28 - 29 Settembre 2017
Medical Devices and Pharmaceuticals: Assessing Value and Market Access Challenges.
There are existing similarities in process and requirements for drugs and devices. Although for medical devices, payers do not require certain level of evidence as for pharmaceuticals, requirements actually grow and get stringent as for pharmaceuticals.
Medical devices may have more challenges doing randomized clinical trials and generating high-quality economic evidence than pharmaceuticals; the pace of innovation is different too.
Because of the way medical devices are produced, the price for the obsolete technology is rapidly driven down to help to create head room to fund the new approved technology. Price differences of new and obsolete technologies increase the cost difference too what results in changing implied incremental cost-effectiveness ratio.
In general, quality of manufacturing, safety, effectiveness, and cost effectiveness should be the four pillars underpinning the evaluation of medical devices.