OBJECTIVES: To assess the potential number of PICOs under an additive PICO approach across Member States in the European joint HTA process.

METHODS: For a hypothetical new medicine, X, launching in first-line treatment of non-actionable mutation metastatic non-small cell lung cancer (hereafter: 1L NSCLC), relevant populations, comparators and outcomes were determined based on secondary research. HTA reports on the latest medicine launched in 1L NSCLC from HTA agencies in the EU were reviewed to assess the populations, comparators and outcomes of interest in each country. Based on the above information the likely PICOs for product X were determined by applying the EUnetHTA 21 proposed draft scoping process.

RESULTS: EMA has approved 11 different products for 1L NSCLC, aligned with current ESMO guidelines. Based on a review of 6 national HTA bodies in the EU there would have been 10 different PICOs for the JCA of product X. 6 out of the 10 PICOs would be driven by the needs of one country only. In total 17 unique outcomes would be anticipated per PICO, excluding sub domains. Most endpoints requested were in line with endpoints in the EPAR. Applying the outcomes to all PICOs would result in 170 outcomes in total. When looking at only the clinical endpoints 32 of the 80 clinical analyses required in the assessment would not be relevant to any of the 6 HTA bodies.

CONCLUSIONS: Based on just 6 or the 27 Member States, the proposed additive PICO approach for some medicines would lead to substantial analyses, of which a sizeable proportion are either not requested by any country or used by only one country. A transparent, evidence-based methodology is required to streamline the European PICO, ensuring efficient use of resources towards the timely delivery of a high-quality assessment, supplemented by Member States complementary clinical analyses.