CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Voraxaze (glucarpidase) — Coverage Criteria for Methotrexate Toxicity

Defines accepted indications, exclusions, coding, and authorization expectations for Voraxaze (glucarpidase) use in adult and pediatric cancer patients, and applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVoraxaze (glucarpidase) — Coverage Criteria for Methotrexate Toxicity

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing delayed methotrexate clearance (plasma methotrexate >1 µmol/L at 48 hours) and creatinine clearance ≤60 mL/min.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

50 units/kg (max 2,000)single-dose maximum

>1 µmol/L @48hmethotrexate threshold

CrCl ≤60 mL/minrenal impairment threshold

C9293HCPCS code

Commercial/Medicaid/MA/CHIP/Exchangelines of business

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Coverage Criteria for Voraxaze (glucarpidase)

Methotrexate Toxicity

Covered when ALL of the following are met

Methotrexate toxicity indication: Patient (adult or pediatric) has delayed methotrexate clearance due to renal impairmentcreatinine clearance ≤ 60 mL/min

from policy

Methotrexate concentration: Plasma concentration of methotrexate > 1 micromole per liter at 48 hours after start of methotrexate prior to first dose of glucarpidase>1 micromole/L at 48 hours

from policy

Members are not eligible for Voraxaze (glucarpidase) if they have normal or mildly impaired renal function, defined as a creatinine clearance greater than 60 mL/min. Requests will also be excluded when dosing exceeds the single-dose maximum of 50 units/kg (maximum treatment dose of 2,000 units), or when treatment exceeds the policy-supported maximum of one dose.

Use of Voraxaze (glucarpidase) for investigational or off-label indications that lack sufficient evidence or are not generally accepted by the medical community is excluded. Determination of insufficient evidence considers whether the patient and regimen are represented in published evidence, whether outcomes are clinically meaningful (for example ASCO-recommended thresholds), and the overall quality of study design; case reports and meeting abstracts without full peer-reviewed publication are generally inadequate to support use.

Regimen	Indication / Criteria	Dose and administration	Coverage status
Voraxaze (glucarpidase) single IV dose	Rescue after high‑dose methotrexate with delayed methotrexate clearance due to renal impairment: patient (adult or pediatric) has delayed methotrexate clearance and creatinine clearance ≤ 60 mL/min; plasma methotrexate >1 micromole/L at 48 hours prior to first dose	Single IV dose up to 50 units/kg (maximum 2,000 units) — single‑dose maximum per policy	Covered

Coding and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

C9293

Injection, glucarpidase, 10 units

Methotrexate level and renal function

Plasma methotrexate level> 1 micromole per liter at 48 hours after start of methotrexate

Renal function thresholdCreatinine clearance ≤ 60 mL/min

Clinical requirementDelayed methotrexate clearance due to renal impairment prior to first dose of glucarpidase

Provider Requirements and Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Voraxaze (glucarpidase) requests processed by Evolent and must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature; clinical documentation must demonstrate delayed methotrexate clearance with renal impairment and a plasma methotrexate concentration >1 micromole/L at 48 hours prior to the first dose.

Covered HCPCS code: C9293 (Injection, glucarpidase, 10 units)

Step Therapy

Continuation request exemption

Continuation (renewal) requests for previously authorized Voraxaze may be exempt from this policy if all conditions are met: no disease progression on the medication, the drug was used within the last year without a lapse greater than 30 days of active authorization, and no additional medications are being added to the continuation request.

Approved Dosing Regimens

Clinical scenario	Required supporting data	Dosing limits / restrictions	Coverage status
Rescue after high‑dose methotrexate with delayed clearance	Documentation demonstrating delayed methotrexate clearance: plasma methotrexate concentration >1 micromole/L at 48 hours after start of methotrexate; evidence of renal impairment (creatinine clearance ≤60 mL/min). Prior authorization required and clinical documentation must support these findings	Single IV dose up to 50 units/kg (maximum 2,000 units); treatment limited to one dose (second dose not supported by policy); requests exceeding single‑dose limit or >2,000 units may be denied	Covered when all criteria met; requests not meeting criteria or exceeding dosing limits are not covered

Line of Therapy / Salvage Use

salvage

Rescue therapy setting: Used as rescue for delayed methotrexate clearance due to renal impairment in patients receiving methotrexate-containing regimensclinical scenario

policy defines accepted indication

Definitions

Delayed methotrexate clearance

DefinitionCondition in which plasma methotrexate concentration remains > 1 micromole per liter at 48 hours after start of methotrexate

Associated renal impairmentTypically occurring with creatinine clearance ≤ 60 mL/min

Timing for measurementMethotrexate level assessed at 48 hours after start of methotrexate, prior to first glucarpidase dose

Background

Glucarpidase (Voraxaze) is an exogenous enzyme used as rescue therapy for patients with delayed methotrexate clearance due to renal impairment. It rapidly reduces plasma methotrexate concentrations and is indicated for adult and pediatric patients who meet the policy criteria for renal impairment and methotrexate level prior to administration.