Family wins High Court challenge to NHS England’s refusal to fund life-changing treatment for seven-year old boy

The parents of a seven-year-old boy have been successful in their quest to have an NHS England decision about life-changing treatment for their seven-year old son quashed.

In a judgment handed down today, the Honourable Mrs Justice Andrews ruled that “their claim for judicial review succeeds and the decision of 14 December 2016 is quashed and must be remitted to the individual funding requests (IFR) panel for reconsideration in the light of this judgment.”

The IFR panel is now expected to meet within the next 28 days to review its decision on funding this treatment.

The boy, who is subject to an anonymity order and is known as “A”, has a genetic and rare metabolic condition phenylketonuria (“PKU”), which means he is unable to metabolise phenylalanine, a substance contained in most protein-rich foods. Untreated, phenylalanine will accumulate in blood in dangerous concentrations and can cause serious cognitive impairment and/or permanent brain injury.

Dr Santra from Birmingham Children’s Hospital, the NHS Consultant with responsibility for treating A’s PKU, first applied to NHS England by an IFR for funding for A for a drug known as ‘Kuvan’ on the grounds his case was “exceptional”. Kuvan is a new and expensive treatment which is not routinely commissioned for PKU, but can help certain patients metabolise phenylalanine, reducing the danger to themselves and enabling them to lead a more normal life.

This, and further requests for funding were repeatedly refused on the grounds that A was not sufficiently exceptional to warrant funding, and subsequently on the grounds that the clinical effectiveness and cost effectiveness of Kuvan had not been established.

In her ruling today, Judge Andrews stated that the IFR panel’s earlier decision to ‘decline this application on the basis that the clinical effectiveness of this drug/intervention had not been demonstrated’, was a misinterpretation of the phrase “clinical effectiveness” or a misunderstanding or material mischaracterisation of the evidence.

Judge Andrews went on to say that: “If “clinical effectiveness” is properly interpreted, the evidence that Kuvan is clinically effective is overwhelming.”, and as such found in favour of A’s family on the basis of common law rationality.

Peter Todd of Hodge Jones & Allen, who is representing A’s family said: “A’s family are understandably greatly heartened by today’s ruling. Although no mandatory order for funding was made, it would be wholly extraordinary if the IFR panel was to, once again, find reason to not fund this life-changing drug for a child. My clients have felt increasingly disillusioned with NHS England, and frustrated by their constantly changing reasons to not fund the treatment. We hope that the panel will now take prompt action and secure the funding to ensure that A’s long-term health is no longer endangered.”

A’s father added: “We are very pleased that the court has ordered that NHS England reconsider their decision not to fund Kuvan for our son. It’s been a very difficult two years for our whole family and we are hoping that the funding will be granted soon, so that our son’s quality of life can be improved significantly.”

PKU is generally managed through dietary restrictions limiting proteins to restrict intake of phenylalanine supplemented with protein replacements to ensure development and growth is maintained.

Though most patients with PKU are able to manage their diet to avoid protein rich food, A also has autism. His autism is at the severe end of the spectrum, and he is currently non-verbal. Helping A to control his diet to ensure he ingests enough of his protein replacement has been extremely difficult. Due to the sensory needs inherent to his autism, A often rejects supplements and will only accept foods with a high protein content, rejecting substitutes leading to heightened levels of phenylalanine (a protein) in his blood representing a significant risk of serious injury to A.

In the last 12 months, about 60% of A’s blood tests indicated his phenylalanine was outside the target range – despite huge efforts to help A to manage his condition by his parents and school.

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For further information, please contact Lizzie Hannaway on 020 3567 1208 or at lizzie.hannaway@blacklettercommunications.co.uk.

Notes for Editors

Hodge Jones and Allen

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