Health economic modelling for SaMD and AI devices
Health economic modelling for SaMD and AI devices
We help SaMD and AI medical device companies prove the clinical and financial value of their products to payers on both sides of the Atlantic.
Obtaining CE marking or FDA clearance allows you to place your device on the market, but adoption depends on whether payers are willing to fund it. In Europe, this decision usually involves NICE and national HTA bodies, while in the United States, coverage and reimbursement are determined by CMS and commercial health plans, and our HEOR team develops the economic evidence that each of these decision makers expects to see.
What our HEOR team delivers for SaMD and AI medical devices
What our HEOR team delivers for SaMD and AI medical devices
- Early health economic models developed before your clinical investigation, which show whether your value proposition is likely to hold up in front of payers
- Budget impact analysis showing a payer how much adopting your device will cost or save over a period of three to five years
- Cost effectiveness analysis comparing your device with current standard of care, including QALYs, ICERs, and sensitivity analyses that test every key assumption
- Models that draw on clinical data, published literature, real world evidence and patient reported outcomes, with every assumption documented for reviewers
- Evidence for NICE in line with the Evidence Standards Framework for digital health technologies, adapted to the requirements of other European payers
- Budget impact models for US health plans and support in planning your route to coverage, including the path to a CPT code