Evidence-gathering across industry and academia on early Health Technology Assessment (HTA) of medical devices: survey design and piloting

摘要

The adoption and reimbursement of a new or novel medical device frequently occurs after an economic evaluation of the innovation. One important factor for reimbursement rejections by the English National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) appears to be the scarce or no attention to early assessment. This protocol describes a mixed methods research strategy employed to develop and test the quality, validity and consistency of two survey questionnaires aiming to explore the early Health Technology Assessment (HTA) level of adoption, and potential barriers to its adoption, across industry and academia. Qualitative interviews involved two types of key stakeholders: people working in the R&D or market access departments of small and medium enterprises, and academics working in the field of health economics, across England and Italy. We analysed the content of 25 informant interviews, constructed, and piloted two different academia and industry-tailored questionnaires. We then piloted the revised questionnaires with 15 professionals (5 developers and 10 academics) and re-piloted both a month later. To our knowledge, this study is the first to develop and test a survey that investigates the views in academia and in private companies on how conducting early HTA might affect the introduction of new medical devices to the market. Due to few original research papers on early HTA in the published literature and limited application of the guidance for early HTA in reimbursement claims, the incorporation of a more robust analytical framework including a societal perspective is necessary to understand whether early assessment can be effectively embedded into all aspects of the development process.