Case details
Summary
A public healthcare authority may set local funding priorities and apply an exceptionality policy, but the policy must leave a genuine and workable possibility of exceptional funding. A requirement that the patient be unique, or automatic refusal because other patients may share relevant characteristics, converts exceptionality into an unlawful policy of exclusion.
The court reviews the lawfulness, not the merits, of funding decisions. Life-or-death decisions require rigorous scrutiny. A decision is irrational where material clinical or financial evidence is misunderstood, relevant savings and the proposed treatment period are ignored, or the authority applies population-level commissioning considerations to an individual exceptional case.
Factual background
The claimant, who had relapsed multiple myeloma, sought judicial review of the West Sussex Primary Care Trust’s refusal to fund Lenalidomide with Dexamethasone, with or without Cyclophosphamide. Earlier treatments had caused intolerable peripheral neuropathy, leaving palliative treatment as the only alternative.
The Trust’s Review Panel refused funding on grounds of exceptionality, clinical efficacy and cost effectiveness. Its Appeal Panel upheld that decision, and a later Review Panel again refused funding after further evidence. The issues were whether the Individual Cases Policy was lawful and whether the decisions were irrational, based on material errors of fact, or unlawfully fettered the Trust’s discretion.
Held
- Outcome. The decision of the PCT was quashed. The court also directed, as interim relief following the handed-down judgment, that treatment should be facilitated immediately, subject to further consideration of final relief and the possibility that treatment might later cease.
- The court was not entitled to decide whether Lenalidomide was medically meritorious or whether the funding decision represented the best allocation of resources. Its function was to review legality. Nevertheless, a life-or-death funding decision required rigorous scrutiny. The PCT retained substantial discretion to allocate finite resources and to set its own rational policies.
- The Individual Cases Policy was unlawful. By providing that funding must be refused where the patient was representative of a group, it effectively required proof of uniqueness. That approach made the exceptionality test incapable of practical fulfilment, because another patient could always be identified as comparable. The policy’s examples also confused ordinary unpleasant side effects with intolerable peripheral neuropathy that made further treatment impossible.
- The panels materially misunderstood the clinical evidence. They failed to distinguish the evidence supporting Lenalidomide and Dexamethasone from the limited evidence concerning the addition of Cyclophosphamide. They also misunderstood the significance of placebo patients crossing over to Lenalidomide in the randomised trials. That mistake of fact materially affected the reasoning.
- Clinical efficacy and cost effectiveness remained relevant even after exceptionality was established. However, an exceptional case involving life extension rationally required a less restrictive approach to cost effectiveness than routine commissioning. The panels wrongly looked beyond the proposed four treatment cycles, double-counted response assumptions, misunderstood the survival evidence and failed to consider savings from treatments to which the claimant had become intolerant.
- These errors meant that no reasonable authority could have reached the conclusion that the claimant’s case was not cost effective. The decision was therefore irrational and unlawful.
The court’s approach to earlier authorities
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Key cases cited
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