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Consumer access to pharmaceutical benefits

CHAIR —I now welcome representatives of the Consumers Health Forum of Australia. I know you have both done this many times before and I understand you have been given information many times on parliamentary privilege and the protection of witnesses and evidence. We do have your submission. I invite either of you or both or you to make an opening statement and then we will ask you some questions.

Ms Bennett —Thank you. I appreciate the opportunity to present the views of Australia’s peak national body representing health consumers on this very important issue. I would also like to thank you for your willingness to engage in this important process of reviewing PBS policy. It is an issue that is very important to Australia’s health consumers.

On that note, I would like to begin by emphasising the value of the Pharmaceutical Benefits Scheme to health consumers. The Consumers Health Forum has been in operation for more than 22 years and medicines policy, including PBS policy, has been a bread-and-butter issue for us throughout that time. CHF is supportive of the National Medicines Policy and its four objectives—the timely access to medicines that Australians need at a cost that individuals and the community can afford, medicines meeting appropriate standards of quality, safety and efficacy, quality use of medicines and maintaining a responsible and viable medicines industry. The PBS works to ensure that these objectives are met. CHF believes it is essential that the PBS remains viable into the future and supports PBS reform that allows for its continuing sustainability.

Australia has managed to keep medicines access high while costs remain comparatively low in spite of the small size of this market. We are the envy of the world due to our ability to maintain the low cost of and high access to pharmaceuticals through the PBS. We acknowledge the costs of the PBS have grown at an average of 10 per cent in the last decade and the need to find ways to ensure this sustainability is important as long as there is no major detriment to consumers. We also acknowledge that the viability of the industry is a consideration in order that Australian consumers have continued access to quality medicines.

CHF members have consistently championed the PBS as a key component in supporting them to maintain their health. This is particularly important for consumers with long-term and chronic conditions. In relation to the latest PBS reforms, CHF has consulted with consumers, who reported no major detriment overall. CHF argues that consumers will experience a major benefit from the reforms due to the PBS’s ongoing viability. For any PBS reform, CHF considers that there are several tests that must be applied. Consumers must not be disadvantaged, whether in access, cost or safety and quality. When the PBS reform was announced in November 2006, the Minister for Health and Ageing stated that consumers would not be disadvantaged by the reform. While CHF has not received any indication from our members overall that they have been disadvantaged by the PBS reforms that we are talking about today, we are aware that there are particular groups that have concerns about interchangeability in therapeutic groups and it is important that the impact on consumers continues to be monitored.

We would like to specifically highlight two aspects of the new reforms in our evidence—the therapeutic groups and the cabinet approvals. In terms of therapeutic groups, CHF is, on the whole, not opposed to this policy and does not believe that overall this policy has disadvantaged the majority of consumers. Consumers acknowledge that new therapeutic groups should not reduce access to necessary medicines, including high-cost medicines, as there are mechanisms in place to allow consumers to access any medicine in a group at the base price as long as it is requested by the prescriber. We would argue that these safeguards are an essential component of this policy in ensuring access by containing costs for consumers. As the senators on this committee would well know, out-of-pocket costs for consumers, particularly those with chronic conditions who are met with a range of costs, is a big issue.

Our consultations with consumers clearly indicate that consumers are faced with a choice about whether to forgo essential medicines when they are struggling to pay food, heating and other essential costs of living. Consumers and health professionals should be informed about exemptions from therapeutic group premiums where higher cost drugs are required and it is important that exemptions are applied for consumers who need, but would otherwise suffer from a decision to use, a higher cost drug.

Medicines within therapeutic groups must be interchangeable. CHF believes that clinical effectiveness must be the basis on which these decisions are made and they should be rigorous and transparent. While we are satisfied that the Pharmaceutical Benefits Advisory Committee is the appropriate body to provide this assurance in its role in advising on therapeutic groups, therapeutic groups are not subject to public consultation and transparency, something we heard a lot about this morning from the consumer groups. The criteria upon which clinical evidence is based by the PBAC are unclear. Transparency must occur if public confidence is to be maintained in claims of therapeutic equivalence of medicines within a particular group. Where there are significant concerns about interchangeability, therapeutic groups should not be formed. CHF is aware of the concerns that have been raised in relation to the interchangeability of some new therapeutic groups, particularly the oral bisphosphonates, selective serotonin reuptake inhibitors and of course the anti-epileptic group of drugs, which are also a concern for consumers although they are not a therapeutic group.

CHF argues that stakeholder consultation, including consumer consultation, is required in the formation of therapeutic groups to ensure that the relevant benefits and potential disadvantages are considered. Consumers are the people who are living with their medications on a daily basis and will suffer the most if they are switched to an inappropriate medicine that is not interchangeable. Their experiences must be taken into account in the assessment of interchangeability. Where CHF has undertaken consultation for the PBAC on the listing of particular drugs on the PBS through the development of consumer impact statements, this has been really valuable. Consultation must also be proactive in order to bring these important decisions to the attention of consumer groups, who are often under-resourced not-for-profit organisations without the capacity to monitor and assess the impact of emerging policies on the people that they represent.

In terms of the cabinet approvals process, CHF has identified that we would like to see greater transparency about the priority and time frames that are assigned to their consideration. Consumers should not be unduly disadvantaged by lengthy cabinet approvals. We have seen that in relation to the PNH group and bone marrow disease, where there have been quite significant time delays in cabinet approval. Clinical effectiveness must be the basis on which these decisions are made and consumers have expressed some scepticism about whether that is the case. Where a conflict exists between timely access and gathering of evidence on which to base clinical effectiveness, clinical evidence should take precedence to ensure an informed decision that will protect consumers’ safety. CHF notes the proposal in a number of other stakeholders’ submissions that the threshold for cabinet approvals be increased from $10 million to $20 million. CHF would not be opposed to this increase, particularly where it would expedite access to necessary medicines.

In conclusion, CHF supports PBS reform as a way of ensuring the future viability of the PBS provided that there are no major negative impacts on consumers in terms of access, safety and cost. We also recognise that the viability of the industry and its capacity to continue to deliver quality medicines to the Australian market is a factor that must be taken into account in this policy initiative. CHF overall supports the reforms to the PBS. It is important that the criteria and evidence for clinical effectiveness for selection of therapeutic groups is transparent. Any major concerns raised by consumer groups about interchangeability should be taken into consideration of the ongoing viability of a particular therapeutic group.

Timely access is desirable but consumer safety is absolutely paramount and must take precedence over other considerations for cabinet approvals. Where possible, transparency about decision making and time frames should be available to the public. Consumers, as the payers and users of the PBS, must be involved in the process of decision making about therapeutic groups, and mechanisms to ensure consultation should be a fundamental part of this policy. I thank you for your time today, senators, and we look forward to the outcomes of this inquiry.

Senator FIERRAVANTI-WELLS —You were present this morning and you heard the exchanges that I had with various people about the definition of ‘interchangeability’. Would you like to expand on what you see is an appropriate definition of ‘interchangeability’ and the sorts of processes you would like to see put in place.

Ms Bennett —We are not experts on what is interchangeable in terms of the clinical and therapeutic nature of medications. The Pharmaceutical Benefits Advisory Committee is the body that does provide advice about the clinical effectiveness of drugs for the listing on the PBS. The difference with this therapeutic groups policy is that the process for listing other drugs is a little more transparent in terms of the criteria that are used for looking at clinical effectiveness and in terms of the kind of evidence that is used by the PBAC to assess that effectiveness. With therapeutic groups that has not been the case. I suppose what we are really asking for is greater transparency about what the criteria are and what the basis of the evidence is for making those decisions.

Senator FIERRAVANTI-WELLS —In previous evidence one company talked about the 30,000 pages of material that are submitted for the listing of a drug. Does part of that process include consultation with organisations such as yours?

Ms Bennett —Not necessarily. In terms of the companies consulting with consumer groups?

Senator FIERRAVANTI-WELLS —No, in terms of the listing of drugs.

Ms Bennett —In terms of the listing of drugs, the agenda for the Pharmaceutical Benefits Advisory Committee is placed on their website six weeks before meetings and there is an opportunity at that stage for consultation with consumers; however, there has not been a capacity for that consultation to be very thorough. It is not always possible, as I said, for small not-for-profits to be proactive and to be monitoring the websites of all of the different health bodies that are making decisions in order to be able to provide good, rigorous consultative evidence to those processes. I think that is a really detrimental factor that could be improved.

Senator FIERRAVANTI-WELLS —Just on a practical level, we talked about the changes to transparency. You might like to take this on notice: do you have suggestions for how practically that process could be altered? I would appreciate your comments in relation to that.

You talked about the cabinet approval and priority. Indeed, the figures do stack up in terms of the length of time. The time between PBAC approval and cabinet consideration has doubled in recent years. Indeed, the figures show that the number of medicines costing over $10 million that were listed on the PBS between 2006 and 2009 actually halved. Obviously, there is a consumer concern from that perspective. It is taking twice the time to get half the number of medicines in the system.

Ms Bennett —Yes, and that is why we would support a review of the threshold and an increase in that threshold where it would enable more timely access to medicines and their consideration.

Senator FIERRAVANTI-WELLS —From your perspective, you do not know why it is taking twice as long to consider half as much?

Ms Bennett —No, we do not. I imagine it is because there are other priorities on the cabinet agenda. I guess greater transparency about the priority that is allocated to the decision making around drugs that consumers are relying on getting access to would be really useful. Short of that, if there is another way of providing more timely consideration of those approvals then we would support that.

Senator FIERRAVANTI-WELLS —One suggestion that has been made is that if everyone knew the criteria in terms of both the PBAC determining therapeutic goods or other processes then it would be easier to address those before you went through that process rather than later.

There was evidence given earlier by an organisation about the whole issue of the $10 million to $20 million, which you have raised as well. Did you seek any assurances and did you receive any assurances before the last federal election from the then opposition spokeswoman or anyone else now in government about revising or reviewing that $10 million to $20 million threshold?

Ms Bennett —I was not in this role at that point, so I cannot comment on the organisation—

Senator FIERRAVANTI-WELLS —You might like to take that on notice.

Ms Bennett —Yes.

Senator FIERRAVANTI-WELLS —If you did receive any communication or advice to that effect, I would appreciate it if you could produce a copy of it. Thank you.

Ms Bennett —Okay.

Senator MOORE —I am focused on the role of consumers in the process, as you know. You heard my question to the consumer groups early. The PBAC does have a consumer representative on it—not a community representative; a consumer representative—under the current processes. Is there any link through the consumer network with that person in terms of understanding and getting information about what consumers need in the PBAC process?

Ms Bennett —The person representing consumers on the PBAC was nominated by CHF some years ago. It is now a ministerial appointment. That position is governed by the terms of confidentiality that are agreed upon on the appointment of that person. Therefore, it is very difficult for that person to consult broadly with consumer networks. Although they certainly do have access to consumer networks, they cannot consult on the detail of the committee deliberations. That makes that a very difficult thing for them to do.

Having a consumer representative sitting on the PBAC is one mechanism for involving consumers. It is fairly limited in terms of the scope of what that position can provide, and you cannot expect one person to deliver a consumer perspective on the whole range of drugs being considered by the PBAC. That is not possible. The confidentiality clauses in the terms of their engagement preclude that engagement.

So that is one mechanism and there are others. We are happy to provide you with some examples. Certainly we have been involved in consulting with consumers and developing consumer impact statements on particular medications that are being considered by the PBAC. That is another mechanism. Having the agendas available on the website is a good thing and enables the groups who have a particular interest to comment directly to the PBAC. There are also others. We will take that question on notice. We appreciate that question. There is a limit to what one representative can provide.

Senator MOORE —Having the agendas available publicly is something that people have talked about in a positive way. If people have a particular interest in a condition or pharmaceutical—we often hear about a particular one that people are seeking—is that then a way they can lobby the PBAC or its members about why it would be important to get x drug approved? Is that a process that your organisation does?

Ms Bennett —Generally speaking, the sorts of drugs that people are interested in lobbying about will be particular drugs for a particular condition. We would not necessarily be scoping the website and checking which drugs are coming up for consideration by the PBAC, but certainly some groups are. It is of great importance to some groups that their drug gets approved. So, yes, it is a mechanism for that lobbying to happen, but I would argue that that is a very good thing in that it does provide a greater level of evidence beyond clinical efficacy for the PBAC upon which they can make a decision. We heard this morning from consumer groups that clinical evidence is important and the scientific evidence is critical to the process and must be the basis of decisions, but you also need that consumer perspective on how these drugs actually impact on them. That is a good mechanism to provide that.

Ms Wise —While we certainly welcome the publication of the agendas, as I think Carol mentioned earlier, many consumer groups are not for profit and have very limited resources so do not have the capacity to be monitoring the PBAC website to see the agenda. It is one mechanism.

Senator MOORE —The other issue we talked about last week in another hearing is consumer knowledge when talking with their practitioner. We heard evidence today about a consumer and their practitioner talking through what medication they should have and decisions being made about what they should do and the role of therapeutic groups in determining whether someone is forced onto one form of medication or another. In your experience, what is the knowledge amongst the consumer groups about their role in these discussions? Do they know they have the ability to talk with their practitioner about what medication they should be on, at what level, in what form and all those things? What is the level of knowledge of people about their own medication and the safety of that medication? I imagine you would like to comment on that.

Ms Bennett —Certainly it is variable. Not all consumers are informed and in a position to have that kind of conversation with their health practitioner. You could look at the therapeutic groups policy as an opportunity for consumers to have a conversation with their practitioner. Where particular drugs are interchanged that should absolutely be the basis upon which a discussion is had about the reasons for that interchangeability, any particular cost that may result from the provision of a different drug and certainly any side-effects or other issues that could potentially arise. It is an opportunity to do that. We would strongly encourage consumers to do that, but we would also like to see health professionals engage in that informed consent process.

Senator MOORE —The other process was where you can get the authority to have the dearer drug at the cheaper price. Do consumers know that their practitioner has the ability to apply for that? If they are told they have to have drug A because drug B costs more, do they know they can say, ‘Why can’t you ask for the provision?’

Ms Bennett —I would say generally no. We would certainly hope that practitioners are having that conversation with consumers and would use that option where they know it would be really difficult for people to afford the additional costs—and we are reliant on health practitioners to know somebody’s circumstances, but we know they do not always know people’s circumstances. That is an ongoing issue that we have in general terms about affordability.

Senator MOORE —Thank you.

CHAIR —Thank you very much. As usual, we very much appreciate your time and commitment to the Senate Community Affairs Committee’s processes, because you participate a lot. Thank you very much. It is much appreciated.

Ms Bennett —Thank you, senators.

Ms Wise —Thank you.

Proceedings suspended from 12.29 pm to 1.24 pm