Standpoints

Requirement for PP medicine - tenecteplase

The opinion is set out in feedback number 659 - https://www.cksdrg.sk/sk/spatna-vazba/stanoviska/659

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.

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.

From 1.1. 2025, medicines that are listed in the CMP in the list of PPs are newly subject to administration and possible withdrawal in accordance with the indication restrictions. Medicines listed in the list are also administered at the Department of Haematology outside the indication limitation under the ministerial exemption. The exemption permits the use of the drug in an unregistered indication but does not guarantee reimbursement by a health insurance company. Therefore, a problem arises with the possibility to report as PP DRG drugs in patients who do not meet the indication restriction. The CKS DRG on its website provides information on the introduction of indication restrictions for discharged patients from 2024: " in order to maintain the continuity of their treatment, attributable items may continue to be recognised when continuing treatment even if they do not comply with the indication restrictions"... However, new patients for whom treatment is indicated from 1.1.2025 and who do not comply with the indication restrictions are not addressed. Since the health insurance company does not guarantee reimbursement under the ministerial exception, we ask to reconsider how to resolve this situation, which has arisen since 1.1.2025 and has caused the complications reported by the haematology clinic.

Reimbursement for medicines in the DRG system is initially determined by the case lump sum, i.e. a relative weight that is multiplied by the base rate. This reimbursement is the basic and standard reimbursement, which also reflects the cost of the medicines administered. Reimbursement through add-on items is a reimbursement that is only paid for medicines that are not administered as standard but are rarely administered to similar patients and are also high cost. The complete methodology for determining add-on items is available here: https://www.cksdrg.sk/sk/dokumenty/568/Metodika%20aktualizácie%20pripočítateľných%20položiek%20pre%20SK-DRG%202026.pdf

Indication restrictions (IO) in the DRG system are aligned with the IOs that are listed in the categorisation list of medicines, which defines which medical treatment for which diagnoses is reimbursed in Slovakia. As the SK-DRG system is updated only once a year and new indications enter the categorisation list all year round, in order to avoid misalignment of these systems, reporting of indication restrictions has been transferred to marker reporting, which makes the DRG system more flexible and as soon as a medicine is categorised under a new indication, it can also be reported under the DRG system.