Mozobil (Plerixafor) Effective Date Begin: March 4, 2009 Effective Date End: Original Date: March 4, 2009 Review Date(S): March 3, 2010 March 4, 2009

Pharmacy Policy Bulletin

Category: Prior Authorization Number: J-125 Subject: Mozobil (plerixafor) Effective Date Begin: March 4, 2009 Effective Date End: Original Date: March 4, 2009 Review Date(s): March 3, 2010 March 4, 2009

Policy applies to: Commercial and Medicare plans

Background:

Plerixafor is a hematopoietic stem cell mobilizer, indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).

Multiple myeloma (MM) consists of the accumulation of malignant plasma cells in the bone marrow. As of 2003, the overall 5-year survival rate reported by the Surveillance Epidemiology and End Results Database was 34%. Treatment of patients with active MM, stage II or higher consists of induction chemotherapy followed by high dose chemotherapy with autologous hematopoietic stem cell transplant (auHSCT). In clinical trials, auHSCT achieved higher complete response rates, event free survival or overall survival compared to conventional chemotherapy. Accordingly the NCCN practice guidelines classifies auHSCT as a category I recommendation as follow up treatment to induction therapy.

Non-Hodgkin's lymphoma

Non-Hodgkin's lymphoma (NHL) represents a heterogeneous group disorder originating in B, T and natural killer lymphocytes. The B- cell lymphomas represent about 80-85% and the T- cell lymphomas represent 15-20% of cases reported in the U.S. NGL is the fifth leading site of new cancer cases and is the ninth leading cause of cancer related deaths among men and the sixth among women. Autologous HSCT along with high dose chemotherapy are recommended treatment options in patients with NHL how have relapsed or are refractory after standard therapy.

Current Guidelines for auHSCT

According to the American Society for Clinical Oncology (ASCO), a growth factor with or without chemotherapy are considered the standard of care for peripheral blood stem cell mobilization. Both G-CSF and GM-CSF are FDA approved for mobilization. A minimum of > 2 000 000 CD34+ cells/kg are preferred for auHSCT. Clinical trials have shown a positive correlation between CD34+ cell counts and faster neutrophil and platelet recovery. Cell counts of > 5 000 000 CD34+ cells/kg has been shown to decrease length of hospitalization, decrease the number of blood transfusions and antibiotic use in auHSCT patients. Phase III clinical trials have demonstrated that the addition of plerixafor to G-CSF results in significantly higher proportion of NHL and MM patients collecting a target number of stem cells ( > 5 000 000 CD34+ and > 6 000 000 CD34+ cells/kg, respectively ) for transplantation, and in fewer apheresis days, compared to G-CSF alone.

Approval Criteria: When a benefit, plerixafor may be approved when all of the following criteria are met:

1. Plerixafor is to be prescribed under the supervision of an oncologist/hematologist. 2. Plerixafor is to be used in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma or non-Hodgkin's lymphoma.

Use of plerixafor for diseases outside of its FDA approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

Duration of Authorization:

If approved, authorization should be granted for a period of up to one year.

References:

1. Mozobil (plerixafor) [Prescribing Information]. Genzyme Corporation. Cambridge:MA. December 2008. 2. Brenner H, Dondos A, Pulte D. Recent major improvement in long-term survival of younger patients with multiple myeloma. Blood 2008; 111:2521-26. 3. Kumar SR, Rajkumar SV, Dispenzieri A et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood 2008; 111:2516-20. 4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Multiple Myeloma. V.2. 2009. Available at: http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf. 5. Jemal A, Siegel R, Ward E et al. Cancer Statistics, 2008. CA Cancer S J Clin 2008;58:71-96. 6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Non-Hodgkin's Lymphomas. V.1.2009.Available at: http://www.nccn.org/professionals/physician_gls/PDF/nhl.pdf.

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