Empaveli (pegcetacoplan) — United Healthcare
paroxysmal nocturnal hemoglobinuria (PNH)
Initial criteria
- Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
- AND
- One of the following:
- (1) Patient will not be prescribed Empaveli in combination with another complement inhibitor used for the treatment of PNH (e.g., Bkemv, Fabhalta, PiaSky, Soliris, Ultomiris)
- OR
- (2) Patient is currently receiving another complement inhibitor (e.g., Bkemv, Fabhalta, PiaSky, Soliris, Ultomiris) which will be discontinued and Empaveli will be initiated in accordance with the United States Food and Drug Administration approved labeling
Reauthorization criteria
- Documentation of positive clinical response to Empaveli therapy
- AND
- Patient is not receiving Empaveli in combination with another complement inhibitor used for the treatment of PNH (e.g., Bkemv, Fabhalta, PiaSky, Soliris, Ultomiris)
Approval duration
12 months