As medicinal technologies continue to advance, the development of new drugs, especially those targeting serious conditions like cancer and rare diseases, has been on the global rise. These highpriced specialty drugs account for an increasing share of pharmaceutical expenditure. Also, facilitating the availability of new drugs has become a subject of growing attention, and new methods of ensuring prompt availability of new drugs, such as accelerated approval and risk-sharing arrangements (RSAs),
have been used widely around the world. With the reliance on fast-track approvals growing, however, the evidence on which to base reimbursement decisions is becoming increasingly uncertain.