Delays in access to affordable medicines: Putting policy into perspective

Abstract

Background. To save costs, the Australian Government recently deferred approval of seven new medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for up to 7 months. Objectives. The aim of this research is to examine the timelines of PBAC applications following approval by the Therapeutic Goods Administration (TGA), allowing the recent Cabinet delays to be considered in the context of the overall medicines approval process. Methods. All new chemical entities and products for new indications approved in 2004 by the Australian Drug Evaluation Committee (ADEC) were identified. Outcomes of PBAC meetings from 2004 to 2010 were then searched to identify if and when these products were reviewed by PBAC. Results. ADEC recommended 63 eligible products for registration in 2004. Of the 113 submissions made to PBAC for these products, 66 were successful. Only 43% of the products were submitted to PBAC within 2 years, with an average 17-month delay from TGA approval of a product to consideration by the PBAC. Conclusions. Cabinet decisions to defer listing of new medicines delays access to new treatments. This occurred in addition to other longer delays, earlier in the approval process for medicines, resulting in a significant impact on the overall timeliness of listing. What is known about the topic? There is evidence that the time from registration of new drugs on the TGA to their listing for subsidised availability is increasing. The government's recent decision to delay the listing of seven new drugs for subsidisation raised concerns about the potential for additional delays to impact the accessibility of new, affordable medicines for patients. What does this paper add? This paper examines delays at various stages in the process of approval for pharmaceutical subsidies on the Pharmaceutical Benefits Scheme (PBS), putting the deferral of new medicine listings in the overall context of the approval process. It identifies the potential role of pharmaceutical companies and product sponsors in delaying access to new, affordable medicines early in the approval process. What are the implications for practitioners? Delays in the subsidisation of medicines, wherever they occur in the process, not only reduce patient access, but may also lead to pressure in other areas of the health care system to finance such medicines. This makes these results of particular interest to clinician managers, health care managers and policy makers. © AHHA 2012.