High Court overturns NHS England's decision on refusal of drug funding

The High Court has overturned NHS England’s decision to refuse funding for a drug used to treat narcolepsy.

Executive summary

The High Court has overturned NHS England’s decision to refuse funding for a drug used to treat narcolepsy.

Ruling in R (on the application of S (a child) By her father and litigation friend M v NHS England [2016] EWHC 1395, the judge Mr Justice Collins found that the claimant, S, suffered from a rare form of her condition and that her circumstances were “exceptional”. The judge made an interim order that NHS England should fund the provision of the drug, called sodium oxybate (under the brand name Xyrem), for S for a trial period of three months. 

In detail

The claimant, S, was a 17 year old woman with narcolepsy and cataplexy, a serious condition which causes disruption to night-time sleep, excessive daytime sleepiness and hallucinations. 

The claimant’s conditions had seriously affected her school work and personal life and the usual treatments that were administered for her conditions had not been effective in her case. A drug had been developed which provided a real chance of offering sufferers a normal life, but it was not recommended for children and NHS England had no general policy to fund it. The claimant's treating clinicians had made a number of individual funding requests (IFRs) for the drug on the grounds that S had “exceptional clinical circumstances”, as per the governing policy document, but the applications has all been rejected. 

The basis of S’s case was that the IFR policy had not been correctly applied by the defendant. 

The decision

The court recognised and accepted that NHS England’s resources were not infinite and that it could not fund every treatment for every patient. They had to make decisions, which might sometimes seem extremely harsh for individual patients, to ensure the best possible outcome for all patients. The appropriate group of people who should be considered was those who did not respond to the usual treatment and not only was S failing to respond to the usual treatment, she was in fact deteriorating which demonstrated that she was suffering from a particularly severe form of her condition.                  

S was suffering from a particularly rare form of the condition and this particular issue had not been dealt with in the responses of NHS England’s panel or their screening group. The judge’s view was that it was difficult, if not impossible, to see how S should not be considered to meet the exceptionality test. In addition, there was clear evidence that both her mental and physical health were suffering and would in fact get worse. This meant that she would benefit from the treatment with the drug to a greater extent than others who were merely not receptive to the usual treatment. 

The judge went on to find that it would be cost effective to fund the drug because S would be unlikely to need medical care to the extent that she would if she were not treated. He concluded that there had been failures by NHS England to have regard to all the matters raised by S’s lead consultant in her IFR application and that the approach to the application of ‘exceptionality’ had been too restrictive and was incorrect. 

Conclusion and implications

Mr Justice Collins recognised the clear evidence that S was suffering from a particularly rare form of her condition. He was satisfied that the claimant’s position was ‘exceptional’ and at the conclusion of the hearing made an interim order that NHS England should fund the provision of the drug for a three month trial period.

He also recognised that anyone reading the circumstances of this case would be ‘surprised that sodium oxybate is not available for children generally’ and added his ‘hope’ that ‘this particular problem and a case such as this will go away when the decision is reached whether sodium oxybate will be recommended and in principle available for children’. 

Whilst the decision is an interesting one, the principal difficulty for all parties involved is that cases such as this will, almost inevitably, turn on their individual facts when an objective IFR policy is being applied to individual and unique sets of clinical circumstances which do not lend themselves to certainty in terms of the application of that governing policy. 

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