i) The original Review Panel failed to appreciate the clear need for expert advice from a specialist in the field of oncology such as Professor Sikora. His report highlighted its failure to understand the studies which made a clear case of clinical efficacy of Lenalidomide for patients who could not tolerate Thalidomide, and, as regards the question of cost effectiveness, the report pointed out that the Panels had not taken into account the savings in not providing the other life prolonging drugs to which the Claimant had become intolerant.

ii) The PCT’s policy was unlawful in that it stated that an application ‘must’ be refused where a patient was ‘representative of a group of patients’. This was not a policy for exceptional cases but one that required the patient to show that he was unique. The Review and Appeal Panels erred, as they clearly thought that, because other patients could find themselves in the Claimant’s position, the Claimant could not be exceptional.

iii) In any event, the Panels misdirected themselves that it was not exceptional to suffer unpleasant side effects to Thalidomide and therefore failed to appreciate the vital distinction that it was the Claimant’s intolerance to the peripheral neuropathy which made him an exception. For these reasons the decision to refuse funding on the ground of exceptionality was logically flawed and on the evidence before the Panel the application ought to have been upheld on an ordinary reading of the term ‘exceptional’.

iv) Once exceptional circumstances were established clinical efficacy and cost effectiveness should not be ignored. However, once an exceptional case was made out, particularly where matters of extending life were concerned, a PCT should take a less restrictive approach to cost effectiveness than when considering the case for funding a drug as part of its Operational Plan.

v) As regards clinical efficacy, the Panels failed to understand the strength of the evidence in favour of treating a patient such as the Claimant with Lenalidomide, as they had fundamentally misunderstood the results of the randomised control studies. They ought to have upheld the clear case on clinical efficacy presented to them.

vi) The Panels’ decisions on cost-effectiveness were such that no reasonable authority could reach because they misunderstood the clinical effectiveness of Lenalidomide; they failed to understand that the actual sums sought were for 4 cycles, and if the Claimant did not respond, treatment would probably be discontinued; they misunderstood the median survival advantage figure; account was taken of those patients who would not have a response of one year’s additional life, when logically, any additional cost would only arise in the event that the Claimant was responding to the treatment which would make it both clinically and cost effective; and they failed to take account of the saving to the PCT of not having to provide the expensive life prolonging treatment which had been given to the Claimant within the Operational Plan before he developed his intolerance to that treatment.

vii) The decision of the PCT was one which no reasonable authority could have made on the application before it and should be quashed.