Prior Auth Protocol

FDA Approved Indications:

For the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
For the treatment of patients with Chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL)
For the treatment of patients with Chronic lymphocytic leukemia/ Small lymphocytic lymphoma (SLL) with 17p deletion
For the treatment of patients with Waldenstroms macroglobulinemia

Health Net Approved Indications and Usage Guidelines:

Diagnosis of mantle cell lymphoma and received at least one prior therapy

OR

Diagnosis of chronic lymphocytic leukemia(CLL) or small lymphocytic lymphoma (SLL) with or without 17p deletion

OR

Diagnosis of Waldenstroms macroglobulinemia

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:

Prior therapies for MCL include: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), BR (bendamustine, rituximab), R-CVP (rituximab, cyclophosphamide, vincristine, prednisone), R-DHAP (rituximab, dexamethasone, high dose cytarabine, and cisplatin), Hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, and dexamethasone, alternating with high-dose methotrexate and cytarabine, with or without rituximab)

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)	MCL Varies	Varies
BR (bendamustine, rituximab)	MCL Varies	Varies
R-CVP (rituximab, cyclophosphamide, vincristine, prednisone)	MCL Varies	Varies
R-DHAP (rituximab, dexamethasone, high dose cytarabine, and cisplatin)	MCL Varies	Varies
Hyper-CVAD, (cyclophosphamide, vincristine, doxorubicin, and dexamethasone, alternating with high-dose methotrexate and cytarabine, with or without rituximab)	MCL Varies	Varies
fludarabine, cyclophosphamide and rituximab (FCR)	CLL or SLL Varies	Varies
fludarabine plus rituximab (FR)	CLL or SLL Varies	Varies
HDMP + rituximab	CLL or SLL Varies	Varies
Bendamustine plus rituximab	CLL or SLL Varies	Varies
pentostatin, cyclophosphamide and rituximab (PCR)	CLL or SLL Varies	Varies
Obinutuzumab + Chlorambucil	CLL or SLL Varies	Varies

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Imbruvica	MCL: Four 140 mg capsules (560 mg) taken PO once daily CLL or SLL or Waldenstrom's macroglobulinemia: Three 140 mg capsules (420 mg) taken PO once daily	Length of Benefit

Product Availability:

Capsules: 140 mg

References:

1. Imbruvica [Prescribing Information] Pharmacyclics, Inc. Sunnyvale, CA USA, May 2016.
2. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 18, 2015, May 9, 2016
3. Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 18, 2015, April 14, 2016
4. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 18, 2015, May 12, 2016
5. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 18, 2015.
6. Burger J, Tedeschi A, Barr P, et al. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia (RESONATE-2) N Engl J Med 2015 December 17 ;373(25) :2425-2437.
7. Byrd J, Furman R, Coutre, et al. Targeting BTK with Ibrutinib in Relapsed Chornic Lymphocytic Leukemia. N Engl J Med 2013; 369: 32-42.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending