Package advice on pegcetacoplan (Aspaveli®) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH)
The National Health Care Insititute has completed its assessment whether pegcetacoplan (Aspaveli®) can be included in the basic health care package for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH). The reason for this advisory report was the placement of pegcetacoplan (Aspaveli®) in what is known as the ‘lock procedure’ for expensive medicinal products. The National Health Care Institute advises the Minister to include pegcetacoplan in the health insurance package, provided that a price reduction is achieved.
Registered indication
Reimbursement is requested for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.
The National Health Care Institute's advice
The National Health Care Institute has concluded that pegcetacoplan meets the established medical science and medical practice for the indication above. The National Health Care Institute has determined that pegcetacoplan has added value compared to eculizumab and ravulizumab. However, the use of pegcetacoplan is associated with additional costs. The National Health Care Institute is unable to determine the exact amount of these additional costs because the actual price of eculizumab is not known. We advise the Minister to include pegcetacoplan in the package, provided that a price reduction is achieved.
If the application of pegcetacoplan is included in the package after successful price negotiations, the National Health Care Institute recommends the following reimbursement condition: