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NICE Recommendations: what are 'exceptional circumstances'?

09/09/2016
R (S (a child)) v NHS England [2016] EWHC 1395 In this case, NHS England was challenged by a patient who had been refused funding for treatment under NHS England's Individual Funding Request (IFR) policy. NHS England had decided that the appellant's situation was not exceptional enough to warrant funding treatments beyond those recommend by NICE, however this decision was not only quashed but replaced by Mr Justice Collins, holding that a situation could be exceptional even if it was not unique.

R (S (a child)) v NHS England [2016] EWHC 1395

In this case, NHS England was challenged by a patient who had been refused funding for treatment under NHS England's Individual Funding Request (IFR) policy. NHS England had decided that the appellant's situation was not exceptional enough to warrant funding treatments beyond those recommend by NICE, however this decision was not only quashed but replaced by Mr Justice Collins, holding that a situation could be exceptional even if it was not unique.

The Appellant, S, was a 17 year old who began to suffer from narcolepsy (a sleep disorder) and cataplexy (temporary involuntary muscle weakness) in 2011 having previously been very strong both academically and in sports, but now struggling considerably. Both conditions are rare. S's condition did not respond to the usual treatment, but an alternative treatment, sodium oxybate had been suggested. While sodium oxybate is available in the UK, it is not recommended for children and NHS England does not have a general policy to fund its use.

As a result, S's clinician made an IFR request to NHS England (this originally went to the local Clinical Commissioning Group, but it was eventually agreed that funding was the responsibility of NHS England). The policy stated that IFRs could only be met where the patient had "exceptional clinical circumstances". The policy went on to state that, while failure of the usual treatment may be a ground for exceptionality, this would depend on the proportion of patients who did not respond to the usual treatment. In addition, a patient needed to demonstrate that they were both "significantly clinically different to the group of patients with the condition in question" and "likely to gain significantly more clinical benefit than others in the group of patients with the condition in question."

In a protracted process, S’s IFR request was refused on the basis that her situation was not exceptional; approximately 10% of patients would not respond to the usual treatment and not enough information had been provided on the severity of her symptoms. When further information showing the severity of her symptoms was provided, NHS England replied that severity of symptoms was not in itself grounds for exceptionality, and the effect on her academic achievement could not be considered. In addition, NHS England stated that it needed to guard against allowing patients who actively lobbied for treatment being prioritised over others. However, Mr Justice Collins found that “this comes perilously close to undermining the IFR policy since the whole point of it is that there will be patients who are entitled to a particular treatment not available generally to others because of their exceptional need.”

Mr Justice Collins recognised “that the defendant has finite resources and, as the courts have recognised… cannot fund every treatment for every patient. It has to make decisions, which may sometimes seem extremely harsh for individual patients, to ensure the best possible outcome for all patients.” He stated that the appropriate cohort to consider would be those who do not respond to the usual treatment. Mr Justice Collins noted that S was suffering from a rare condition, that her symptoms were particularly severe, and that it was also rare for her condition not to respond to the usual treatment. He stated that “Since exceptional cannot mean unique, it is in my view difficult if not impossible to see that that claimant should not be considered to meet the exceptionality test. If she is not unique, who is?” As S’s mental health as well as physical was deteriorating, the judge found that she was suffering more than most. Furthermore, rather than requiring NHS England to make a new decision, he instead held that S’s case should be treated as exceptional, overturned the original decision and made an interim order for her to receive the sodium oxybate for a three month trial period.

This is a somewhat unusual decision from the Administrative Court to intervene on the facts. It is impossible not to be moved by S’s position, and her situation does indeed seem to be exceptional, however NHS England's decision was a policy one. In situations such as this commissioners (and decision makers in general) are normally afforded significant discretion, and the courts are usually reluctant to intervene in a policy decision based on the allocation of finite resources. It is even more significant here that, not only did the court intervene in such a policy decision, it felt moved to substitute its own decision in place of requiring the commissioner to make a new decision itself.

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