OBJECTIVES: The Dutch oncology and pulmonology societies revised their PASKWIL (palliative, adjuvant, specific side effects, quality of life, impact of treatment and level of evidence) criteria to emphasise the benefit of prolonging overall survival (OS). This study aimed to assess the impact of the revised criteria on reimbursement decisions for oncology drugs in a palliative setting in the Netherlands and to compare them with duplicate submissions in Germany and the United Kingdom (UK).

METHODS: We comprehensively reviewed health technology assessment (HTA) submissions (since January 2017) on solid tumours in a palliative setting (locally advanced or metastatic disease) in the Netherlands, Germany and the UK. Only submissions for the same treatment available from all three agencies were included. For each submission, information was extracted on scope, supporting evidence on OS and progression-free survival (PFS), and reimbursement decision. For Dutch submissions, we retrospectively applied the new PASKWIL criteria to determine their impact on the reimbursement decision.

RESULTS: Sixteen submissions with a positive decision in the Netherlands were included. Given an indication for a sufficiently long survival, OS or PFS data (accepted for decision-making in these cases) would likely result in a positive recommendation being maintained in ten Dutch submissions. Two submissions would result in a negative recommendation due to an insufficiently large OS and/or PFS benefit over standard of care. In four submissions, OS data were too immature for reimbursement under the new criteria. Decision changes of these six Dutch submissions would result in differences to decisions made in Germany (four) and the UK (six).

CONCLUSIONS: The revised PASKWIL criteria will lower the acceptance rate of oncology drugs and restrict patient access. This may create inequalities across countries, especially considering the new European Union Joint Clinical Assessment aiming to unify patient access to promising drugs. Additional data collection may provide an alternative solution to evidence uncertainty.