Last week, the annual conference of ISPOR – the International Association for Health Economics and Outcome Research, which hosted thousands of participants in the physical event and thousands more in a hybrid connection to the conference – ended in Washington. The conference, which includes decision-makers and regulators, leaders of health organizations and insurers, and senior executives from the pharmaceutical and medical-tech industry in the United States and around the world, discuss current issues in the process of approving, funding, using and evaluating drugs, medical devices and digital medicine solutions.
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This year, the conference was chaired by Prof. Ran Blitzer, head of Clalit’s innovation division, who led the conference’s opening plenum, entitled Health technology assessment on the run, which raised a number of issues relevant to decision-makers in each country and in Israel.
Prof. Blitzer summarizes for Doctors Only the main points that arose in this framework: The world of innovation in health is advancing at an accelerated pace – the investment in digital health alone in 2020 was double the peak achieved in 2018 and stood at $ 10 million. In 2021 the amount doubled again and reached $ 20 million. The range of products, devices and solutions that reach a growing application stage.
Regulatory authorities and insurers in different countries are having a hard time keeping up. For U.S. medical devices, regulators have difficulty obtaining information based on product efficacy and safety, particularly regarding minority and elderly populations. And artificial intelligence.
In practice, therefore, there is significant difficulty in knowing whether newly approved equipment is indeed new and improved. There are still not enough incentives to encourage post-marketing research, which has the power to achieve the numbers and variety that allows critical questions to be answered. In particular, the panel dealt with the use of real world data that is not based on clinical research, in order to address post-marketing research.
Dr. Noa Dagan presented examples from the use made in Israel of information from medical files, in drawing quick conclusions about the effectiveness of corona vaccines and how rapid and continuous agile development is an integral part of the product life cycle in the field of artificial intelligence in medicine.
The FDA, the conference said, is planning new approaches to addressing these medical device challenges, with the goal of providing entrepreneurs and companies with a “total product lifecycle” approach, to avoid a situation where small companies invest efforts in gathering the minimum information required. For regulatory approval and fail to pass the stage of obtaining financing from insurers.
In this regard, the German DiGA program is discussed in depth, as part of which a dedicated budget is given for the widespread use of digital medical tools that are worthy of the regulator in this program, and in practice the authorities instruct insurers to fund advanced products for testing For measurable improvement in the patient’s quality of life and health.
The research and data systems in the State of Israel, as well as the large number of start-up companies and the implementation of solutions within the Israeli health system, have received widespread recognition and sympathetic treatment from all speakers. According to Prof. Blitzer, there is a unique opportunity in the State of Israel to use these tools of efficiency research after implementation with reduced costs and high accuracy, as a critical tool in improving existing information in the international arena about the actual effectiveness of medical devices and advanced artificial intelligence-based digital medicine.