On 13th November, there was a hearing before Mr Justice Collins in the High Court on the application for permission to apply for Judicial Review of the refusal of funding of sodium oxybate by NHS England for a child. At that point, permission to apply was granted, meaning there will be a substantive hearing in due course. This is expected to happen in February 2016.
NHS England were asked by the court to reconsider their refusal of funding and did so but decided to maintain their refusal.
At this point, the child concerned does not have access to the treatment her consultant believes she requires.
NHS England Clinical Commissioning Policy for Sodium-Oxybate (Xyrem) to control symptoms of narcolepsy with cataplexy in children
On November 20th 2015, we received less than two days advance notice of NHS England’s intention to circulate a Draft Policy Proposition for NHS England to commission the use of Sodium Oxybate (Xyrem) to control symptoms of narcolepsy with cataplexy in children.
This policy forms part of a backlog of approximately 100 clinical commissioning policies that NHS England are challenged with completing by May 2016.
On November 24th, we received details of the draft policy and were asked for our views on the proposal and if approved, what level of public consultation would be most appropriate.
We would like you to know that we undertook the following actions within the extremely short timescale prescribed.
Formally objected to the inadequate period of time that was allotted for both advance notice & completion of the Stakeholder Engagement.
Returned 10 A4 pages of feedback on the draft policy.
Provided 5 supplementary PDF documents covering topics relevant to narcolepsy in children.
Supported the position of key Paediatric Clinicians in the UK who had also written objecting to the approach taken and detail contained within the review.
Requested additional time (14 days) for Public Consultation (initially planned for a standard 30 day period running from Friday, 18th December 2015).
Identified clinicians, organisations and YOU, CARERS, FAMILY & FRIENDS as people who should be involved.
Secured an extension to the original timeline (TBC) to ensure that the right people are involved.
We also commented that despite all efforts, there is no such policy in operation for ADULTS and that this should be examined and rectified at the same time.
The closest we have got to this currently is for the group responsible for the NHS England policy review to extend the search for research data to include adults.
However, NHS England are NOT RESPONSIBLE for adult commissioning. This is carried out by individual Clinical Commissioning Groups across England.
So, a decade on from licensing, decisions around the provision of this drug are taken via Clinical Commissioning Groups across the UK who routinely ignore the advice of specialist neurologists as they blindly follow the only policy open to them, the "Individual Funding Request" or "IFR".
The IFR requires an individual's "exceptionality" and the "cost-effectiveness" of the drug to be taken into account. Both of these mean that an IFR is a veritable tail-chasing and ultimately money-wasting exercise for both patient & clinician.
So, whilst people with narcolepsy may well be judged as unexceptional and not worth the investment, this medicine has been licensed in the European Union for ten years; for NHS England to not have a clinical commissioning policy for either adults or children is unforgivable.
As soon as we hear the potential dates for the Public Consultation we will let you know so that we can all respond accordingly.