BLENREP (Belantamab mafodotin-blmf)

BLENREP (Belantamab mafodotin-blmf)

OFFICE ADMINISTRATION- INTRAVENOUS

Indication for Prior Authorization:

• Indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
  • This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Patient has a documented diagnosis of relapsed or refractory multiple myeloma (RRMM), AND
• Prescribed by or in consultation with an oncologist/hematologist, AND
• Patient has received at least four prior therapies which include all of the following:
  • An anti-CD38 monoclonal antibody (e.g., daratumumab)
  • A proteasome inhibitor (e.g., bortezomib, carfilzomib)
  • An immunomodulatory agent (e.g., lenalidomide, thalidomide)

Reauthorization Criteria:

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

Dosing:

• Recommended dose: 2.5 mg/kg of actual body weight given as an IV infusion over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity
• Recommended dose reduction for adverse reactions: 1.9 mg/kg intravenously once every 3 weeks
• Discontinue Blenrep in patients who are unable to tolerate a dose of 1.9 mg/kg

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 Committee.

Additional Information:

• Black Box Warning for ocular toxicity
  • Blenrep caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes
  • Perform an ophthalmic exam prior to initiation of Blenrep and during treatment
  • Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist
• Additional warnings for: thrombocytopenia, infusion-related reactions, embryo-fetal toxicity
• Pregnancy: Based on its mechanism of action, Blenrep can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, MMAF) and it targets actively dividing cells
  • Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Blenrep and for 6 months after the last dose
• Lactation: There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Blenrep and for 3 months after the last dose
• The safety and effectiveness of Blenrep in pediatric patients have not been established

Review History:

• 2/16/21- Original review

References:

• Blenrep Prescribing Information. GlaxoSmithKline. Research Triangle Park, NC. August 2020.