After a constant struggle, the British High Court has finally granted a 17-year old narcolepsy patient a little relief. The judge had ruled a verdict stating that National Health Service (NHS) England had incorrectly applied the policy on exceptional drug funding for sodium oxybate and that the claimant be allowed a three-month funded drug trial.

The court verdict and its implications regarding treating young adults who suffer from narcolepsy were also published by The British Medical Journal (BMJ) recently.

According to studies, the prevalence of adult and pediatric narcolepsy collectively accounts for 20-50 per 100,000 sample population in western countries. Characterized by a disrupted sleep-wake cycle, narcolepsy often goes misdiagnosed in children. In this incurable neurological disorder, the neurotransmitter hypocretin begins to deplete which causes wakefulness.

If narcolepsy is combined with cataplexy (involuntary muscle weakening), it is indicative of a discrete loss of brain cells which produce hypocretin. Excessive daytime sleepiness, sleep paralysis, disrupted nocturnal sleep, obesity and hallucinations are commonly observed in patients suffering from narcolepsy. 1 in 2,000 people in the UK alone develop narcolepsy.

 A 17 year old girl, “S” whose identity is kept anonymous, was diagnosed with narcolepsy in year 2012.  Since then, she had been prescribed stimulants for keeping her up during the day, depressants to help her with nighttime sleep and other drugs for cataplexy. No treatment seemed to help her before she was advised to try sodium oxybate by her NHS consultants in May 2014.

Commercially known as Xylem, sodium oxybate is said to be the most effective drug for treating narcolepsy symptoms. It helps patients by inducing prolonged nighttime sleep which in turn helps cope with excessive daytime sleepiness and tiredness.

According to the Clinical Commissioning Policy, drafted by NHS, “post-pubescent children are not licensed to take Sodium Oxybate as a medication for narcolepsy. However, if children below the age of 18, weighing above 40 kg are suffering from narcolepsy and cataplexy according to International Classification of Sleep Disorders 3 criteria and have co-morbidity with other sleep disorders, they may be included in the drafted scheme.” These stringent criteria also say that sodium oxybate can only be made available if the first and second line of medications do not help the patient but instead cause adverse health-related effects.

In 2014, “S” applied to the NHS to fund her three-month long trial which roughly cost £2,000. The NHS delayed their response till May 2015 only to reject the funding request. Left helpless, the claimant and her family applied for a judicial review to challenge NHS’s refusal in November, 2015. Permission was granted by the court and NHS agreed to review their decision. However, NHS did not deviate from their stance and justified their decision stating that “S” did not fall in the “exceptionality” criteria to receive funding.

A court hearing on May 4 saw things moving in favor of the claimant with the judge ordering a three-month trial of the drug which cost £ 13,000 per annum. On June 15, the claimant’s solicitor, Peter Todd claimed that “S” was responding to the treatment and was getting her life back.

The ruling judge, Justice Collins said that “S” was a very intelligent student who had hoped to receive enrollment in a highly reputed university but because she was denied timely access to the drug, she fell behind in her work.  Consequently, she could no longer compete in sporting activities and had lately become isolated at school due to her ailment.

Defeated, NHS stated that the condition of “S” did not qualify to be classified as an exception, which was originally defined as a term for a group of children and adults who had developed narcolepsy as a side effect of Pandemrix vaccination for swine flu in 2009-2010.  In addition, NHS admitted that “S” suffered from a severe condition but according to the law, they couldn’t help her. NHS representatives added that by granting “S” funding for drug trial, they would have to approve requests from other children who were faced with the same situation as “S”.

However, the judge disagreed and suggested that the case of “S” was unique as her condition was not improved by other drugs. She should have been classified as an exception by NHS and the scheme should not be confined to a degree that causes inconvenience for patients and delays their right to treatment.

Justice Collins, “I would only add a 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.”

With the surfacing of this verdict, NHS, which is responsible for taking decisions about services of rare conditions in accordance with the recommendations of the National Institute for Health and Care Excellence (NICE), will have to re-evaluate and revise their policies about licensing sodium oxybate to children who do not benefit from other treatments.