Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Moxetumomab pasudotox-tdfk (Lumoxiti™)
Policy #:MA08.103b

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY
  • Moxetumomab pasudotox-tdfk (Lumoxiti) is considered medically necessary and, therefore, covered for the treatment of adult individuals with relapsed or refractory hairy cell leukemia (HCL) for maximum of six cycles, when all of the following criteria met:
    • The individual must have histologically confirmed relapsed or refractory hairy cell leukemia
    • The individual is pseudomonas-immunotoxin na´ve (i.e., na´ve to moxetumomab pasudotox)
    • The individual received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA) (eg., cladribine or pentostatin)
    • The individual does not have severe renal impairment (CrCl less then or equal to 29 ml/min)
    • The individual's age is greater or equal to 18 years

EXPERIMENTAL/INVESTIGATIONAL

All other uses for moxetumomab pasudotox-tdfk (Lumoxiti) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Policy Guidelines

There is no Medicare coverage determination addressing moxetumomab pasudotox-tdfk (Lumoxiti); therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, moxetumomab pasudotox-tdfk (Lumoxiti) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in the medical policy are met.

DRUG INFORMATION

In accordance with US Food and Drug Administration (FDA) prescribing information, moxetumomab pasudotox-tdfk (Lumoxiti) is administered as an intravenous infusion over 30 minutes on Days 1, 3, and 5 of each 28-day cycle. Recommended dosage: 0.04 mg/kg. Maximum of six cycles.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Moxetumomab pasudotox-tdfk (Lumoxiti) was approved by the FDA on September 13, 2018 for for the treatment of treatment of adult individuals with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). The safety and effectiveness have not been established in pediatric individuals.

Description

Hairy cell leukemia (HCL) is a rare B cell malignancy characterized by high CD22 expression. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells, and platelets are produced. Accumulation of neoplastic cells typically results in splenomegaly; a variable reduction in the production of normal red blood cells, platelets, mature granulocytes, and monocytes; and complications of anemia, bleeding, and infection. Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin, that binds CD22 on the cell surface of B-cells and is internalized. Moxetumomab pasudotox-tdfk internalization results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death.

Moxetumomab pasudotox-tdfk (Lumoxiti) a first-in-class treatment approved by the US Food and Drug Administration (FDA) for hairy cell leukemia. Prior to its approval, treatment options consisted of Purine analogs (ie, cladribine or pentostatin), splenectomy or interferon for hairy cell leukemia. Variant hairy cell leukemia — HCL variant (HCL-v) is poorly responsive or resistant to standard treatment (ie, splenectomy, interferon, purine analogs). Although treatment data are sparse, individuals with HCL-v were candidates for treatment with monoclonal antibodies (eg, rituximab, alemtuzumab).

PEER-REVIEWED LITERATURE

SUMMARY
The study of Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (HCL) was a phase III, multicenter, single-arm study of moxetumomab pasudotox in individuals with relapsed/refractory hairy cell leukemia. Between 2013 and 2018, 77 individuals with HCL were inrolled to participate. Moxetumomab pasudotox-tdfk (Lumoxiti) was infused intravenously on days 1, 3 and 5 of each 28 day cycle for a maximum of 6 cycles or until disease progression, unacceptable toxicity occurs, the subject begins alternate therapy, or documented CR (for subjects who have no assessable minimal residual disease [MRD] and not to exceed 6 cycles). Primary outcome measures were to determine percentage of participants with Durable Complete responce (CR) at the end of the treatment (EOT) up to 24 weeks and post (EOT) Day 181. In the study, 50% of individuals received three or more prior courses of purine nucleoside analogs and 75% received prior rituximab.

Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for complete response (CR), followed by a >180 day duration of hematologic remission (HR).

Responses were seen in 60 individuals (75 percent) overall with 33 individuals (41 percent) achieving a CR and 27 individuals (34 percent) achieving MRD negativity. Of these, 24 individuals (30 percent) maintained hematologic remission for more than 180 days. MRD negativity was associated with prolonged CR. None of the three individuals with HCL-variant achieved CR.

OFF-LABEL INDICATION

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References

Elsevier’s Clinical Pharmacology Compendium. Moxetumomab pasudotox-tdfk (Lumoxiti™). [Clinical Key Web site] 09/21/2018. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed October 30, 2018.

Kreitman RJ, Dearden C, Zinzani PL. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018;32:1768–1777.

Lexi-Drugs Compendium. Moxetumomab pasudotox-tdfk (Lumoxiti). 10/25/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only].
Accessed October 30, 2018.

(Lumoxiti) Moxetumomab pasudotox-tdfk. [prescribing information]. Wilmington, DE:AstraZeneca Pharmaceuticals LP.; 9/2018. Available at: https://www.azpicentral.com/lumoxiti/lumoxiti_pi.pdf#page=1. Accessed October 30, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Hairy Cell Leukemia. V.2.2019. [NCCN Web site]. 09/10/2018. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hairy_cell.pdf [via free subscription]. Accessed October 30, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Moxetumomab pasudotox-tdfk (Lumoxiti). [NCCN Web site]. 2018. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed October 30, 2018.

Truven Health Analytics. Micromedex« DrugDex« Compendium. Moxetumomab pasudotox-tdfk (Lumoxiti). 09/14/ 2018. Greenwood Village, CO. [Micromedex« Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed October 30, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. (Lumoxiti) Moxetumomab pasudotox-tdfk prescribing information and approval letter [FDA Web site]. updated 09/2018. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed October 30, 2018.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C91.40 Hairy cell leukemia not having achieved remission

C91.42 Hairy cell leukemia, in relapse



HCPCS Level II Code Number(s)



J9313 Injection, moxetumomab pasudotox-tdfk, 0.01 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References




Policy History

Revisions from MA08.103b
10/09/2019This policy has been reissued in accordance with the Company's annual review process.
10/01/2019This policy has been identified for the HCPCS code update, effective 10/01/2019.

The following HCPCS codes have been termed from this policy:
J3590 Unclassified biologics
C9045 Injection, moxetumomab pasudotox-tdfk, 0.01 mg

The following HCPCS code has been added to this policy:
J9313 Injection, moxetumomab pasudotox-tdfk, 0.01 mg

Revisions from MA08.103a
04/01/2019This policy has been identified for the HCPCS code update, effective 04/01/2019.

The following HCPCS codes have been termed from this policy: C9399 Unclassified drugs or biologics

The following HCPCS code has been added to this policy:
C9045 Injection, moxetumomab pasudotox-tdfk, 0.01 mg

Revisions from MA08.103
12/31/2018This new policy has been developed to communicate the Company’s coverage position for moxetumomab pasudotox-tdfk (Lumoxiti™).






Version Effective Date: 10/01/2019
Version Issued Date: 10/04/2019
Version Reissued Date: 10/10/2019