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If children or someone in our constituency were about to be deprived of drugs, we would all say as constituency MPs what my hon. Friend the Member for Stockton, North (Frank Cook) said: Pay it. It is only £20 million. It is nothing in the context of the health service budget, but we must take some responsibility for the policy that NICE has to implement on our behalfa thankless taskand acknowledge that NICE is not the problem. We beg NICE to pay for the drugsI do not think that it has any choicebut, ultimately, the
answer is not to ask NICE to pay whatever is demanded by greedy pharmaceutical companies that need to get their balance sheets right.
Ann Winterton: Surely the whole tenor of this debate is not just about the drugs but about the fact that NICE is ignoring its own guidelines. That is the position. NICE is not considering ultra-orphan drugs in a specific category, as it ought to.
Paul Flynn: I repeat that I support the campaign of my hon. Friend the Member for Carmarthen, West and South Pembrokeshire, which is of long standing. I acknowledge what the hon. Lady says, but we have to take on what has been happening since NICE was formed. Pharmaceutical companies set up cynical campaigns to boost drugs and exaggerate the effects of drugsnot this one, but others.
I investigated a drug on behalf of a constituent who was suffering from a particular form of cancer. The drug was recommended as the cure for it. I said to her, Go along and see your physician. I was approached not by the drug company but by a group of its lobbyists who put forward a case for the drug that was wholly dishonest and optimistic. Having made inquiries, I learned that the cost was £16,000 for each patient, that the drug increased life expectancy for cancer sufferers by 12 days, and that it had adverse side effects, including death, in 10 per cent. of cases. The balanced judgment was that the drug, in the state that it was in then, was a poor gamble and certainly not worth investing £16,000.
We are being subjected to marketing and lobbying campaigns by pharmaceutical companies that are likely to destabilise NICE decisions altogether. We cannot constantly say to NICE, Whatever the drug companies ask, you must pay. I support this specific case entirely, but I cannot go along with many of the things that have been suggested today about a blanket condemnation of the decisions that NICE has to take. Thank goodness we as politicians do not have to take them.
I cannot rival the hon. Gentlemans knowledge, but I do know that pulmonary arterial hypertension, whether in the secondary or primary form, is dangerous, debilitating and difficult to treat. It is dangerous because it is often fatal. Life expectancy is not good: the death rate is high. It is debilitating because it destroys ordinary life. We heard some touching stories of heroic endurance. One wonders how people put up with the situation and do so with such apparent cheerfulness at times. The condition is also difficult to treat, because there is no cure, some of the treatment is invasive and good treatment is hard to access. In my constituency, people have to travel as far as Newcastle to get specialist treatment.
It has been suggested that NICE has added to the woes of poor, suffering patients by recommending no further use of prostacyclins, intravenous epoprostenol or inhaled iloprost, which are regarded as gold standard treatments. It is suggested that that adversely affects 25 per cent. of sufferers, particularly those who are most severely or terminally ill.
As has been said, all arguments about NICE tend to follow a familiar pattern. Incidentally, I must put on record the recent welcome change in NICEs decision about Lucentis. That shows that NICE does occasionally listen to arguments and have second thoughts. However, what usually happens is that a cheaper alternative is held up by NICE and set against an expensive proprietary drug. The reasons that the drug is expensive have been explored in some depth already.
On one side, we have NICE and the primary care trusts, and, on the other side, we have patients, patient groups and the drug companies. NICE will normally claim that cheap alternatives are availablein this case, sildenafiland that they are as efficacious as the more expensive alternatives. The drug companies and patient groups will argue, with some plausibility, that the more expensive alternatives have special benefits orthis is importantspecial benefits to particular patients, if not the whole patient group.
No one per se is against NICE, which is a necessary evil. We all must acknowledge that health care is, if not rationed, at least finite, but people will argue with decisions if NICE has not followed its own guidelines and procedures sufficiently rigorously, or if guidelines have been inappropriately applied. That, I understand, is the argument proposed by the hon. Gentleman in favour of ultra-orphan drugs, notwithstanding the cost. In laymans terms, he suggests that the principles applicable to common complaints should be applied to this cruel and rare disease and its therapies, which is against NICEs guidelines. On the face of it, he appears to be correct, and his case was extraordinarily well made.
However, I sound a general caution against assuming two things: first, NICEs infallibility; and, secondly, the total objectivity of its procedures. NICE assessments are undeniably rigorous, and its inspection of evidence is thorough. I have attended sessions at which it inspected drugs, and there was a huge amount of documentation; they were long sessions, during which patients groups were consulted. It seems to be an impressive procedure, but at the end of the day I would say that it is a judgment call. That call is based on the assessment of this strange unit called the QALYthe quality adjusted life year.
The QALY reminds me of the great utilitarian 19th century philosopher Jeremy Bentham, who invented the hedona unit of happiness and pleasure. He suggested that all legislative and moral dilemmas could be solved by counting hedons, using what he called a hedonic calculus. One could work out units of happiness in order to discover whether proposed laws would increase or decrease the overall level of happiness. As a method, it has some advantages over parliamentary democracy. However, Benthams method led to interminable debates about how to count hedons.
Today, we have the same debatehow to assess the QALY. It is not simple arithmetic; indeed, it is not arithmetic at all. However, NICE and the QALY is the best that we have, provided always that NICE guidance is mediated and offset by patient experience, which is not always the case. Patient experience needs to be judged over time, and it needs to take account of proper clinical caution and casework experience. That is especially important for diseases that are rare and not understood, such as the one that we are debating today. We do not understand pulmonary arterial hypertension as well as
we might. We know the symptoms, but we do not know its cause. Caution should be applied to removing therapies that are not obviously redundant or otiose in the light of patient experience and that of the clinicians who care for them.
When we do not understand the cause of a disease, we often do not know why a drug works for some individuals, but not allor not with a control group. That is why the voice of the patient group must be heard. Thanks to the hon. Gentleman, it will be heard even more loudly. In this case, cautious wisdom genuinely has a place.
I congratulate the hon. Member for Carmarthen, West and South Pembrokeshire (Nick Ainger), as have many other hon. Members, on securing this debate. I was touched by the passion that he displayed on the subject and the enormous amount of work that he has done on it. The debate is not about a new drug, or another NICE problemsomething that we often facebut about an existing and established treatment that has been available for about 15 years. As many hon. Members said, the treatment is considered to be the gold standard.
Pulmonary arterial hypertension is one of five sub-types of pulmonary hypertension. It is rare; as the hon. Member for Carmarthen, West and South Pembrokeshire said, it is the result of an increase in pressure in the pulmonary artery. We have not focused much on the symptoms or how it might feel to be a patient with the disease, but it is characterised by fatigue, shortness of breath, chest pains, fainting, swollen ankles and legs and a swollen stomach. Patients often tell of extreme breathlessness and exhaustion.
It is important to remember that rare diseases are often difficult to diagnose. Of particular note with this disease is the fact that people might have been attending their GPs for some time before a diagnosis is made. Before treatment starts, they may have suffered a year or more with symptoms not being affected by the treatments offered. They will see a diminution in their quality life; and, as with any complex and incurable disease, the poor survival rate will be associated with depression. The disease has a profound effect on the family, which is another subject that has not been touched on today.
The debate is about whether NICE is operating within its guidelines. The hon. Member for Upper Bann (David Simpson) spoke of the cost of drugs in the USan interesting pointand highlighted the much higher price that we pay for prostacylins, and I hope that the Minister will address that point.
My hon. Friend the Member for Congleton (Ann Winterton) mentioned another important group of patientsthose who suffer similar disorders such as Raynauds and scleroderma. She said that NICE appears to be ignoring its own rules.
My hon. Friend the Member for Macclesfield (Sir Nicholas Winterton) spoke with his usual clarity about the subject. I was, as always, flabbergasted by his expert medical knowledge on such matters, especially as I used
to be a nurse. He raised concerns about the preliminary recommendation and emphasised that we are considering a very small number of patients for whom there is no alternative. If NICEs recommendation goes through, there will be no alternative.
My hon. Friend said that there is no argument about the efficacy of the drugsNICE does not disagreebut he raised concerns about the modelling that is used by NICE. Although most hon. Members would support much of the work done by NICE, the debate has highlighted and drawn out concerns about the treatment of those with pulmonary hypertension. I hope that the Minister will take that point.
The hon. Member for Stockton, North (Frank Cook) spoke about his tangle with the NHS over stents. I am pleased to hear that his stents appear to be serving him well, enabling him to contribute with clarity and some passion to todays debate. He reminded usespecially those on the Front Benches, who sometimes forgetthat we are here to fight for individuals. He mentioned the case of one of his constituents, and we all appreciate it when Members quote from letters, as it brings home to us the fact that we are fighting for individuals. He said that epoprostenol and iloprost are part of a toolbox, which is a point that no other Member mentioned today. Clinicians have a range of drugs at their disposal, and if we remove some of those from their toolbox they will be less able to deal with symptoms.
The hon. Member for Newport, West (Paul Flynn) raised an extremely important issue, about which I feel strongly. It was good to hear someone speaking up for NICE, which does a good and difficult job. But he also raised the important question of the huge amount of money that drug companies put into marketing and selling their drugs. All Members have at some time been caught up with drug companies pushing particular treatments. Much more work needs to be done with drug companies, which often fund patient groups and work behind the scenes in ways that are not clear. I appreciate that they put a huge amount of money into research and development, but it is notable how much they put into marketing. To some extent, that is one of the challenges facing the NHS. Part of the money that, in fairness, the Government have put into the NHS has gone into drugs budgets.
The hon. Member for Southport (Dr. Pugh) said that, ultimately, however much evidence NICE has, it must make a judgment, which must be offset against patient experience and clinical expertise. Although that patient experience should not overrule its judgment, it is important, especially in relation to rare conditions for which robust evidence of what works is difficult to find. Conservative Members respect NICEs independence, and it is important that calls on health service budgets are made by experts and not by politicians, who should not interfere. The criteria for assessing not only drugs, but treatments in the NHS, should be their clinical effectiveness and cost-effectiveness. It is also important that NICE conducts its work quickly, openly and transparently, and has the publics confidence.
The current use of QALYs, which has come up again today, has often been criticised as inflexible. The Conservative party is considering whether larger societal costs should be taken into account. I go back to where I started, and to the impact that such diseases can have on families. The hon. Member for Carmarthen, West
and South Pembrokeshire said that if alternative drugs are not available, withdrawal of a drug may incur considerable extra costs in hospital care, the patient losing their job and family members having to give up work to care for the person who is unwell.
Pulmonary arterial hypertension is not the only illness or disease in relation to which effective treatment could save society considerable costs in the long term. Investment up front will sometimes produce a saving further down the line. Therefore, removing some of NICEs inflexibility is important. It is a shame that we do not always have the opportunity to consider the emotional and humane cost of treating diseases. Sadly, in this day and age, we are fixed on budgets. They are important, but it is also important to put on record that we recognise the profound emotional cost for families who are battling this illness.
We would like NICEs role to be extended. Although it is not the subject of the debate, it is important to mention that NICE has a wider role in producing evidence and setting guidelines on standards of care that encourage best practice and achieve outcome objectives.
On NICEs relationship with the drug companies, we want a better dialogue with the pharmaceutical industry, and the hon. Member for Carmarthen, West and South Pembrokeshire referred to that. NICE needs to be aware of what is being developed, what treatment regimes are available and what regimes are being trialled. It should work with drug companies to try to reduce prices. We must understandI hope that the Minister will address thiswhy there are huge variations in the cost of drugs. That would help not only us in developing our ideas of where NICE should go, but clinicians and patient groups better to understand why its decisions are made.
We cannot turn the clock back on NICEs preliminary report on PAH, but it will have caused considerable concern to those who are reliant on the drugs. Life is difficult enough for people who have a rare disease; it is difficult enough if they have an incurable disease; it is difficult enough if the symptoms interfere with daily activities, so that perhaps making a cup of tea is almost impossible. But this preliminary report is a huge added burden for them, given the concern about whether treatments will continue to be available, and, for clinicians, whether they will be available for new patients.
I urge the Minister to keep an open mind about NICE. This has been a non-partisan debate, and I always welcome such debates, but I would like to hear what she is doing and what steps she will take to ensure that NICE remains flexible and is encouraged to work more closely with drugs companies. I would also like to hear her response to the more general concerns about how NICE operates, and to understand why it seems to have ignored the ultra-orphan status of the group of drugs involved. I hope that she will address those matters.
I congratulate my hon. Friend the Member for Carmarthen, West and South Pembrokeshire (Nick Ainger) on securing this debate. I know, as do all hon. Members, that for many years he has been a strong and persistent advocate of behalf of sufferers of pulmonary hypertension. He has actively engaged many of my predecessors, and
rightly so, in helping to advance the case for improvements in treatment and to promote awareness of the disease throughout the United Kingdom, together with the Pulmonary Hypertension Association UK. I thank him, too, for sharing the transcript of the recent House of Commons stakeholder investigation, to which many patients, carers, professional staff and MPs contributed. Many of those MPs are present for this debate.
I agree that this has been an emotional and educative debate. Hon. Members who have taken part are senior and experienced, with a track record of standing up not only for their constituents, but on health issues. The hon. Member for Macclesfield (Sir Nicholas Winterton) has apologised for having to leave early to attend another meeting. Serious attention must be paid to what he, the hon. Member for Congleton (Ann Winterton) and all hon. Members who have made a contribution said. One could not help but be moved by the contribution of my hon. Friend the Member for Stockton, North (Frank Cook) about the little boy. I, too, have constituents with the disease. One little girl who had a transplant, sadly did not make it, but had often attended fund-raising events.
Hon. Members have described the effects of pulmonary hypertension, which is a rare and potentially fatal condition that affects the heart and lungs. It requires expert care, expensive drug treatment and sometimes specialised surgery if life is to be prolonged. There has been considerable progress in treatment over the years, and I hope that hon. Members will allow me to explain current services: what we have achieved, how services are organised, how the commissioning of specialised services for the condition has developed and changed over the past few years, and the role of guidance on clinical care. I shall also address the issues concerning NICE.
There are six centres for the treatment of adults with pulmonary hypertension in England, in Newcastle, Sheffield, Papworth, Hammersmith and the Royal Free and Royal Brompton hospitals. Several of those centres run outreach clinics at other hospitals to ensure that patients do not have to travel too far. Those centres offer a high-quality service and are run by dedicated, highly professional clinicians. It is to their credit that more patients are being treated and that outcomes are improving.
The six centres have been nationally designated by the National Specialist Commissioning Advisory Group, which became the National Commissioning Group in 2001, to ensure that highly specialised services are restricted to a small number of expert centres allowing the development and long-term maintenance of expertise in treating rare conditions. Commissioning responsibility has remained with local primary care trusts and specialised commissioning groups. The number of patients at the six centres has doubled over the past five years for two reasons. First, local hospitals are more aware of the condition and refer pulmonary hypertension patients to the centres at an earlier stage in the disease. The diagnosis is improvingI am aware that much more work must be done on thatand we should congratulate professionals and clinicians on the progress that has been made. The Pulmonary Hypertension Association can take great credit for that.
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