آیا استرالیایی ها قادر به دسترسی به داروهای جدید در طرح کم و بیش مزایای دارویی شیوه به موقع هستند؟ تجزیه و تحلیل مزایای دارویی توصیه های کمیته مشورتی، 1999-2003

Objective Timely access to necessary medicines that Australians need is one of the four pillars of the Australian Government's National Medicines Policy. We were interested to determine whether there was a change in the time taken for medicines to be listed once recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). Methods Descriptive statistics were used to show the pattern of recommendations for PBAC meetings from 1999 to 2003. For successful recommendations, we developed a linear regression model to analyze the time to list from the PBAC meeting to date of listing (time to list). The model determined whether this time had changed over the 4-year period, and the reasons for any changes. Results The PBAC made 307 positive recommendations at its 17 meetings over the study period. Ninety percent resulted in a Pharmaceutical Benefits Scheme (PBS) listing on or before April 1, 2005. Eighty-two percent of the recommendations made in 1999 and 2000 resulted in early or on-time listings. In 2001, 2002, and 2003, the comparable proportions were 67%, 68%, and 75%. Mean times to list for the years from 1999 to 2003 were similar (approximately 23 weeks), except in 2001 where it was 30 weeks. Conclusions Over the study period, 90% of all PBAC recommendations resulted in a PBS listing. In 2001 there was a statistically significant increase in the mean time to list. In addition, it appears that recommendations for new listings and new indications (medicines that are likely to result in substantial Government expenditure) were associated with a longer time to list.

Australia has a national scheme to provide subsidized access to necessary medicines—the Pharmaceutical Benefits Scheme (PBS). The Pharmaceutical Benefits Advisory Committee (PBAC) was established as a statutory body to advise the Minister of Health and Ageing (Minister) on matters relating to the listing and availability of medicines on the PBS [1]. The PBAC is required by law to consider cost and effectiveness, among other factors, when reviewing an application to list a (new) medicine on the PBS (“value for money” assessment) [2]. The PBAC has produced Guidelines for the pharmaceutical industry on the preparation of applications [3]. For many years, the PBAC met on a quarterly basis. Since 2004, meetings occur three times a year. The PBAC makes three types of decisions (outcomes): • It can decide to recommend the listing of a medicine on the PBS (so-called recommendation); • It can decide not to recommend the listing of a medicine on the PBS (rejection); • It can defer a decision pending the provision of specific additional information that would be relevant and important to its decision (deferral). Once a medicine has been recommended by the PBAC, it is referred to the Pharmaceutical Benefits Pricing Authority (PBPA) for consideration. The PBPA is a nonstatutory body that advises the Minister on matters relating to the pricing of medicines on the PBS [4]. The PBPA usually meets 4 to 5 weeks after each PBAC meeting. Recommendations are referred to the Minister, or to Cabinet if the estimated annual cost to the PBS is greater than AU$10 million in any of the first 4 years of listing, for approval. It is most unusual for a Minister not to accept a PBAC recommendation. The listing process, from PBAC application to listing, takes a minimum of 8 months. The PBS listing of a PBAC-recommended medicine can be delayed if the sponsor and the PBPA cannot agree on price; the recommendation is referred to Cabinet and its consideration is delayed or deferred; or there are supply issues. For many years PBAC decisions were not made public. Following an agreement between the PBAC and the pharmaceutical industry in mid-1999, all positive PBAC recommendations have been made public since the December 1999 PBAC meeting. Further agreement has been reached such that from its June 2003 meeting, all PBAC “decisions” (recommendations, rejections, and deferrals) will be made public, although the extent of disclosure will be limited.

Timely access to the medicines that Australians need, at a cost that individuals and the community can afford, is one of the four pillars of the Australian Government’s National Medicines Policy. Our study is one of the first public attempts to assess the timely access to subsidized medicines by the Australian community on a quantitative basis. (Note the recent development of process and impact indicators for the National Medicines Policy by the Australian Pharmaceutical Advisory Council [14].) We conducted our analysis on those medicines that were recommended by the PBAC, and were therefore considered to be necessary and cost effective. The policy does not define “timely access” in an absolute sense and we have not attempted to do so. Our objective was to see whether there had been a change in access over a 4-year period. A reasonable expectation is that Australians should be able to access via the PBS all new PBACrecommended medicines, because the Committee only recommends those that it believes are necessary. There is an absence of public policy and/or discussion on what constitutes a necessary medicine and what is an acceptable proportion of PBAC recommendations that should result in a PBS listing (on-time or at any time). We hope that the publication of our analysis will be the catalyst for further public discussion and debate on this important issue. Our analysis shows that only 90% of all PBAC recommendations for medicines resulted in a PBS listing at any time. A total of 98 (32%) of PBAC recommendations were for new medicines of which 90 (92%) resulted in a PBS listing at any time. Furthermore, our analysis showed a statistically significant increase in the mean time to list medicines recommended in 2001. This tendency continued into 2002, albeit not significantly. We note that the Cabinet review process was introduced at a time when the annual growth rate of PBS expenditure was approaching 20% and the mean time to list was at its peak [15]