OBJECTIVES : Recently introduced second line-treatments for stable angina (ivabradine, nicorandil, ranolazine, trimetazidine) require further examination from a health technology assessment (HTA) viewpoint. The review aims to analyze the existing approvals and reimbursement decisions on newly introduced drugs for second line-treatment of stable angina in selected counties.

METHODS : Approval and clinical trial data of second line-treatments for stable angina were searched in Medline as well as on drugs regulatory authorities` websites that are published before June 2020. The reimbursement decisions that are based on the results of the economic evaluations of these drugs were carried out by the key HTA agencies such as the Canadian Agency for drugs and Technologies in Health (CADTH), National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC), and Pharmaceutical Benefits Advisory Committee (PBAC).

RESULTS : EMA approves all four drugs for the second-line treatment as an add-on therapy for stable angina. TGA has approved all selected drugs, except trimetazidine. The only drug that is supported by the FDA is ranolazine. Lastly, ivabradine is authorized for sales in Canada. The decisions on reimbursements are based on economic evaluations that prove the cost-effectiveness of these drugs for stable angina. Nicorandil is not reimbursed in Canada and Scotland. In terms of reimbursement, trimetazidine is the only drug that is not refunded in any of these countries due to the lack of data proving long-term efficacy and safety. Ranolazine is reimbursed in Australia and the UK.

CONCLUSIONS : The review sheds light on the lack of available economic evaluations for ranolazine, ivabradine, trimetazidine, nicorandil in the context of stable angina. Further research is essential to generate reliable clinical data that will allow conducting economic evaluations to enrich appropriate decision-making for angina drugs.