CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aphexda (motixafortide) — Drug Policy (Hematopoietic Cell Mobilization)

Defines clinical and utilization management criteria for authorization of Aphexda (motixafortide) for hematopoietic stem cell mobilization in multiple myeloma and describes applicable process and evidence standards for coverage decisions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAphexda (motixafortide) — Drug Policy (Hematopoietic Cell Mobilization)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionSubmit prior authorization to Evolent with supporting FDA labeling or recognized compendia/guideline evidence for requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Indications

1.25 mg/kgDose limit

Nov 29, 2024Effective

EvolentApproval Body

Coverage Criteria — Hematopoietic Cell Mobilization

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Coverage criteria — hematopoietic cell mobilization

Covered when ALL of the following are met:

Initial or continuation use for mobilization: Member has indication of hematopoietic stem cell mobilization in combination with filgrastim (G-CSF) for collection and subsequent autologous transplantation in multiple myeloma.

Based on FDA‑approved indication for hematopoietic cell mobilization.

Continuation exemption conditions: For continuation requests, 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 active authorization; and no additional medications are being added to the continuation request.

Continuation exemption per policy inclusion criteria.

Dose limit: Dosing does not exceed the single dose limit of 1.25 mg/kg.<= 1.25 mg/kg

Exceeding the single dose limit is exclusionary.

Requests for Aphexda (motixafortide) will be excluded when any of the following apply: disease progression occurred while the member was taking Aphexda; the ordered dosing exceeds the single dose limit of 1.25 mg/kg; or the requested use is investigational — including off‑label indications that lack sufficient supporting evidence or are not generally accepted by the medical community. The policy defines insufficient evidence as inadequate representation of patient or cancer characteristics in the literature, inadequate representation of the concomitant oncologic regimen, lack of clinically meaningful outcomes (for example, survival benefits meeting ASCO standards), inappropriate experimental design for the question, reliance solely on uncontrolled case reports or abstracts, or other evidence gaps that fall short of CMS‑recognized compendia or acceptable peer‑reviewed literature.

Off‑label uses of Aphexda will be considered not covered unless supported by sufficient evidence as required by this policy. Sufficient evidence must be consistent with CMS‑recognized compendia or acceptable peer‑reviewed literature and should demonstrate that the patient and cancer characteristics and the administered oncologic regimen are adequately represented, that study outcomes are clinically meaningful (e.g., meeting ASCO thresholds such as hazard ratios and minimum survival benefit where applicable), and that study design is appropriate. Case reports and meeting abstracts without full peer‑reviewed publication generally do not meet the evidence threshold.

Prior Authorization, Documentation, and Decision Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for all medication requests for Aphexda (motixafortide). Evolent is responsible for processing all requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Final approval authority resides with the Utilization Management Committee/Utilization Management.

All requests must be submitted to Evolent for prior authorization.
Medications not authorized by Evolent may be denied and not reimbursed.
Supporting evidence must include FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards.

Documentation Required

Continuation Request Conditions

Continuation (renewal) requests may be processed without reapplying the full initial authorization criteria when all of the following are met: the member has not experienced disease progression while receiving the requested medication; the medication was used within the last year with no lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

Continuation exemptions apply only if there has been no disease progression on the requested medication.
There must be an active authorization within the past year and no gap >30 days.
No new medications can be added to the continuation request for the exemption to apply.

Denial Risk

Denial Triggers / Exclusion Criteria

Requests will be denied when exclusion criteria are met, including but not limited to: documented disease progression while on Aphexda; dosing that exceeds the single-dose limit of 1.25 mg/kg; or use for investigational or off-label indications lacking sufficient evidence (i.e., not supported by CMS compendia, NCCN/ASCO guidelines, FDA labeling, or qualifying peer-reviewed literature). Sufficient evidence considerations include representativeness of patient and regimen, clinically meaningful outcomes (ASCO benchmarks), appropriateness of study design, and the strength of the published evidence.

Disease progression on Aphexda is a basis for denial.
Single dose >1.25 mg/kg will be denied.
Off-label or investigational uses lacking adequate supporting evidence (per CMS compendia, NCCN/ASCO, FDA labeling, or acceptable peer-reviewed literature) will be denied.
Peer-reviewed evidence is evaluated for patient/regimen representation, meaningful clinical outcomes (e.g., HR <0.80; OS/PFS benefit ≥3 months per ASCO), study design appropriateness, and strength of evidence (case reports/abstracts generally insufficient).

Initial Therapy Criteria

Initial therapy — Initial use must meet indication and be supported by recognized evidence

Initial use must meet indication and be supported by recognized evidence:

Approved indication: Use in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in multiple myeloma per FDA labeling.

Support by FDA label, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature is required.

Continuation Therapy Criteria

Continuation therapy — Continuation requests for previously authorized therapy may be exempt from reauthorization when all conditions are met

Continuation requests for previously authorized therapy may be exempt from reauthorization when all conditions are met:

Continuation conditions: Member has not experienced disease progression on the requested medication; medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

When all conditions are satisfied, continuation requests are exempt from this policy per Evolent criteria.

Continuation exemption conditions
Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of active authorization
No additional medication(s) are being added to the continuation request

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAphexda (motixafortide) — Drug Policy (Hematopoietic Cell Mobilization)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionSubmit prior authorization to Evolent with supporting FDA labeling or recognized compendia/guideline evidence for requests.

SourceLink

On This Page

OpenPayer

Aphexda (motixafortide) — Drug Policy (Hematopoietic Cell Mobilization)

Coverage Criteria — Hematopoietic Cell Mobilization

Coding and Dose Limits

Prior Authorization, Documentation, and Decision Triggers

Clinical Background

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy / Continuation Exemptions

Quantity and Dosing Limits

Administration Setting