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Health: Drug Tariff Part IX
5.09 pm
Earl Howe asked Her Majesty’s Government what are their aims in reviewing Part IX of the Drug Tariff, with particular reference to stoma and incontinence products.
The noble Earl said: My Lords, I am the first to acknowledge the somewhat specialist nature of the subject matter. It is, however, a subject of life-changing importance to a large number of people. Because of that, and because I shall not give a winding-up speech at the end of the debate, I hope that the House will forgive me if I overshoot my time allocation by a couple of minutes.
There are some 300,000 users of incontinence products and services alone, many of them extremely vulnerable. We are talking about people with spinal injuries, MS or disability resulting from a stroke, and about the frail elderly as well as about a sizeable group of children and young adults. A wide range of appliances and products is available on prescription to enable these patients not only to manage their condition but in many cases to lead regular lives without having to worry about the risks and difficulties that they would otherwise experience. If someone can manage their own incontinence condition at home, this will obviously reduce demands on primary and community care as well as on hospitals.
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For the past two years, there has been a series of consultations reviewing the arrangements whereby manufacturers in this field are reimbursed for their products and services. It is important to make it clear straightaway that I completely support the Department of Health in seeking to secure better value for money for the taxpayer and in trying to identify areas of the budget where justifiable savings can be made. I also recognise that any process of that kind is bound to be tough and to include some hard bargaining. Businesses that find the heat turned on them in this sense will never find it comfortable and will naturally object to anything that might threaten their profit and loss account. Unfortunately, not much can be done about that. I therefore say to the Minister that a review of these reimbursement arrangements is not objectionable. On the contrary, when it started its review the department articulated several aims with which none of us could possibly disagree. The principal aims were to maintain, and where applicable improve, the quality of care to patients; to secure value for money for the NHS; to ensure equitable payment for services and transparency in pricing; to facilitate innovation; and to maintain local choice—all very admirable objectives.
The problems have arisen in the way in which the review has been conducted. The system proposed would classify products and appliances into categories. In each category, the cheapest product, as long as it had a certain very small market share, would set the benchmark price. That benchmark price would determine the maximum price for any product in the same category; namely, 20 per cent higher, subject to a maximum price reduction of 35 per cent for any product. The alternative proposal is simpler: a straightforward price reduction across the board of 12 per cent. Either of these formulae would deliver budget savings of around £25 million a year.
The striking feature of these proposals is their arbitrary character. Neither of the proposed approaches appears to have any rationale beyond a desire to save a pre-determined amount of money. However, the system of product classification also defies logic. What the Commercial Directorate has done is classify high-quality, specialist appliances alongside inferior items that are priced at a lower level. If I were to place three types of incontinence bag on the Table, noble Lords might at first glance see little difference between them. However, one of them would be a cheap bag designed to be thrown away after a single use. Another, by contrast, would be a more expensive bag, designed to be used and re-used for a week or longer. The third would be a bag, also of a more sophisticated design, intended for use at night. The cheap, single-use bag would be the price-setter in that category.
Under the department’s proposals, no recognition is given to either the quality or the cost-effectiveness of the other products. Nor are the benefits to patients in having a more sophisticated product and thereby a better quality of life anywhere taken into account. The result of lumping into one category all articles falling under the heading of urine collection bags, where there is a very wide range of quality and functionality, is that you are bound to end up with a classification that is frankly bogus. The very fact that
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The consequence of these proposals, if they were implemented, would be the withdrawal from the market of many specialist products and appliances. They would no longer be economically viable to make and distribute. These products would almost certainly be the ones that are the most innovative and technologically advanced. The losers in that situation would, of course, be the patients who have come to rely on them. It is difficult to believe that such patients would see their choice as having been enhanced.
There would also be the practical consequences for the NHS. Every patient who was obliged to start using a different product would have to be assessed and, alongside that, there would be a significant cost attached to nursing and nurse training. Cheaper products bring with them a higher risk of infection and other complications. To the extent that patients experience such complications, the burden on GPs and accident and emergency departments will be the greater.
The department is also proposing a capped and banded payment structure for remunerating the various services provided to those who use incontinence and stoma products. We are talking here about home delivery, telephone helplines, nurse advisory services and items provided to patients at no charge, such as refuse bags and wipes. People who suffer from spinal injury and other serious medical conditions often have impaired mobility and are confined to their homes for long periods. Many are dependent on home delivery and help from nurses if anything should go wrong. The advice I have received from product manufacturers is that the reimbursement being proposed for these services would make them, in many cases, uneconomic. That is of huge concern, not least for patients living in rural areas who find it difficult or impossible to get to a pharmacist, even if they have a pharmacist who is open at the necessary times.
The system of product classification leads to a further very grave concern. When the consultation first began, one of the stated objectives of the review was to facilitate innovation. Since then, however, the commercial directorate has made it clear that the product classification it is proposing would be a once-and-for-all exercise. If you ossify a classification in this way, there is no means by which new and innovative ideas will be able to get a look-in. Indeed, it is far from clear how a new product that is not compatible with one of the existing categories will be listed at all. One of the hallmarks of UK manufacturers has been their ability to respond to the needs of patients by producing innovative solutions. The interim report published by the noble Lord, Lord Darzi, emphasised the importance of harnessing new treatments and technologies as swiftly as possible. I simply do not see how the department’s current approach is consistent with that aim.
The department’s position is apparently that manufacturing costs have gone down, but the NHS is not benefiting from these efficiencies. That view ignores the GDP deflator, which forms part of the existing
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It is not the position of manufacturers that I am principally concerned about, but the position of patients. In preparing for this debate, I spoke to a number of patient groups, including the Spinal Injuries Association. Thirty years ago, a large proportion of people with spinal injuries died not from their injuries, but of bladder and kidney infections. Average life expectancy for a paraplegic was 10 to 15 years. Since the introduction of better and more sophisticated products, such as sterile catheters, thousands of lives have been saved. If these catheters were to be withdrawn from the market, it is no exaggeration to say that there would be a risk to the lives of many wheelchair-bound patients. The damage to their quality of life would also be significant. The single biggest cause of relationship breakdown among spinally injured people is incontinence. It was quite extraordinary to hear from the association that no impact assessment of the department’s proposals has yet been carried out. Although there was supposed to be a consultation with users, the consultation document is so technical as to be unintelligible to anyone other than a professional. It is true that the association was permitted to meet the Commercial Directorate, but only to discuss a list of questions submitted in advance. No supplementary questions were allowed. That does not seem to me to be an approach that could be described as open or patient-friendly.
Another group of patients I want to talk about briefly is children. Bowel and bladder problems affect three main groups of children: namely, those who are not toilet trained because they are slow developers; those with spinal injury or congenital problems, such as spina bifida and cerebral palsy; and those with a learning disability. All three groups combined number about half a million children across the UK. Many of those children will have lifelong problems. Every single one will need individual assessment and a service that can deal with more complex needs when they arise. Industry, once again, has responded to those needs, not least for incontinent children with congenital defects or spinal cord injury, many of whom are able to become independent and to take responsibility for themselves at a very young age.
In the old days, a child who required a catheter had to have it permanently inserted with collection apparatus attached to his or her legs. That, quite apart from any psychological trauma, brought with it a very high risk of renal damage. The single most important innovation in the past 30 years has been the low friction hydrophilic catheter. It is essentially a lubricated device which can be inserted into the urethra when the bladder needs emptying and then can be removed. The incidence of renal failure since the introduction of that product has fallen dramatically.
The difference in price is between a basic item, not dissimilar to a length of windscreen washer tubing, which costs 40p, and a more modern, fit-for-purpose
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I mention those unpleasant details to emphasise one point: any review of the reimbursement system for stoma and incontinence products has to be more than just an accountancy exercise. The Commercial Directorate is full of people from Deloitte who I am sure know about money, but they may not know quite as much as they should about the reality of living with incontinence as a wheelchair-bound person or the major advance in patient safety and quality of life that the newer technologies have offered.
If the inadvertent result of this review should be the imposition of suffering and risk on patients, that would be quite unacceptable. The department’s pronouncements on the matter, though superficially reassuring, leave their ultimate intentions opaque. It is unsettling that a number of the aims that were articulated at the very start of the exercise appear to have been abandoned. I hope very much that the Minister, with her customary understanding and good sense, will wish to look into the concerns I have raised and will make sure that the worst fears harboured by some of us are not borne out.
5.23 pm
Baroness Pitkeathley: My Lords, I congratulate the noble Earl on securing this debate and on the small, but very select, number of speakers he has assembled to discuss a rarely mentioned topic but one which is of immense importance to huge numbers of people, and their families, who have difficulties with continence. The changes proposed clearly are complex and I do not pretend to understand whether they will have the effect described by the noble Earl. But I know many people fear that they will have this effect. I, too, have spoken to quite a lot of people who are using those products.
I should like to ask the Minister to ensure that in her response she addresses and gives reassurance on issues such as the loss of specialist products from the Drug Tariff, which will reduce patient choice; the increased chances of medical complications such as infection by a change of the use of a product and the lack of sufficient guidance in a new product; the removal of incentives to innovate, as mentioned by the noble Earl, which are of great importance where techniques are developing so fast; and the possible removal of the additional services which are currently provided by dispensing appliance contractors. I know that that delivery and collection of appliances is of immense value to those who use these products.
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I have two major areas of interest in this topic, the first a personal one as someone who at one time, because of a colostomy, was a user of stoma products and a receiver of services from stoma nurses. I was among the fortunate ones able to have a reversal after a few months, but I have never forgotten those months and how dependent I was on the effectiveness of the products and the efficiency of the service providers.
My second interest is on behalf of carers. There are 6 million people with continence problems, and we can depend on possibly half of those having a family member or friend who helps them. Incontinence is a major factor in the failure of care at home. There are statistics which show that incontinence, especially faecal incontinence, may be the factor that prevents informal carers from being able to continue caring, resulting in admission to care home or hospital. Services which are easily accessible, products which can be delivered to the home and support staff who can advise and help are almost as important to carers as they are to sufferers. Many a carer has been surprised that incontinence can be treated as well as contained, and delighted by the effects the treatments can sometimes have. For this reason it is important that innovation and the development of stoma and other products are not stifled at this time.
I hope it will be apparent that ensuring that those services continue to be provided makes sound economic as well as moral sense in this context. I am sure all noble Lords are familiar with the figure that I never hesitate to give this House, that carers save the nation £87 billion per year. They give care willingly and with love, but often with severe financial strain to themselves and their families. Carers are often required to give up paid employment to care, but the most frequent explanation given by carers for their worsening financial situation is the extra costs of disability and illness. These are many and varied. As we know, caring for someone with incontinence can double the cost of laundry, bedding and clothing. Carers have difficulty getting out to do the shopping, let alone to collect incontinence supplies, and value home deliveries hugely—as do the users of stoma products.
Remember, too, that the experts who advise on the choice and use of these products are as important as the products themselves. We must ensure that access to specially trained nurses and technicians is maintained and improved.
I hope that when any changes in services are considered, Ministers will ensure that what results is an improvement not a curtailment and that we will bear in mind the financial circumstances of the families who deal with this problem—usually in silence and often in secret. We must ensure that they are supported, recognised and not given yet another problem to face in the emotional, practical and financial difficulties they are already wrestling with.
5.28 pm
Lord Roberts of Conwy: My Lords, I support my noble friend Lord Howe on the Front Bench and compliment him on raising this debate on the
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Before I proceed, I declare my interest as a patient user of stoma items and have been for a decade. I hope that my personal experience and account of it will give noble Lords a clearer insight into the sensitivities involved in this area. Ten years ago, I was diagnosed as suffering from diverticulitis and underwent a colostomy operation, which resulted in the removal of the sigmoid section of the colon. The operation left me with a stoma which enables excretion through it into a bag on my lower left side. I would have wished to spare the House these medical details, but they have to be presented to enable anyone who is unfamiliar with a colostomy to appreciate what is involved in the physical management of the resulting stoma.
Over the 10 years I have had no significant problems, which I attribute in no small part to the high quality of the prescribed items used, from the flange surround of the stoma, which has to be changed weekly, to the bag attachment, which I change as necessary, at least on a daily basis and sometimes more frequently. I must also commend the reliability, celerity and smoothness of the home delivery service providing these essential items, without which I really do not know how I could live a near normal life. In my case, the items are supplied by an assembly and distribution company at Fittleworth in West Sussex. The items include some made by ConvaTec, a Bristol-Myers Squibb company, which has a manufacturing plant in north-east Wales—a plant that I opened 25 years ago.
In the early stages of managing my stoma, there were accidental mishaps, all due to my own inexperience or lack of care. Mercifully, none occurred in public. I can only imagine one’s consternation and others’ disgust if these accidents happened coram publico. Such accidents are, of course, always possible, but the excellent quality of the items supplied means that one can depend on and be confident in their reliability, which is clearly of vital importance.
When one reads about the history of this lengthy review, and the Minister’s reply to me on 9 May last year that savings might be made of some £27 million in the total cost of Tariff List items of some £169 million, one cannot but wonder what is to be sacrificed. One hopes that it will not be the quality or reliability of the products. My noble friend on the Front Bench in his opening speech gave us an indication where those cuts might occur. The suppliers, who numbered about 68 last year, are fearful that all kinds of sacrifices will be required of them to the disadvantage of their patient customers. Coloplast, one of the major suppliers, is especially concerned; it believes that it will bear a disproportionate part of the cost cut and will have to abandon the making of certain products. Research and care services are also at risk.
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The Minister at the Department of Health last year was the noble Lord, Lord Hunt of Kings Heath, who told me on the Floor of the House:
“Let me make it absolutely clear that the last thing I want to do is to inhibit the provision of the kind of services that he”—
- “has described. This is about value for money and ensuring that we move away from the difficult-to-understand financial regime and payments to the various contractors to a transparent system that is based on value and enhancing the service to the public. We should make sure that that happens”.—[Official Report, 24/4/07; col. 556.]
There were other assurances to the same effect. On 12 June, he told me in a Written Answer:
“In conducting this review, a key objective has been to maintain and improve the quality of patient care”.—[Official Report, 12/6/07; col. WA 243.]
Like my noble friend, I sincerely hope that the Government adhere to the principle that the object of the review is to improve patient care.
I hope that the Minister will reassure us today that the quality of the service will not deteriorate—and I am sure that my hope is endorsed by the 450,000 patients who receive the 4.5 million dispensed items covered by the tariff lists. Those figures were given to me by the Government, so they must be right. Many of those patients are victims of other illnesses and are highly vulnerable. We must make certain that we do not add to their suffering.
5.36 pm
Baroness Wilkins: My Lords, I am extremely grateful to the noble Earl, Lord Howe, for initiating this important debate and for his excellent opening speech. I declare an interest: along with nearly everyone with a spinal cord injury, I have had to use continence products—in my case for 40 years, after I broke my neck while a student at university. Sadly, this debate was announced at short notice, so not as many people were available to speak as would have liked to. There is deep, widespread concern about what is proposed. I hope the Minister will do all she can to ensure that these concerns are addressed.
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