CurrentCignaPolicy IP0698

Hematology - Plerixafor

Cigna coverage policy for use of plerixafor (Mozobil) to mobilize hematopoietic stem cells for collection and subsequent transplantation, applicable to patients with multiple myeloma, non-Hodgkin's lymphoma, and certain stem cell donors under specified conditions.

Policy Summary

PayerCigna

PolicyHematology - Plerixafor

Policy CodePolicy IP0698

Change TypeAnnual review with material updates

Effective Date

Next Review DateNov 1, 2024

Key ActionObtain prior authorization documenting indication, combination with a colony-stimulating factor after ≥4 days of CSF, and that the prescriber is a hematologist or stem cell transplant physician.

SourceLink

POLICY UPDATE CHANGES

For multiple myeloma and non-Hodgkin's lymphoma, the medication must be prescribed by a hematologist or a stem cell transplant physician.

Dosing regimens clarified: for patients ≤83 kg a fixed 20 mg or 0.24 mg/kg once daily; for patients >83 kg up to 40 mg/day (0.24 mg/kg) once daily, given after 4 days of CSF and ~11 hours before apheresis for up to 4 days.

Hematopoietic stem cell donors added as an approvable population with listed criteria and dosing.

Removed prior coverage statements allowing use as a mobilizing agent for an allogeneic stem cell donor and use following myeloablative allogeneic transplant to augment recovery.

WHIM syndrome listed as a condition not covered due to insufficient data.

Policy name updated from 'Plerixafor' to 'Hematology - Plerixafor'.

3approved groups

up to 4max consecutive days

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Coverage Criteria for Plerixafor (Mozobil)

inv-01: FDA-Approved Indications

Plerixafor is considered medically necessary when ONE of the following are met:

FDA-Approved Indications

Multiple Myeloma - Approve for 1 month: A) The agent is utilized for mobilization of hematopoietic stem cells for subsequent autologous transplantation; AND B) Use is in combination with a granulocyte-colony stimulating factor (e.g., filgrastim products such as Granix or Neupogen, including biosimilars); AND C) The medication is prescribed by a hematologist or a stem cell transplant physician.
Dosing: after 4 days of CSF, plerixafor is given approximately 11 hours prior to each apheresis for up to 4 consecutive days. For patients ≤83 kg give 20 mg fixed or 0.24 mg/kg once daily; for patients >83 kg give 0.24 mg/kg up to 40 mg/day once daily.
Non-Hodgkin's Lymphoma - Approve for 1 month: A) The agent is utilized for mobilization of hematopoietic stem cells for subsequent autologous transplantation; AND B) Use is in combination with a granulocyte-colony stimulating factor (e.g., filgrastim products such as Granix or Neupogen, including biosimilars); AND C) The medication is prescribed by a hematologist or a stem cell transplant physician.
Dosing: after 4 days of CSF, plerixafor is given approximately 11 hours prior to each apheresis for up to 4 consecutive days. For patients ≤83 kg give 20 mg fixed or 0.24 mg/kg once daily; for patients >83 kg give 0.24 mg/kg up to 40 mg/day once daily.

inv-02: Other Uses with Supportive Evidence

Hematopoietic Stem Cell Donors - Approve for 1 month: A) Patient meets ONE of: i) used for mobilization of hematopoietic stem cells for subsequent autologous transplantation (meeting applicable autologous donor criteria in policy) OR ii) used for mobilization for subsequent allogeneic transplantation; AND B) The medication is prescribed by a hematologist or a stem cell transplant physician.

Use in combination with a colony stimulating factor; dosing: after 4 days of CSF, give plerixafor approximately 11 hours prior to each apheresis for up to 4 consecutive days. For patients ≤83 kg give 20 mg fixed or 0.24 mg/kg once daily; for patients >83 kg give 0.24 mg/kg up to 40 mg/day once daily.

Any use of plerixafor outside the specified FDA‑approved indications and the other uses supported by evidence in this policy is considered experimental, investigational, or unproven. The policy explicitly lists certain conditions that are excluded from coverage, including leukemia and WHIM syndrome.

Plerixafor is not covered for use in patients with leukemia. The policy states that plerixafor may mobilize leukemia cells and thereby risk contamination of the products collected during apheresis; therefore it is not intended for hematopoietic stem cell mobilization and harvest in leukemia patients.

Use of plerixafor for WHIM syndrome (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) is listed as not covered / insufficient evidence. The policy notes that available data are inadequate to support this indication and further study is required; WHIM syndrome was explicitly added to the Conditions Not Covered list in the most recent annual review.

Regimen	Dosing and administration
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Regimen

Dosing and administration

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Coding and Collection Targets

Considered Medically Necessary when criteria metHCPCSCovered

J2562

Injection, plerixafor, 1 mg

Stem cell collection targets

Minimum collection target2 x 10^6 CD34+ cells/kg

Recommended collection target (preferred)3 to 5 x 10^6 CD34+ cells/kg

Context/sourceASBMT and consensus guidelines for autologous stem cell transplant

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Plerixafor (J2562) will be approved only when the documented indication meets the medical necessity criteria in this policy and a prior authorization has been obtained before the service is rendered.

Code: J2562 — Injection, plerixafor, 1 mg

Documentation Required

Required Concomitant Colony-Stimulating Factor (CSF)

Plerixafor must be used in combination with a granulocyte-/colony-stimulating factor (for example, filgrastim products such as Granix, Neupogen, or related biosimilars). The colony-stimulating factor should be given for at least 4 days prior to initiation of plerixafor; plerixafor is then administered approximately 11 hours prior to each apheresis and may be given for up to 4 consecutive days per mobilization attempt.

Examples of CSFs: filgrastim (Neupogen, Granix) and related biosimilars
CSF administered ≥ 4 days before first plerixafor dose; plerixafor ~11 hours before apheresis; up to 4 consecutive days

Background

Plerixafor is a hematopoietic stem cell mobilizer used in combination with a granulocyte‑colony stimulating factor (G‑CSF) to move CD34+ hematopoietic stem cells from the bone marrow into the peripheral blood for collection by apheresis prior to transplantation. It is indicated for mobilization before autologous transplantation in patients with multiple myeloma or non‑Hodgkin's lymphoma and may be used for selected stem cell donors under policy criteria. Collection targets referenced in guidelines are a minimum of 2 x 10^6 CD34+ cells/kg with a preferred target of 3 to 5 x 10^6 CD34+ cells/kg. Per the policy, plerixafor is given in combination with G‑CSF after at least 4 days of CSF, administered approximately 11 hours before apheresis for up to 4 consecutive days, with weight‑based dosing specified in the criteria.

Definitions and Targets

Recommended and minimum CD34+ collection targets

Recommended CD34+ collection target3 to 5 x 10^6 CD34+ cells/kg

Minimum acceptable CD34+ collection2 x 10^6 CD34+ cells/kg

Guideline basisASBMT consensus and autologous stem cell mobilization recommendations

Line of Therapy / Salvage Use

inv-14: Salvage

Use for autologous transplantation mobilization (salvage): Indicated in combination with G-CSF to mobilize hematopoietic stem cells to peripheral blood for collection and subsequent autologous transplantation in patients with NHL or multiple myeloma; consider for donors if insufficient collection with G-CSF (NCCN category 2A).

Guideline-supported use as a salvage strategy for mobilization when prior collection is inadequate.

Revision History and Policy Changes

2024-11-01Annual review - multiple substantive policy updatesLatest

Policy updated: title changed from 'Plerixafor' to 'Hematology - Plerixafor'; prescriber restriction added requiring a hematologist or stem cell transplant physician for multiple myeloma and non-Hodgkin's lymphoma; dosing and timing clarified for weight-based regimens and administration up to 4 days; hematopoietic stem cell donors added as an approvable population with dosing; specific prior covered contexts removed and WHIM syndrome added to conditions not covered.

Coding clarification

Listed HCPCS code J2562 (Injection, plerixafor, 1 mg) included as the relevant billing code when criteria are met.