Shedding light on the HTA consultancy market: Insights from Poland.

Research on health technology assessment (HTA) from a policy perspective typically examines public HTA bodies, with little attention devoted to how manufacturers develop their evidence submissions. Taking Poland as a crucial case, we explored the market of HTA consultancy firms which assist drug manufacturers in developing these submissions, called HTA reports. We reviewed 318 HTA reports from 2012 to 2015, data from the Polish National Company Registry, the content of HTA consulting firms' websites, and appraisal reports developed by the Polish HTA body. We identified HTA consultancy firms which developed 96-98% HTA reports. We found that the transparency of information about the authors of HTA reports provided by the HTA body had improved between 2012 and 2015. Six companies with market shares from 10 to 30% dominated the market. The market size was estimated to be 5-6 million EUR annually. HTA consultancies had a broad service portfolio related to preparation of HTA reports. Over 90% of HTA reports did not meet the official minimum quality requirements, and only half of the resubmissions took into account remarks made by the HTA body. Our study provides insights into the structure, evolution and role of the for-profit HTA consultancy market as a crucial part of the public HTA system. This raises important policy points about transparency and regulation at the intersection of public and private sectors in HTA