Abstract

Early Engagement with Health Technology Assessment: Its Role in Evidence Generation

Ailish Higgins, Analyst, National Institute for Health and Care Excellence (NICE)

Health technology assessment (HTA) has become an increasingly important part of the healthcare landscape. Where payer resources are constrained, life sciences companies need to demonstrate the value of their product relative to existing systems in order to justify reimbursement or funding of their technology. Early stage engagement with payers and HTA bodies can help developers to understand the perspective of decision makers before starting pivotal clinical trials, and enable appropriate evidence generation to facilitate reimbursement decisions. Specifically, HTA scientific advice can help identify the most appropriate populations, comparators and position in the care pathway for a product. It can also help companies to implement plans for economic evidence generation at clinical trial stage, through appropriate outcome measurement. A strong value proposition supported by relevant evidence can help decision makers and payers to have increased certainty about the claimed value of a product. In England, NICE Scientific Advice works with life science companies to answer their questions on proposed clinical development and economic evaluation plans. The aim of Scientific Advice is to help companies make better strategic decisions around their clinical development plans, leading to more effective decision-making by payers, HTA agencies and reimbursement agencies. This ensures faster access of cost-effective treatments to patients and minimises unnecessary delays surrounding decisions.