OBJECTIVES:

Patient reported outcomes (PRO) are becoming more important in oncology health technology assessments (HTA). IQWiG reviews PROs as part of patient-relevant morbidity and health-related quality of life (HRQoL) outcomes. The institute also assesses the mortality and safety outcomes. The overall benefit rating typically aligns with the mortality rating in these HTAs as mortality remains the golden standard in oncology. Our objective is to understand whether PROs can influence IQWiG’s benefit rating recommendation for oncology drugs.

METHODS:

Non-orphan oncology HTAs since 2011 were identified through the IQWiG website. For each subgroup in the identified HTAs, the outcome ratings and the overall benefit rating were collected. Finally, the impact of each outcome on the overall benefit rating was assessed.

RESULTS: CONCLUSIONS:

PRO data is held to the same standard as other outcomes data, and thus should be used if significant changes to the appropriate comparator are seen in a specific subgroup. Even if survival outcomes are immature or statistically insignificant, positive PRO data can lead to a favourable benefit rating.