Ravulizumab dávkovanie

Organisation: Alexion, zastúpený AstraZeneca AB

Created at: 21.03.2025

Processed at: 07.04.2026

Question

The current status of the dose ranges in the KPP does not reflect the necessary dosing of ravulizumab at initiation of treatment as defined in the Ultomiris SPC. In the event of a patient hospitalization of more than 2 weeks, the patient requires the administration of a saturation and a first maintenance dose of ravulizumab. E.g. in the case of a patient weighing 60-100 kg, 2700+3300 mg of ravulizumab is required, for a total of 6000 mg. In the current version of the CPP, the maximum PP reimbursement amount is calculated for 3600 mg and above only, at EUR 51890.56. However, with the need to administer both a saturation and a first maintenance dose, the amount in the KPP does not cover the cost of the drug to the provider and additional dosing intervals need to be added to the KPP.

Addition of lines in the KPP - see attached file - to cover treatment cases in patients of any weight, including those with the maximum possible dosage as defined in the SPC (100 kg or more).

The rationale for the necessary modification is partly explained in the description of the status quo and in the proposed solution. Lines need to be added to the KPP up to 6600 mg, which represents the saturation (3000 mg) and first maintenance dose (3600 mg) of ravulizumab in a patient weighing 100 kg or more.

Answer

The reporting of the administered amount of medicine has been comprehensively revised and set up via markers in the DRG system from 1.1.2026 due to a number of suggestions of a similar nature, which makes the DRG system more flexible in the reporting, as the markers report the exact administered amount of medicine without limits.