OBJECTIVES: This research aims to identify and compare the key drivers influencing HTA outcomes for oral oncology products across Latin America and Europe. Its goal is to help elucidate how HTA drivers may vary between countries to understand the impact of HTA outcomes on market access.

METHODS: The study involved a comprehensive qualitative analysis to identify differences across key drivers from HTA bodies for twelve oral oncology products and thirteen indications across the UK, DEU, FRA, ESP, and BRA. Due to data limitations in BRA, therapies were selected based on the availability of an HTA assessment by BRA's HTA body (ANS) between 2022 and 2023. All data were collected from publicly available HTA assessments.

RESULTS: Positive recommendations were issued by HTA bodies in the following percentage of cases: ESP (80%), BRA (69%), UK (45%), DEU (36%), and FRA (25%). Efficacy improvement was a shared driver across markets, but key differences existed. DEU required statistically significant overall survival (OS) improvements, while FRA, UK, ESP, and BRA accepted surrogate endpoints like progression-free survival (PFS) and major cytogenetic response (MCR). FRA and ESP were the countries that focused the most on hazard ratios (HR); values < 0.75 were generally considered acceptable. Cost-effectiveness was crucial in BRA and the UK. Quality of submitted evidence was a key driver in BRA, FRA, and DEU. Improving patient quality of life (QoL) was more important in the UK and DEU compared to other markets. Clinical evidence with an appropriate comparator was essential in DEU; other markets accepted indirect comparisons and placebo.

CONCLUSIONS: Understanding key drivers behind HTA decisions is crucial for understanding pricing, access, and reimbursement differences. By tailoring submissions to align with the specific criteria and expectations of each HTA body, pharmaceutical companies can enhance the likelihood of favorable outcomes, leading to more timely and equitable patient access to therapies.