Prior Authorization Guideline

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1 Prior Authorization Guideline Guideline: PS Inj - Velcade Therapeutic Class: Antineoplastic Agents Therapeutic Sub-Class: Antineoplastic Client: PS Inj Approval Date: 10/2/2004 Revision Date: 5/22/2007 I. BENEFIT COVERAGE Table 1. Formulary status Non-Formulary Products Velcade (bortezomib)* Formulary Products *Benefit coverage may vary based on the member s benefit plan. II. INDICATIONS A. FDA Approved Indications 1. Multiple Myeloma Velcade is indicated for the treatment of multiple myeloma patients who have received at least 1 prior therapy Mantle Cell Lymphoma Velcade is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. III. GUIDELINE A. Multiple Myeloma 1. Velcade will be approved based on all of the following criteria: a. Diagnosis of multiple myeloma. 1,5 -ANDb. Received at least one prior therapy for multiple myeloma. 1 -ANDc. Prescribed by a hematologist/oncologist

2 -AND- Authorization of therapy will be issued for length of therapy. B. Mantle Cell Lymphoma 1. Velcade will be approved based on all of the following criteria: 1,3,4,6 a. Diagnosis of mantle cell lymphoma -AND- b. Received at least one prior therapy for mantle cell lymphoma (refer to Section VII.C.2. National Guidelines) -AND- c. Prescribed by a hematologist/oncologist Authorization of therapy will be issued for length of therapy. IV. CONTRAINDICATIONS AND WARNINGS A. Contraindications Velcade is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. 1 B. Warnings V. DOSING Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. 1 Velcade is Pregnancy Category D. Women of child potential should avoid becoming pregnant while being treated with Velcade. Velcade 1 Recommended dose: 1.3 mg/m 2 /dose administered as a 3 to 5 second bolus IV injection twice weekly for 2 weeks (Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12-21). For extended therapy of more than 8 cycles, Velcade may be administered on the standard schedule or on a maintenance schedule of once weekly for 4 weeks (Days 1, 8, 15, and 22) followed by a 13-day rest period (Days 23 to 35). At least 72 hours should elapse between consecutive doses of Velcade.

3 Dose modification: Velcade therapy should be withheld at the onset of any Grade 3 non-hematological or Grade 4 hematological toxicities excluding neuropathy. Once the symptoms of the toxicity have resolved, Velcade therapy may be reinitiated at a 25% reduced dose (1.3 mg/m 2 /dose reduced to 1.0 mg/m 2 /dose; 1.0 mg/m 2 /dose reduced to 0.7 mg/m 2 /dose). Table 2 contains the recommended dose modification for the management of patients who experience Velcade related neuropathic pain and/or peripheral neuropathy. Patients with preexisting severe neuropathy should be treated with Velcade only after careful risk-benefit assessment. Table 2. Recommended dose modification for Velcade related neuropathic pain and/or peripheral sensory neuropathy Severity of Peripheral Neuropathy Signs and Modification of Dose and Regimen Symptoms Grade 1 (paresthesias and/or loss of reflexes No action without pain or loss of function) Grade 1 with pain or Grade 2 (interfering with Reduce Velcade to 1.0 mg/m 2. function but not with activities of daily living Grade 2 with pain or Grade 3 (interfering with Withhold Velcade therapy until toxicities activities of daily living) resolves reinitiate with a reduced dose of Velcade at 0.7 mg/m 2 and change treatment schedule to once per week. Grade 4 (disabling) Discontinue Velcade VI. AVAILABILITY Velcade is supplied as individually cartoned 10 ml vials containing 3.5 mg of bortezomib as a white to off-white cake or powder. 1 VII. BACKGROUND A. Description The proteasome inhibitor bortezomib induces apoptosis, reverse drug resistance of multiple myeloma cells, and affects their microenvironment by blocking cytokine circuits, cell adhesion, and angiogenesis in vivo. 2 B. Clinical Studies 1. Multiple Myeloma A randomized, open-label, phase III trial was conducted to compare bortezomib with high-dose dexamethasone in 669 patients with relapsed multiple myeloma who had received one to three previous therapies. 2 Patients were randomly assigned to receive either IV bolus of bortezomib (1.3 mg/m 2 of BSA) on days 1, 4, 8, and 11 for eight threeweek cycles, followed by treatment on days 1, 8, 15, and 22 for three five-week cycles, or high-dose dexamethasone (40 mg orally) on days 1 through 4, 9 through 12, and 17 through 20 for five week cycles, followed by treatment on days 1 through 4 for five fourweek cycles. Patients treated with bortezomib had higher response rates (combined complete and partial rate of 38% vs. 18%, p<0.001), a longer time to progression (6.22 months vs months, p<0.001), and longer survival than patients treated with

4 dexamethasone (1 year survival rate of 80% vs. 66%, p=0.003). Bortezomib was superior to high-dose dexamethasone for the treatment of patients with multiple myeloma who had a relapse after one to three previous therapies. 2. Mantle Cell Lymphoma (MCL) MCL is found in lymph nodes, the spleen, bone marrow, blood, and sometimes the gastrointestinal system. 3 MCL is characterized by CD5-positive follicular mantle B cells. Like the low-grade lymphomas, MCL appears incurable with anthracycline-based chemotherapy and occurs in older patients with generally asymptomatic advanced-stage disease. The median survival, however, is significantly shorter (3 5 years) than that of other lymphomas. It is unclear which chemotherapeutic approach offers the best longterm survival Bortezomib shows response rates close to 50% in relapsed patients, prompting clinical trials combining bortezomib with rituximab and cytotoxic agents in first-line therapy. The safety and efficacy of bortezomib in relapsed or refractory MCL was evaluated in an open-label, single-arm, multicenter study of 155 patients with progressive disease who had received at least 1 prior therapy. 1,4 In 91% of the patients, prior therapy included all of the following: an anthracycline or mitoxantrone, cyclophosphamide, and rituximab. A total of thirty seven percent (37%) of patients were refractory to their last prior therapy. An IV bolus injection of VELCADE 1.3 mg/m2/dose was administered twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period (Days 12 to 21) for a maximum of 17 treatment cycles. The median number of cycles administered across all patients was 4; in responding patients the median number of cycles was 8. The median time to response was 40 days (range 31 to 204 days). The median duration of follow-up was more than 13 months. Response Analyses (N = 155) N (%) 95% CI Overall Response Rate (CR + CRu + PR) 48 (31) (24, 39) Complete Response (CR + CRu) 12 (8) (4, 13) CR 10 (6) (3, 12) CRu 2 (1) (0, 5) Partial Response (PR) 36 (23) (17, 31) Duration of Response Median 95% CI CR + CRu + PR (N = 48) 9.3 months (5.4, 13.8) CR + CRu (N = 12) 15.4 months (13.4, 15.4) PR (N=36) 6.1 months (4.2, 9.3) Cru= unconfirmed complete response The National Comprehensive Cancer Network (NCCN, 2004) also recommended bortezomib as a second-line treatment of MCL. According to the NCCN, first line treatment of mantle cell lymphoma includes rituximab plus combination chemotherapy (e.g., hypercvad, CHOP, EPOCH). C. National Guidelines 1. National Comprehensive Cancer Network (NCCN) [Multiple Myeloma] (2006) 5 Patients with smoldering or stage I myeloma do not need primary therapy because they can do well for many months to years before the disease progresses. These patients should be initially observed at 3 to 6 months intervals (category 1; there is uniform NCCN consensus, based on high-level evidence, that the recommendation is

5 appropriate). If their disease progresses to stage II or higher, then patients should be treated according to the guidelines for advanced multiple myeloma. Most patients who present with advanced multiple myeloma (Durie-Salmon stage II and stage III) require primary therapy with conventional dose chemotherapy and bisphosphonates. Complications such as hypercalcemia or hyperviscosity should be treated with adjunctive measures. Examples of primary conventional chemotherapy include the following: Melphalan/prednisone (MP) Vincristine/doxorubicin/dexamethasone (VAD) Dexamethasone Thalidomide/dexamethasone Liposomal doxorubicin/vincristine/dexamethasone (DVD) (category 2B; there is no uniformed NCCN consensus but no major disagreement, based on lower level evidence including clinical experience, that the recommendation is appropriate) Patients with progressive disease after primary therapy can be treated with salvage therapies such as: Repeat primary conventional therapy (if relapse at >6 months) Cyclophosphamide-VAD High-dose cyclophosphamide Thalidomide Bortezomib (category 1) Thalidomide/dexamethasone Dexamethasone, thalidomide, cisplatin, doxorubicin, cyclophosphamide, and etoposide (DT-PACE) Asenic trioxide in combination with vitamin C (category 2B) High dose steroids 2. NCCN [Non-Hodgkin s Lymphoma] (2007) 6 Mantle Cell Lymphoma Bortezomib is listed as a second-line therapy. First-line Therapy Rituximab + CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in selected older patients who cannot tolerate more intensive therapy Rituximab + HyperCVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) alternating with methotrexate and cytarabine Rituximab + EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) First-line Consolidation Allogeneic transplant in the context of a clinical trial (nonmyeloablative or myeloablative) ASCT (autologous stem cell transplant,) Second-line Therapy Bortezomib Cladribine

6 FCMR (fludarabine, cyclophosphamide, mitoxantrone, rituximab) ± rituximab maintenance FMR (fludarabine, mitoxantrone, rituximab) FC (fludarabine, cyclophosphamide) ± rituximab PCR (pentostatin, cyclophosphamide, rituximab) Thalidomide + rituximab VIII. REFERENCES 1. Velcade Prescribing Information. Millennium Pharmaceuticals, Inc. February Richardson PG, Sonneveld P, Schuster MW, et al, for the Assessment of Proteasome Inhibitor for Extending Remissions (APEX) Investigators. N Eng J Med.2005; 352: National Cancer Institute. About Non-Hodgkin s lymphoma PDQ: Treatment. Available at: Accessed April 10, Fisher RI, Bernstein SH, Kahl BS, et al.: Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol.2006; 24 (30): National Comprehensive Cancer Network. Clinical Practice in Oncology: Multiple Myeloma- Version Available at: Accessed January 10, National Comprehensive Cancer Network (NCCN). Non-Hodgkin's Lymphoma. NCCN Clinical Practice Guidelines in Oncology. Version Jenkintown, PA: NCCN; November 1, 2004: Available at: Accessed April 10, This Prior Authorization Guideline represents the recommendation of Prescription Solutions Pharmacy and Therapeutics (P&T) Committee. It is based upon the P&T Committee s review of the available evidence as of the date of drafting or revision of this Prior Authorization Guideline. It is subject to updating from time to time, based upon changes in scientific knowledge and information. This Prior Authorization Guideline is intended as a resource for making coverage decisions for Health Plan members, but it does not replace an individualized case-by-case review and medical necessity determination for each Health Plan member. Copyright 2007 by Prescription Solutions. All rights reserved. This Prior Authorization Guideline is intended for use by Prescription Solutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in this Prior Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferred in whole or in part without Prescription Solutions prior written consent.

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