BlueCross and BlueShield of Montana Medical Policy/Codes
Plerixafor Injection (Mozobil)
Chapter: Drugs - Medical Benefit
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Description

On December 15, 2008, the U.S. Food and Drug Administration (FDA) approved plerixafor injection (Mozobil™) as an orphan drug to mobilize or increase the number of hematopoietic stem cells within the peripheral blood required for collection and subsequent autologous stem cell infusion following ablative therapy, for the treatment of non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).  Plerixafor is given in conjunction with a granulocyte-colony stimulating factor (G-CSF).  (1, 2, 6, 7)  It is manufactured by Genzyme Corporation, Cambridge, Massachusetts.  (1)

An orphan drug (orphan product designation [OPD]) is defined in the 1984 amendments of the Orphan Drug Act as "a drug intended to treat a condition affecting fewer than 200,000 persons in the United States or will not recover development cost, plus a reasonable profit, within seven years following FDA approval.  The Orphan Drug Act was signed into law on January 4, 1983."

Policy

Prior authorization is recommended. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-441-4624. A retrospective review will be performed if services are not prior authorized.

Medically Necessary

BCBSMT may consider plerixafor injection (Mozobil™), when given in conjunction with a granulocyte-colony stimulating factor (G-CSF) in preparation for autologous stem cell harvesting, medically necessary for the following indications:

  • Non-Hodgkin’s lymphoma (NHL), and
  • Multiple myeloma (MM).

Investigational

BCBSMT considers all other use of plerixafor injection (Mozobil™) experimental, investigational and unproven, including but not limited to the treatment of:

  • Acute myeloid leukemia,
  • Germ cell tumors,
  • Hodgkin’s disease,
  • Liver failure, acute,
  • Lung cancer,
  • Neuroblastoma, metastatic,
  • Testicular cancer,
  • Thalassemia major, or
  • WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome.

Federal Mandate

Federal mandate prohibits denial of any drug, device, or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone. Call the BCBSMT FEP Customer Service Department at 1-800-634-3569 for benefit information.

Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. BCBSMT recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

The efficacy and safety of plerixafor in combination with granulocyte-colony stimulating factor (G-CSF) in non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM) were evaluated in two placebo-controlled studies (Studies 1 and 2).  Patients were randomized to receive either plerixafor 0.24 mg/kg or placebo each evening prior to apheresis.  All patients received G-CSF 10 micrograms/kg daily for four-days prior to the first dose of plerixafor or placebo and prior to apheresis.  Results from 298 patients with NHL from Study 1 and 302 patients with MM from Study 2 were analyzed.  The FDA orphan product designation (OPD) was based upon these two studies.  (1, 3, 6)

In Study 1, 59% of patients with NHL who were mobilized with plerixafor and G-CSF collected > 5 X 106 CD34+ cells/kg from the peripheral blood in four or fewer apheresis sessions compared with 20% of patients who were mobilized with placebo and G-CSF (p < 0.001).  The median number of days to reach > 5 x 106 CD34+ cells/kg was three-days for the plerixafor group and not evaluable for the placebo group.  (1, 3, 4)

In Study 2, 72% of  patients with MM who were mobilized with plerixafor and G-CSF collected > 6 X 106 CD34+ cells/kg from the peripheral blood in two or fewer apheresis sessions compared with 34% of patients who were mobilized with placebo and G-CSF (p <0.001).  The median number of days to reach > 6 x 106 CD34+ cells/kg was one-day for the plerixafor group and four-days for the placebo group.  (1, 3, 4)

Safety data for plerixafor in combination with G-CSF were obtained from 983 patients enrolled in 16 clinical studies (593 patients enrolled in randomized Studies 1 and 2 plus 410 patients enrolled in 14 additional non-randomized studies).  Patients were primarily treated with plerixafor at daily doses of 0.24 mg/kg subcutaneously.  Median exposure to plerixafor was two-days (range one- to seven-days). (1)

Clinical trials are currently being conducted in the United States to determine the efficacy of plerixafor for the mobilization of stem cells to treat other types of cancers, including but not limited to small cell lung carcinoma.  (5)  

2012 Update

This medical policy has been updated with a literature review through May 2012.

The FDA labeled indications remains unchanged from the previous update.  Treatment using Mozobil for acute myeloid leukemia, germ cell tumors, Hodgkin’s disease, acute liver failure, lung cancer, metastatic neuroblastoma, testicular cancer, thalassemia major, or WHIM (wars, hypogammaglobulinemia, infections, and myelokathexis) syndrome are under investigation in clinical studies in both human and animal models. (8-20) Therefore, based on available evidence use of Mozobil is considered experimental, investigational and unproven for all other treatment indications, which are not included in the FDA labeling.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

162.3, 162.4, 162.5, 162.8, 162.9, 183.0, 183.9, 186.0, 186.9, 194.0, 194.1, 194.3, 194.4, 194.5, 194.6, 194.8, 194.9, 200.0, 200.1, 200.2, 200.3, 200.4, 200.5, 200.6, 200.7, 200.8, 201.40, 201.41, 201.42, 201.43, 201.44, 201.45, 201.46, 201.47, 201.48, 201.50, 201.51, 201.52, 201.53, 201.54, 201.55, 201.56, 201.57, 201.58, 201.60, 201.21, 201.62, 201.63, 201.64, 201.65, 201.66, 201.67, 201.68, 201.70, 201.71, 201.72, 201.73, 201.74, 201.75, 201.76, 201.77, 201.78, 201.90, 201.91, 201.92, 201.93, 201.94, 201.95, 201.96, 201.97, 201.98, 202.80, 202.81, 202.82, 202.83, 202.84, 202.85, 202.86, 202.87, 202.88, 203.0, 203.00, 203.01, 203.02, 205.00, 205.01, 205.02, 220.0, 222.0, 231.2, 279.06, 279.09, 282.40, 282.41, 282.42, 282.43, 282.44, 282.45, 282.46, 282.48, 282.49, 570, V10.72

Procedural Codes: J2562
References
  1. FDA – Mozobil (plerixafor injection) – Product Information, Label, Approval Letter, News Release.  Food and Drug Administration (2008 December 18).  Available at <http://www.fda.gov> (accessed – 2009 November 10).
  2. Wagstaff, A.J.  Plerixafor: in patients with non-Hodgkin’s lymphoma or multiple myeloma.  Drugs (2009) 69(3):319-26.
  3. Stiff, P., Micallef, I., et al.  Treatment of plerixafor in non-Hodgkin’s lymphoma and multiple myeloma patients to increase the number of peripheral blood stem cells when given a mobilizing regimen of G-CSF: implications for the heavily pretreated patient.  Biology of Blood Marrow Transplantation (2009 February) 15(2):249-56.
  4. DiPersio, J.F., Stadtmauer, E.A., et al.  Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma.  Blood (2009 June 4) 113(23):5720-6.
  5. Burger, J.A., and D.J. Stewart.  CXCR4 chemokine receptor antagonists: perspectives in SCLC.  Expert Opinions in Investigational Drugs (2009 April) 18(4):481-90.
  6. Brave, M., Farrell, A., et al.  FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation.  Oncology (2010) 78(3-4):282-8.
  7. Basak, G.W., Knopinska-Posluszny, W., et al.  Hematopoietic stem cell mobilization with the reversible CXCR4 receptor inhibitor plerixafor (AMD3100) – Polish compassionate use experience.  Annals of Hematology (2011 May) 90(5):557-68.
  8. Saure, C., Wigelt, C., et al.  Plerixafor enables successful hematopoietic stem cell collection in an extensively pretreated patient with testicular cancer.  ACTA Haematologica (2010) 124(4):235-8.
  9. Tuffaha, H., and F.A. Abdel-Rahman.  Successful stem-cell mobilization and transplantation using plerixafor in a patient with a germ cell tumor.  Hematology and Oncology Stem Cell Transplantation (2010) 3(4):203-5.
  10. Mark, A.L., Sun, Z., et al.  Stem cell mobilization is lifesaving in an animal model of acute liver failure.  Annals of Surgery (2010 October) 252(4):591-6.
  11. Wesson, R.N., and A.M. Cameron.  Stem cells in acute liver failure.  Advances in Surgery (2011) 45:117-30.
  12. Heckman, D., Laufs, S., et al.  A Lentiviral CXCR4 overexpression and knockdown model in colorectal cancer cell lines reveals plerixafor-dependent suppression of SDF-induced migration and invasion.  Onkologie (2011) 34(10):502-8.
  13. Burger, J.A., Stewart, D.J., et al.  Potential of CXCR4 antagonists for the treatment of metastatic lung cancer.  Expert Reviews of AntiCancer Therapy (2011 April) 11(4):621-30.
  14. Worel, N., Rosskopf, K., et al.  Plerixafor and granulocyte-colony-stimulating factor (G-CSF) in patients with lymphoma and multiple myeloma previously failing mobilization with G-CSF with or without chemotherapy for autologous hematopoietic stem cell mobilization: the Austrian experience on a named patient program.  Transfusion (2011 May) 51(5):968-75.
  15. Kobold, S., Isernhagen, J., et al.  Plerixafor is effective and safe for stem cell mobilization in heavily pretreated germ cell tumor patients.  Bone Marrow Transplantation (2011 August) 46(8):1053-6.
  16. McDermott, D.H., Liu, Q., et al.  The CXCR4 antagonist plerixafor corrects panleukopenia in patients with WHIM syndrome.  Blood (2011 November 3) 118(18):4957-62.
  17. Dale, D.C., Boylard, A.A., et al.  The CXCR4 antagonist plerixafor is a potential therapy for myelokathexis, WHIM syndrome.  Blood (2011 November 3) 118(18):4963-6.
  18. Yannaki, E., Papayannopoulou, T., et al.  Hematopoietic stem cell mobilization for gene therapy of adult patients with severe thalassemia: results from clinical trials using G-CSF or plerixafor in splenectomized and non-splenectomized subjects.  Molecular Therapy (2012 January) 20(1):230-8.
  19. Modak, S., Cheung, I.Y., et al.  Plerixafor plus granulocyte-colony stimulating factor for autologous hematopoietic stem cell mobilization in patients with metastatic neuroblastoma.  Pediatric Blood Cancer (2012 March) 58(3):469-71.
  20. Uy, G.L., Rettig, M.P., et al.  A phase ½ study of chemosensitization with the CXCR4 antagonist plerixafor in relapsed or refractory acute myeloid leukemia.  Blood (2012 April 26) 119(17):3917-24.
History
May 2013  New 2013 BCBSMT medical policy.  Possibly investigational. 
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Plerixafor Injection (Mozobil)