Prior Auth Protocol

FDA Approved Indications:

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 and multiple myeloma.

Health Net Approved Indications and Usage Guidelines:

For use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

Mozobil may mobilize leukemic cells and should not be used in patients with leukemia.
There is lack of clinical evidence to support the use of Mozobil monotherapy.
There is clinical evidence to support patients who have previously received a conventional mobilization regimen, which resulted in mobilization of insufficient CD34+ cells for transplant.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Neupogen^R (filgrastim)*	10 mcg/kg/day SC Neupogen should be given for at least 4 days before the first leukapheresis procedure and continued until the last leukapheresis.	Maximum use for 7 days per course
Neulasta^R (pegfilgrastim)*	6 or 12 mg SC	Once per transplant

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Mozobil (plerixafor)	Initiate Mozobil after the patient has received G-CSF once daily for 4 days. Mozobil may be dosed for up to 4 consecutive days. The recommended dose of Mozobil is 0.24 mg/kg (actual body weight) SC. Mozobil dose should not exceed 40 mg/day.	4 days

Product Availability:

Vial: 1.2 mL of a 20 mg/mL solution containing 24 mg of Mozobil

References:

Mozobil [Prescribing Information] Cambridge, MA; Genzyme Corp; December 2014.
Calandra G, McCarty J, McGuirk J, et al. AMD3100 plus G-CSF can successfully mobilize CD34+ cells from non-hodgkin`s lymphoma, hodgkin`s disease and multiple myeloma patients previously failing mobilization with chemotherapy and/or cytokine treatment: compassionate use data. Bone Marrow Transplantation. February 2008: 331-337.
Mozobil. In DrugPoints^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 22, 2015.
Mozobil. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 22, 2015.