NHS England loses in court on a medical treatment case – yet again

The judgment in the case of R (on the application of SB) v NHS England[2017] EWHC 2000 (Admin) which was handed down this week was another occasion on which an NHS England decision has been struck down by the High Court. Coming after the PreP case (R (on the application of National Aids Trust) v The National Health Service Commissioning Board (NHS England) & Ors [2016] EWCA Civ 1100) and S (a child) v NHS England [2016] EWHC 1395 (Admin), there appears to an unfortunate trend of NHS England’s decisions being susceptible to legitimate challenge in the Court.  However, on this occasion, not only did the Judge quash the decision but Mrs Justice Andrews also unleased a volley of unrestrained criticism of the NHS England decision making process. That must have made the judgment very difficult reading for those who had been involved in the Individual Funding Arrangement (“IFR”) panel. I suspect that there may have been an element of the use of the forensic "retrospectascope" but, even given that allowance, the criticism was pretty chilling.

Things have not quite got the stage of the advocate saying, “This is a challenge to an IFR decision by NHS England”, and the Judge asking, “Yes, … and what are your other grounds of challenge?”, but this case in particular will not have endured NHS England to the judiciary. It perhaps contains some salutary lessons for NHS commissioners, both in NHS England and in CCGs.

The core issue in the latest case was whether the decision documents relied upon by the NHS England IFR panel showed that the panel had properly understood the clinical case upon which they were being asked to make a decision and had understood the evidence supporting that case. The irrationality challenge made by the Claimant was grounded in a case that the referring clinician who made the case for funding did so for specific reasons; and that the panel refused funding without properly understanding those reasons, and thus did not understand the case they were making a decision about. It was also alleged that the panel failed to understand the evidence that supported the case. This was an exceptionality case but, for once the issue of exceptionality was not in issue. The panel accepted that the patient had exceptional circumstances. There is a clear message in the conclusions of the Judge at §49:

“… once it is accepted that the incidence and severity of S's autism is such that, compared with the other children of a similar age with PKU (even those who also have less severe autism) his behaviour precludes his phenylalanine blood levels from being satisfactorily managed within target levels on the standard treatment of diet and supplements alone, it is difficult to see how the Panel could reach any other rational conclusion than that he was likely to gain significantly more clinical benefit from taking Kuvan than other children with PKU whose condition could be managed by the conventional treatment alone, …”

That was, one might feel, a warning of the criticism that was to follow. The Judge then asked what was meant by “clinical effectiveness” and said at §56 that this term meant:

“…whether it achieves the intended clinical outcome in respect of the relevant condition from which the patient is suffering (or, as a lay person would put it, it works) ..”

That is different, so the Judge decided from the question as to how long a drug would remain clinically effective over an extended period. That must be right though it is somewhat unclear how the difference is supposed to operate in practice. Maybe this means that a clinically effective drug will not necessarily be cost effective if the benefits are only delivered over a short period.

The Judge then “put the boot in” to the decision making process demonstrated from the minutes of the meeting and the decision letter saying:

 “ … this decision was informed by error upon error, the most fundamental of which was that the Panel misunderstood (and/or mischaracterised) what Dr Santra [the referring clinician] was saying about the clinical implications of S's inability to control his blood phenylalanine levels to levels falling consistently within the target range. Whilst it is open to an IFR Panel to disagree with the requesting clinicians if they have valid reasons for doing so, a decision based on a misinterpretation of what the clinicians are saying will be fundamentally flawed, and so it is with this one”

That is not evidence of judicial reticence but giving both judicial barrels to the decision maker. It makes painful reading. If that were not enough expression of judicial displeasure, it gets worse at §79 where the Judge says:

“If there were any doubt that the Panel were labouring under a misapprehension, it is resolved by a statement made in the decision framework document (though not repeated in the letter to Dr Santra) at section 7: "The Panel noted that it is very important to point out at this stage that the patient is currently within the desired range for phenylalanine levels." That statement is demonstrably incorrect. Even the most recent two readings were above the range. At best, it is a half-truth, because the evidence was that S's levels were within the range for less than 50% of the time, and then, just about within the upper limit, a situation which, according to the treating clinicians, was likely to be well-nigh impossible to sustain going forward, given his behavioural difficulties”

Accusing an NHS England decision makers of telling “half-truths” is not going to get the Judge, Mrs Justice Andrews, onto Simon Stevens’ Christmas Card list. But this will not have bene the first NHS reasons document that glosses over the difficult issues by trotting out half-truths. However such an approach may well end now up being subject to extended criticism for doing so when brought under the forensic microscope of the court.

There are important messages for IFR panels – which almost all operate at the CCG level – from this case. The main lessons are that the paperwork from an IFR panel needs clearly to demonstrate:

• that the panel they have properly and fully understood the case that they are being asked to consider;
• that the panel have properly got to grips with the medical and statistical evidence advanced to support or undermine that case; and
• that the reasoning in the final decision has to be consistent with the evidence that the panel has received and based upon a careful consideration of that evidence.

IFR panels that don’t reach this standard may find their decisions successfully challenged, and if the reasons don’t meet these standards, any judgment may be accompanied by a distinct sharpening of the judicial pencil.

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David Lock QC has appeared in many judicial reviews about NHS treatment and rationing, acting for NHS bodies and (in other cases) for those challenging NHS decisions.