My Lords, the department has not issued definitive guidance on this difficult issue. Indeed, there is a paradox in the whole concept of defining an exception. However, good practice in the NHS suggests that a patient can be considered for treatment which is not normally provided locally if the patient has exceptional clinical need or is likely to derive exceptional clinical benefit. The decision is made by the local commissioner.
My Lords, I thank the noble Earl for that reply. However, is he aware that there is a young doctor in Northallerton, North Yorkshire, whose PCT has denied her a vital operation for a genetic pancreatic condition? If she does not have this operation, she will remain in excruciating pain all the time, she will not be able to work, and there will be a risk of cancer.
My Lords, I hasten to reassure the noble Baroness that I have every sympathy with the individual in question, and I was aware of this particular case. The chief executive of the NHS will shortly be writing to her clinical tutor to suggest a possible way forward. However, I should put on record my view that the commissioner is acting reasonably in insisting that its decision on exceptionality should depend solely on the clinical need of the patient, and not on any broader social factors. If there is now good clinical evidence to support the use of this particular treatment, commissioners should be considering whether to make it available to all patients with similar clinical needs, and not just to a few individuals.
Is my noble friend aware that the pancreatic unit at Leicester is not able to do any islet cell transplantation operations because the PCT refuses to fund them? The excuses used to justify not funding these operations are that these may be “procedures of limited value” and “experimental surgery”. There are, in fact, four clinical units throughout the UK doing islet cell transplantation, with good records and good outcomes. I want to know whether the PCTs are not funding these operations in order to present a clean sheet to the incoming CCGs in April 2013, or whether there is another reason.
My Lords, no, that is not the reason. My noble friend is quite right that this treatment has been around for a little while. However, it is not yet in mainstream practice. It is expensive, it is not routinely available in the NHS, and indeed NICE has published interventional procedure guidance which concludes that it,
“shows some short term efficacy, although most patients require insulin therapy in the long term”.
That does not seem to me to be a resounding endorsement of this treatment.
There is no clear-cut answer to that question. A patient might be suffering unusually severe symptoms from a given condition, or they might suffer from some comorbidity, with the result that in the absence of treatment his or her quality of life would be unusually severely affected. The underlying principle should be that the patient has some exceptional characteristic which would justify more favourable treatment being given to them than to the average patient with that condition.
Given the vulnerability of the patients, the exceptional nature of the illness in such cases, and the consequential problems in terms of access and capacity to appeal, will the Minister tell the House what arrangements exist to scrutinise the fairness and consistency of decisions by PCTs and by their exceptional cases review processes?
My Lords, under the NHS Constitution, all patients have the right to an individual review of a decision not to fund a particular treatment if they and their doctor believe that it would be appropriate. They also have the right to an explanation of the basis of the decision. The commissioner must in turn have a process to enable such individual funding requests to be considered, so the watchwords here are transparency and publishing an explanation.
Does the Minister agree that there are other decision-making bodies? I refer in particular to the UK National Screening Committee. Is he aware that, probably correctly, it makes its decisions only on research results? Why does it claim that it does not have the money to spend on research into Streptococcus B infections, when international research shows a clear choice for screening as opposed to risk assessment? That change that has been made in other countries has resulted in reductions of strep B infections in children of 80% in the USA, 60% in Spain, 82% in Australia and 71% in France. The screening of pregnant mothers could prevent that very serious condition, which can be fatal, being passed to a small number of babies.
My Lords, the UK National Screening Committee advises Ministers and the National Health Service in all four UK countries on all aspects of screening policy, including for group B Streptococcus carriage in pregnancy. The committee is currently reviewing the evidence for screening for that condition in pregnancy against its criteria. It will take into account the international evidence and a public consultation on the screening review will be opening shortly.
My Lords, the Minister said that this treatment is not routinely carried out. The doctor concerned, who works in the NHS, is aware that pancreatectomy is carried out in other PCTs. Can the noble Earl explain where it is being carried out so that we can understand what is routine and what is not?
My Lords, I hope that my earlier answers gave a clear indication of the definition of exceptionality, which should demonstrate to the House that something that is exceptional is not routine. Our advice is that that treatment is not routinely available in the NHS. There is a handful of centres in England with doctors who are trained to carry out the operation, but although the technique has been in use since 1977, it is available only in a few centres worldwide, which does not suggest to me that other countries are ahead of us in this area.