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The decision-making process is long and bureaucratic and requires a trip to Leicester. By the time the decision is made, patients sight will have deteriorated considerably, or they could have gone blind. Such an alleged choice is in fact no choice at all. I suggest that that criterion, which was put in place only recently, was cobbled together solely to avoid patients suing the PCT. I believe that the decision is made not on clinical grounds but, sadly, on financial grounds.
Through recent clinical trials, Lucentis has been shown to improve sight in 70 per cent. of patients with wet AMD, and 40 per cent. of patients experience the significant improvement of three lines on a vision chart. When someone goes to an optician, they are asked to read letters on a vision chart. Let us imagine the improvement to their quality of life if, after treatment, they could suddenly read three more lines on the vision chart.
Let me give an actual example by describing how the delays and bureaucracy have affected one of my constituents. Mrs. Durrant contacted me after waiting for an unacceptably long time to hear whether she was eligible for treatment. Her consultant went through the correct procedure to try to get her treated with Lucentis on the NHS. He filled out all the necessary forms and sent them on to the east midlands specialised commissioning group for its approval. After a long wait, Mrs. Durrant was told that she was not eligible for Lucentis treatment on the NHS because she did not meet the interim criteria. However, she was also told that the criteria were now being changed and she would be referred for a second opinion. Once again, the decision took an inordinate amount of time, but this time round with devastating consequencesMrs. Durrant went blind while waiting for a decision on her treatment.
When such decisions are made on financial grounds rather than on the basis of clinical judgment, the long-term effects on cost and funding are phenomenal. Costs for courses of treatment with Lucentis or Avastin vary greatly from hospital to hospital, but they are about £500 to £1,000 to the patient per injection. A course usually involves three injections of Avastin or six injections of Lucentis. Let us compare that to the hundreds of thousands of pounds that it costs to support someone who is registered blind. The state must support people who are registered blind with care in their daily lives. Why not save those costs and give back peoples independence by spending just a fraction of the money that would be needed to care for a blind person and giving them sight-saving treatments when needed?
One of my constituents, Mrs. Doreen Marshall, who is in her 80s and suffers from wet AMD, contacted me after being refused sight-saving treatment on the NHS. Mrs. Marshall, a lovely lady, is the main carer for her disabled husband, who is in his 90s; they live independently. Mrs. Marshall cannot afford to go blind, as she has to give her husband 24-hour care. Although the authorities were well aware of her situation, the only option that they gave her was to pay privately for treatment. She was going blind in both eyes and had no choice but to pay for treatment so that she could continue to look after her husband.
What an incredibly shocking situation. Had Mrs. Marshall not paid for treatment and gone blind, the state would have had to pay out hundreds of thousands of pounds, not only on her care but on her husbands as well. Of course, Mrs. Marshall did not want to go blind or to be a burden on the state, so she was forced to scrape together the money to save her sight. However, there is some good news to report. Whittlebury Hall hotel and spa in Northamptonshire heard of Mrs. Marshalls plight and has very kindly refunded the cost of her private treatment.
Another of my constituents, Mrs. Ruby Waterer, had to use savings that were meant for her funeral to pay for sight-saving drugs. Mrs. Waterer was the first of my constituents to approach me after being told that the local NHS would not treat her. She used her funeral savings to pay for her first injection of Avastin, and her family paid for the second injection. However, to complete the treatment, she needed three injections and she had no way of raising any money to pay for the final injection.
Mrs. Waterers situation attracted a lot of local and regional media interest, and I brought my constituents case up on several occasions in Parliament. Kettering general hospital, rather than the PCT, agreed to fund Mrs. Waterers third injection and refunded her the money for her second injection. The reason why it agreed to fund the last parts of the treatment was that there was such a delay in making a decision on her case that she was losing her sight more rapidly day by day. Congratulations to the hospital on stepping in. However, it took a huge media campaign for that to happen. I can now report that, following her course of treatment, Mrs. Waterer has regained her sight. Imagine how many other peoples sight could be saved if decisions were made on a clinical basis rather than one of cost.
My local PCT is the worst funded in the whole country, according to the national capitation formula. This year, Northamptonshire PCT was underfunded by £38 million. Over the past four years, the Government have given local health care almost £150 million less than the Government themselves say that it needs as a minimum. It is for that reason and that reason alone that sight-saving treatment in my area cannot be given on the NHS.
This is not a case of the postcode lottery. That implies that underfunding happens by chance, on an accidental basis, but it is a deliberate action by the Government not to fund health care in north Northamptonshire to the level to which it should be funded. Where PCTs are funded properly, sight-saving treatments are available; where PCTs are underfunded, such as in my area, sight-saving treatments are not available. Northamptonshire PCT must receive the level of funding that the Government say that it should receive, so that people in my area are not forced to go blind when their sight can be saved.
I very much hope that NICE will grant approval for both Lucentis and Macugen very quickly, so that PCTs cannot hide behind NICE interim guidelines any longer. That has done nothing but cause confusion to local health professionals and patients. The most recent case that I have been contacted about sums the point up perfectly. Mrs. Elderton contacted me last week in despair. In January, February and March of this year,
she paid out privately for three injections of Avastin, as she was told that she could not have the treatment on the NHS. She could not really afford the treatment, as she survives on her state pension, but somehow she managed to pay the money to save her sight.
In May this year, Mrs. Elderton was told by the specialist in Leicester by letter that should her sight deteriorate, she would now be eligible for treatment on the NHS. Though her sight has deteriorated, she has now been told that the NHS will not fund her treatment because the criteria have changed since she was promised NHS treatment in May. She has been informed that she has to start losing the sight in her second eye before she will be eligible for NHS treatment. Mrs. Elderton cannot afford to pay for more sight-saving treatment privately. Moreover, my constituent was given a promise of treatment on the NHS, but now that the criteria have changed, that promise has been broken. That is just not acceptable.
I ask the Minister to do the following things to stop people in my constituency and many others throughout the country going blind unnecessarily. First, Northamptonshire PCT must be funded properly. Underfunding our local health service by £150 million in the past four years has had a profound effect on the level of health care that my constituents receive compared with those in other parts of the country. Will she undertake to ensure that in future Northamptonshire PCT will be funded to the full level of the national capitation formula? Secondly, will she put pressure on NICE to make a decision quickly on prescribing Lucentis and Macugen on clinical, not financial, grounds? Thirdly, will she intervene with Northamptonshire PCT to make it mandatory for sufferers of wet AMD to be treated on the NHS with sight-saving treatments?
PCTs across the country must be informed by the Government that sight-saving treatments must be compulsory on the NHS so that there are no loopholes or excuses that local health authorities can hide behind. If a nationalised health service is to have any point, the Government must have the power to step in and direct PCTs to undertake certain treatments, as they have correctly done in certain areas of cancer care. Will the Minister take up the sad cases of the constituents whom I have mentioned and of others in my constituency who have been affected?
Finally, I know that we have a well-respected and compassionate Minister replying to the debate. The Department of Health has already agreed to send a Health Minister to Kettering hospital to discuss health problems in the area. I hope that by the time that visit takes place we will be well on the way to solving the problem of those constituents of mine who are going blind unnecessarily.
I am sure that we would all be greatly concerned at any risk to our sight or that of our loved ones. Approximately 26,000 new cases of wet age-related macular degeneration occur every year. As the hon. Gentleman illustrated so graphically, it is the most
common cause of sight loss in people aged over 60. We can only try to understand how worrying and difficult it must be for someone who is at risk of losing their sight.
We all want to see the best treatments made available as rapidly as possible. Understandably, there is a lot of interest in the subject. Not only has the hon. Gentleman undertaken energetic work on behalf of his constituents, but other hon. Members have mentioned the issue to me. Indeed, I have constituents who have mentioned it, too. There is a lot of interest, particularly surrounding the development of new treatments that potentially offer hope to more patients.
In order to try to provide that best possible service to patients, we have a duty to ensure that new treatments used on the NHS are both clinically effective and cost-effective. I know that the hon. Gentleman would feel strongly about that. That is why NICE was set up in 1999. Before that, prescribing practice varied across the country and we still see variations. Through NICE, we are trying to ensure that guidance is issued that gives certainty, clarity and transparency to the national health service. We are trying to move away from different appraisals at local, regional and national levels, with different evidence being used, which can mean that different recommendations are given about access to treatment. It is about trying to ensure that we have coherent guidance.
NICE was asked to consider the matter of wet AMD, which is complex. It has already recommended the use of photodynamic therapy to treat wet AMD in some patients, and all PCTs are funding that treatment in accordance with the guidance. NICE is currently appraising Lucentis and Macugen for the treatment of AMD. Its appraisal committee met on 14 November to consider the responses it has received from stakeholders on the additional economic modelling for the original appraisal. The hon. Gentleman talked clearly about some of the issues to do with the interdependencies between families and communities and about what needs to be taken into account. NICE is appraising the two treatments together. That makes it more complicated. It is difficult, and NICE has to get it right if we are to have clear guidance across the NHS in England about what works and what should be available to patients, as the hon. Gentleman and I both want.
Macugen and LucentisI shall talk about Avastin separatelyhave been developed at about the same time and for the same condition, and so it is sensible to appraise the two treatments against each other to ensure that the NHS receives one piece of guidance and patients receive the most clinically effective and cost-effective treatments. That means that the appraisal is more complex. The hon. Gentleman asked me to put pressure on NICE and to encourage it to make progress, while respecting its independence. I, too, want to see a conclusion as quickly as possible, as would all hon. Members. However, we want to see it done correctly because of the difficulties and the importance of the subject.
I remind the hon. Gentleman that even while that process is taking place, doctors can prescribe Macugen or Lucentis in advance of NICE guidance if they
believe it is the right treatment for their patient. The PCTs should be undertaking that. Guidance has been issued to the effect that decisions should not be based simply on cost. We have made it clear to the NHS that treatment should not be withheld simply because NICE has not issued guidance.
The Department issued guidance on managing the introduction of new health care interventions in December 2006. It advises NHS organisations that until NICE has published final guidance on a treatment, NHS bodies should continue with local arrangements for introducing new technologies based on an assessment of the available clinical evidence. The hon. Gentleman rightly mentioned variations, which are part of the system that we are trying to rectify. We have given the clearest possible guidance to ensure that all the sources of information help PCTs to make the right assessment. I cannot put it any more strongly. The hon. Gentleman asked me to balance the local accountability and decision making of the health service with the knowledge and understanding of what it needs to provide to its population. Clear national guidance about the parameters in which that should be done is aimed at ensuring that we do not have a postcode lottery like the one that he described.
The hon. Gentleman also mentioned Scotland. The Scottish Medicines Consortium approved Macugen and Lucentis and accepted them for use in the national health service in Scotland to treat wet AMD. Once NICEs appraisal of Macugen and Lucentis has been completed, and the guidance issued, it will supersede the guidance from the Scottish Medicines Consortium on Macugen. It is crucial, therefore, to make the right decision.
Avastin is not licensed for the treatment of wet AMD, although it is used by some clinicians if patients agree. The companies involved in its making and distribution have no plans to seek a licence for its use in treating wet AMD, and no clinical trials have been conducted for that purpose. The hon. Gentleman may think that it is regrettable, but the Government have no power to make a manufacturer seek a licence for a particular drug, although clinicians can still prescribe it.
The hon. Gentleman mentioned funding for his PCT. The 2007 comprehensive spending review continues a decade of unprecedented investment through a three-year settlement for the Department, which has increased the NHS budget by four per cent. a year in real terms. That takes the total funding from £35 billion in 1997-08 to £110 billion by 2010-11. I do not blame him for pressing his point about his PCTs funding, but he will know that the House has discussed the fact that other areas of the country are receiving considerably more than the funding formula recommendations. The Government inherited that situation.
We are trying to ensure a growth in the budgets of every PCT and that, through the pace of change programme, PCTs receive the funding suggested by the formula. The hon. Gentleman understands the complexities of those finances and will appreciate that that process must be sensitive. It is not just a question of taking money away from an over-funded area and moving it somewhere else. I assure him, however, that the Government are taking action, and will continue to do so.
Mr. Bone: This point is the most difficult for my constituents to understand: despite the fact that the Government correctly work out a national capitation formula, some areas are being overfunded. Arguments in defence of that do not wash in my area. I understand the Ministers problem, but will she give us hope that the gap will be closed perhaps next year and that we will get our full capitation allowance?
Dawn Primarolo: I do not want to mislead the hon. Gentleman: that cannot be dealt with in one year. A few months ago, this House debated extensively the Governments intention to close the gap. I know the details of that because I was a Minister replying. I am happy to write to him about our efforts to close the gap, which include an independent committee looking at the weighting in the formulae towards different PCTs.
The hon. Gentleman agrees that it is necessary for PCTs to determine how they use their funding allocations to commission services that meet the health care needs of their local populations. That has to be transparent, which should include judgments where there is no relevant NICE guidance, which we have in this case. The Government have done a great deal to make clear to all PCTs how we intend to proceed in the interim.
In conclusion, we all hope that Macugen and Lucentis fulfil their potential. It is important not to prejudge NICEs evaluation of those drugs, which is why clear guidance has been given. I am as keen as anyone for those results to be made available as soon as possible, but they must be correct and the economic analysis and the evidence as full as possible.
I hope that my comments today, and what I shall send in writing to the hon. Gentleman, about funding and treatment for age-related macular degeneration, will be provided when a PCT judges the evidence in order to justify an intervention. I hope also that I have set out the importance of an evidence-based approach to dealing with the introduction of new treatments. On this matter in particular, I could not agree more with his points and those of my hon. Friend the Member for Halifax (Mrs. Riordan) about the importance of dealing with this condition and of sending clear messages to our communities about our determination to get this right. I hope that I have made the Governments intentions clear. We cannot intervene directly in NICEs work, because it is independent. If he wishes to raise further issues, I am happy to speak to or correspond with him, and I undertake to get details of the funding issues to him as quickly as possible.