OBJECTIVES : Radiopharmaceuticals encompass all medicinal products containing radioisotopes. Whilst traditionally utilized as diagnostics, radiopharmaceuticals are increasingly emerging as an innovative modality for targeted therapy. Their unstable and hazardous nature necessitate distinct handling, manufacturing and storage requirements versus conventional pharmaceuticals, which are associated with additional costs. However, in many major markets, these therapeutic radiopharmaceutical products are subject to the same appraisal process by Health Technology Assessment (HTA) bodies which aim to align the publicly reimbursed price to their incremental clinical and/or economic value versus standard-of-care. This abstract aims to evaluate how therapeutic radiopharmaceuticals have been evaluated by HTA bodies to date.

METHODS : FDA and EMA websites were screen to identify any approved therapeutic radiopharmaceuticals. Publicly-available published HTA reports on these radiopharmaceuticals were analyzed from ICER, NICE, SMC, HAS, G-BA and key data extracted.

RESULTS : Two therapeutic radiopharmaceuticals were identified, both of which had received marketing authorization by the FDA and European Commission: Lutathera® (lutetium Lu-177 dotatate; EC-approval: 2017, FDA-approval: 2018) and Xofigo® (radium-223 dichloride; FDA- and EC-approval: 2013). Both were licensed for oncology indications. These agents have received generally positive HTA appraisals: SMC have accepted both (Xofigo® conditional on a Patient Access Scheme [PAS]) and NICE recommended both (conditional on PAS; Xofigo® received an ‘optimized’ recommendation). G-BA deemed Xofigo® offered a ‘considerable’ additional benefit in one population and Lutathera® received automatic additional benefit as an orphan drug. Lutathera® attained ASMR III by HAS and the only identified negative HTA outcome was that by HAS of Xofigo® (ASMR IV). The ICER body had not evaluated either radiopharmaceutical. The mean time from EC-approval to positive HTA decision was 182.8 days.

CONCLUSIONS : The limited number of therapeutic radiopharmaceuticals available have achieved broad and rapid reimbursement in major European markets. Their additional handling, manufacturing and storage costs have not outweighed the value of their patient benefits.