ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Ecg 3112 For Voraxaze Glucarpidase_Final

Defines accepted indications, inclusion and exclusion criteria, coding, applicable lines of business, and prior authorization handling for Voraxaze (glucarpidase) used to treat delayed methotrexate clearance/toxicity in adult and pediatric members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEcg 3112 For Voraxaze Glucarpidase_Final

Policy CodePolicy N/A

Change TypeRevised (template conversion and content updates)

Effective Date

Next Review Date

Key ActionProvide authorization requests to Evolent with documentation demonstrating inclusion criteria (creatinine clearance ≤60 mL/min and 48-hour methotrexate level >1 micromole/L) and adhere to single-dose billing limits (50 units/kg, maximum 2,000 units).

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces prior UM ONC_1225 Voraxaze guideline.

Updated administrative/verbiage change in June 2024 from NCH to Evolent.

2Core inclusion thresholds

4Primary exclusion rules

1HCPCS drug code listed

Coverage Summary

Coverage stance: covered_with_criteria. Subject: Voraxaze (glucarpidase) coverage for methotrexate toxicity. Intended population: adult and pediatric members. Scope summary: Defines accepted indications, inclusion and exclusion criteria, coding, applicable lines of business, and prior authorization handling for Voraxaze (glucarpidase) used to treat delayed methotrexate clearance/toxicity in adult and pediatric members. Brief background: Voraxaze is indicated as a rescue agent for high-dose methotrexate–induced nephrotoxicity or delayed methotrexate clearance. Coverage requires documentation meeting the policy inclusion criteria (e.g., creatinine clearance threshold and 48‑hour methotrexate level) and evidence from recognized sources: FDA approved product labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Key Thresholds

Creatinine clearance<= 60 mL/min for inclusion; > 60 mL/min is an exclusion

Plasma methotrexate concentration at 48 hours> 1 micromole per liter prior to first dose

Single dose limit50 units/kg (maximum 2,000 units per single dose)

Maximum durationOne dose only (second dose excluded)

Initial Therapy Criteria

Medically Necessary (Methotrexate Toxicity)

Voraxaze (glucarpidase) may be used in adult and pediatric members with ALL of the following conditions:

ALL of the following

Delayed methotrexate clearance due to renal impairment (e.g., creatinine clearance is 60 mL/min or less)<= 60 mL/min for inclusion
Plasma concentration of methotrexate, 48 hours after start of methotrexate, is greater than 1 micromole per liter prior to the first dose of Voraxaze (glucarpidase).> 1 micromole per liter at 48 hours after start of methotrexate

Exclusion Criteria (Not Covered / Not Approvable)

Voraxaze (glucarpidase) is excluded when ANY of the following apply:

ANY of the following

The member has normal or mildly impaired renal function (i.e., creatinine clearance greater than 60 mL/min).> 60 mL/min for exclusion
Dosing exceeds single dose limit of Voraxaze (glucarpidase) 50 units/kg (maximum treatment dose of 2,000 units).<= 50 units/kg and <= 2000 units per single dose required
Billing must adhere to single dose limits; dosing beyond these limits is excluded
Treatment with Voraxaze (glucarpidase) exceeds the maximum duration limit of one dose (patients who received a second dose failed to achieve efficacy with the first dose, this is supported per policy).One dose maximum; second dose excluded
Policy supports only one dose; second doses are considered exclusion
Insufficient evidence defined by any of the following
- Clinical characteristics of the patient and the cancer are not adequately represented in the published evidence.
- The administered chemotherapy/biologic/immune/targeted/other oncologic therapy regimen is not adequately represented in the published evidence.
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions such as hazard ratio < 0.80 and survival benefit for OS/PFS >= 3 months).Hazard Ratio < 0.80; OS/PFS >= 3 months
- Experimental design is inappropriate to address the question (e.g., lacking necessary design elements where required).
- Case reports or meeting abstracts without full peer-reviewed articles are considered inadequate supportive clinical evidence.

Investigational/off‑label use guidance: Off‑label indications that are not supported by adequate evidence or are not generally accepted by the medical community are excluded. Examples of inadequate evidence include: case reports (generally uncontrolled and anecdotal), meeting abstracts without a full peer‑reviewed article, experimental designs inappropriate to address the question, reported outcomes that do not represent clinically meaningful benefit as defined by ASCO (e.g., hazard ratio ≥ 0.80 or survival benefit below recommended thresholds), and situations where the clinical characteristics or administered regimens are not adequately represented in the published evidence.

Provider Actions / Prior Authorization

Prior Authorization

Authorization required and Evolent processing

Evolent is responsible for processing all medication requests. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

C9293

Documentation Required

Clinical evidence requirements

Use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Documentation should demonstrate that inclusion criteria are met, including renal function (creatinine clearance) and a methotrexate plasma concentration at 48 hours after start of methotrexate.

Denial Risk

Denial risk for investigational/off-label uses

Requests for off-label or investigational indications that lack adequate supporting evidence per the policy’s definitions (for example, case reports or meeting abstracts without full peer-reviewed articles, inadequate representation of patient/therapy characteristics, or outcomes not meeting clinically meaningful thresholds) may be denied.

Billing Rule

Dose/billing limits

Single dose billing and dose limits apply. The policy supports a single dose up to 50 units/kg with a maximum treatment dose of 2,000 units; dosing beyond these limits is excluded and not payable.

C9293

Background

Background: Voraxaze (glucarpidase) is used as a rescue agent for high‑dose methotrexate–induced nephrotoxicity and delayed methotrexate clearance and may be used in both adult and pediatric members. The policy defines inclusion thresholds (e.g., creatinine clearance ≤ 60 mL/min and plasma methotrexate concentration at 48 hours > 1 micromole per liter) and limits dosing to a single dose not exceeding 50 units/kg (maximum 2,000 units). Use must be supported by evidence from FDA labeling, CMS‑recognized compendia, NCCN, ASCO, or peer‑reviewed literature meeting CMS standards.