Presentation (CTI)

OBJECTIVES: While several pharmaceutical products are undergoing Joint Clinical Assessment (JCA) based on the EU HTA Regulation (HTAR), the scope of the JCA extends beyond pharmaceuticals. JCA is mandatory for selected high-risk medical devices (MDs) and in vitro diagnostic MDs (IVDs). This creates challenges and opportunities for MD and IVD manufacturers. This work assesses challenges and opportunities and suggests measures to drive organizational readiness.
METHODS: A qualitative assessment was conducted based on publicly available documents, including guidance for JCAs and Joint Scientific Consultations (JSCs). Pharmaceuticals and MD were compared based on JCA timelines, expected trial designs, outcomes and consequences for national reimbursement. Findings were interpreted considering IQVIAs experience with 20 JCA dossiers and market access of MDs to assess implications for MD/IVD manufacturers.
RESULTS: While the framework of the HTAR is similar for pharmaceuticals and MD/IVD, critical differences emerge. MD and IVD manufacturers face uncertainty regarding the selection of products for JCA. Furthermore, with MD trials often being difficult to blind and relying on surrogate outcomes, JCA evidence requirements form a high obstacle, with RCT being seen as gold standard and patient-centered outcomes being very important. Manufacturers also face a new complexity from a high number of PICOs.
CONCLUSIONS: Regarding these complexities and a fragmented reimbursement landscape across Europe, it is unclear how the JCA will affect national HTA processes and reimbursement decisions. Conversely, MD and IVD manufacturers could leverage the framework of the HTAR to drive change towards harmonizing requirements and expediting reimbursement decisions. Provided sufficient evidence, a beneficial JCA appraisal might support national reimbursement discussions. The HTAR prompts MD and IVD manufacturers to change perspective on market access. Anticipating PICOs by conducting simulations, well designed evidence planning as well as cross-functional alignment and resource allocation form the building blocks for successful MD/IVD market access in the future.