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Blenrep®

Drugs - Blenrep® (belantamab) [GlaxoSmithKlein LLC.]

March 2021

Therapeutic area - Oncology

Initial approval criteria

  • Patient is > 18 years AND
  • Patient has relapsed or refractory multiple myeloma AND
  • Patient had disease progression on ≥ 4 prior anti-myeloma treatment regimens, which must have included ≥ 1 agent(s) from each of the following categories:
    • proteasome inhibitor
    • immunomodulatory agent
    • anti-CD38 monoclonal antibody
  • Both patient AND prescriber are enrolled in the Blenrep REMS program AND
  • Patient has an ophthalmic exam (e.g., visual acuity and slit lamp) at baseline, prior to each dose, and as needed AND
  • Therapy will be used in combination with preservative-free lubricant eye drops AND
  • Patient does NOT have current corneal epithelial disease (excludes mild punctate keratopathy) AND
  • Patient has NOT had a prior allogeneic stem cell transplant AND
  • Patient does NOT have any of the following comorbidities: symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), and active plasma cell leukemia AND
  • Therapy will be used as single-agent therapy
  • Initial approval is for 6 months

Renewal criteria

  • Patient must continue to meet the above criteria AND
  • Patient must demonstrate disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., ocular toxicity, thrombocytopenia, infusion-related reactions)
  • Renewal approval is for 6 months

Quantity limits

  • 2.5 mg/kg every 21 days
  • Patient’s weight (in kg) must be provided at time of request

Billing for Blenrep

Blenrep must be billed as a medical claim.

Background

Blenrep is FDA-approved for the treatment of adult patients 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 confirmatory trial(s),

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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