EU Pharma industry calls for greater clarification of HTA guidance and PICO exercises
The application of Joint Clinical Assessments (JCA) of medicines under Regulation (EU) 2021/2282 (EU HTA) which is initiated through a PICO framework- Population, Intervention, Comparator(s), and Outcomes - that defines the JCA scope was implemented in January 2025 for oncology medicines and advanced therapeutics. The Coordination Group on HTA (HTACG) published the 'Guidance on the scoping process' in November 2024 followed by six 'PICO simulation exercises' in February 2025. The EFPIA has issued a response to these support materials by presenting a three questions that require further clarification and recommendations for the successful implementation of the JCA process under the HTA Regulation. In particular, it cites the interplay between population and comparator is an area of concern which determines the number of PICOs required and states that 'further refinement is needed' for how PICOs are proposed, consolidated, and communicated. It highlights that the overall scoping process lacks transparency on how assessors and co-assessors formulate initial PICO proposals and suggests that a formal consultation process with health tech developers be introduced during the drafting of proposed PICOs. It questions the logic of consolidated decisions and feels the role of Member State dialogue is unclear in the guidance and PICO exercises. Finally, it cautions that if the JCA contains an overwhelming volume of data or insufficient evidence where the consolidated PICO imposes an evidence standard then this can undermine the purpose of the JCA.