WHA

VELCADE (bortezomib)

Medical Administration - IV/SC injectable

Diagnosis considered for coverage:
  • Indicated for the treatment of patients with multiple myeloma.
  • Indicated for the treatment of patients with mantle cell lymphoma.
Coverage Criteria:

For the diagnosis of multiple myeloma OR mantle cell lymphoma:

  • Dose does not exceed 1.3 mg/m2; AND
  • Diagnosis of multiple myeloma OR mantle cell lymphoma; AND
  • Prescribed by or in consultation with a hematologist/oncologist; AND
  • For Velcade only: contraindication or intolerance to bortezomib
Reauthorization Criteria:

For the diagnosis of multiple myeloma OR mantle cell lymphoma:

  •  

  • Dose does not exceed 1.3 mg/m2; AND

  • No disease progression or unacceptable toxicity

Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
NCCN Recommended Uses (off-label):
  • Multicentric Castleman’s disease (B-cell lymphoma subtype) - as subsequent therapy;
  • Systemic light chain amyloidosis;
  • Adult T-cell leukemia/lymphoma - as subsequent therapy;
  • Waldenström macroglobulinemia/lymphoplasmacytic lymphoma;
  • T-cell acute lymphoblastic leukemia (T-ALL) – for relapsed or refractory disease;
  • Pediatric acute lymphoblastic leukemia (ALL) - as subsequent therapy;
  • Pediatric Hodgkin lymphoma (HL) - as subsequent therapy in combination with ifosfamide and vinorelbine;

Refer to NCCN guidelines for further guidance.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

  • Dosing:

    • VELCADE is for intravenous or subcutaneous use only. Do not administer VELCADE by any other route. Because each route of administration has a different reconstituted concentration, use caution when calculating the volume to be administered.

    • The recommended starting dose of VELCADE is 1.3 mg/m2 administered either as a 3 to 5-second bolus intravenous injection or subcutaneous injection. VELCADE is administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL

    • VELCADE retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with VELCADE and who have relapsed at least six months after completing prior VELCADE treatment. Treatment may be started at the last tolerated dose.

    • When administered intravenously, administer VELCADE as a 3 to 5-second bolus intravenous injection.

    • VELCADE is administered in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles

    • In Cycles 1-4, VELCADE is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29, and 32). In Cycles 5-9, VELCADE is administered once weekly (days 1, 8, 22, and 29)

    • At least 72 hours should elapse between consecutive doses of VELCADE

    • Velcade Schedule (per 6-week period):

      • Cycles 1-4

        • Week 1: Velcade (Days 1 + 4); oral melphalan + prednisone  (Days 1-4)

        • Week 2: Velcade (Days 8 + 11)

        • Week 3: Rest period

        • Week 4: Velcade (Days 22 + 25)

        • Week 5: Velcade (Days 29 + 32)

        • Week 6: Rest period

      • Cycles 5-9

        • Week 1: Velcade (Day 1); oral melphalan + prednisone  (Days 1-4)

        • Week 2: Velcade (Day 8)

        • Week 3: Rest period

        • Week 4: Velcade (Day 22)

        • Week 5: Velcade (Day 29)

        • Week 6: Rest period

  • Prior to initiating any cycle of therapy with VELCADE in combination with melphalan and prednisone:

    • Platelet count should be at least 70 x 109 /L and the absolute neutrophil count (ANC) should be at least 1.0 x 109 /L

    • Non-hematological toxicities should have resolved to Grade 1 or baseline

  • Drug-Drug Interactions:

    • CYP3A4: Closely monitor patients using strong CYP3A4 inhibitors. Avoid concomitant use with patients using strong CYP3A4 inducers.

  • For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.

  • Administration precautions: VELCADE is a hazardous drug. Follow applicable special handling and disposal procedures.

Policy Updates:
  • 11/15/2022 – Updated policy and format
  • 07/20/2016 – Last reviewed.
References:
  1. Velcade Prescribing Information. Millennium Pharmaceuticals, Inc. Cambridge, MA. August 2022.
  2. Richardson PG, Sonneveld P, Schuster MW, et al. Assessment of Proteasome Inhibition for Extending Remissions (APEX) Investigators. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005 Jun 16;352(24):2487-98.
  3. National Cancer Institute. Adult Non-Hodgkin Lymphoma Treatment (PDQ). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adult-non-hodgkins/healthprofessional. Accessed April 20, 2021
  4. 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):4867-74.
  5. The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org. Accessed April 20, 2021.
  6. Bortezomib Prescribing Information. Fresenius Kabi USA, LLC. Lake Zurich, IL. September 2018.

 

Last review date: December 1, 2022