OBJECTIVES: Innovation is a critical consideration for pharmaceutical companies and health technology assessment (HTA) bodies. A medicine being recognised as innovative can result in financial rewards and accelerated approval processes for the manufacturer. However, the definition and interpretation of ‘innovation’ differs across jurisdictions, potentially leading to inconsistencies in the recognition and reward of innovative medicines. This study investigates how various HTA bodies define and measure innovation, as well as whether there are any benefits or trends for medicines classified as ‘innovative’.

METHODS: Data was collected from the websites of three HTA bodies during the first quarter of 2023 (January to March): NICE (England), HAS (France), and AIFA (Italy). An extensive review of HTA and innovation reports was carried out to determine which medicines were classified 'innovative' and identify any prevailing trends regarding the types of innovative medicines gaining reimbursement.

RESULTS: Out of a total of 76 publicly available appraisals, 26 (30.3%) technologies were recognised as ‘innovative’ by either NICE (8/23 [34.8%]), HAS (16/37 [43%]), or AIFA (3/16 [18.7%]). The majority of assessments classified as innovative by HAS pertained to orphan drugs (9/16 [56.25%]), while NICE and AIFA appraisals each only classified one orphan drug as innovative. The granting of innovative status was often based on whether drugs represented a significant advancement in treatment or addressed conditions with substantial unmet needs. Most innovative products were for oncology treatment (17/28 [62.96%]), with only one categorised under each of the other therapeutic areas in each country.

CONCLUSIONS: This study demonstrates the varying rates of recognition for innovative medicines by highlighting how different HTA bodies define and measure innovation. The findings emphasise the importance of harmonising the definition and assessment of innovation across jurisdictions to ensure consistency in the recognition and reward of innovative medicines if innovation is to be used as a criterion for appraisal.