Aliqopa™

Drug - Aliqopa™ (copanlisib) [Bayer HealthCare Pharmaceuticals Inc.]

July 2018

Therapeutic area - Oncology

Approval criteria

Patient must be 18 years old or older AND
Have diagnosis of relapsed follicular lymphoma AND
Have an adequate trial and failure of at least 2 systemic therapies which included rituximab and an alkylating agent
Initial approval is for 6 months

Renewal criteria

Patient must continue to meet the above criteria AND
Have documented efficacy as defined by tumor response with stabilization of disease or decrease in size of tumor or tumor spread AND
Not have experienced any treatment-restricting adverse effects including infections grade 3 or higher, persistent hyperglycemia, persistent hypertension, non-infectious pneumonitis grade 3 or higher, neutropenia, thrombocytopenia, or severe cutaneous reactions
Renewal approval is for 6 months

Quantity limits

Three 60 mg vials per 28-day cycle

Background

Accelerated approval was granted for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Billing of Aliqopa

Aliqopa is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim.

Questions?

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