S (a child) v NHS England

The High Court found that NHS England had applied its Individual Funding Request (IFR) policy too restrictively and had failed to have proper regard to the clinical material supplied that demonstrated the claimant met the policy's test of "exceptional clinical circumstances". The judge concluded that the claimant, a child with severe refractory narcolepsy and cataplexy, was significantly different from the comparator group of patients who do not respond to usual treatment and was likely to obtain significantly greater clinical benefit from sodium oxybate (Xyrem).

Because of those failures the court held the decision-making was unlawful and, as an immediate and proportionate remedy, made an interim order requiring NHS England to fund sodium oxybate for a three month trial under clinical supervision. The court did not need to decide the separate grounds of discrimination or breach of s.11 Children Act 2004 because the IFR ground succeeded.

Background and parties: The claimant is a girl born in 1999 who developed narcolepsy with cataplexy in 2011/2012. Standard drug treatment was ineffective for her. The claimant sought funding from NHS England for sodium oxybate (Xyrem), a drug effective where usual treatment fails. NHS England refused funding under its IFR arrangements.

Procedural posture and relief sought: The claimant brought judicial review proceedings challenging NHS England's refusal. The amended claim pleaded (i) unlawful application of the IFR policy (procedural and substantive error), (ii) discrimination (including between Pandemrix vaccine sufferers and between adults and children), and (iii) breach of s.11 Children Act 2004 (best interests duty). The court first addressed whether the IFR policy had been correctly applied.

Issues framed:

• What is the appropriate comparator cohort for assessing "exceptional clinical circumstances" under NHS England's IFR policy?
• Whether NHS England had properly considered and given weight to the claimant's clinical evidence demonstrating exceptionality, including deterioration and objective scores supplied by treating clinicians.
• Whether the decision-making was procedurally lawful and not unreasonably restrictive in its interpretation of the IFR exceptionality test.

Decision and reasoning: The judge accepted that the IFR policy legitimately focuses on clinical factors and that resources are finite, but concluded that NHS England had misapplied the policy by an unduly restrictive approach to exceptionality and by failing to take into account the detailed clinical evidence provided by the treating consultant (including deterioration and objective symptom scores). The appropriate comparator cohort was taken to be those who do not respond to usual treatment; within that cohort the claimant exhibited a particularly severe and rare form of the condition and so met the IFR test of being "significantly clinically different" and likely to gain "significantly more clinical benefit".

Because the defendant's decision-making process was flawed and the claimant plainly met the IFR criteria, the court made an interim order requiring NHS England to fund a three month trial of sodium oxybate under clinical supervision. The court noted this was an unusual remedial step but was justified on the facts.

Subsidiary matters: The judge declined to decide the discrimination and s.11 Children Act grounds because they were unnecessary once the IFR ground succeeded. The judgment recorded awareness of the policy tensions between equal access and funding on exceptional clinical grounds and lamented the broader policy context, but confined relief to the individual case.

This first-instance claim succeeded on the ground that NHS England had applied its IFR policy unlawfully by an unduly restrictive application of the exceptionality test and by failing to take into account all relevant clinical evidence. The court concluded the claimant met the IFR criteria of being clinically exceptional among patients refractory to usual treatment and was likely to obtain significantly greater clinical benefit from sodium oxybate. As a proportionate remedy the court ordered NHS England to fund a three month trial of sodium oxybate for the claimant under clinical supervision.