CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aphexda (motixafortide)

Defines coverage, inclusion and exclusion criteria, and utilization management authority for Aphexda (motixafortide) requests processed by Evolent Specialty Services/Neighborhood Health Plan of Rhode Island, including FDA-labeled use for hematopoietic stem cell mobilization in multiple myeloma and criteria for continuation and investigational/off-label use.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAphexda (motixafortide)

Policy CodePolicy N/A

Change Typeclarified

Effective DateNov 29, 2024

Next Review Date

Key ActionEvolent Specialty Services (UM) is responsible for processing all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

POLICY UPDATE CHANGES

Committee reviewed and approved Aphexda (motixafortide) policy on 11/13/24 with effective date 11/29/24.

1Covered Indications (explicit)

3Exclusion criteria items

1Continuation exemption rule set

Coverage Summary

Coverage stance: covered_with_criteria. Scope:

This policy governs Aphexda (motixafortide) use primarily for hematopoietic stem cell mobilization in multiple myeloma in combination with G-CSF. Effective date: 2024-11-29. Last review: 2024-11-13.

Initial Therapy Criteria

Approved Indication - Hematopoietic Cell Mobilization

Aphexda (motixafortide) is covered when used in combination with filgrastim (G-CSF) for the following ALL of the following:

ALL of the following

Indication: Mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation
Patient diagnosis: Multiple myeloma
Used in combination with filgrastim (G-CSF)

Continuation Therapy Criteria

Continuation Requests Exemption Criteria

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 30 days lapse
Additional medication(s) are not being added to the continuation request

Unproven / Exclusions

Exclusion Criteria (Not Approvable)

Aphexda is NOT approvable when ANY of the following apply:

ANY of the following

Disease progression while taking Aphexda (motixafortide)
Dosing exceeds single dose limit of Aphexda (motixafortide) 1.25 mg/kgsingle dose > 1.25 mg/kg
Investigational use with an off-label indication that is not sufficient in evidence or is not generally accepted by the medical community

Evidence insufficiency criteria (defines 'not sufficient')

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 cited: e.g., HR < 0.80; OS/PFS benefit < 3 months not considered sufficient)HR < 0.80; OS/PFS < 3 months
ASCO definitions cited
Experimental design is inappropriate to address the investigative question
Non-randomized trials with insufficient subject numbers or case reports/meeting abstracts without full peer-reviewed articles are inadequate to support use

Provider Actions

Prior Authorization

Prior authorization required

Evolent Specialty Services (UM) is responsible for processing all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Support with recognized evidence

Use must be supported by FDA approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial for investigational/off-label use lacking sufficient evidence

Requests for off-label indications lacking adequate supportive evidence (per the policy’s evidence sufficiency criteria—e.g., inadequate representation of patient/therapy characteristics in published evidence, outcomes not clinically meaningful, inappropriate experimental design, reliance on case reports or abstracts without full peer‑reviewed articles) are exclusionary and may be denied.

Key operational threshold: single dose limit of Aphexda (motixafortide) is <= 1.25 mg/kg. This dosing threshold is an explicit operational limit and should be confirmed on all dosing requests.

Background

Background: This policy governs Aphexda (motixafortide) primarily for hematopoietic stem cell mobilization in multiple myeloma when used in combination with filgrastim (G-CSF). Continuation requests may be exempt when all specified continuation criteria are met (no disease progression on the medication; used within the last year without >30 day lapse of active authorization; no additional medications are being added). Use must align with FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Definition - Continuation request exemption: A continuation request for a medication deemed not-approvable that meets all three specified conditions: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.