ATHEROSCLEROSIS TRIALS : APPROVAL, IMPLEMENTATION AND REIMBURSEMENT CHALLENGES
Saturday, December 5th, 6:30 – 8:30pm
In 2010, seven of the top 20 grossing drugs in the US were cardiovascular medicines. By 2020 this had dropped to three medicines (including two anticoagulants), and this number is likely to continue to fall. The underlying pattern is the emergence of more specialised and more expensive drugs used to treat non-cardiovascular conditions (e.g. autoimmune diseases, macular degeneration, certain cancers) which each affect relatively few patients. The journey for an effective cardiovascular medicine from randomized trial to regulatory approval to adoption by payers is complex and sometimes unpredictable, partly due to their differing priorities – efficacy and safety for regulators, value for money for payers, symptomatic improvement and survival for patients. Can trialists design trials to satisfy these various demands, and how should they go about it? In this session we will hear the views of colleagues from industry, regulatory bodies and payers, and also from patients.