Mozobil (plerixafor)
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Clinical coverage criteria for use of Mozobil (plerixafor) to mobilize hematopoietic stem cells for autologous (and select allogeneic donor) transplantation and for use during development of ex vivo gene therapy; applies to Anthem medical benefit review and prior authorization. Affects providers requesting Mozobil for eligible patients or donors.
Wording and formatting criteria updates; coding reviewed and clarification note for billing added; ICD-10-CM C88.9 replaced with C88.90.
Expanded explicit allowance for use of Mozobil in autologous HSC mobilization as part of development of FDA-approved ex vivo gene therapy (e.g., Zynteglo).
Coverage Criteria for Mozobil (plerixafor)
Approved Indications / Pathways
Requests for Mozobil (plerixafor) may be approved if the following criteria are met:
Pediatric approval pathway
Meets labeled dosing and NCCN 2A recommended regimens; start after 4 days of filgrastim and administer ~11 hours before apheresis for up to 4 days; weight-based dosing per label
Per NCCN guidance
Specific allowance for ex vivo gene therapy development
Requests for Mozobil (plerixafor) may be approved when the following criteria are satisfied: the agent is being used to mobilize hematopoietic stem cells for autologous transplantation or related authorized pathways (including use as part of development of an FDA‑approved ex vivo gene therapy such as Zynteglo), the individual has an appropriate diagnosis (for example lymphoma, multiple myeloma, testicular carcinoma, or other diagnoses for which autologous HSC transplant is indicated), a subsequent autologous HSC transplant is anticipated when applicable, Mozobil is used in combination with an approved mobilization regimen (for example filgrastim/pegfilgrastim or chemotherapy plus growth factor per NCCN/labeling), and dosing/administration limits are respected (see limits below). Prior authorization is required and will be granted only when these documented criteria are met.
Requests will not be approved when Mozobil is used to mobilize leukemic cells or when the listed clinical criteria are not met. Requests for any other indications beyond those explicitly allowed are also not approved.
| Regimen | Notes |
|---|---|
| Mozobil (plerixafor) in combination with filgrastim (or biosimilar or tbo‑filgrastim) or pegfilgrastim (or biosimilar) | Per labeling and NCCN 2A recommendations: used with daily G‑CSF (filgrastim/pegfilgrastim or biosimilars) for stem cell mobilization prior to apheresis. |
| Mozobil in combination with cyclophosphamide plus filgrastim (or biosimilar or tbo‑filgrastim) or sargramostim | Chemo‑mobilization regimen pairing cyclophosphamide with growth factor as an accepted NCCN 2A combination. |
| Mozobil with filgrastim (or biosimilar or tbo‑filgrastim) plus disease‑specific chemotherapy | Used when disease‑specific chemotherapy is part of the mobilization strategy in addition to G‑CSF. |
| Mozobil used after insufficient collection with prior growth factor alone (filgrastim/pegfilgrastim or biosimilars) or after chemo‑mobilization | Allowed for allogeneic donors or patients with prior inadequate peripheral stem cell collection; administer in combination with G‑CSF per NCCN guidance. |
Coding and Quantity Limits
| J2562 | Injection, plerixafor, 1 mg [Mozobil] |
| C62.00-C62.92 | Malignant neoplasm of testis |
| C81.00-C81.99 | Hodgkin lymphoma |
| C82.00-C88.90 | Non-Hodgkin lymphomas |
| C90.00-C90.32 | Multiple myeloma and malignant plasma cell neoplasms |
| Z52.001 | Unspecified donor, stem cells |
| Z52.011 | Autologous donor, stem cells |
| Z52.091 | Other blood donor, stem cells |
| Z92.86 | Personal history of gene therapy |
| Z94.81 | Bone marrow transplant status |
| Z94.84 | Stem cells transplant status |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required; approval only if documented criteria met
Prior authorization is required for J2562 (plerixafor). Approval is granted only when documented criteria are met, including age or indication, use for autologous or qualified allogeneic donor scenarios, concomitant G-CSF or chemo/G-CSF regimens per NCCN, and adherence to dose/administration limits and maximum injections per cycle.
- Covered HCPCS: J2562
- Approval requires documented planned subsequent autologous HSC transplant when used for autologous mobilization
- Approval requires adherence to maximum Mozobil injections (≤4 doses per cycle; up to 2 cycles for autologous, 1 cycle for allogeneic insufficient collection)
Combination and step requirements — must be given with specified G-CSF or chemo + growth factor regimens
Mozobil must be used in combination with specified growth factor or chemo-mobilization regimens per labeling and NCCN (e.g., filgrastim/pegfilgrastim or biosimilars, cyclophosphamide + filgrastim/sargramostim, filgrastim + disease-specific chemotherapy) or following insufficient collection with growth factor alone for donor rescue.
- Allowed combinations: filgrastim (or biosimilar/tbo-filgrastim) or pegfilgrastim (or biosimilar)
- Or cyclophosphamide plus filgrastim (or biosimilar/tbo-filgrastim) or sargramostim
- Or filgrastim plus disease‑specific chemotherapy
- Or use after insufficient collection from prior growth factor alone (including for allogeneic donors)
Provide supporting diagnosis codes with the request
Submit diagnosis codes that support the indication; examples listed in the policy include testicular cancer, Hodgkin and non-Hodgkin lymphomas, multiple myeloma, and donor/ transplant history and gene therapy Z-codes.
- Examples: C62.00-C62.92 (testis malignancy); C81.00-C81.99 (Hodgkin lymphoma); C82.00-C88.90 (non-Hodgkin lymphomas); C90.00-C90.32 (multiple myeloma)
- Relevant Z-codes: Z52.011 (autologous donor, stem cells), Z52.001 (unspecified donor), Z92.86 (history of gene therapy), Z94.81/Z94.84 (transplant status)
Denial risk: leukemic cell mobilization or failure to meet policy criteria
Requests will not be approved when Mozobil is used to mobilize leukemic cells or when the policy’s required clinical criteria are not met; requests for all other unlisted indications are also not approved.
- Not approved when used to mobilize leukemic cells
- Not approved if the required autologous or allogeneic donor criteria (including combination regimens and maximum injections) are not satisfied
Regimens and Combinations Covered with Mozobil
| Regimen | Notes |
|---|---|
| Mozobil (plerixafor) in combination with filgrastim (or biosimilar or tbo‑filgrastim) or pegfilgrastim (or biosimilar) | Per labeling and NCCN 2A recommendations: used with daily G‑CSF (filgrastim/pegfilgrastim or biosimilars) for stem cell mobilization prior to apheresis. |
| Mozobil in combination with cyclophosphamide plus filgrastim (or biosimilar or tbo‑filgrastim) or sargramostim | Chemo‑mobilization regimen pairing cyclophosphamide with growth factor as an accepted NCCN 2A combination. |
| Mozobil with filgrastim (or biosimilar or tbo‑filgrastim) plus disease‑specific chemotherapy | Used when disease‑specific chemotherapy is part of the mobilization strategy in addition to G‑CSF. |
| Mozobil used after insufficient collection with prior growth factor alone (filgrastim/pegfilgrastim or biosimilars) or after chemo‑mobilization | Allowed for allogeneic donors or patients with prior inadequate peripheral stem cell collection; administer in combination with G‑CSF per NCCN guidance. |
Pre-Transplant Mobilization
pre-transplant mobilization
Timing and dose per product labeling; supports mobilization prior to autologous transplant
Definitions
Background
Plerixafor (Mozobil) is a CXCR4 (chemokine receptor type 4) inhibitor used in combination with granulocyte‑colony stimulating factor (G‑CSF) to mobilize hematopoietic stem cells into the peripheral blood for collection prior to hematopoietic stem cell transplantation. Labeling and guideline‑based practice support initiating Mozobil after approximately 4 days of filgrastim (or equivalent) and administering the drug about 11 hours before apheresis for up to 4 consecutive days. Use is intended for autologous mobilization (including specified gene‑therapy related collection) and for select allogeneic donor scenarios after insufficient prior collection; dosing must follow the documented per‑cycle limits and combination regimens per NCCN and product labeling.
Policy Revision History
Wording and formatting criteria updates; coding reviewed with a clarification note for billing and ICD-10-CM code C88.9 replaced with C88.90.
Annual review completed with no changes to clinical criteria; coding reviewed with no changes.
Added NCCN-recommended combination regimens and allowed use in allogeneic donors for insufficient collection per NCCN; removed 'may not approve' sections regarding allogeneic donors; coding reviewed with no changes.
Expanded criteria to allow use of Mozobil with ex vivo gene therapy; coding updated to add ICD-10-CM Z92.86.
Updated criteria to include all diagnoses for which autologous hematopoietic stem cell transplant is indicated and updated wording/formatting; coding updated to add ICD-10 codes Z52.001, Z52.011, Z52.091, Z94.81, Z94.84.
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