Exceptionality

Most decisions are made by applying general policies, but it is normally necessary for policies to admit of exceptions in order to avoid being blanket bans. It is therefore common that patients need to show ‘exceptionality’ when making an Individual Funding Request. Policies do not have to define what the exceptional circumstances might be. Such a policy is lawful provided – as stated in R (Rogers) v Swindon NHS PCT – that ‘it is possible to envisage, and the decision-maker does envisage, what such exceptional circumstances might be’. The court in that case held that, where the PCT had excluded reliance on financial considerations or NICE recommendations, it was difficult to see how any particular woman could show an exceptional clinical need for Herceptin. The result was that the policy was unlawful and the decision made pursuant to it not to fund Ms Rogers’ treatment was quashed.

Another attempt to define exceptionality was where a patient was not ‘representative of a group of patients’. The court held that test was unlawful because it was looking for uniqueness not exceptionality and that on the primary care trust’s policy:

‘it becomes difficult, if not impossible, to envisage who and in what circumstances might be successful in overcoming this hurdle in respect of the drug Lenalidomide. It is no coincidence that no application for funding of Lenalidomide has been approved by this PCT. The crucial point, as I accept, is that the policy states that an application “must” be refused where a patient is “representative of a group of patients”; that the inevitable result of the policy is that if a patient is representative of a cohort of patients, then he is automatically refused treatment …’

A vital issue with an exceptionality test is to whom the patient should be compared. S (a child) v NHS England concerned an IFR by a 17 year old with narcolepsy seeking treatment with sodium oxybate at a cost of up to £13,000 per year in circumstances where the usual treatment was not effective. This was refused by NHS England on the basis that exceptionality was not shown by severe and deteriorating symptoms. The claimant contended that the comparator group should be all patients with narcolepsy and the defendant that the comparator group should be those who do not respond to the usual treatment. Although preferring the latter comparator group (compared to which it is clearly harder to be ‘exceptional’) the court concluded that the claimant was exceptional because her form of narcolepsy was rare, her failure to respond to treatment was also rare, her mental and physical health were deteriorating and she would benefit from treatment to a greater extent than others in the comparator group.

An example of using statistics to mount a challenge is R (SB) v NHS England. The case concerned a child with the condition Phenylketonuria, a metabolic condition that prevents the body from breaking down a particular amino acid. It therefore builds up in the body and could cause brain damage, including severe learning delay and seizures. The standard treatment approach provided by the NHS is to control the condition with diet and supplements, but SB had autism and learning difficulties and developed fixations on particular foods. He could not use a diet-based approach and applied for funding to take Kuvan, a medication which lowered the levels of the relevant amino acid in some patients. His application was twice refused on the basis that his position was not exceptional. On a third application the IFR panel found his circumstances exceptional when presented with evidence that the rate of people with severe autism who both had Phenylketonuria and would respond to Kuvan was 0.03 per million – up to two people in the UK, including SB.