Imbruvica™ (Ibrutinib)

Imbruvica™ (ibrutinib) (Oral) Document Number: IC-0187 Last Review Date: 3/29/2016 Date of Origin: 01/28/2014 Dates Reviewed: 01/2014, 08/2014, 02/2015, 01/2016, 03/2016

I. Length of Authorization

Coverage will be provided for six months and may be renewed.

II. Dosing Limits

A. Quantity Limit (max daily dose) [Pharmacy Benefit]: − Imbruvica 140 mg capsule: 120 capsules per 30 days (4 capsules per day) B. Max Units (per dose and over time) [Medical Benefit]:

Male 560 mg daily

Female 560 mg daily

III. Initial Approval Criteria

Coverage for is provided for treatment of the following conditions:

• Patient age is 18 years or older; AND

Mantle Cell Lymphoma †

• Patient’s disease is relapsed, refractory or progressive; AND • Must be used as a single agent

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) †

Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma †

• Must be used as a single agent; AND • Primary therapy; OR • 2nd line or later therapy for progressive, relapsed and/or refractory disease

†FDA Approved Indication(s) ‡Compendia Approved Indication(s)

IV. Renewal Criteria

Authorizations can be renewed based on the following criteria:

• Patients continues to meet criteria in section III; AND • Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: hemorrhage, severe infections, myelosuppression (neutropenia, thrombocytopenia, anemia), renal toxicity, and second primary malignancies.

V. Dosage/Administration

Indication Dose Mantle Cell Lymphoma Four 140 mg capsules (560 mg) orally once daily CLL/SLL Three 140 mg capsules (420 mg) orally once daily Waldenström's Macroglobulinemia Three 140 mg capsules (420 mg) orally once daily

VI. Billing Code/Availability Information

Jcode:

J8999 - Prescription drug, oral, chemotherapeutic, Not Otherwise Specified NDC:

• Imbruvica 140 mg capsule: 57962-0140-xx (Celgene)

VII. References

1. Imbruvica [package insert]. Horsham, PA; Janssen Biotech, Inc. March 2016. Accessed March 2016. 2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for ibrutinib. National Comprehensive Cancer Network, 2016. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2016. 3. Wang ML, Rule S, Martin P, et al. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.

4. Treon SP, Tripsas CK, Yang G, et al. A Prospective Multicenter Study of the Bruton’s Tyrosine Kinase Inhibitor Ibrutinib In Patients With Relapsed Or Refractory Waldenstrom’s Macroglobulinemia. [abstract]. Hematol Oncol. 2013; 31 (suppl 1):119:067.

Appendix 1 – Covered Diagnosis Codes

ICD-9 Codes Diagnosis 200.40 Mantle cell lymphoma, unspecified site, extranodal and solid organ sites 200.41 Mantle cell lymphoma, lymph nodes of head, face, and neck 200.42 Mantle cell lymphoma, intrathoracic lymph nodes 200.43 Mantle cell lymphoma, intra-abdominal lymph nodes 200.44 Mantle cell lymphoma, lymph nodes of axilla and upper limb 200.45 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb 200.46 Mantle cell lymphoma, intrapelvic lymph nodes 200.47 Mantle cell lymphoma, spleen 200.48 Mantle cell lymphoma, lymph nodes of multiple sites 200.80 Other named variants of lymphosarcoma and reticulosarcoma, unspecified site, extranodal and solid organ sites 200.81 Other named variants of lymphosarcoma and reticulosarcoma, lymph nodes of head, face, and neck 200.82 Other named variants of lymphosarcoma and reticulosarcoma,intrathoracic lymph nodes 200.83 Other named variants of lymphosarcoma and reticulosarcoma, intra-abdominal lymph nodes 200.84 Other named variants of lymphosarcoma and reticulosarcoma, lymph nodes of axilla and upper limb 200.85 Other named variants of lymphosarcoma and reticulosarcoma, lymph nodes of inguinal region and lower limb 200.86 Other named variants of lymphosarcoma and reticulosarcoma, intrapelvic lymph nodes 200.87 Other named variants of lymphosarcoma and reticulosarcoma, spleen 200.88 Other named variants of lymphosarcoma and reticulosarcoma, lymph nodes of multiple sites 204.10 Chronic lymphoid leukemia, without mention of having achieved remission 204.12 Chronic lymphoid leukemia, in relapse 273.3 Macroglobulinemia V10.79 Personal history of other lymphatic and hematopoietic neoplasms

ICD-10 ICD-10 Description C83.00 Small cell B-cell lymphoma, unspecified site C83.01 Small cell B-cell lymphoma, lymph nodes of head, face, and neck C83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodes

ICD-10 ICD-10 Description C83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limb C83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb C83.06 Small cell B-cell lymphoma, intrapelvic lymph nodes C83.07 Small cell B-cell lymphoma, spleen C83.08 Small cell B-cell lymphoma, lymph nodes of multiple sites C83.09 Small cell B-cell lymphoma, extranodal and solid organ sites C83.10 Mantle cell lymphoma, unspecified site C83.11 Mantle cell lymphoma, lymph nodes of head, face, and neck C83.12 Mantle cell lymphoma, intrathoracic lymph nodes C83.13 Mantle cell lymphoma, intra-abdominal lymph nodes C83.14 Mantle cell lymphoma, lymph nodes of axilla and upper limb C83.15 Mantle cell lymphoma, lymph nodes of inguinal region and lower limb C83.16 Mantle cell lymphoma, intrapelvic lymph nodes C83.17 Mantle cell lymphoma, spleen C83.18 Mantle cell lymphoma, lymph nodes of multiple sites C83.19 Mantle cell lymphoma, extranodal and solid organ sites C88.0 Waldenström macroglobulinemia C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission C91.12 Chronic lymphocytic leukemia of B-cell type in relapse Z85.72 Personal history of non-Hodgkin lymphomas Z85.79 Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare- coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

N/A