National Health Service—Pharmaceutical services —Supply of medicine or drug

Queen’s Bench Division, Administrative Court, Judge Grenfell sitting as a judge of the High Court, 10 September 2008

The Individual Cases Policy of the West Sussex Primary Care Trust pertaining to funding of treatments not routinely commissioned, is unlawful, because it effectively requires a patient to show not that his case is unusual, but that it is unique.

Richard Clayton QC and Vikram Sachdeva (instructed by Irwin Mitchell) for the claimant. Martin Forde QC and Matthew Barnes (instructed by Mills & Reeve) for the defendant.

The claimant was a multiple myeloma sufferer, diagnosed in 2004. He had been treated with a variety of chemotherapy treatments. His most recent treatment was composed of Thalidomide, but by February 2008, the side effects of Thalidomide, particularly peripheral neuropathy, had become too debilitating for him to tolerate and the drug was stopped. The only alternative treatment was lenalidomide, which had not been assessed by the National Institute for Health and Clinical Excellence (NICE).

It was common ground that without the chance of attempting the life-extending properties of Lenalidomide in conjunction with one or two other drugs, which were themselves uncontroversial, the claimant’s life expectancy was limited to the progress of the myeloma. In those circumstances, the consultant haematologist treating the claimant applied to the defendant primary care trust for funding for Lenalidomide. Supporting evidence was included with that application.

Where funding was sought for treatments which were not routinely commissioned, applications were considered under the defendant’s “individual cases policy” (ICP). The ICP allowed for “exceptional” cases to be funded. Guidance on the meaning of exceptionality was contained in the document setting out the terms of reference for panels considering applications made pursuant to the ICP.

After several hearings by different review panels the application for Lenalidomide funding was rejected. The panel held that the claimant’s case was not exceptional on the basis that a cohort of patients would have suffered the side effects of neuropathic pain as a result of treatment with thalidomide. Moreover, the evidence in support of the application had failed to meet the clinical and cost efectiveness requirements of the ICP. The claimant sought judicial review of that decision.

Judge Grenfell:
The claimant submitted that the policy itself was unlawful, that the decision proceeded on the basis of material errors of fact and that the decision was irrational in its approach to: (i) clinical efficacy; (ii) exceptionality; and (iii) cost effectiveness. He further submitted that the defendant had unlawfully fettered its discretion.

The defendant argued, (i) the issue of funding lenalidomide was at an early stage, with no suggestion by the cancer networks that the evidence supporting funding was so compelling that it should be fast tracked; (ii) accordingly, it could only be funded in individual cases on the basis of exceptionality; (iii) the claimant’s case was plainly not exceptional among fellow sufferers from multiple myeloma who were intolerant of thalidomide; and, (iv) in any event, the efficacy of lenalidomide, and its cost effectiveness, were not such as to warrant funding.

Unlawful policy
His lordship was satisfied that the defendant’s policy was unlawful because it was a contradiction as defi ned by its own terms because:

(i) it was not a policy for exceptional cases because a person was automatically disqualified if he could be likened to another: in order to qualify, a patient must show in effect that he is unique, rather than merely exceptional in the ordinary sense of the word as being “of the nature of or forming an exception; out of the ordinary course, unusual, special.” (Oxford English Dictionary);

(ii) in practical terms, in a case such as the instant, it was impossible to show uniqueness, so the policy was incapable of fulfilment because (a) it would always be possible for another patient to emerge who was appropriately comparable; and (b) the comparison depended on how widely a label was drawn by the defendant, for example whether the claimant should be compared to any cancer patient who suffered unpleasant side effects or to something more specific;

(iii) it was impossible to envisage circumstances other than those where the applicant showed that his circumstances were unique, whereas in a simple policy of exceptionality a reviewing panel would have no difficulty in applying the ordinary meaning of “exceptional”.

His lordship held further that the views expressed by the various review panels were such that no reasonable authority could reach in terms of its decision that the claimant’s case was not cost effective because:

(i) they misunderstood the effectiveness of lenalidomide: with the result that they could not rationally assess its “cost effectiveness”;

(ii) they had failed to understand that the actual sums sought were for four cycles, with the potential for a total of 11 cycles if the claimant responded to lenalidomide; that, if he did not respond, the treatment would probably not be continued so that further cost would not arise;

(iii) they misunderstood the median survival advantage figure of 9.4 months, and erroneously appeared to apply to a double discount for the 60% partial response rate and the 15% full response rate;

(iv) they had failed to take account of the saving to the defendant of not having to provide the expensive life prolonging treatment which had been given to the claimant within its operational plan before he developed his intolerance to it, which could have been another ground for holding that his circumstances were exceptional to the plan.

The decision was accordingly one which no reasonable authority could have made.
The decision would be quashed.