|Implemented in this survey?|
Since June 2003, the PBAC has published decisions not to recommend listing and deferrals. The objective of changing the policy is to open the decisions to greater public scrutiny.The policy change affects the pharmaceutical companies and (indirectly) any consulting groups or companies whom they employ, for example, to undertake economic modelling as part of a submission to the PBAC.It may also ultimately affect the PBAC as more companies may appeal decisions.
Since December 1999, the Pharmaceutical Benefits Advisory Committee (PBAC) has published its positive recommendations on its website, including the drug and form for which listing was requested, the type and proposed use of the drug and any reasons given for the proposed listing or request. Since June 2003, the PBAC has also published the following types of decisions:
The objectives of changing the policy of publication are to put as much as possible of the material the PBAC considers and the reasons behind decisions in the public domain.
The policy change affects the pharmaceutical companies and (indirectly) any consulting groups or companies whom they employ to provide them with information (e.g. economic modelling) contained in any submission to the PBAC as the reasons for refusal or deferral are stated explicitly and publicly, thus potentially having an impact on their reputation. It may also ultimately affect the PBAC as, in explicitly and publicly addressing the reasons for not listing, they may be opening the way for more companies to appeal decisions.
The objectives of the change in policy are to make the material considered in decisions and the reasons behind the decisions available for public information and comment.
The incentive for the PBAC is that making the information available would assist understanding of the decisions made and thus potentially reduce criticism of PBAC decision making as being not open to scrutiny and challenge.
pharmaceutical companies, PBAC, consumers
|Degree of Innovation||traditional||innovative|
|Degree of Controversy||consensual||highly controversial|
|Structural or Systemic Impact||marginal||fundamental|
|Public Visibility||very low||very high|
In line with the innovative nature of the PBAC, publishing decisions to list or not list and the reasons behind such decisions are also relatively innovative. However, they have been made with the
agreement of the consumer movement and the pharmaceutical industry, even though the former thinks that the move is a very limited one and the latter may be nervous of any expansion of the amount
and/or type of information made available.
There is unlikely to be any broad systemic imoact due to the small and limited nature of this change. Public visibility has not been high. There is no reason why changes such as this could not be made by all health technology decision making bodies (eg NICE).
The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established on 12 May 1954 under section 101 of the National Health Act 1953 to make recommendations and give
advice to the Minister about which drugs and medicinal preparations should be made available as pharmaceutical benefits. No new drug may be made available as a pharmaceutical benefit unless the
Committee has so recommended.
The Committee is required by the Act to consider the effectiveness and cost of a proposed benefit compared to alternative therapies. In making its recommendations the Committee, on the basis of community usage, recommends maximum quantities and repeats and may also recommend restrictions as to the indications where PBS subsidy is available. When recommending listings, the Committee provides advice to the Pharmaceutical Benefits Pricing Authority (PBPA) regarding comparison with alternatives or their cost effectiveness.
The Pharmaceutical Benefits Advisory Committee (PBAC) established the Economic Subcommittee (ESC) in December 1993 under section 101A of the National Health Act 1953 to review and interpret economic analyses of drugs submitted to the PBAC, advise the PBAC on these analyses and to advise the PBAC on technical aspects of requiring and using economic evaluations. The Pharmaceutical Benefits Advisory Committee (PBAC) established the Drug Utilisation subcommittee (DUSC) in 1988 under section 101A of the National Health Act 1953 to collect and analyse data on drug utilisation in Australia for use by the PBAC, make inter-country comparisons of drug utilisation statistics and to assist in generating information relating to rational use and prescribing of medicines. The DUSC secretariat is responsible for publishing the Australian Statistics on Medicines on an annual basis.
Recently, Australia and the USA have agreed on the terms of a Free Trade Agreement. One of the areas in which it is expected that the Agreement will have an impact is in relation to the Pharmaceutical Benefits Scheme. Under the terms of the agreement the following has been agreed:
Thus, this measure can be seen as part of the agreement to improve the transparency and timeliness of the PBS processes. It has also been suggested that one way in which the PBS will enable companies to have input to the processes will be to set up an appeal process. However, whether this will be independent of the PBS and the extent to which it will enable decisions of the PBAC to be reversed has not been clarified.
|Implemented in this survey?|
The PBAC has long considered it desirable to make as much of the material it uses in making its decisions and the reasons behind the decisions open to the public's view. The main purpose is to
assist understanding of the decisions which are frequently based on information supplied by the pharmaceutical companies which is not available to either the wider medical community or the
general public (including additional trial data, costing information and expert advice about the usefulness of the drug under evaluation).
One of the reasons this has not been done until now is that the companies were sensitive about information being made available which was "commercial in confidence". This included the information about the effectiveness and cost-effectiveness of the drug being evaluated (submitted by the company) and the analyses that the PBAC develops from these submissions.
Discussions between the PBAC and the pharmaceutical industry resulted in the decision being made to publish a list of decisions "not to list" including a limited amount of information about the reasons for the decision.
All the actors involved in this policy change (the PBAC, the pharmaceutical industry and consumer advocates) support, in principle, greater transparency including publication of the decisions of the PBAC and the justification for these decisions. However, while the industry is nervous about what and how much information is made available, consumers have criticised the PBAC on the grounds that the information being provided about decisons not to list are too vague and do not provide consumers and members of the public with enough detail.
|Government||very supportive||strongly opposed|
|Providers||very supportive||strongly opposed|
|Patients, Consumers||very supportive||strongly opposed|
|Scientific Community||very supportive||strongly opposed|
|Private Sector or Industry|
|Private Sector||very supportive||strongly opposed|
|Patients, Consumers||very strong||none|
|Scientific Community||very strong||none|
|Private Sector or Industry|
|Private Sector||very strong||none|
The implementation of the policy change has taken place. In June 2003, 22 positive recomendations were made by the PBAC as well as 8 "first time" decisions not to recommend listing, 3 "subsequent"
decisions not to recommend and 3 decisions to defer listing. In September 2003, 20 positive recomendations were made by the PBAC as well as 1 "first time" decision not to recommend listing and 3
"subsequent" decisions not to recommend.
The main reasons given by the PBAC for not recommending listing were:
In response, most pharmaceutical companies affected by the decision stated that they disagreed with the decision; however, some followed this with a statement about intending to clarify the decision with the PBAC, while others stated that they would need to consider their position. A stated decision to re-submit was made in relation to 3 decisions.
The aim of the PBAC is to move to a position of even greater disclosure but it acknowledges that there is a substantial way to go before this occurs.
Consumer advocates consider that the disclosure now available is a very small step in the right direction - "the glass through which we viewed the PBAC and the processes of the PBS was entirely black, now it's very dark grey" (Goddard, 1/8/2003).
In the future, the pressure of consumer groups and the desire of the PBAC for greater disclosure will be pitted against the pharmaceutical companies' nervousness about commercially sensitive information being made public, which underpins their agreement with the government that information made available to the PBAC for the purposes of evaluation are confidential.
The policy as it currently stands satisfies neither the objective of the PBAC nor the demands of consumers. However, it does go some way to making the decision making process of the PBAC more
transparent and open to scrutiny.
It seem unlikely that it will have an impact on the costs of the PBS. It may have an impact on the way in which future submissions to the PBAC are made and on decisions of consumers and doctors regarding the use of drugs which are not listed - which in turn may have some impact on the quality of care delivered.
The provision of more information than has previously been made available has increased the equity of information but, given the limited information available, any improvement must be regarded as marginal.
|Quality of Health Care Services||marginal||fundamental|
|Level of Equity||system less equitable||system more equitable|
|Cost Efficiency||very low||very high|
The changes may, in some instances lead to higher quality health services being delivered. For example, the information given may change consumers' and/or providers' decisions about requesting or
prescribing drugs which may enhance the quality of care for individual patients.
Increased information about the decisions of the PBAC has the potential to increase equity, but, given the limited information currently being made available, any increase is likely to be marginal.
This change is unlikely to have any impact on efficiency as it has not changed the decisions of the PBS, hence no change has been made to either the costs of the PBS or the effectiveness of the drugs made available under this scheme.
Pharmaceutical benefits Scheme http://www.health.gov.au/internet/wcms/publishing.nsf/Content/health-pbs-general-outcomes.htm Accessed
Australia-United States Free Trade Agreement - Health. http://www.dfat.gov.au/trade/negotiations/us_fta/final-text/letters/02_pbs.pdf Accessed 1/4/2004
Wilson, A. personal communication. 7/4/2004
ABC online. PM- criticisms the PBAC website information too vague. http://www.abc.net.au/pm/content/2003/s915621.htm. Accessed 1/4/2004