Evaluation in a disconnected healthcare system: problems and suggested solutions from the Australian HTA review

Abstract

HTA in Australia & the review In Australia, three advisory bodies at the national level are responsible for evaluating evidence relating to the safety, effectiveness and cost–effectiveness of new medical technologies. The Therapeutic Goods Administration (TGA) has assessed the quality, safety and efficacy of medicines and regulated the quality, safety and performance of medical devices at a national level since 1991 [2]. The Pharmaceutical Benefits Advisory Committee (PBAC) was established under section 101 of the National Health Act 1953 to assess the effectiveness of prescription pharma ceuticals prior to subsidy on the Pharmaceutical Benefits Scheme (PBS), and since 1994, it has formally assessed cost–effectiveness [3]. The Medical Services Advisory Committee (MSAC), set up in 1998, assesses health technologies and medical procedures in the private health sector, subsidized under Medicare, the national insurance scheme [4]. The maturity of this two-tier centralized model of HTA assessment for market entry and then for public subsidy contrasts with most other countries where there is a much shorter history of HTA, often only at the market entry level, with perhaps an advisory role in utilization, an indirect relationship to funding, and rarely at the national level. However, the maturation of the system in Australia has not been without controversy. The early years of the PBAC saw a review with particular emphasis on its internal efficiency and fairness [5]. The recent HTA review focused on the MSAC, the Prostheses and Devices Committee (PDC) and the regulatory process by the TGA. A key concern was that sponsors of new medical procedures or devices must navigate at least two separate independent processes (TGA and MSAC or PDC), and in a small number of cases, all three, and if a new diagnostic technology is linked to a medicine, the PBAC might also be involved.