CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lumoxiti (moxetumomab pasudotox) — Coverage Criteria

Defines accepted indications, exclusion criteria, and utilization management process for Lumoxiti requests submitted to the payer; affects providers requesting authorization and UM staff reviewing requests for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLumoxiti (moxetumomab pasudotox) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApril 26, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent/UM for prior authorization; ensure supporting evidence (FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature) is included.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6maximum treatment duration

0.04 mg/kgsingle dose maximum

11+committee review history entries

UM Committeefinal approval body

Coverage Criteria for Lumoxiti (moxetumomab pasudotox)

Inclusion / Indication rules

Covered when ALL of the following are met:

Continuation request exemption: Continuation requests for a not-approvable medication are exempt provided ALL of: the requested medication was used within the last year; the member has not experienced disease progression and/or has not had intolerance to the requested medication; and additional medication(s) are not being added to the continuation request.

from II.A

Hairy cell leukemia indication: Lumoxiti (moxetumomab pasudotox) is not supported by Evolent for the treatment of hairy cell leukemia due to voluntary manufacturer withdrawal; follow Evolent-recommended alternative regimens.

from II.B

Exclusion criteria

Use or continuation is not allowed when ANY of the following apply:

Exclusions: Lumoxiti (moxetumomab pasudotox) is excluded if any of the following apply: it is used after disease progression with the same regimen; it is used concurrently with other chemotherapy; dosing exceeds the single dose limit of 0.04 mg/kg; treatment exceeds the maximum duration limit of 6 cycles; or it is used investigationally/off-label without sufficient evidence as defined by lack of support in CMS-recognized compendia or acceptable peer‑reviewed literature.

from III

Lumoxiti (moxetumomab pasudotox) is not covered for use when any of the following exclusion criteria apply. Requests should be denied when Lumoxiti is: used after documented disease progression on the same regimen; used concurrently with other chemotherapy; prescribed at a single dose that exceeds 0.04 mg/kg; or continued beyond a maximum of 6 cycles.

Additionally, requests for investigational or off-label indications that lack sufficient supporting evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded. The policy defines adequacy of evidence by whether the patient population and regimen match published data, reported outcomes are clinically meaningful (e.g., ASCO-recommended thresholds), study design is appropriate, and that uncontrolled case reports or meeting abstracts without full peer‑reviewed articles generally do not provide adequate support.

Lumoxiti (moxetumomab pasudotox) is not supported by Evolent for the treatment of hairy cell leukemia due to the voluntary withdrawal of the product by the manufacturer; providers should follow Evolent’s recommended alternative agents/regimens.

Use of Lumoxiti for other investigational or off‑label indications is considered not medically necessary unless supported by CMS‑recognized compendia or acceptable peer‑reviewed literature meeting the policy’s evidence standards described in the exclusion criteria.

Prior Authorization, Documentation & Provider Requirements

Prior Authorization

Prior authorization and review pathway

Evolent processes all medication requests from network ordering providers; requests are reviewed by the Utilization Management Department and final approval is granted by the Utilization Management Committee. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Step Therapy

Continuation exemption conditions

Continuation (exemption) requests for a previously used, otherwise not-approvable medication are allowed only if ALL of the following are met: the 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 regimen.

Documentation Required

Supporting evidence required

Use must be supported by one of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Exclusion criteria that trigger denial

Requests will be denied if any exclusion criteria apply, including post‑progression use on the same regimen, concurrent chemotherapy, dosing above 0.04 mg/kg per single dose, treatment beyond 6 cycles, or investigational/off‑label use lacking sufficient evidence per CMS compendia or acceptable peer‑reviewed literature.

Used after disease progression on the same regimen
Concurrent use with other chemotherapy
Single dose exceeds 0.04 mg/kg
Treatment exceeds 6 cycles
Investigational/off‑label use without sufficient CMS‑recognized compendia or acceptable peer‑reviewed evidence

Background

Lumoxiti (moxetumomab pasudotox) is a recombinant anti‑CD22 immunotoxin used in oncology. This policy references the FDA labeling and oncology evidence sources recognized by CMS and requires that use be supported by CMS‑recognized compendia or acceptable peer‑reviewed literature consistent with the policy’s evidentiary criteria.

Evolent’s policy explicitly notes that Lumoxiti’s manufacturer voluntarily withdrew the product for the indication of hairy cell leukemia; as a result, that indication is not supported by Evolent and alternative regimens are recommended.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLumoxiti (moxetumomab pasudotox) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApril 26, 2024

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Lumoxiti (moxetumomab pasudotox) — Coverage Criteria

Coverage Criteria for Lumoxiti (moxetumomab pasudotox)

Coding, Dose Limits, and Quantity

Quantity Limits for Lumoxiti

Prior Authorization, Documentation & Provider Requirements

Continuation Therapy Criteria

Definitions and Indication Status

Background