OBJECTIVES: Due to rising costs and aging populations, countries with public health systems are increasingly utilising Health Technology Assessments (HTAs) to determine pricing and reimbursement of new treatments. This research evaluates the fees charged to industry for HTAs in countries with obligate cost-utility HTA bodies (UK, Canada and Australia) relative to their respective market size.

METHODS: HTA appraisal fees were identified from publically available websites from the HTA bodies: National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), and Pharmaceutical Benefits Advisory Committee (PBAC) and annual national market size were sourced from the UK National Health Service, Canadian Institute for Health Information, and the Pharmaceutical Benefit Scheme.

RESULTS: HTA bodies are increasingly requiring partial funding from industry. NICE is proposing to charge £142,000 (€160,727) for a single technology appraisal where the annual national pharmaceutical market is £16 billion (€18.1 billion), which provides an Appraisal Cost to Market Size (ACMS) ratio of 112,676. CADTH charges CN$72,000 (€48,374) for a Schedule A submission with a market of CN$8.8 billion (€5.9 billion). PBAC charges AU$131,407 (€88,377) for a Major Lodgment with a market of AU$10.8 billion (€7.3 billion). ACMS ratios for Canada and Australia were 122,222 and 82,187, respectively.

CONCLUSIONS: In order to be publically funded in the UK, Canada and Australia, therapies need to receive positive appraisals by HTA bodies which require financial contributions from manufacturers. These contributions bear little relation to the market size and cumulatively exceed €290,000 (even assuming no need for resubmissions). By adopting charging/cost recovery models, HTA bodies may be able to reinvest the proceeds to increase the efficiency and capacity of appraisals, expediting patient access. However, these fees may be burdensome especially for SMEs with promising therapies for orphan/rare diseases, and they may thus have the potential to deter and delay their submissions.