PSY188 - USE OF MANAGED ENTRY AGREEMENTS IN INFLAMMATORY DISORDERS AMONG KEY HEALTH TECHNOLOGY ASSESSMENT AGENCIES

Abstract

Recession and cuts in public pharmaceutical expenditure have limited access to market of pharmaceutical innovations in last few years. As a solution, public health authorities and pharmaceutical companies have searched for alternative funding formulas, such as managed entry agreements (MEAs) to share the risks and uncertainties arising from public coverage of new products. This review aims to identify the use of MEAs in selected inflammatory disorders among key health technology assessment (HTA) agencies in Australia, Canada, and Europe. HTA decisions in rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis, Crohn’s disease, and ulcerative colitis (UC) published between 2013 and 2018 across seven HTA agencies were reviewed for use of MEAs. The number and type of MEAs by therapeutic area and agency were assessed. The review identified 295 HTA submissions, which assessed 39 interventions across five inflammatory conditions. Across all seven HTA agencies, 85% of submissions resulted in an intervention being recommended or recommended with restrictions, of which 19% of recommendations included an MEA. Use of MEAs was highest in UC (24%), followed by RA and PsA (22% each). The maximum use of MEAs was observed in the UK (National Institute of Clinical Excellence [NICE]: 86%, Scottish Medicines Consortium [SMC]: 41%). HTA agencies in Canada, France and Germany did not use MEAs for any of the reviewed indications. The application of MEA differed across different indications and agencies for the same intervention. All MEAs were financial based and the majority included a fixed discount to the drug cost. The use of MEAs was limited to biological drugs only. Currently, the use of MEAs for inflammatory disorders is limited and financial based. MEAs are likely to play a substantial role in market access negotiations in future for development and early access to novel biological therapies in these indications.