OBJECTIVES: To simulate the PICO (population, intervention, comparator, outcome) scoping process in the framework of the European Joint Clinical Assessment by assessing a hypothetical new drug for adults with metastatic castration-resistant prostate cancer.

METHODS: A targeted review of European and national guidelines and past health technology assessments (HTAs) was conducted across 16 European countries in May 2024. PICOs were collected through an online survey with Cencora market access experts and consolidated based on the EUnetHTA21 scoping process practical guideline.

RESULTS: Country-specific PICOs were obtained in a 3-week timeframe, including a 1-week clarification phase. Four subpopulations were identified in addition to the full population defined in the hypothetical target product profile. Subpopulations were requested by 11 out of 16 countries. In total, 11 comparators were identified for the assessment scope. The number of relevant comparators for the national assessments varied widely across countries. While for some countries, evidence on at least one of the comparators is likely sufficient, 5 out of 16 countries would request data against each of the identified comparators covering a range of 2 to 7 products. Differences in national PICO requirements resulted in 18 consolidated PICOs, of which 9 were for the full population. The number and type of relevant outcomes for the assessment scope differed between countries. Overall survival was the only outcome that was considered relevant by all assessed countries.

CONCLUSIONS: Our analysis shows that a 2-to-3-week timeframe would be sufficient to collect comprehensive country PICOs. Variations in clinical guidelines and treatment standards at the time of the scoping process could result in numerous consolidated PICOs to address. The ultimate populations and comparators considered relevant by HTA bodies may depend on the manufacturer’s positioning of the product under assessment. A substantial number of countries is likely to request additional data beyond clinical trials, like indirect treatment comparisons.