TALVEY (talquetamab)

TALVEY (talquetamab)

Medical Administration – injectable

Diagnosis considered for coverage:

• Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody

Coverage Criteria:

For diagnosis of relapsed or refractory multiple myeloma:

• Patient has a diagnosis of multiple myeloma; AND
• Disease is one of the following:
  • Relapsed 
  • Refractory; AND
• Patient has received at least four prior lines of therapy which include all of the following:
  • An immunomodulatory agent (e.g., lenalidomide, thalidomide) 
  • A proteasome inhibitor (e.g., bortezomib, carfilzomib) 
  • A CD38-directed monoclonal antibody (e.g., daratumumab)

Reauthorization Criteria:

For diagnosis of relapsed or refractory multiple myeloma:

• Patient does not show evidence of progressive disease while on therapy

Dosing: 

• Weekly Dosing Schedule:
  • Step-up Dose
    • 0.01 mg/kg on Day 1
    • 0.06 mg/kg on Day 4
  • Treatment Dose
    • 0.4 mg/kg on Day 7
    • 0.4 mg/kg once weekly until disease progression or unacceptable toxicity
• Biweekly Dosing Schedule:
  • Step-up Dose
    • 0.01 mg/kg on Day 1
    • 0.06 mg/kg on Day 4
    • 0.4 mg/kg on Day 7
  • Treatment Dose
    • 0.8 mg/kg on Day 10
    • 0.8 mg/kg every 2 weeks until disease progression or unacceptable toxicity

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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: 

• For subcutaneous injection
• Talvey should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS)
• Talvey 3 mg/1.5 mL (2 mg/mL) vial and TALVEY 40 mg/mL vial are supplied as ready-to use solution for injection that do not need dilution prior to administration
• Do not combine Talvey vials of different concentrations to achieve treatment dose

Policy Updates:

• 3/1/2024 – New policy approved by WHA P&T Committee. (P&T, 2/20/2024)

References:

• Talvey Prescribing Information. Janssen Biotech, Inc. Horsham, PA. August 2023.