Plerixafor
Customize your policy alerts
Sign up for Aetna Policy 0779 alerts
Get alerted when Policy 0779 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity criteria, dosing information, coding, and background evidence for plerixafor (Mozobil or generic) used to mobilize hematopoietic stem cells prior to autologous transplantation, primarily affecting clinicians and billing staff managing patients with non-Hodgkin lymphoma or multiple myeloma.
No material clinical or coverage changes in this revision.
Coverage Criteria for Plerixafor (Mozobil)
inv-01: Initial Approval — Hematopoietic Stem Cell Mobilization — Covered when ALL of the following are met
Covered when ALL of the following are met
inv-02: Continuation of Therapy — continuation criteria node
Includes member transfers/new members who meet initial criteria.
inv-03: FDA-approved indication — adults with MM or NHL — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Based on pivotal randomized trials demonstrating improved CD34+ yields and collection outcomes with plerixafor + G-CSF versus placebo + G-CSF (Studies 1 and 2).
Trials used G-CSF 10 μg/kg daily prior to and during apheresis; dosing and timing per FDA-approved regimen.
inv-04: Remobilization or inadequate prior mobilization (non-hematologic or pediatric reports) — Considered medically reasonable when ALL apply
Considered medically reasonable (case series and small studies) when ALL of the following apply:
Published series report successful remobilization when plerixafor is added after prior mobilization attempts.
Evidence largely from small case series and reports; use reserved for remobilization scenarios.
inv-05: Investigational or adjunctive oncology uses — Not established/experimental
Not established/experimental — use only in clinical trials or with strong justification:
Preliminary phase I/II data exist but require validation; leukemia mobilization is contraindicated for standard harvests.
Evidence limited to early-phase trials, preclinical studies, or in-silico screens.
inv-06: Other Indications — investigational/insufficient evidence
Plerixafor use outside approved stem cell mobilization indications is described in multiple early-phase studies and preclinical reports; coverage is contingent on robust clinical evidence and is generally considered investigational.
Aetna considers plerixafor (Mozobil) experimental and investigational for all indications other than mobilization for autologous transplantation in non‑Hodgkin lymphoma and multiple myeloma because effectiveness for other uses has not been established.
Plerixafor is not intended for hematopoietic stem cell mobilization and harvest in patients with leukemia because it may mobilize leukemic cells and contaminate the apheresis product; this contraindication can lead to denial of coverage for leukemia indications.
Most other reported indications for plerixafor are supported only by preclinical data, early‑phase clinical reports, case series, or single‑center observational studies and therefore require further clinical trials and validation; as such they are effectively excluded from routine coverage.
Use of plerixafor for antibody‑mediated lung transplant rejection and as an antiviral for dengue or West Nile virus is not established; current reviews and screening studies identify these as emerging or hypothesis‑generating areas but provide insufficient evidence to support medical necessity.
Several indications are supported only by in‑silico analyses, preclinical models, hypothesis‑generating reports, or very small early‑phase clinical studies (for example, malaria, post‑herpetic neuralgia, and various oncology settings); these uses remain investigational and require additional validation before they can be considered medically necessary.
Coding and Billing
| 38205 | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic |
| 38206 | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous |
| 38230 | Bone marrow harvesting for transplantation; allogeneic |
| 38232 | Bone marrow harvesting for transplantation; autologous |
| 38240 | Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor |
| 38241 | Hematopoietic progenitor cell (HPC); autologous transplantation |
| 96372 | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular |
| J2562 | Injection, plerixafor, 1 mg [Mozobil] |
| J1442 | Injection, filgrastim (G-CSF), excludes biosimilars, 1 microgram |
| J1447 | Injection, tbo-filgrastim, 1 microgram [Granix, Neutroval] |
| J2505 | Injection, pegfilgrastim, 6 mg |
| J2506 | Injection, pegfilgrastim, excludes biosimilar, 0.5 mg |
| J2820 | Injection, sargramostim (GM-CSF), 50 mcg |
| Q5110 | Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram |
| Q5111 | Injection, Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg |
| C82.00 | |
| C82.99 | |
| C83.00 - C83.99 | Lymphosarcoma and related malignant tumors of lymphatic tissue |
| C84.00 - C84.99 | Other malignant neoplasms of lymphoid and histiocytic tissue |
| C88.4 | |
| C88.8 - C90.32 | Malignant immunoproliferative diseases and multiple myeloma |
| C91.40 - C91.42 | |
| C96.0 - C96.9 |
| A90 | Dengue fever |
| A91 | Dengue hemorrhagic fever |
| A92.30 - A92.39 | West Nile virus infection |
| C33 - C34 | Malignant neoplasm of trachea, bronchus, and lung |
| C53.0 - C53.9 | Malignant neoplasm of cervix uteri |
| C71.0 - C71.9 | Malignant neoplasm of brain [glioma] |
| C91.00 - C91.02 | Acute lymphoblastic leukemia [ALL] |
| D57.00 - D57.819 | Sickle-cell disorders |
| D70.0 - D70.9 | Neutropenia [treatment or prophylaxis] |
Provider Responsibilities, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for HCPCS J2562 (plerixafor, 1 mg) and associated injection/procedure codes when used for hematopoietic progenitor cell (HPC) mobilization prior to transplantation. Follow Aetna prior authorization processes and submit requests before therapy initiation.
Prior Authorization for plerixafor (Mozobil)
Plerixafor (Mozobil) is FDA-approved for use in combination with G-CSF for mobilization of hematopoietic stem cells in adults with multiple myeloma (MM) or non-Hodgkin lymphoma (NHL). Prior authorization should document the indication and planned use with G-CSF per the FDA regimen.
- FDA indication: adults with MM or NHL in combination with G-CSF (Genzyme PI)
- Document that plerixafor will be given per approved regimen (e.g., evening doses after G-CSF)
- Evidence: phase 3 trials demonstrating improved CD34+ collection with plerixafor + G-CSF
Plerixafor for HPC Mobilization (Amyloidosis)
Plerixafor plus G-CSF has been used for HPC mobilization in light chain (AL) amyloidosis and reported as safe and effective in cohort studies; include this context in authorization requests when mobilization is for AL amyloidosis prior to transplant.
- AL amyloidosis data: cohort of 53 patients with good collection yields and acceptable toxicity (Badar et al., 2019)
- These findings require validation in larger controlled studies but may support individual clinical justification
G-CSF or Chemo-mobilization Prerequisite
Plerixafor must be administered after the member has received G-CSF or chemo-mobilization prior to authorization; requests should state prior mobilization regimen and timing relative to planned plerixafor dosing.
- Prerequisite: G-CSF (e.g., filgrastim) or chemo-mobilization completed before plerixafor per policy criteria
- Typical regimen: G-CSF daily for 4 days prior to first plerixafor dose (per FDA studies)
Step Therapy Context
Step therapy context: evidence supports plerixafor plus G-CSF, particularly for patients who fail initial mobilization with G-CSF ± chemotherapy. No explicit step-therapy sequence is defined in this policy, but prior mobilization attempts and rationale should be documented.
- Studies show lower failure rates with G-CSF + plerixafor versus G-CSF alone
- Document prior mobilization attempts (dates, regimens, and outcomes) when applicable
- No formal step sequence mandated by policy
Mobilization Alternative in SCD
Plerixafor has been explored as an alternative mobilization strategy in sickle cell disease (SCD) due to the vaso-occlusive risk associated with G-CSF; include this consideration and any relevant trial identifiers in authorization notes.
- Preclinical and early clinical data suggest plerixafor may mobilize HPCs without vaso-occlusion seen with G-CSF
- Clinical trials in SCD (e.g., NCT02193191) are ongoing — use in SCD should be justified with supporting data
Required Clinical Documentation
Required clinical documentation: Prior authorization requests must include indication (MM, NHL, or specific off-label justification such as AL amyloidosis), planned combination with G-CSF per regimen, prior mobilization attempts and outcomes, and intended dosing schedule for harvest.
- Indication and transplant intent (mobilization for collection prior to transplantation)
- Confirmation that G-CSF or chemo-mobilization was given prior to plerixafor
- Details of prior mobilization failures (if any) including CD34+ yields and dates
- Planned plerixafor dosing schedule and duration (not to exceed 4 consecutive days or beyond completion of harvest)
Trial Dosing and Pharmacokinetic Documentation
Trial dosing and pharmacokinetic documentation: clinical trial regimens and pharmacokinetic data (e.g., 0.24 mg/kg evening dosing in phase 3 trials; PK/CSF/tissue levels in early glioma studies) may be referenced to support dosing rationale — include trial details when relevant.
- Phase 3 studies used plerixafor 0.24 mg/kg given each evening prior to apheresis after G-CSF priming
- Early-phase glioma studies report higher dose ranges (example: 320 µg/kg) with PK sampling — include such data only when supporting investigational use
References to Prescribing Information and Clinical Guidelines
References that should be included or cited in authorization/supporting documentation: Genzyme (Mozobil) prescribing information, NCCN Drugs & Biologics Compendium, HCT and IMWG guidelines, and key clinical studies showing efficacy of plerixafor + G-CSF.
- Genzyme Corporation. Mozobil (plerixafor) Prescribing Information (latest revision)
- NCCN Drugs & Biologics Compendium — Plerixafor (January 2023)
- IMWG and HCT consensus/guidelines and pivotal clinical trials (Pusic 2008; Genzyme Phase 3 studies)
Indication-Based Denial Risk, Investigational Use, and Contraindication (Leukemia)
Indication-based denial risk and investigational use: Requests for indications other than mobilization prior to transplantation (or indications listed as appropriate in policy) are subject to denial as experimental/investigational. Use in leukemia is contraindicated due to risk of mobilizing leukemic cells and potential contamination of the apheresis product.
- Experimental/Investigational indications include leukemia, many solid tumors, SCD (outside trial context), and others listed in the policy
- Contraindication: leukemia — plerixafor may mobilize leukemic cells and is not intended for HSC mobilization in leukemia patients
- Policy denials may be issued when requested use is outside approved/medically necessary criteria
No Explicit Denial Triggers Stated
Administrative note: The policy does not list explicit single denial triggers beyond the stated coverage criteria; Clinical Policy Bulletins (CPBs) do not guarantee coverage. Adjudication follows standard Aetna medical necessity review processes.
- No explicit additional denial triggers are specified in this CPB
- Coverage determinations are made case-by-case and prior authorization approval does not guarantee payment
Dosing Regimens and Supported Combinations
| Regimen | Indication / Setting | Timing / Notes | Coverage status |
|---|---|---|---|
| Plerixafor 0.24 mg/kg subcutaneously (given evening prior to apheresis) plus G-CSF (e.g., G-CSF 10 µg/kg daily) | |||
| Stem cell mobilization for autologous transplantation in adults with multiple myeloma (MM) or non-Hodgkin lymphoma (NHL) | |||
| Plerixafor administered each evening prior to planned apheresis after daily G-CSF for at least 4 days; dosing and schedule per pivotal trials (approximately 11 hours prior to apheresis) | |||
| Covered |
| Regimen | Indication / Setting | Timing / Notes | Coverage status |
|---|---|---|---|
| Single‑agent plerixafor (subcutaneous) with apheresis performed ~4–6 hours after dose | |||
| Investigational mobilization approach for patients where G-CSF/chemomobilization is contraindicated or in pediatric/solid tumor contexts (case series and small studies) | |||
| Small series used single‑agent subcutaneous plerixafor followed by apheresis 6 hours later; further study recommended to optimize route, timing, and yield | |||
| Experimental |
| Regimen | Indication / Setting | Timing / Notes | Coverage status |
|---|---|---|---|
| Plerixafor 320 µg/kg subcutaneously on days 1–21 plus bevacizumab 10 mg/kg IV on days 1 and 15 of each 28‑day cycle | |||
| Phase I dose‑escalation regimen evaluated in recurrent high‑grade glioma (recurrent HGG) patients | |||
| Part 1 used a 3x3 escalation to a maximum tolerated dose (plerixafor 320 µg/kg days 1–21); plasma, CSF and tumor penetration assessed; no DLTs at MTD reported | |||
| Experimental |
| Regimen | Indication / Setting | Timing / Notes | Coverage status |
|---|---|---|---|
| Plerixafor administered in combination with G‑CSF and/or added to regimens containing bortezomib and cyclophosphamide | |||
| Used in difficult‑to‑mobilize patients, including dialysis‑dependent multiple myeloma and other case‑series populations where prior mobilization yielded low CD34+ counts | |||
| Case reports/series describe adding plerixafor to prior regimens (e.g., bortezomib + cyclophosphamide) to markedly increase CD34+ yields (one report noted a 6‑fold increase); evidence is limited to small observational reports | |||
| Experimental |
Line of Therapy Context
inv-42: first-line | salvage — 1 top-level node
Trials support both first-line efficacy and improved remobilization outcomes.
inv-43: salvage — 1 top-level node
Primarily a salvage/experimental setting.
Biomarker and Laboratory Thresholds
Definitions
Background and Evidence Summary
Plerixafor (Mozobil) is a CXCR4 antagonist that disrupts SDF‑1α/CXCR4 interactions to mobilize hematopoietic stem cells (HSCs) into the peripheral blood for collection and subsequent autologous transplantation. It is FDA‑approved for use in combination with granulocyte‑colony stimulating factor (G‑CSF) in adults with multiple myeloma or non‑Hodgkin lymphoma and is supplied for subcutaneous injection; pivotal trials and the prescribing information describe its administration approximately 11 hours before apheresis and use for up to 4 consecutive days in the mobilization setting.
Revision History
Policy reviewed by Aetna (last review date recorded).
Policy became effective for plerixafor coverage criteria and prior authorization processes.
Target date set for the next policy review (next review).
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.