Drugs, co-payments and PCTs decisions

The ministerial statement in response to Mike Richards’ report on the vexed question of top up payments for drugs not available on the NHS has the potential to create almost as many problems for PCTs as it resolves.

Whilst on the one hand welcome confirmation is given to the proposition that patients should not have NHS treatment withdrawn if they also arrange parallel private treatment, there is a significant risk that the announcement and the way in which it has been reported will have created expectations that it goes further than it does. Indeed if one looks at the draft guidance issued for consultation it is clear that a minimalist approach to this is being taken by the Department, and indeed I would say that the guidance in fact reflects what Bevan Brittan have always been advising. You cannot be a private and an NHS patient in the same treatment episode, but that does not stop the patient making separate arrangements for additional treatment - quite possibly the same day - as a private patient. The difficulty is that this is not always possible - indeed the problem often arises in the context of emerging research which suggests that the addition of a new drug to the cocktail of chemotherapy increases the effectiveness. This creates problems if the NHS is saying that the unfunded drug is to be given separately. It also raises issues around monitoring and supervision.

It is also apparent that the intention is to limit any ability to top up treatment to those situations where the additional treatment can be separated out. It will therefore not apply to other situations such as wanting to pay to upgrade a residential care package or other form of treatment. In those cases the patient can accept what the NHS offers or make their own arrangements entirely.

However the ministerial announcement and the Report from Mike Richards do not stop there. The Report endorses the Departmental initiative to accelerate the NICE process, but it also suggests that the way in which cost effectiveness is addressed in the NICE appraisal process should be adjusted to allow for drugs which provide some benefit for patients at the end of their lives but which on the current QALY approach would not get approval. There are serious political and moral issues here around how these decisions should be taken, but the problem for PCTs is then working out how this should have an impact on the decisions that PCTs either alone or collectively have to take in connection with drugs where there is no current NICE guidance.

The Report also commends collective assessment and decision making between groups of PCTs which may go some way to avoiding allegations of a post code lottery, but they will require care in establishing the groups and the status of any joint body. Who is taking decisions? The basic principle of co-operation particularly across cancer networks for the assessment and information gathering part of the process is to be commended, and indeed we would go further and recommend cross network collaboration so that the research is not being duplicated unnecessarily, although decisions will probably need to be taken nearer home.

There may also be concerns around patient safety and risk for the clinicians and the PCT. Where the patient is making a separate arrangement the Department is clear that the risk should be outside the NHS and a matter for the clinician in their private capacity, but there is inevitably a degree of risk for the NHS where the problem is not so much either individual treatment but the implications of the combination, and where the duty lies for advising the patient on the risks is yet to be clarified.

A final area of concern for PCTs is the current trend of cases in relation to this type of decision making process. Following the case of Otley last year which amongst other issues appeared to regard evidence of benefit from private treatment as relevant to PCT decision making, there have been two new cases which have been decided in favour of claimants :-

R (Murphy) v Salford PCT which held that although the PCT had considered individually all the points raised on behalf of the claimant it had not done so in the round and therefore the case was sent back to them by the judge for a fresh decision.

R ( Ross) v West Sussex PCT where the decision of the Trust was criticised on a number of grounds, but which do seem to make the approach to exceptionality very difficult for the PCT at least if defined as whether the individual is an exceptional case. It may be a more sophisticated approach to move away from the phraseology of exceptional cases to say that the PCT has a policy – often a policy not to fund new drugs without NICE or local cancer network approval, but to allow consideration of individual cases to see whether there are reasons why the policy should not be applied in the instant case. This would involve a degree of formulation of why the policy was there in the first place and looking at whether the justification for the policy did not apply to the individual case. A facile example might be that a treatment is not funded because there are better or more cost effective alternatives – but if in the particular case those alternatives are not available then that might be a reason to disapply the general rule.

There are sure to be a number of legal challenges for PCTs with major funding or reputational issues and it is clear that this is a fast moving, well publicised area justifying specialist advice.

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