Background: The belief that all new medicines bring a therapeutic innovation and better health outcomes is widely shared among the public, health professionals and policy makers.
Objectives: To examine the therapeutic value of new medicines marketed in Australia using two classification systems.
Methods: The therapeutic value of new medicines was categorised using the Motola's s and the Ahlqvist-Rastad's systems for all approvals made by the Australian Therapeutics Goods Administration (TGA) between 2005 and 2007. Scores were assigned independently by the three authors on the basis of the Public Summary Documents and Prescrire' review articles.
Results: Overall, 217 approval recommendations were made including 81 (37.3%) for new indications and 69 (31.8%) for new medicines. In Motola's rating system, 31 (52.5%) of the 59 drugs were rated as pharmacological or technological innovations and 28 (47.5%) were rated as therapeutic innovations. Only seven of the 59 drugs (11.9%) were rated as important innovations. In Ahlqvist-Rastad's system, only a third of the new drugs were rated as "added therapeutic value".
Conclusion: Only a minority of the new medicines marketed in Australia provide added therapeutic value compared to existing treatments. Stricter regulatory approval criteria would ensure better safety of the public and simplify the reimbursement processes.
Keywords: Innovation; Medicine regulation; New medicine; Therapeutic value.