coverage criteria

Covered when ALL of the following are met (per form fields):

Pedmark coverage criteria: Patient is receiving cisplatin therapy.

Form field: 'Is the patient receiving cisplatin therapy?'

Pedmark coverage criteria: Indication is ototoxicity risk reduction for a solid tumor (examples includes medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, anaplastic astrocytoma).

Form field: 'Does the patient have a solid tumor?' with examples provided.

Pedmark coverage criteria: Disease is localized, non-metastatic.

Form field: 'Does the patient have localized, non-metastatic disease?'

Policy Summary

PayerCigna

PolicyPedmark (sodium thiosulfate) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Pedmark coverage criteria: Baseline serum sodium is less than or equal to 145 mmol/L.<= 145 mmol/L

Form field: 'Does the patient have a baseline serum sodium level less than or equal to 145 mmol/L?'

Pedmark coverage criteria: Requested medication is prescribed by or in consultation with an oncologist.

Form field: 'Is the requested medication being prescribed by or in consultation with an oncologist?'

Pedmark coverage criteria: Prescriber supplies required clinical and administrative information: medication (Pedmark), dose (g/m2), quantity, duration, frequency, ICD-10 diagnosis, patient height, weight, and body surface area (BSA).

Derived from medication request and medication/demographic fields on the form.

The prior authorization form does not list any explicit exclusions. For indications or diagnoses not listed on the form, providers must specify the condition under the “Other indications or diagnoses” field on the request so the case can be reviewed against medical necessity criteria.

The form does not enumerate specific not medically necessary conditions. Instead, approval depends on meeting the affirmative clinical items collected on the form; failure to provide the required answers (for example confirming cisplatin therapy, tumor type, localized non‑metastatic disease, baseline serum sodium, and oncologist involvement) may result in denial of the request.

Coding and Diagnostic Codes

Requested diagnosis codesICD-10

ICD10

ICD10 code(s) to be provided by prescriber on form

Baseline serum sodium

Baseline serum sodium<= 145 mmol/L

Threshold typeSerum sodium concentration

ApplicabilityRequired for ototoxicity risk reduction requests

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Pedmark (sodium thiosulfate). Complete and submit the Cigna prior authorization form for Pedmark with all required patient and physician identifiers. Requests lacking required documentation may be delayed or denied.

Medication requested (Pedmark 12.5 g/100 mL solution for injection) and dosing, duration, frequency
Patient identifiers: full name, Cigna ID, date of birth, address, phone
Physician identifiers: name, specialty, DEA/NPI/TIN, office contact, phone, fax, office address
Clinical details: indication (ototoxicity risk reduction), confirmation of cisplatin therapy, tumor type and stage (solid, localized non‑metastatic), baseline serum sodium ≤145 mmol/L, oncologist involvement (prescribing or consult)
Patient anthropometrics: current height (cm), weight (kg), BSA
Facility/infusion site information: facility name, state, tax ID, address; home infusion candidate status; in‑office infusion capability
Attestation and prescriber signature with date

Documentation Required

Required Documentation

Provide the completed prior authorization form and include supporting clinical documentation such as recent labs (serum sodium), oncology notes confirming cisplatin therapy and tumor details, treatment plan showing timing relative to cisplatin, and any consultation notes from the prescribing oncologist.

Baseline serum sodium result (document value ≤145 mmol/L if applicable)
Oncology treatment plan confirming cisplatin administration and schedule
Pathology or oncology notes documenting solid tumor type and localized non‑metastatic status
Consultation note if prescribing clinician is not the treating oncologist

Note

Site‑of‑Care Consideration

Infusion must occur in the lowest cost, medically appropriate setting per some Cigna plans. Confirm site‑of‑care requirements prior to scheduling; failure to infuse in the required setting may affect coverage or result in denial.

Indicate whether patient is a candidate for home infusion
Indicate whether physician has an in‑office infusion site
Provide facility/dispensing location with Tax ID and address

Initial Therapy Authorization Requirements

Initial therapy requirements

Initial authorization information collected on form

Initial authorization data: Medication requested including product (Pedmark) and formulation; dose in g/m2; quantity; duration of therapy; and frequency of therapy.

Form medication request fields

Initial authorization data: ICD-10 diagnosis code for the requested indication.

Form requests ICD10

Initial authorization data: Patient demographic and anthropometric data: current height (cm), current weight (kg), and calculated body surface area (BSA).

Form fields for height, weight, and BSA

Initial authorization data: Confirmation of cisplatin therapy.

Form field: 'Is the patient receiving cisplatin therapy?'

Initial authorization data: Tumor type and staging information: affirmation that the patient has a solid tumor (examples provided) and that disease is localized, non-metastatic.

Form fields asking about solid tumor and localized non-metastatic status

Initial authorization data: Baseline serum sodium value and confirmation it is <= 145 mmol/L.<= 145 mmol/L

Form field: baseline serum sodium threshold

Initial authorization data: Confirmation that medication is prescribed by or in consultation with an oncologist.

Form field: oncologist prescribing/consultation

Step Therapy and Site-of-Care Questions

Question	Options / Notes
Is your patient a candidate for home infusion?	Yes; No
Does the physician have an in-office infusion site?	Yes; No
Site where medication will be obtained	Accredo Specialty Pharmacy; Prescriber's office stock (billing on a medical claim form); Other (specify)

Site of Care Requirements

Billing Rule

Specify site of care and pharmacy source

Indicate on the form where the medication will be obtained and ensure infusion is planned for the lowest‑cost, medically appropriate setting (home, prescriber office, infusion center, or retail pharmacy) as required by some plans.

Form question: Where will this medication be obtained? (Accredo, prescriber’s office stock, retail pharmacy, home infusion)
Facility/dispensing details: facility name, tax ID, address must be provided when applicable

Background

Pedmark (sodium thiosulfate) is requested to reduce the risk of cisplatin‑related ototoxicity. The form targets patients who are receiving cisplatin therapy for a solid tumor (examples listed on the form include medulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, and anaplastic astrocytoma), have localized, non‑metastatic disease, a baseline serum sodium of ≤ 145 mmol/L, and whose therapy is prescribed by or in consultation with an oncologist.

Definitions

Pedmark

Medication namePedmark (sodium thiosulfate)

Formulation listedPedmark 12.5 g/100 mL solution for injection

Drug classSodium thiosulfate

Solid tumor (examples)

Examples of solid tumorsmedulloblastoma, osteosarcoma, germ cell tumor, neuroblastoma, hepatoblastoma, anaplastic astrocytoma

ContextUsed when indication is ototoxicity risk reduction for patients receiving cisplatin

Disease localization requirementForm asks whether disease is localized, non-metastatic