Fabhalta (iptacopan) — United Healthcare

Initial criteria

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
• AND
• One of the following:
• Patient will not be prescribed Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris)
• OR
• Patient is currently receiving another complement inhibitor (e.g., eculizumab, Empaveli, PiaSky, Ultomiris) which will be discontinued and Fabhalta will be initiated in accordance with the United States Food and Drug Administration approved labeling

Reauthorization criteria

• Documentation of positive clinical response to Fabhalta therapy
• AND
• Patient is not receiving Fabhalta in combination with another complement inhibitor used for the treatment of PNH (e.g., eculizumab, Empaveli, PiaSky, Ultomiris)

Approval duration

12 months