PIASKY (crovalimab) - Paroxysmal nocturnal haemoglobinuria (PNH)

Summary of opinion

Unfavourable opinion for reimbursement “as monotherapy for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH):

• in patients with haemolysis with clinical symptom(s) indicative of high disease activity;
• in patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.”