ModifiedHealth NetPolicy N/A

Clinical Policy: Moxetumomab Pasudotox-tdfk (Lumoxiti)

Defines medical necessity and authorization criteria for Lumoxiti for treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) and addresses continued therapy, contraindications/boxed warnings, dosing, coding, and policy references for Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Moxetumomab Pasudotox-tdfk (Lumoxiti)

Policy CodePolicy N/A

Change TypeMODIFIED (manufacturer market withdrawal; criteria updated)

Effective DateOct 16, 2018

Next Review Date

Key ActionNew initiation of Lumoxiti is not permitted—providers should not submit requests to start therapy; only continuation requests for members already receiving therapy may be considered

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria for HCL removed due to manufacturer withdrawal; Appendix E/market withdrawal details added (manufacturer announced permanent discontinuation Nov 18, 2022; distribution stopped Aug 2023).

Approval duration changed to 6 months for initial and continued therapy and maximum of 6 cycles added per PI.

Modified HIM line of business assignment and added HCPCS codes.

Removed Appendix D and drugs listed in Appendix B as not relevant to current criteria.

1FDA Approved Indication (HCL)

6Maximum Treatment Cycles

Coverage Summary

Indication: Lumoxiti (moxetumomab pasudotox-tdfk) is indicated for adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two systemic therapies including a purine nucleoside analog.

Manufacturer withdrawal/market discontinuation: AstraZeneca announced permanent discontinuation of Lumoxiti from the US market on November 18, 2022, advising distributors to stop distribution in August 2023 (distribution stopped August 2023).

Coverage stance and scope: Policy stance is mixed — new initiation of Lumoxiti is not permitted while continuation requests for members already receiving therapy may be considered per the continued therapy criteria. Effective date: 10.16.18; Last review date: 11.24.

Key limits & thresholds

Maximum treatment cycles6 cycles (total)

Dosage per administration0.04 mg/kg/dose (actual body weight) on days 1, 3, and 5 of each 28-day cycle

Minimum exposure before continued therapyAt least 30 days of therapy before continued treatment consideration

Renal impairment limitationNot recommended in patients with severe renal impairment (CrCl < 29 mL/min)

Initial Therapy Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

Authorization is not permitted; member may not initiate therapy with Lumoxiti

If member is currently using Lumoxiti, proceed to continued therapy criteria

Hairy Cell Leukemia — Continued Therapy Criteria

Hairy Cell Leukemia - Continued Therapy

Covered for members currently receiving therapy when ALL of the following are met:

Current therapy: Member is currently receiving medication via Centene benefit; or documentation supports that member is currently receiving Lumoxiti for a covered indication and has received this medication for at least 30 daysAt least 30 days of therapy
Provider must submit office chart notes, lab results, or other clinical information
Response: Member is responding positively to therapy
Maximum cycles: Member has not received > 6 treatment cycles

Other Diagnoses / Off-Label Use

Diagnoses/Indications Not Authorized

Not covered unless off-label policy criteria are met:

Diagnoses/Indications Not Authorized: Non-FDA approved indications which are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Refer to off-label use policies CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Applicable Codes

HCPCS (drug billing)HCPCS

J9313

Injection, moxetumomab pasudotox-tdfk, 0.01 mg

Provider Actions & Billing

Prior Authorization

Prior authorization requirement for initiation

New initiation of Lumoxiti is not permitted. Providers should not submit requests to start therapy; only continuation requests for members already receiving therapy may be considered.

J9313

Documentation Required

Documentation to support continued therapy

Provider must submit office chart notes, laboratory results, or other clinical information demonstrating the member meets continued therapy criteria, including documentation that the member has been receiving the medication for at least 30 days and evidence of a positive response to therapy.

Clinical Evidence & References

Evidence entries: Prescribing Information — Lumoxiti Prescribing Information, AstraZeneca, February 2022.

Manufacturer notice: AstraZeneca announcement of permanent withdrawal (November 18, 2022), with distributor stop of distribution in August 2023.

Notes: Appendix/market withdrawal details were added in the 4Q2023 review (documented in the revision history).

Background

Lumoxiti is a CD22-directed cytotoxin indicated for treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) after at least two systemic therapies including a purine nucleoside analog.

The manufacturer announced permanent discontinuation of Lumoxiti from the US market on November 18, 2022, and advised distributors to stop distribution in August 2023; distribution was stopped August 2023.

Quick facts

FDA Approved Indication (HCL)1

Primary HCPCS CodeJ9313

Manufacturer withdrawal announcement dateNov 18, 2022

Maximum Treatment Cycles6

Definitions

CLS: Capillary leak syndrome.

HUS: Hemolytic uremic syndrome.

NCCN: National Comprehensive Cancer Network.

Revision History

4Q 2024revised

Removed Appendix D and drugs listed in Appendix B as not relevant to current criteria; references updated.