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I took up the case and discovered, as I said to my hon. Friend the Member for Newport, West, that the price of that drug in north America was between one eighth and one tenth of its price in the United Kingdom. I made an arrangement with the pharmacist at Withybush hospital in my constituency, and we started to import drugs from north America at one eighth of the price that was quoted in this country. There is room for serious negotiation. I know that the price has come down; I do not dispute that. I know also that, because they are ultra-orphan drugs, they are extremely expensive. However, the price that is quoted in the NICE appraisal must be examined to check that it is the actual price,
because the appraisal committees report refers to the fact that prices are negotiated locally. I cannot see why we should not have national negotiations for an ultra-orphan drug. We do not leave it up to individual pharmacists or hospitals to negotiate a separate deal, so surely, with only 400 patients, we should be able to negotiate a far lower price with those two companies, and perhaps compensate them by putting a penny on the price of aspirin or on something else.
Chris Ruane (Vale of Clwyd) (Lab): I congratulate my hon. Friend on securing the debate and on his sterling work over the years on this important issue. He makes the eminently sensible suggestion that we should negotiate a national price, but would he consider negotiating an international priceperhaps throughout the European Unionand using EU buying capacity to reduce the cost of the drugs?
Nick Ainger: I do not care whether negotiations are national, international, universal or whatever. The important thing is that they are ultra-orphan drugs that are used on a very small number of patients. That is the only difference. The things work. There is no question about the clinical efficacy of the drugs; it is purely about their unit costs. If that is the issue, we need to address it nationally, and ideally, internationally.
Paul Flynn: I am fascinated by my hon. Friends enterprise as a drug importer, and I should like to know how successful it was. My hon. Friend the Member for Vale of Clwyd (Chris Ruane) points out that there is an international market in drugs, which are accessible through the internet and other sources internationally. Is it not possible to get around the extraordinary difference in the price that GlaxoSmithKline charges in this country and in America? Is it possible to do so by investing in the enterprise to which my hon. Friend the Member for Carmarthen, West and South Pembrokeshire (Nick Ainger) referred? If so, I shall buy shares in it first thing tomorrow.
Nick Ainger: Circumstances have changed since 1999-2000. Nevertheless, there is no question but that at the time the arrangement saved the national health service about £120,000 on that one patient, compared with the price that it would have paid the following year. The situation illustrates that throughout the world, different prices are charged for the same product. The irony was that we imported from the United States something that had been produced 250 miles away in Dartford, Kent.
That was nonsense. It was obscene that a system could operate whereby in the United States, which is not a developing country by any stretch of the imagination, the cost was one eighth to one tenth of the price in this country, because of the arrangements that were made there. I also learned that, for individuals who are on Medicaid in the US, once their Medicaid ended, the deal was that the drug supplier would give the hospital the prostacyclins free of charge, which was a very generous arrangement. Perhaps that arrangement is indicative of the different deals that can be done with the drug companies.
For 15 years, prostacyclins have significantly improved quality of life and extended the lives of PAH patients. If the drugs are withdrawn, patients will die unnecessarily.
To withdraw prostacyclins on the basis of a flawed appraisal and prevent their future use is medically unsupportable, and I trust that NICE will take on board all the submissions that are made today and reverse its preliminary recommendations.
Sir Nicholas Winterton (Macclesfield) (Con): May I congratulate the hon. Member for Carmarthen, West and South Pembrokeshire (Nick Ainger) on securing this debate and on the very balanced and reasonable way in which he has advanced his case? I attended the meeting to which he referred in his speech and I am a sponsoring signatory of the early-day motion that he has tabled.
This is a very important debate. The Minister, with her nursing and medical experience, will take what is said today very seriously and I hope that she will ensure that NICE is made well aware of the strong feelings on this subject in the House of Commons.
As the hon. Member for Carmarthen, West and South Pembrokeshire said, there is understandably great concern among the health community and the pulmonary arterial hypertension community in this country about future treatment in the United Kingdom for this rarehe was right to describe it as suchbut deadly disease. Patient organisations are not only disappointed but extremely concerned for their members about NICEs preliminary recommendations on the treatment of PAH.
To take up another point made by the hon. Gentleman, it would appear that there has been a complete lack of understanding of the implications for patients, particularly those with connective tissue disease-related PAH, such as Raynauds and scleroderma, to which my hon. Friend the Member for Congleton (Ann Winterton) drew attention in her intervention.
PAH is the greatest single cause of death in people with connective tissue diseases, of which scleroderma is perhaps the most deadly. It causes a most distressing form of death. Until approximately 10 years ago, the only standard treatment was parental prostanoids. As the hon. Member for Carmarthen, West and South Pembrokeshire said, intravenous prostacyclin still remains the accepted therapy for very advanced cases of PAH in all treatment centres, not only in the UK but in the United States of America, Canada and many European countries.
Hope, in the form of oral therapies, has made a tremendous difference to a patients quality of life. Therefore, endothelin receptor antagonists, or ERA, should be the first line of treatment for use in cases of connective tissue diseases associated with PAH, for which it is considered to be the best treatment option. When patients deteriorate despite oral therapy, they should have the choice of using intravenous prostanoids or possibly combinations of oral therapies, as evidence of their success increases.
The hon. Member for Carmarthen, West and South Pembrokeshire has already stated this, but let us be clear that we are only considering a very small number of patientsapproximately 1,500of which a third
have connective tissue disease. Without the option of prostacyclin, patients will have no option other than palliative care when their condition deteriorates. They will then be condemned to six to 10 months of what one can only describe as a miserable existence: being breathless; suffering progressive right heart failure; and experiencing recurrent prolonged hospital admission, with all the costs that the hon. Gentleman outlined in his speech.
That would not be the case if the treatments shown to be effective in other countries were standard in the United Kingdom in future. NICE has accepted that the therapies are effective; again, I take up a point made by the hon. Member for Carmarthen, West and South Pembrokeshire. The problems arise from the assertion that there is no difference between scleroderma and idiopathic PAH in terms of individual drug efficacy or modelling of cost-efficacy and that the appropriate cost comparator should be palliation. The standard therapy is intravenous prostanoids, which was proven more than 10 years ago to be effective, and which all guidelines accept is the gold standard therapy for the conditionI highlight that to the Minister.
As the hon. Gentleman also said, the model developed by NICE to determine cost-efficacy is not fit for purpose; I stress that to the Minister. The NICE appraisal acknowledged that the model failed to predict the actual outcome in the treated population. In fact, the national survey shows a 6 per cent. mortality rate every 12 weeks for patients with class 3 scleroderma-associated pulmonary hypertension on treatment. Surely it is totally irrational to choose to ignore real data and to determine the treatment of the condition on the basis of a model that is acknowledged to fail to accord with reality.
The PAH centres in the UK are the envy of the world, as was stated at the well-attended and well-informed meeting organised recently by the hon. Gentleman. However, should the NICE recommendation be implemented, very sick people will continue to die unnecessarily. Surely the Minister must accept that message and take it to NICE.
How can NICE even consider taking away the only hope from this small group of patients, who, through no fault of their own, have developed a highly lethal condition? It is tantamount to condemning them to a death sentence. That is a very harsh thing to say, and I am sure that that outcome is not what NICE wants, but if its recommendation is acted on that is precisely what it will be doing; it will be condemning a small number of people to a death sentence.
With that small patient population, it is estimated that appropriate access to all available treatments would cost the NHS between £20 million and £25 million per year; again, I quote the figures given by the hon. Gentleman. Surely that is a very small sum. Moreover, patient outcomes are vital. The importance of getting people back to work, with their subsequent financial contribution to the economy as a whole and the reduced costs for the NHS, together with the patients improved quality of life, are factors that do not appear to have been taken into account at all. That is an oversight, and a very sad one.
NICE must be urged to review its provisional guidance to ensure that patients continue to receive life-saving treatments and to maintain the UK service record as the envy of the world in this area of health care; that status was highlighted at the meeting to which the hon.
Gentleman referred in his speech. I trust that NICE will reconsider this unbelievable and extremely serious recommendation and make patients, not just money, its main priority in its considerations on this critical matter.
I, too, offer the customary congratulation to my hon. Friend the Member for Carmarthen, West and South Pembrokeshire (Nick Ainger) on securing the debate, and I couple that congratulation with a commendation for his determination, because it is not easy to acquire these opportunities. Sometimes, one has to try and try again, and he has been an exemplar in that regard. I commend him heartily for that.
My hon. Friend said that he did not want to attack NICE, but I cannot promise to maintain the same degree of passivity. I have tangled with NICE before, when it issued its diktat that drug-eluting stents should not be used any more. As I have three of them in my left anterior descending artery, I felt a bit peeved about that decision. They might need replacing in the future, but the fact that they are drug-eluting has made their replacement less likely. I also thought that everyone, including me, should be able to have the same degree of comfort. Having taken issue with NICE, I looked at its systems of econometric assessment and found them to be somewhat lacking. The issue that we are discussing today is a similar example of accountants having gone mad. We have heard from my hon. Friend the Member for North-West Leicestershire (David Taylor), who is a well qualified accountant, but who is different from all the other accountants whom I have met in that he has a degree of compassion. Most accountants do not, so I think that we should put him in charge of NICE or in a similar position.
There is a mega weakness in NICEs attitude to assessment. I am sure that it approaches its medical analyses in a professional way, but perhaps it gets so bogged down with them that it forgets other aspects. It is our job, in this place, to fight for individuals in our constituencies and throughout the nation, and it is with that intention that my hon. Friend the Member for Carmarthen, West and South Pembrokeshire secured the debate. I am pleased to join him in seeking to push the issue forward.
Thomas Woolley is 13 and a half years old, and he lives in my constituency on the Wynyard estate. His parents wrote to me and asked me to attend a meeting, which was convened by my hon. Friend. I had to struggle to get there; we always have lots of petitioners and people who are lobbying on this, that and the other, and it is not always possible to find out how important a matter is until one gets there. Had I not received a letter from Mr. and Mrs. Woolley, I probably would not have arrived at the meeting, but when I got there, I was stunned by the presentation, which was remarkably controlled. It had a great impact on me that people who live with such a problem could relate their difficulties in such a measured manner and with such politeness. That is why I have committed to give every kind of support that I can summon, meagre though it be.
I got another letter from Mr. and Mrs. Woolley, but it was not addressed to me. It was addressed to the hon. Member for Romford (Andrew Rosindell), who kindly passed it on. With your leave, Mrs. Dean, I shall read it out. It says:
Dear Andrew, we came to ask for your help some time ago with regards to the Pulmonary Hypertension Association. At the time, we were living at 25 Albert Road, Romford, and our son Thomas had Pulmonary Hypertension. Since we last saw you we have moved home and on October 26th 2007, Thomas had a double lung transplant at Great Ormond Street Hospital. He has made an excellent recovery and is living a full and active life now. Once again we are asking for your support. If preliminary recommendations by the National Institute of Health and Clinical Excellence (NICE) are implemented, then drugs like Epoprostenol will not be available. As you know, this drug allowed Thomas to live a good quality of life for four years up to his transplant
and it would be a dreadful thing if other patients were not given this opportunity because of the expense of the drug. We hope this letter finds you well.
If NICE had taken its decision five years ago, Thomas Woolley would be dead now. Is that the kind of health service that we display such pride about? Is it the kind of decision that NICE ought to be capable of? Are we going to remove tools from the toolbox that consultants normally have available, and say, You cant do that. Theres a life there, but you cant save it? How can we justify that?
I am trying to manage the resources of the NHS against a vote that Parliament gave me, and that is what we are trying to do in the most effective and efficient way. What I can say is that...decisions...can now be taken wholly on clinical grounds, not on the basis of whether we have the resource.
What I can say is that...decisions...can now be taken wholly on clinical grounds, not on the basis of whether we have the resource.
Because there is enough money to do it on clinical grounds.
The NHS, by its good management and organisation, has created a healthy financial position for most of the country.
So, what are we about? We have heard some interesting suggestions about taking up drug trafficking, which has apparently been done very successfully. I wish that I could have bought a few shares in that. My hon. Friend the Member for Newport, West (Paul Flynn) made the even more effective suggestion that we should take more effective measures in that direction. We must certainly question NICEs assessment. The response that I eventually got from the Ministernot this Minister but a different one at the time, although it was not so long agoafter a fairly long delay was that the evidence that NICE had examined when it came up with the drug-eluting stent decision and restriction was being re-examined. I hope that NICE has learned from that lesson and in future
will check every kind of evidence that is placed before it with a view to arriving at decisions that are sustainable afterwards. The drug-eluting stent decision was not sustainable, and the recommendations on epoprostenol and similar drugs are equally unsustainable. I hope that NICE thinks again about its decision and that the Minister insistently recommends that it does so.
Paul Flynn (Newport, West) (Lab): I did not intend to speak, but some balancing comments should be made about the National Institute for Health and Clinical Excellence. The debate seems to involve another attack on NICE for making a decision that none of us would like to make. We have set up NICE to shift away from politicians the impossible choices that have to be made under a limited health budget. It always is limited, but we do not want to believe that. It is unfair to put all the blame on NICE, or to suggest that it does not put patients first. I am sure that it does, but it must put itself in a position where it can challenge the pharmaceutical companies.
My hon. Friend the Member for Carmarthen, West and South Pembrokeshire (Nick Ainger) mentioned the usual story from pharmaceutical companies that they have to charge large amounts for some drugs because few clients use them, it is a small market, and they have to pay for the cost of research. That argument might be convincing if they, particularly GlaxoSmithKline, did not spend a great deal more on marketing drugs than they do on researching them. They spend a large amount on research for drugs for stomach pains, headaches and those ailments that involve huge demand but very little on research into drugs for ailments that affect a small number of people.
There can be no justification for blaming NICE if it asks the pharmaceutical company, How on earth can you justify this life-saving drugwhich can offer so much, as we heard today in moving storieswhich is made in Britain, costing 10 times as much outside the factory gate as it costs on the other side of the world? That cannot make sense, except for commercial reasons.
I repeat what I said in my intervention, because I remember the meeting held by my hon. Friend, who has been persistent and campaigned on this matter for years. I was shocked when we cross-questioned the lady who was running the drug company and she told us the cost. Twenty years ago, many of us would have thought that it was impossible for anyone to have a course of drugs that cost more than £10,000. One would not have believed that possible, but now we hear that the drug companies charge £165,000. What if they were to charge £1 million or £2 million per patient? Would we tell NICE to pay, regardless of the cost?
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