Hta Epidemiology Data in Different Geographical Regions: Investigation of Requirements For Oncology Drugs.

Abstract

Harmonisation of health technology assessment (HTA) processes between countries is a logical and efficient solution to complex data gathering exercises required of pharmaceutical manufacturers when preparing submissions. However, harmonisation is a slow process and potentially substantial differences between countries exist. Further, some types of data will inevitably need to be country-specific to meet local HTA requirements. Epidemiological data can be considered one such source of information. We reviewed HTA requirements in Australia, England and Wales, Japan and Scotland for epidemiology data requirements in their submission. Specific data types were identified and compared across the geographical regions. Clear requirements were available for Australia (Pharmaceutical Benefits Advisory Committee [PBAC] ), England and Wales (National Institute for Health and Care Excellence [NICE] ), and Scotland (Scottish Medicines Consortium [SMC] ). As of April 2014, there is an ongoing development of the HTA process in Japan, which is excluded from this analysis. NICE, PBAC and the SMC all require the number of patients with the indicated disease and a clear statement of patient numbers eligible for treatment per year for 5 years. Beyond this, the requirements of the Australian PBC and the SMC were similar, specifying prevalence, incidence and mortality data, whereas NICE requires a measure of disease burden (not clearly defined) and life expectancy among those with the disease. The epidemiology requirements did not differ by disease area. HTA bodies stipulate the inclusion of epidemiological data to estimate economic impact of interventions. Some requirements are common to all agencies, but there are also some important differences. Specific epidemiological data needs for individual agencies must be considered by drug developers when planning and gathering information for HTA submissions.