Challenges and opportunities in assessing cost-effectiveness for novel oncology drugs

Oncohematology is a priority area for drug development, with 40-50% of new drugs being registered for cancer therapy. Modern oncohematology drugs often do not meet the traditional cost-effectiveness criteria of payers, especially in countries with a healthcare structure and cost level similar to that of Hungary, due to the high cost per patient involved in their therapy.

The availability of not cost-effective oncology and haematology drugs is supported by various funding policy instruments and financing mechanisms, which are not usually exclusively targeted at these medicines. These include cost and risk-sharing agreements, methodological adjustments for cost-effectiveness assessment, and alternative funding solutions.

In Hungary, cost-effectiveness assessment is one of the pillars of the reimbursement system, but, in international comparison, the country also makes extensive use of mechanisms to support the availability of not cost-effective therapies. Cost and risk-sharing agreements are extensively used (in tenders and price-volume agreements), differentiated thresholds in cost-effectiveness assessment have been applied since November 2021, and the named-patient reimbursement system also allocates a significant amount within the overall pharmaceutical expenditure to support treatments, which are formally not listed and are often not cost-effective at list price.