These trends are summarized in their Web page and in a greater report. Here they are with some key excerpts from their report:
- Real world evidence. “As RWE continues to gain significant ground in healthcare, agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Institute for Healthcare Excellence and the Care (NICE) and the Canadian Drug and Health Technology Agency (CADTH) have recently published guidance on different aspects of the generation and use of RWE. “The key issues have been data quality, appropriate use, registries and external monitoring arms.”
- Drug prices. “The debate has been fueled by policies such as the Inflation Reduction Act (IRA) in the United States, under which the US Medicare program will enter into negotiations with manufacturers over the prices of 10 high-cost drugs, as well as with the pharmaceutical industry of the European Union. strategy, which proposes several ways to improve access and affordability”
- Artificial intelligence. “In health economics, these machine learning (ML) algorithms can be employed to look at data in a variety of ways that can help researchers and payers better understand treatment safety and effectiveness. Machine learning algorithms could also be used to create medical diagnostic tools, act as quality control for human work (such as doctors’ assessments in radiology exams), or create applications that can be used to self-monitor conditions (such as low back pain). . or schizophrenia).”
- Fostering innovation. “…some areas of medicine desperately require innovation, but do not receive the necessary attention due to a lack of financial incentives for drug development. “An excellent example of this is the search for new treatments for drug-resistant bacteria, fungi and other pathogens.”
- Health equity. “The application of social determinants of health (SDoH) to HEOR is increasing… The US Department of Health and Human Services (HHS) Office of Disease Prevention and Health Promotion considers SDoH as part of its Healthy People 2030 initiative. HHS classifies SDoH into five domains: economic stability, access and quality of education, access and quality of health care, neighborhood and built environment, and social and community context.”
- Accelerated drug approval. ” In 2022, 24 of the Center for Drug Evaluation and Research’s 37 new drug approvals, or 65%, used one or more accelerated programs, such as Fast Track, Breakthrough Therapy, Priority Review or Accelerated Approval… In the European Union Of the 89 medicines approved by the European Medicines Agency in 2022, 5 were under accelerated evaluation, 9 received conditional marketing authorizations and 5 received approvals in extraordinary circumstances.
- Value measurement. “There have been several efforts to address these issues with QALYs. ISPOR’s Flower of Courage includes other important aspects of courage, such as severity of illness, equity, and the value of hope, as well as other individual and societal considerations.40 The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) approach ) incorporates risk aversion into people’s attitudes. preferences, uncertainty in treatment outcomes, and many of the elements of Value Flower, as well as some others, in a single economic measure.”
- Patient-centered. “…[FDA] has been involved in a number of patient engagement initiatives, including the development of a series of four patient-centred drug development guidance methodological documents to gradually address how stakeholders can collect and submit data on patient experience and other relevant patient and caregiver information for medical product development and regulatory decision making. EUnetHTA, in its “Guidance on the participation of patients and healthcare professionals”, recommends that the Joint Clinical Evaluation planned to facilitate collaboration between countries in the assessment of health technologies in Europe includes meaningful participation of patients to reflect their views about coverage and reimbursement decisions.
- precision medicine. “…in 2022, the US Food and Drug Administration (FDA) approved 12 personalized medicines, representing approximately 34 percent of all newly approved therapeutic molecular entities. “Personalized medicines accounted for at least a quarter of new drug approvals in each of the last eight years.”
- Public health. Factors such as communicable diseases, social unrest and economic recessions can affect health and were mentioned in the ISPOR report.
Read the full report to learn more and also learn about many of ISPOR’s initiatives on these 10 topics.