Health technology assessment (HTA) bodies, like the National Institute for Health and Care Excellence (NICE) in the UK and the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, have become increasingly important in countries across the world as arbiters who determine the reimbursement fate of healthcare interventions in national systems, in addition to ensuring fair access to target populations. For these agencies, such reimbursement decisions are dependent on evidence of clinical efficacy and safety from pivotal clinical trials in the indicated population as well as evidence of cost-effectiveness by means of health economic evaluations. Other bodies like the Institute for Quality and Efficiency in Healthcare (IQWiG) in Germany and the French National Authority for Health (HAS) have a slightly different approach, with economic evaluations considered necessary only after new technologies have demonstrated additional clinical benefit.
Healthcare reimbursement decision-making in the US has historically been an anomaly, given that there is no designated national reimbursement body for the sectored healthcare payer system. In marked contrast to countries with single-payer or national systems for reimbursement, the US healthcare system is fragmented, with myriad payer systems at regional and national levels. US payers also function at individual, group, employer, and government levels and provide varying benefits depending on choice, socioeconomic level, and eligibility. Coverage for and access to prescription drugs or other innovative technologies can vary widely depending on what type of insurance coverage individual patients have. The previously clear difference between the US and other industrialized countries with regards to HTA bodies is becoming increasingly blurred, however, by the role of the Institute for Clinical and Economic Review (ICER), a private research organization founded in 2006 that evaluates the value of emerging healthcare interventions from clinical and health economic perspectives.