Innovations in medical technologies are one of the leading areas of economic growth in the world. Whether new technologies take the form of pharmaceutical, medical device, biotechnology, information technology of some combination of these innovations, the opportunities for both private enterprise and social welfare are substantial. However, these innovations are not without cost, and require reimbursement from either a privately or publicly financed health care delivery system to enter the marketplace.
This course aims to provide knowledge of the concepts, data, and methodology required to critically evaluate new medical technologies in order to secure financial investment, reimbursement, and regulatory compliance objectives, such as FDA approval. The course is designed to provide understanding of the analytic tools needed to evaluate medical technologies. After completing this course, students will have the skills needed to:
– Understand the reimbursement systems financing medical technology use.
– Understand the role of government and regulatory agencies in the development and use of new medical technologies.
– Identify a population to be served by a medical technology.
– Use health care data to evaluate a medical technology.
– Perform cost/benefit and cost/effectiveness analysis of a new technology.
Medical Technology Assessment in the Current Health Care Financing and Regulatory Environment
This module includes an overview of the healthcare industry, focusing on the U.S., and provides context for why medical technology evaluations are important sources of information within the industry. The module begins by discussing the aspects of health care industry that make it unique from other industries and the many stakeholders who have interests in the results of medical technology evaluations. The remainder of the module covers the various regulation and payment systems that exist within the industry and where and how medical technology evaluations are necessary elements of those systems.
Clinical Trials and Insurance Claims Data
This module discusses the two most common types of data used in medical technology evaluations: clinical trial data and health insurance claims data. The discussion of clinical trial data covers the basic elements of trial design that help ensure the results will be reliable inputs to technology evaluations. The discussion of claims data covers what types of information is available in claims and how it differs from clinical data. It also covers potential sources of data. The module concludes with a few lessons that discuss general considerations and precautions when using data to ensure the validity of a technology evaluation.
The Elements of Medical Technology Assessments
In this module we will discuss a variety of types of medical technology evaluation approaches and the types of assessments. We will go into detail about the pros and cons of each type of assessment as a way to illustrate situations where one approach may be better than another. Finally, we will also cover the details of the two fundamental features of any evaluation: measuring costs and benefits.
Methodological Approaches and Considerations
Module 4 brings everything together from the first three modules. We will go into more detail about some of the more common quantitative methodologies you may encounter with an evaluation. We will talk about incorporating the effects of uncertainty and time into a medical technology evaluation model as well as the type of models that allow for the dynamic nature of patient responses to medical technology.