Dáil Éireann Debate, Wednesday - 16 May 2012
4Deputy Billy Kelleher asked the Minister for Health if he will consider reversing the decision of the National Centre for Pharmaeconomics to halve the threshold used to measure value for money; if his attention has been drawn to the knock-on effects this decision is having on sufferers of major illnesses including prostate cancer; and if he will make a statement on the matter. [24408/12]
View answerThe National Centre for Pharmoeconomics, NCPE, plays an important role in the assessment process for new medicines. Its findings are not, however, the sole deciding factor in the process of allocating resources for new and expensive treatments. Its report is an input into decision making, but it is not the decision. The NCPE investigates the robustness of pricing proposals and cost-effectiveness documentation forwarded by pharmaceutical companies at a range of values. It is entirely appropriate to investigate cost-effectiveness at a range of values. Such investigations provide very useful information for the HSE on the most appropriate use of resources and potential negotiating positions with pharmaceutical companies when discussing price. Furthermore, the assessment process may identify where additional information is required from a pharmaceutical company.
The assessment process conducted by the HSE and the NCPE is a perfectly legitimate tool in assessing the best application of limited resources. It is designed not to prevent access to medicines but to ensure the best value can be achieved in order that more medicines can ultimately be provided from within limited budgets. The NCPE economic assessment process is robust and internationally respected and an important input for decision makers.
There are a number of new and expensive drug treatments being considered by the HSE. Drugs for the treatment of prostate cancer, including Zytiga and Jevtana, are within the decision making process. It would be inappropriate for me to comment further while this process is ongoing.
There has been recent media coverage of reimbursement approval for new and expensive medicines. Following on from recent discussions in this regard, the Chief Medical Officer is exploring with the HSE the adoption of a new and robust system for decision making on drugs in order to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.
I am disappointed with the decision of the HSE to reduce the threshold used for determining cost-effectiveness. The NCPE makes recommendations, but these are based on values of life expectancy and quality of life. The HSE has decided to reduce the threshold from €40,000 to €20,000, which will have a negative impact on many people who are waiting for breakthrough medicines or new drugs that are coming onto the market on a continual basis. The example of Ipilimumab is a case in point. This drug was recommended some time ago for the treatment of melanoma, but the HSE had to be dragged kicking and screaming into making it available. There is a difficulty in that regard. We must get used to the fact that there will be continual advances in technology and increases in the number of available medicines, while life expectancy and survival rates, particularly for people with cancer, will continually increase. That is the most positive thing we can say about the national cancer care strategy. Does the Minister of State accept that reducing the threshold of adjudication from €40,000 to €20,000 will mean that many people may not receive life-saving treatments because of cost-cutting measures and that this will have a detrimental impact on quality of life and even on life itself?
We must consider these matters in the context of the overall cost of the drugs budget. We spend about 16% of the health budget on drugs, which amounts to almost €2 billion. By any standard, that is a very high proportion and it is not sustainable into the future. That is why there is an onus on all of us to ensure we get better value for money in terms of drug costs. We all want to see new and effective drugs coming onto the market as quickly as possible. The HSE estimates that if we were to approve new drugs that are clinically effective, the cost of providing them could be up to €30 million. There is no new pot of money from which we can take more money for the drugs budget. It is a finite budget and there is no potential for increasing it. I do not need to tell the Deputy the reason there is no new money available. We want to ensure these new drugs can be brought onto the market, but it must be done in the context of reducing the prices of other drugs for which we are paying, many of which are over and above the prices in other countries.
I appreciate the Minister of State's reply, but we must recall that the Minister for Health, when on this side of the House, accused a previous Minister of criminal negligence with regard to the delay in the roll-out of the HPV vaccination programme for girls. What we are looking at is a reduction in the threshold for determining value for money which will ensure people will die because they will not be able to access the necessary breakthrough drugs. A case in point was Ipilimumab, but there are many more, including Pradaxa, Sycrest, Victrelis, Brilique and Gilenya. These are all drugs that should be made available, but the HSE has reduced the threshold from €40,000 to €20,000, which means it has put a lower value on life.
The HSE has no role in determining the threshold. It is the role of the NCPE to consider a number of aspects with regard to how new drugs are to be assessed. I want to make it absolutely clear that there was no reduction in the threshold. I was in touch with the unit today and confirmed that since 2009 cost benefit analyses had been done on two levels, €45,000 per quality-adjusted life year, QALY, and €20,000 per QALY. It is absolutely legitimate that new drugs are assessed on this basis and that has been the practice since 2009. There has been no change in this regard.
There has been a change.
Many new drugs either above or below these levels are approved, while many others above or below them are rejected. That input from the NCPE is only one of a number of elements taken into consideration in the decision making process to approve a new drug for reimbursement.
5Deputy Caoimhghín Ó Caoláin asked the Minister for Health if new procedures will be put in place to address both the recurrent problem of supply to pharmacists of vital prescription drugs and the need to make the most effective drugs and treatments available as soon as possible to public patients as shown by the recent case of the cancer drug ipilimumab. [24410/12]
View answerShortages of essential medicines are a source of concern not only in Ireland but also throughout Europe and the rest of the world. It is a global problem affecting health systems in all countries and impacting on patients worldwide. Medicines shortages can be the result of one, several or any combination of factors throughout the pharmaceutical supply chain such as manufacturing difficulties, industry consolidation and commercial decisions by manufacturers to withdraw unprofitable lines. In some cases, pharmaceutical manufacturing is concentrated to such an extent that a production problem in one pharmaceutical plant can have a wide-ranging and international impact on health systems throughout the world.
Irish medicine regulations place an obligation on both manufacturers and pharmaceutical wholesalers within the limits of their respective responsibilities to ensure the adequate availability and supply of medicines on the Irish market in order to meet patient needs. My Department has been engaging with the Irish Medicines Board, IMB, the Health Service Executive, HSE, and the Pharmaceutical Society of Ireland, PSI, to identify ways in which the Irish system can manage medicine shortages as effectively as possible to minimise the impact on patients. International efforts to manage medicine shortages effectively are also being considered.
Pharmaceutical production is carried out by private enterprises and the State or my Department can only intervene to a limited extent to prevent medicine shortages occurring. The IMB and the HSE continue to work closely to manage operationally medicine shortages when they arise. The PSI works with the pharmacy profession and has recently published guidance for registered pharmacists on managing medicine shortages. Manufacturers, wholesalers and pharmacies all have a responsibility to work together to identify shortages quickly and implement alternative arrangements to meet the needs of patients.
Additional information not given on the floor of the House.
Medicine shortages are not related to the negotiation of pricing and the reimbursement of new and expensive medicines such as Ipilimumab. The recent issue regarding this drug was related to the current pricing and supply agreement with pharmaceutical manufacturers. The Department and the HSE are in contact with the Irish Pharmaceutical Healthcare Association, IPHA, with the intention of securing a new pricing and supply agreement to replace the existing agreement which expired on 1 March. The terms of the previous agreement and savings secured thereunder will continue to apply pending successful negotiation of a new agreement. The Department is committed to securing additional savings in the price of medicines in any new agreement.
There has been recent media coverage of reimbursement approval for new and expensive medicines. The position of the Department and the HSE in the ongoing contacts with the IPHA is that financial space needs to be created within current drug expenditure to facilitate the cost of the new and innovative drugs awaiting reimbursement approval. The Chief Medical Officer is exploring with the HSE the adoption of a new and robust system for decision making in regard to drugs to promote and drive evidence-based prescribing. This should help to create capacity on a sustainable basis to provide for necessary new drugs when there is evidence to support their use.
I welcome the fact that the cancer drug in question has been approved. Given the debate on the issue, will the Minister of State bring forward, in conjunction with her colleagues, the Minister for Health, Deputy James Reilly, and the Minister of State, Deputy Kathleen Lynch, a policy to ensure cancer patients and others who require advanced drugs and treatments will receive what they need as soon as possible? Will the Minister of State take on board the current inequity of access? There is a disparity in the approach of the various HSE regions. Tysabri is available in some HSE regions but not in all and that issue needs to be addressed.
Referencing the Minister's reply to Deputy Joan Collins, will the Minister of State confirm that the triple treatment with protease inhibitors for hepatitis C will be available to all affected women as prescribed? Does the Minister of State accept that under the terms of the Health (Amendment) Act 1996, women have a statutory entitlement to all new prescription drugs, as prescribed? Will she ensure all the women affected who require the medication in question will be able to gain access to it without delay?
On last night's "Prime Time" programme a representative of the National Centre for Pharmacoeconomics stated that in cases in which it had not approved particular drugs because of their cost, it had been able to negotiate a lower price with the pharmaceutical companies involved. Does this not expose excessive profiteering by the pharmaceutical companies? What does the Minister of State and her colleagues intend to do about it? This is an issue on which each of the Ministers has reflected when in opposition.
As I stated, cost is but one of the elements taken into consideration. Whatever recommendation is made by the National Centre for Pharmacoeconomics is but one element in the decision making process. Other issues of concern include clinical effectiveness. This is the main factor taken into consideration. Cost-effectiveness, severity of disease, unmet needs, policy considerations, available funding and other funding priorities must also be examined. We need to be reasonable and balanced when taking these factors into consideration.
As I stated, we have a very large drugs bill and must work very hard to reduce it. There is an onus on all the players concerned to reduce it. We need to address this issue from a prescription perspective and also the overall cost of medicines. That is why it is important that people discuss how we can ensure the supply of medicines is guaranteed on a sustainable basis. As the Deputy stated, we are spending a considerable amount on drugs. Expenditure amounts to almost €2 billion. We need to make space within this budget to allow for new drugs to come onto the market. The Government side, just as much as the Opposition side, and those working in the health service and, most of all, patients want to see the new, effective drugs coming onto the market as soon as possible. This is achieved within a limited envelope. If funding must be provided for new drugs, we must secure a better deal on the cost of existing drugs.
The Minister of State did not address the issue of the availability of tysabri in all HSE areas. Will she, please, do so? Will she reiterate and confirm the position outlined by the Minister in response to Deputy Joan Collin's question on women testing positive for hepatitis C? This is very important. The women concerned have a statutory entitlement under the terms of the 1996 Act.
It is not entirely a question of cost, but it is most certainly is a question of availability. The United States Senate has introduced legislation to address what it is referred to as "price gouging" by certain pharmaceutical companies which are driving up the price by making fewer drugs available than are demanded. Has the Minister of State any concerns that such practices are taking place in this jurisdiction or in supply lines to our market?
My understanding is that tysabri is prescribed on the basis of clinical indications. If there are regional variations, I am not aware of them. I will check and revert to the Deputy later in the day.
I agree absolutely with the Deputy that we need to be very vigilant about the prices charged for medicines. In many cases where new drugs are coming onto the market, the suppliers have a monopoly. That is why we need very rigorous assessment of the value for money achieved in the prescribing of the drugs in question. We cannot accept any new drug coming onto the market. There ought to be a very rigorous assessment and such an assessment is absolutely legitimate. History shows that, in many instances, we paid over the odds for drugs. This is partly the reason our drugs bill has increased from €400 million in 1998 to almost €2 billion today. This is not sustainable. We must ensure drug companies, the presence of which in the country we very much welcome because of their research and the employment they provide, are responsible in their pricing systems. If we are paying more for drugs, the cost must be met somewhere else. It means a service cut somewhere else. That is the reality and there are serious implications on foot of a service cut. It is a question of ensuring we are reasonable and that we can bring the drugs budget under some control while ensuring new drugs are made available.
