Question for Short Debate
My Lords, I declare an interest as chair of the Specialised Healthcare Alliance, a coalition of 79 patient-related organisations receiving financial support from 11 corporate members, which campaigns on behalf of people with rare and complex conditions.
The Advisory Group on National Specialised Services, or AGNSS, was established in 2010. Its role was to provide a single source of advice to Ministers on whether services, products or technologies for very small patient populations, usually not exceeding 500 for England as a whole, should be commissioned at national level rather than by PCTs, individually or collectively. Some 65 services are enormously important to over 10,000 people with a range of very severe and frequently life-threatening conditions.
What makes AGNSS different is that it brings eminent clinicians together with commissioners in considering these complex matters and integrates other vital perspectives through members with health economics and ethical expertise and from the lay community. For the first time, AGNSS evaluates services, products and technologies using an ethical decision-making framework that holistically balances a range of factors, including patient need, clinical severity, clinical effectiveness, affordability, service efficiency and the value to society. It would be fair to say that the development of AGNSS and its decision-making framework, with widespread input from all parties, was seen as a model of its kind and that the group, under the capable leadership of Professor Michael Arthur, has only grown in stature over the past two years.
Organisations and others with an interest in the health and welfare of people with very rare conditions were greatly concerned when it was announced at the turn of the year that AGNSS would be entering a moratorium, pending decisions about its future. If the reaction to this debate is anything to go by, it is much appreciated and valued by research scientists, organisations representing patients and pharmaceutical companies, who have all expressed their alarm at its possible demise.
My understanding is that this decision stems from the view that an advisory group for Ministers will be incompatible with the provisions of the Health and Social Care Act 2012, which devolves responsibility for the commissioning of all specialised services to the NHS Commissioning Board. To quote from my noble friend the Minister’s letter of 8 June to Mark Simmonds MP:
“In the future, there will be a clear differentiation between what services the Board should commission and how those services are commissioned. It will remain the responsibility of ministers to consider, on the basis of appropriate advice, the list of services that should be directly commissioned by the Board. Ministers will then consult with the Board on those services before laying regulations that will specify the services that will be commissioned. It will be for the Board to decide how it commissions the service”.
As the letter acknowledges, Ministers will need advice on what services are to be prescribed in regulations for commissioning by the board. My understanding is that the Clinical Advisory Group, presently chaired by a civil servant, Dr Kathy McLean, will fulfil this function in relation to the generality of services. The question is whether highly specialised services should be channelled through the same route.
The views of eminent clinicians presently sitting on AGNSS or leading services commissioned through the AGNSS process suggest that this is at least worthy of debate. In particular, AGNSS is recognised as a route whereby such services can engage with commissioners. I am told that this is an iterative and demanding process, taking some considerable time before a decision is taken. The net result is generally one where there are indeed costs to the NHS, but often costs that are reduced as a result of coherent commissioning. For example, the decision to commission severe acute porphyrias means that young people presenting with potentially fatal attacks should now have speedier access to expert care with less wastage of the relevant drug, haem arginate, which has a short half-life. Similarly, AGNSS was able to advise on the managed introduction of extracorporeal membrane oxygenation, or ECMO, which has saved many people whose lungs are severely distressed, most notably as a result of swine flu.
The danger is that without a clear port of call in the form of AGNSS, these important services may get lost from sight, as will the opportunity to develop them in a way that meets the needs of patients and delivers best value to the NHS. Furthermore, Ministers may be hard pressed to decide on whether the board should commission such services without high-quality advice on what they comprise.
The relevance of these services, not just to England but to all parts of the United Kingdom, would also seem to count in favour of retaining an advisory group alongside Ministers, as would the broader strategic importance of issues such as proton beam therapy. I therefore put it to my noble friend the Minister that in the case of highly specialised services there might be merit in retaining a group providing a single source of advice to Ministers but with a dual reporting function to the board in determining how such services should be commissioned.
As for the composition of this group, I have heard it said from reliable sources that if AGNSS did not exist it would need to be invented. In a recent conversation with Professor Arthur, he outlined the three components that made AGNSS effective, unique and special: the support from the national specialised commissioning team, the strength of the group—an ethicist, a health economist, a geneticist, a pharmacist, representatives of all royal colleges, representatives of SHAs, lay people, carers and patients, commissioners from PCTs and a member of the HTA—and excellent advice to AGNSS from public health doctors.
We are going through a period of enormous change in the NHS, but change for change’s sake is to be avoided at any time—and surely now more than ever. I therefore urge the Minister and the chief executive of the NHS Commissioning Board to think carefully about disbanding AGNSS when the need for it remains unchanged. Historically, the view has been taken that NICE would struggle to combine under one roof the evaluation of products with a cost per quality-adjusted life-year often very substantially higher than the threshold which usually applies. Furthermore, in this highly specialised field, where a service develops around a novel treatment, the distinction between services, products and technology is sometimes difficult to make in areas of previously unmet need.
The AGNSS decision-making framework therefore represents a major step forward. It recognises that the evidence-base for small patient populations may be less developed. At the same time it imposes demanding standards in terms of the number of patients whose condition improves as a result of a treatment, compared to the total number of patients treated. This approaches 100% for more expensive services, products and technologies.
That progress has been hard won and should not be squandered but built upon. In a debate in the House of Commons on 30 April about a strategy for rare diseases, the Minister of State, the right honourable Simon Burns MP, appeared to suggest that value-based pricing will supersede the need for separate arrangements for treatments for very rare conditions, but that alternative options will be explored in case of need.
All are agreed that value-based pricing has exciting potential. The challenge of expressing that potential will be considerable for the generality of treatments, but it will be undoubtedly greater for very rare conditions. In the mean time, retention and development of the AGNSS framework would seem to have great merit.
AGNSS represents something of a jewel in the crown. The dancer cannot be easily separated from the dance in determining which highly specialised services to commission and how to commission them. Ministers will continue to need high-quality advice. I would hope also that the first mandate to the board recognises the value of this heritage and bestows it for safekeeping.
My Lords, I am sure that we are all grateful to the noble Baroness, Lady Jolly, for introducing this debate and setting out the issues so clearly. There is deep concern among the support groups that speak for patients with rare diseases that the loss of this advisory group, newly formed as it is, will be a retrograde step and create confusion and a loss of a valuable asset. I have no doubt that the Minister will try to reassure us by saying that this will all be taken care of by the commissioning board. There is little or nothing in the Health and Social Care Act, or in any other document I have seen, that offers any confidence yet that this has been given enough serious attention. I look forward to him saying rather more than we have heard so far when he comes to round up.
It is the case that the advisory group has been widely regarded as doing a marvellous job. It is recognised not only by the NHS and by patients, but also by other countries as a model for the way services for patients with rare diseases should be provided. It does this by having developed a rational framework that takes account of best practice and societal and health gains. It has done so in a way that is efficient and at a reasonable cost.
I would like to illustrate this by using the example of the group of orphan, or very rare, diseases that rejoice under the name of lysosomal storage diseases. These include Gaucher’s disease, Hurler’s syndrome and a number of others. They affect few patients, almost all in childhood. An average GP in an average year is unlikely to see a case. If she is faced with a case she is unlikely to know what to do about it and left to herself is likely to be reluctant to fund the patient’s care.
These are the sorts of cases that have to be funded and commissioned centrally and cannot be left to CCGs. Only when sufficient knowledge and expertise are available can commissioning be rationally arranged. Here, the advisory group has been invaluable. It is not simply commissioning that is needed. The provider services for rare diseases must be distributed in a limited, rational number of places to make the best use of limited resources. Specialised services for children with lysosomal diseases are located in only three places: London, Birmingham and Manchester. For adults they are located in five places around the country. Only by limiting the number of sites can you expect to develop a critical mass of specialised doctors, nurses and other healthcare workers to provide the best possible care. They are also the places where teaching and research into these diseases can best be done.
That is one example. Similar needs apply to a much larger number of diseases, each of which occurs rarely. The Genetic Alliance UK is an umbrella organisation that brings together over 150 patient-led charities, each set up to support these patients, again mostly children, with genetic diseases. Most of them fit into the category that is covered by the advisory group; that is, they affect fewer than 500 patients a year and currently the advisory group covers about 70 specialised services. For these patients, the advisory group has made all the difference. Yet now there is much concern that all this expertise will be pushed out and dissipated as the commissioning board takes on its multitude of responsibilities.
Can the Minister reassure us and them that there will be a rare disease plan in the mandate for the board? Will the board have access to the specialised expert advice that is so valuable and ready made for this purpose in the advisory board? I am sure that he is well aware of the need and requires no prompting from me on this, but I hope that he is going to be able to say something today that will help allay these concerns.
My Lords, the noble Lord, Lord Patel, is indisposed and we wish him well.
I thank my noble friend Lady Jolly for initiating this debate and for giving a detailed introduction to the problems mentioned in its title. My concern is specifically with the treatment of Gaucher’s disease, the genetic disease mentioned by the noble Lord, Lord Turnberg. It is the most common lysosomal storage disease. It is caused by hereditary enzyme deficiency. Patients in the UK, together with patients suffering from other lysosomal storage disorders, or LSDs, are treated at nationally designated centres run by the Advisory Group for National Services and I am grateful to my noble friend Lady Jolly for reducing that to AGNSS, which saves me from repeating this long name, or the initials. There are eight nationally designated treatment centres in England serving these patients.
Since 2005, the treatment of LSDs has come under the management of AGNSS, which has allowed LSD patients to benefit from national designation with respect to assessment, diagnosis, clinical management of the disease and assessment of the therapies. The centralised management of LSDs previously mentioned by the noble Lord, Lord Turnberg, and my noble friend Lady Jolly is the creation of eight nationally designated centres and has had the following key benefits.
First, there has been provision to patients of access to experts in the management of these rare diseases. Without this access patients have suffered misdiagnosis, as the noble Lord, Lord Turnberg, said, and inappropriate treatment. Secondly, all patients in England—and it is England that we are talking about—have had equity of access to therapies. Thirdly, a nationally funded service has provided budgetary transparency for the NHS, ensuring the efficiency and effectiveness of therapies and avoiding unnecessary costs. Fourthly, the ability to launch national tenders for therapy and home care has resulted in further cost savings. Fifthly, there has been the development of national clinical guidelines defining diagnostic treatment and management criteria.
The Government have determined to disband AGNSS as part of the establishment of the NHS Commissioning Board, as has been referred to by other noble Lords. It is not yet clear how this will work and whether this service for the assessment and management of patients with LSDs will remain a distinct body. The potential disbandment of AGNSS and the subsequent division of the assessment and management of rare diseases raises significant concerns that the issues faced by many LSD patients prior to national designation will resurface. These will include delays in access to diagnosis and treatment, regional inequalities and inconsistencies, misdiagnosis and inappropriate disease management, wasted resources in the NHS, and the separation of clinical management and appraisal of therapies.
The current service is envied around the world and in its existing form is an example of the NHS at its best. In other branches of the NHS we are encouraged to create centres of excellence, in terms of heart treatment, heart attacks, strokes and the like. Many hospitals are ceasing those services—to have centres of excellence—but the rationale for them should apply to these rare diseases as well.
Can the Minister assure patients benefiting from centralised commissioning arrangements provided by AGNSS that they will continue to do so in any new arrangements and that there will not be a break-up of the existing services? Can the Minister confirm that the new NHS Commissioning Board will retain a dedicated budget appropriate to meet the needs of LSD patients currently being treated, with provision for potential additional funds for new therapies in the course of development? Can the Minister give an assurance that the new arrangements will not see a return to what is called postcode lottery for treatments of patients with rare diseases? Does the Minister agree that rare diseases requiring specialised services cannot be treated in the same way as more common conditions, and that structures such as AGNSS need to be put in place to ensure that patients continue to be properly and appropriately managed and treated by the NHS?
Finally, the chairman of the European Gaucher Alliance, which represents patients’ groups from 36 countries, tells me that the current structure for the delivery of healthcare to Gaucher’s patients is envied around the world and is the inspiration for their organisations. I hope that the Minister can provide an assurance to the House that this type of service will continue.
My Lords, until 2008, I was deputy chair of the National Specialist Commissioning Advisory Group, which was a predecessor organisation to AGNSS.
There are some very rare conditions affecting mental health. Services meeting the criteria defined by the noble Baroness have been commissioned, such as: the children’s gender identity development service, for children struggling with the development of their gender identity; services for those with very severe obsessive compulsive and body dysmorphic disorders; secure mental health in-patient services for young people, including those with learning disabilities and those who pose a forensic risk; and services for young deaf people with acute mental health problems. Each of these disorders is low in overall national numbers, which makes it difficult to assess the suitability of proposed services and treatments. The proposal made in the draft mandate to the NHS Commissioning Board is that the board will commission those services that fall into the national specialised services definition set. I understand that 85 services are being considered, of which about 10 are mental health services. These include some services that were previously commissioned following recommendation by AGNSS, such as the services I have already briefly described.
My worry, and I seek ministerial reassurance on this, is that learning disability and mental health services will fall though the specialist commissioning gap. Some of these services are quite messy. They do not conform to the medical model of rare medical diseases that can be researched in the lab, even if they have a serious impact and are rare. Even moving these services to NICE would create a problem since the research investment needed to provide evidence-based treatment has been neglected until now.
If there is to be parity of esteem between mental and physical illness, people with severe mental illness and with learning disabilities need equal attention to their complex clinical conditions. For example, there is no new, well funded research into drugs to treat serious mental illness and no repurposing of drugs, and I am unaware of any investment into exploring, for example, the role of immunology in drug treatment for severe mental illness.
I would like the Minister to comment on the continuing need for such highly specialist commissioning skills that have been developed within AGNSS and its predecessor NSCAG. There is some concern, which I share, that the successful work of AGNSS will be lost, with the risk of forgetting important lessons learnt about national, highly specialised commissioning in the past few decades. The NHS constitution states that the NHS’s resources are to be used,
“for the benefit of the whole community”,
“make sure that nobody is excluded or left behind”.
There are concerns about whether any group which replaces AGNSS would comprise sufficient expertise to assess the unique requirements of highly specialised services, as well as about how the strong relationships built by AGNSS with royal colleges, patients and others will remain within the national Commissioning Board.
For me, the most important message is that some highly specialist services are needed for a small number of people with severe mental illness and learning disabilities which may meet, or nearly meet, existing criteria. New criteria for highly specialist services must ensure parity for these groups. Can the Minister assure the House that the new commissioning arrangements for highly specialised services will indeed mind the gap for complex psychiatric conditions, including those affecting people with learning disabilities and deaf people, and that the skills that AGNSS has demonstrated, which are still needed to commission highly specialist services in the future, will be retained and further developed as suggested by the noble Baroness, Lady Jolly?
My Lords, I thank the noble Baroness, Lady Jolly, for this timely debate on AGNSS. There is no doubt in my mind that there are many really concerned and frustrated people who are involved in highly specialised conditions, be they patients, relatives or doctors treating them. With so much insecurity and with PCTs running down and the national Commissioning Board not operational yet, there is a limbo situation.
When a rare disease strikes, it is the individual who matters. The correct treatment is vital, but with rare conditions risks have to be taken if there are to be improvements. The Chief Medical Officer, Dame Sally Davies, has recently endorsed the value of research into rare diseases by the National Institute of Health Research as a significant source of benefit for patients with rare diseases. The role of AGNSS is to advise Ministers. Does the Minister think that the national Commissioning Board members will be infallible so that they will not need advisers? We have come to a shocking situation when staff in St George’s Hospital, a teaching hospital, neglected a patient of 22 who had suffered a rare condition, following a brain tumour, that required daily drugs. He died of thirst because staff failed to read his notes. Patients with rare conditions need extra-special treatment; they should not be neglected and ignored. What has gone wrong? We need transparency and confession and a fool-proof system for all vulnerable patients. When the Government say that everything is fine when it is not, it is a cover-up.
AGNSS is an independent advisory group providing advice to the Secretary of State for Health regarding the commissioning of services for very small populations of patients—fewer than 500 patients in England. Will the Minister make clear what the future of AGNSS is? To cover all specialised services adequately, the Commissioning Board will have a mammoth task.
I must declare an interest as I have a cousin aged six who has relapsed neuroblastoma. The treatment his parents are trying to access is likely to become available on a trial basis in the UK, but not in time for Jamie. It has been internationally recognised as being one of the most promising therapies with encouraging results against neuroblastoma. I think it is available in Germany. There are only about 100 patients a year in England with this aggressive type of child cancer. It desperately needs research. Parents will do anything for their children. This family is appealing to the North Yorkshire PCT.
I am president of the Spinal Injuries Association, which is concerned about tetraplegics and paraplegics who are not being admitted to spinal units. One case is still residing in St Mary’s, Paddington, on a respirator after a ski-ing accident. He has been waiting to go to the spinal unit at Stanmore for months. This is not good. Correct specialised care means good quality for patients. The noble Earl is Minister for Quality. Does he agree that there should be a special fund for very rare cases so that they are not passed over? I, who have every admiration for our hard-working Minister, do not want the system to give him the reputation of being a Pontius Pilate. Even with AGNSS, there are improvements to be made. There is a black cloud hanging over the NHS: the £20 billion that has to be saved. With so many demands on healthcare, this challenge may just be too great.
My Lords, I am grateful to my noble friend Lady Jolly for this debate. I do not have to declare an interest because, although I have a rare disease, I do not have an ultra-orphan disease. There will be a lot of repetition in what we are saying but perhaps the very fact that we all want the same thing will send a powerful message to the Government. That message has been particularly loud and clear from all the groups that have been lobbying us and are very worried about the future of the commissioning of services for these very small populations of patients with ultra-rare diseases. They all want a version of AGNSS to continue its invaluable work and they do not want its expertise and experience to be lost when the NHS Commissioning Board takes over the responsibility of commissioning specialised services.
It is something of an irony that as medical research finds more and more treatments for these ultra-rare diseases, and as improvements in diagnosis mean that more people will have a correct diagnosis and therefore potentially live longer because their condition can be treated, the actual drugs and therapies they need might be deemed unaffordable. That is why we need AGNSS more than ever at this point where research is at the forefront of the Health and Social Care Act. That Act now gives the Secretary of State, for the first time I believe, the duty to promote research in the NHS. This will inevitably mean that new therapies will be found for rare disorders. This should be great news, but will it be for the very small proportion of the population who have these ultra-rare conditions? Will they be denied access because of the high cost of treatment? The key question is what value-based pricing, due to be introduced in January 2014, will mean for high-cost low-volume drugs and whether these can be adequately assessed within a new value-based pricing framework.
The Department of Health says that the new system will give patients and clinicians greater access to clinically effective and cost-effective medicines. But experts are not convinced that the system will work without the AGNSS framework, particularly given the situation in Scotland where AGNSS does not operate. The last thing we want is to go back to the old days when people diagnosed with Pompe disease, for example—an ultra-rare but treatable neuromuscular condition which affects fewer than 100 people in England—were not always certain that enzyme replacement therapy would be licensed in England because NICE had to be satisfied that it would be cost-effective. Through the leadership of Sir Michael Rawlings, national commissioning of such orphan drugs was transferred to an advisory body which later evolved into AGNSS, and the dreaded threat of a postcode lottery was removed.
In its short life, as we have already heard this evening, AGNSS has garnered high praise for its thorough evaluation process, which is seen to be open and transparent, using the uniform expertise to evaluate funding for service provision and therapies, thereby avoiding inefficient and artificial separation of commissioning for drugs and services. It is likely that this good practice has led to the UK being looked on favourably as a destination for pharmaceutical industry-sponsored clinical trials. Surely we all want this to continue and develop. Can the Minister say what the timescales are for confirming the future work of AGNSS and can he confirm that the Secretary of State for Health has the duty under the new Act to provide specialised services for all who need them, however rare their disease?
My Lords, I too am deeply grateful to the noble Baroness, Lady Jolly, for initiating this important debate. I have been a long-time supporter of the Rare Disease UK consortium, now chaired by the man who recently was the director of the Genetic Interest Group. A recent editorial in the British Medical Journal in June said:
“Three million in the United Kingdom have a rare disease, defined in both Europe and the USA as a disease that affects fewer than one in 2000 people. It is well recognised that those with rare diseases face intrinsic inequalities in healthcare, and in response to a 2010 recommendation by the European Commission, the UK government, like other member states, agreed to produce a strategy for rare diseases by 2013”.
The Government at the moment are consulting on this very important topic.
Before I come to that I want to say a word about AGNSS, which has proved to be remarkably successful. It has been funded by top-slicing of funds—up to about £100 million a year—from primary care trusts across the UK and it has enabled companies such as Shire Pharmaceuticals to develop enzymatic treatments which have in fact been able to reverse diseases like those referred to by the noble Lords who spoke earlier about the various storage disorders. It has been able to control disease in people with Fabry disease, Hunter syndrome, Gaucher’s disease and others. It has been immensely successful and its future is therefore crucial. It is important that the Government recognise in the consultation process they are undertaking that the needs will increase as time goes by, because the developments in genetic medicine and molecular biology are revealing in many of these devastating and rare diseases single genes whose effects can be controlled to an extent by new forms of treatment. As time goes by, more and more orphan and ultra-orphan drugs to control these rare diseases are coming on stream.
One major concern about the proposals in the Government’s consultation document is that, while it contains proposals on diagnosis and services for rare diseases, policy and treatment is deflected to forthcoming proposals on value-based pricing. Value-based pricing is unlikely to be capable of dealing with medicines for orphan and ultra-orphan diseases because, after all, the number of patients affected by these conditions is relatively small. The drugs that are being developed are going to be very expensive and they are not going to be commercially viable unless they are sponsored and subsidised by funds from an organisation like AGNSS. This is a crucial issue which I hope the Government will be able to deal with. At a recent meeting Sir David Nicholson suggested that it was probable that the functions of AGNSS would be taken over by the national Commissioning Board. I know no decision has yet been made but will the Government tell us what the prospects are, whether the responsibilities will be extended and whether funding for AGNSS is likely to be increased?
Finally, in the light of my own private research I want to mention a disease called Duchenne muscular dystrophy—a devastating disease of young boys causing progressive muscular paralysis. For the first time certain drugs are now coming on stream which have been shown by clinical trials to be effective in delaying the actual progression of this condition. These drugs are so-called molecular patches which overcome defects in the actual gene. This is a form of exon skipping. For these drugs to be effective, several different types of molecular patches may have to be developed. Speeding up that process for different mutations will be difficult but the safety issues are all the same. Can the Government give us an assurance as these molecular patches for this devastating disease become increasingly available that not every single patch is going to have to be tested and subject to regulatory control, and that regulation covering all these patches may be acceptable?
We are dealing with a very important group of diseases which cause immense human suffering. AGNSS, in some form or other, must continue and it must have its functions and, I believe, its funding increased.
My Lords, with your Lordships’ consent, I will speak briefly in the gap on the issue of the mental health of families and children and on clinical standards for children and young people in care. My noble friend Lady Hollins raised important points in this area. I will give one further example. The NSPCC’s Young Abusers Project, run for many years by the eminent forensic psychiatrist Dr Eileen Vizard, deals with children who have abused other children. I am afraid there are significant numbers of those children but it is hard to get specialist services for them. In the past, Dr Vizard has explained to me how she has chased her PCT to get the money to provide this specialist service and has failed. The difficulty is that the service starts to treat a child whose behaviour begins to improve and he or she begins to get better. The local authority then whips the child out because the symptoms have gone. But if the service does not intervene effectively in childhood, a child can become an adult with similar problems. We really need to address such issues as regards children’s mental health.
The Cassel Hospital used to provide a service for very damaged families. It enabled mothers who perhaps had lost several children through being taken into care to keep their children because the hospital provided such good, specialist intervention for the mental health of those families. I would be grateful for the Minister’s assurance that the importance of the mental health of families and children specialist services will be carried forward in the new dispensation. Perhaps the Minister could write to me on the clinical standards for young people in care. NICE is responsible for taking those forward. If we can get those right, we will need fewer specialist mental health services for children and families in the future. I look forward to the Minister’s response.
My Lords, I congratulate the noble Baroness, Lady Jolly, on giving us this welcome opportunity to discuss national specialised services. The points that she has made are significant both in terms of specialist services and also in terms of some of the vulnerabilities in the new architecture that we see being brought into the NHS.
One of the issues raised by the shifting of responsibility from Ministers to the NHS Commissioning Board is a concern that Parliament and parliamentarians will not have sufficient influence on the way in which specialist services will be developed. I too would like to acknowledge the work of AGNSS and express our wish to see it continued. I thought that my noble friend Lord Turnberg put it very well. It is important that Ministers continue to receive the advice of this body in the new arrangements. It seems to me that the arguments being put forward by every noble Lord on this matter are persuasive.
I also wonder about the advice that the NHS Commissioning Board is to receive. As I see it, there is a two-stage process. First, there has to be a decision on which services are to be so designated, which will be a subject for Ministers and will have to be done through regulations. I am quite clear that AGNSS has a role to play. Secondly, if there are services to be commissioned, how are they to be commissioned and how much is to be commissioned? Again, I wonder whether AGNSS could play a role in advising the national Commissioning Board. I do not know whether the noble Earl would be prepared to comment on that specific point, which is rather separate from that which we have debated so far on advice to Ministers.
Can the Minister also comment on regional specialist services? Again, we have not really discussed that but, in the past, there has been a mechanism for commissioning at the regional level. Can he say how he thinks that that might be done? Of course, it is possible that the local offices of the national Commissioning Board might do it with the advice of some kind of advisory service. I encourage the noble Earl to go down that route. I really hope that the answer is not that clinical commissioning groups will federate together to commission regional specialist services. Frankly, that will not happen. I would have no confidence whatever in clinical commissioning groups collectively seeing the wisdom of commissioning regional services. At the local level, there has to be leadership. I can see it coming only from the office of the national Commissioning Board. I think that with an AGNSS approach at that level, alongside an ability of the commissioning board at what we call the local level, but which with 28 offices really is at a semi-regional level, there will be scope for that to happen.
The noble Lord, Lord Palmer, raised the issue of postcode prescribing. If too much is devolved to clinical commissioning groups in relation to specialist services, that is almost inevitable. From the action taken recently by a number of primary care trusts, we have seen that they are only too willing to restrict services. The North Yorkshire primary care trust seems to be in the spotlight and to be making some bizarre decisions. It has sought to describe treatment, which is well recognised nationally and internationally, as innovative and almost not proven. The noble Lord, Lord Walton, raised this issue yesterday. I would worry if clinical commissioning groups were given too much discretion in this area.
Finally, I turn to budgets and how much money is to be top-sliced. I gently say to the noble Earl, Lord Howe, that Ministers seem to be in denial about the financial pressures facing the health service at the moment. Recently, I had meetings with the Royal College of Nursing and the Royal College of Physicians. They confirmed my view that the NHS is under extreme pressure, the problem being that primary care—the most vulnerable and most patchy bit of the health service—simply is not stepping up to the plate in terms of demand management or developing the services that were meant to keep people out of hospital. Given that, the acute sector is under huge pressure, and my worry is that the national Commissioning Board will be very reluctant to top-slice sufficient resources in relation to specialist services.
In reminding the House of my health interest, as I should have done at the beginning of my speech, I would be very grateful if the noble Earl could say a little about how resources are to be protected for specialised services in a very strained financial position.
My Lords, perhaps I may begin by congratulating my noble friend Lady Jolly on securing this short debate on the future of the Advisory Group for National Specialised Services. This is undoubtedly an important area for discussion, not only for the members of the advisory group who have worked hard to provide Ministers with advice but for patients and families who have benefitted from the national commissioning on which it leads.
At the outset I would like to say, in particular to my noble friend Lord Palmer and the noble Baroness, Lady Hollins, that in working up plans for the reform of the NHS, we absolutely recognised the needs of people with very rare and rare conditions. We wanted to make sure that we honoured the commitment in the NHS constitution that no one should be “left behind” because of the rarity of their condition. For these reasons, the legislation reflected our view that specialised and highly specialised services were best commissioned at a national level. Services will be set out in regulations, making it very clear what we are expecting the Commissioning Board to directly commission. I can assure my noble friend Lord Palmer that patients with rare conditions, depending of course on their clinical needs, will continue to have access to specialised services and expert treatment. I would say to the noble Baroness, Lady Masham, that the NHS Commissioning Board will retain money centrally to directly commission these services, including services for very rare conditions.
When the coalition Government were formed in 2010 we endorsed the previous Government’s proposal and established AGNSS as an independent stakeholder advisory group, bringing advice and funding together into one body. We also gave AGNSS the specific role of considering whether certain very high-cost, low-volume drugs should be included in the national arrangements for specialised commissioning. In developing this role, AGNSS worked very closely with NICE and developed its own decision-making system.
Under the Health and Social Care Act 2012, this situation will change from April 2013. Instead of highly specialised services being commissioned nationally by the National Specialised Commissioning Team and specialised services being commissioned on a regional basis by specialised commissioning groups, the new NHS Commissioning Board will take responsibility for commissioning all these services. That will all be under a national commissioning policy which will be sensitive to local requirements so that the needs of people with rare and very rare conditions are met.
Ministers will still be responsible for deciding what services the board should be asked to commission, but it will be the responsibility of the board to decide how it commissions those services. The functions of AGNSS cut across both the “what” and the “how” so I do not see a role for AGNSS in its current form from April 2013 and it will cease to be an advisory group offering advice to Ministers.
I would like to set out the current functions of AGNSS and consider in turn where each would sit in the future. The first function of AGNSS is to advise Ministers on which highly specialised services, products and health technologies should be nationally commissioned. That will be expanded to cover all specialised services and not just the highly specialised. Ministers will need to receive advice on whether services can be defined by the rarity of the condition, the cost of providing the service or facility, the number of centres able to provide the treatment, and financial implications for clinical commissioning groups. We are currently considering an appropriate advisory mechanism for Ministers that will keep the list of services directly commissioned by the board under review, ensuring that services are commissioned at the right level. In time, some services might be more appropriately commissioned by clinical commissioning groups, but I emphasise the words “in time”.
The second function of AGNSS is to advise Ministers on which centres should be designated providers for nationally commissioned services. In the new reformed NHS, this is rightly the role of the Commissioning Board in carrying out its commissioning of services. It is no longer for Ministers to decide upon. Therefore, advice to Ministers is no longer required. The same is true for the third function of AGNSS: advising on the annual budget for new and existing nationally commissioned services and the contribution required from PCTs. The fourth function is to advise on funding of the management function of the NSCT as hosted by NHS London. That will no longer be needed. The Commissioning Board will manage one single specialised services budget and commissioning function. So, again, Ministers would no longer need that advice, and it will be a matter for the Commissioning Board.
Whether commissioning a cataract operation or the most highly specialised and long-term treatment, the most important thing is quality of care. We must prioritise good-quality clinical advice on highly specialised services over the structure of a group for its own sake. Work on developing an advisory mechanism for the board on highly specialised services is ongoing. The chair of AGNSS, Professor Michael Arthur, is working with the NHS Commissioning Board Authority on such an advisory mechanism that would build on the skills and expertise of current arrangements. Within the board, there will be a clear focus on specialised services, organised around programmes of care to make sure that services are always top-notch. Commissioning teams will make sure that contracts with providers reflect the needs of people with rare and very rare conditions. On top of that, there will be specific links to innovation, including a specialised services innovation fund. The board will also manage stakeholder engagement.
I mentioned one important aspect of the work of AGNSS, in assessing very high-cost, low-volume drugs, but so far I have not explained where this function will sit in the new system. We have looked at several potential options. I am pleased to announce that, on the basis of a detailed proposal and discussions, we have asked NICE to take on the assessment of very high-cost, low-volume drugs from April 2013. I am aware that some noble Lords may have concerns about NICE taking over this work, as the current cost per quality-adjusted life year that NICE operates for its appraisals of drugs would rule out highly expensive drugs for small numbers of people with rare conditions. We have explored this issue thoroughly with NICE and it has developed a process for assessing such drugs. It will build on the decision-making framework that AGNSS uses at the moment. That framework balances health gain, best clinical practice, societal value and reasonable cost. In addition, recommendations from NICE will not be based solely on a cost per QALY figure.
NICE proposes setting up a dedicated expert panel to produce an assessment of a new drug, usually within six months. Given that we wish the new process to commence in April 2013, NICE will develop interim methods for the first few assessments. The institute plans to subject these processes and methods to a consultation in 2013-14 alongside the assessments it will carry out. NICE’s work will make sure that we have a robust, transparent and consistent process in place for assessing very high-cost, low-volume drugs. We have a number of points of detail that Department of Health officials are still exploring with the institute. I will be able to say more about the detail of this proposal in the coming weeks, but, in the mean time, I thought it important to provide a progress report to the House.
The noble Lord, Lord Turnberg, asked about the mandate. I can tell him that the consultation on the draft mandate, which was launched on 4 July and on which we welcome views and comments, emphasises the importance of driving improvements in the £20 billion- worth of services commissioned directly by the board, including specialised services for people with rare or very rare conditions. One of our proposed objectives in the draft mandate asks the board to put in place arrangements to demonstrate transparently that these services are of high quality and represent value for money.
The noble Lord, Lord Hunt, expressed his dissatisfaction that, as he sees it, Parliament will not have a say in which services are commissioned by the NHS Commissioning Board. The consultation on the mandate provides Parliament and, indeed, others with the opportunity to express views on that matter. I would also reassure the noble Lord, Lord Turnberg, and my noble friend Lord Palmer that within the board there will be a clear focus on specialised services, including experts on highly specialised services, organised around programmes of care and with a national commissioning policy for specialised services that is sensitive to local needs, as I mentioned. Clinical leadership will be the responsibility of Professor Sir Bruce Keogh and advisory mechanisms to the board are being developed. Within 10 of the 27 local area teams of the board, there will be expertise in highly specialised services.
The noble Earl, Lord Listowel, asked about children with specialist mental health issues and whether they would have access to appropriate treatment. I can give the assurance that such services will be available once the board is responsible for commissioning them. Specialised services relating to mental health was the theme taken up by the noble Baroness, Lady Hollins. We are not yet in a position to announce the full list of the services that the board will be commissioning. However, a great deal of work has been going on to draw up that list. The chairs of 60 clinical reference groups have been working on the matter. They are all leading clinicians in their fields. The CRGs hold a broad membership and an assurance process was established that looked at the work of the CRGs. The findings of the CRGs were considered by the CAG in May of this year and Ministers expect to set out the list of services over the summer.
In answer to the noble Baroness, Lady Masham, I am of course very sorry to hear about the child she mentioned who has neuroblastoma. Obviously, for reasons of patient confidentiality, it is not appropriate to comment on individual cases. At the moment the decision for funding treatments for neuroblastoma rests with PCTs. In the future, commissioning decisions for patients with rare conditions will, as I have mentioned, rest with the board. I cannot say definitely whether that will be one, but the noble Baroness may like to draw her own conclusions. I am informed that the evidence base for stem cell-based therapy for neuroblastoma is not yet sufficiently robust despite the comments she made.
The noble Lord, Lord Walton, asked for an assurance that molecular patches will not be subject to constant regular testing. Molecular patches that are found to be safe by the regulatory process can be used on the NHS. My noble friend Lady Thomas spoke eloquently about research. She is absolutely right in the importance she attaches to that. The Government will invest £800 million over five years from April this year in NIHR biomedical research centres and units. Most of these centres are conducting leading-edge research on rare diseases that will benefit patients with these conditions. The NIHR has joined the International Rare Diseases Research Consortium and is actively involved in pursuing the consortium’s goals.
Time is now against me. I beg leave to write to noble Lords who asked me questions that I have not had time to answer. Once again, I express my gratitude to my noble friend for raising this important subject.