ISSUE: Payers are increasingly asked to evaluate the benefit of products from the patient or caregiver perspective. Both patient reports and evidence from patient’s activity levels from wearables can provide information on outcomes from a patient’s perspective and/or help assess caregiver burden. They can provide stronger evidence for the use of new treatment methods particularly for symptomatic conditions, where the traditional, ‘hard’ endpoints may be poorly reflective of the patient’s and caregiver’s well-being. However, there are many different possible metrics from actigraphy and from PRO instruments – making data interpretation challenging. We will debate the issue with various stakeholders: Dr Rudell is a patient evidence scientist, who designs new patinent-relevant endpoints; Dr Regnier is an industry representative who supports development of optimal evidence packages for new interventions including these new outcomes; Dr Tunis has had to advise on and decide whether to use patient experience or evidence from wearables from the payer perspective.

OVERVIEW: The issue panel will present each of the different perspectives with audience discussions to arrive at common principles and new methods on using novel endpoints derived from patient experience and/or data from wearables in reimbursement and payer coverage decisions. The moderator will introduce the topic and questions (10 min) and then invite each panelist to present their perspective (10 min each). Twenty minutes will be allocated to audience discussion and debate. We expect the audience to be comprised of HTA, payer and industry representatives and will aim to make this section interactive.