Value attributes of advanced therapy medicinal products: a documentary analysis of comments received from stakeholders during reimbursement decisions to England's National Institute of Health and Care Excellence.

Objectives: Advanced therapy medicinal products (ATMPs) are transformative healthcare interventions, however, there has been limited research exploring their value. The objective of this study was to conduct a thematic analysis as part of a documentary analysis to identify value attributes of ATMPs.

Methods: As part of the NICE assessment processes in England, stakeholders are invited to provide comments on the technology. Nineteen NICE technology assessments (TAs) related to ATMPs were identified and subsequently included in a thematic analysis. All codes (and themes) were generated inductively from the text to reduce bias.

Results: This study found that the attributes of value of ATMPs can be categorized into three themes: treatment factors, innovation factors, and wider factors. That is, attributes of value of these interventions include not only direct treatment factors, although this was the largest category, but also additional factors such as those related to innovation and wider impacts the intervention may have, beyond the patient receiving therapy.

Conclusions: This thematic analysis of stakeholder comments submitted to NICE as part of TAs for ATMPs enhances the understanding of attributes of value of ATMPs. The findings are applicable to a wider geography.