The prime minister intervened in NHS England’s consideration of funding for drugs to treat several rare conditions with a letter to its chief executive, LGC’s sister title Health Service Journal has learned.
- David Cameron wrote to Simon Stevens about treatments for three rare conditions
- NHS England is creating a funding policy for one
- It is not funding the other two unless ongoing NICE appraisals find in favour
- NHS England said it was making “difficult decisions independently and objectively”
David Cameron wrote to Simon Stevens in late May asking him to ensure “the case” for those seeking access to the medicines “is properly heard”. He also urged NHS England to “set out clearly the process and the timetable” for decisions.
The conditions raised in the letter, released under a Freedom of Information Act request, were Morquio syndrome, Duchenne muscular dystrophy and tuberous sclerosis complex.
NHS England has since agreed to create an in-year commissioning policy in one of the cases, everolimus for tuberous sclerosis. NHS England indicated this was not due to Mr Cameron’s intervention.
However, at the beginning of last month the national organisation said it would not fund the other two – Vimizim (elosulfase alfa) for Morquio and ataluren for Duchenne muscular dystrophy – unless ongoing National Institute for Health and Care Excellence highly specialised technology appraisals find in favour.
Patient groups and manufacturers have called for funding for the treatments and for NHS England to set out clear consideration processes since last year, as HSJ has reported. MP Greg Mulholland, who has pressed their case, previously called the process a “fiasco [which] shows NHS England is a dysfunctional organisation”. NHS England has said it has been following process and disputed several of the campaigners’ assertions.
“During the election campaign I met with [the mother of a child with Morquio syndrome]. I know you are fully aware of the concerns felt by [name deleted] (and other parents in the same position) about the need for clarity from NHS England on the process and timescale for these decisions. Clearly such decisions must be conducted through due process and led by clinical evidence.
“[Name deleted] was able to share with me her evidence of [name deleted]’s own remarkable process and I know you will want to ensure a thorough and rigorous assessment of all the evidence presented by other families and those involved in clinical trials…
“Without compromising due process, the case for these children and their families must be properly heard. I would urge you to set out clearly the process and the timetable for these decisions as soon as possible.”
NHS England medical director Sir Bruce Keogh responded on behalf of Mr Stevens on 23 June, setting out the process for the drugs at that point, including that it was considering developing in-year funding policies for everolimus.
The past two financial years have seen severe pressure on NHS England’s specialised services budgets, and large spending growth. It emerged last month that a new process for deciding which new specialist treatments it would fund would not be fully developed until the end of the year at the earliest.
An NHS England spokesman, commenting on the letters, said: “This correspondence simply underlines two important truths: elected leaders legitimately raise issues of importance, but then – as the prime minister said – it is for the NHS to make difficult decisions independently and objectively, in this case drawing on NICE’s expert clinical reviews.”
Number 10 said it did not have anything to add.
Christine Lavery, chief executive of the Society for Mucopolysaccharide Diseases, which represents people with Morquio, said: “Like David Cameron, we are also very keen to see the clear processes in regards to reimbursement decisions for ultra-rare diseases.”
She complained about what she said was an unclear process and delays to decisions since 2014 (see the full statement). Ms Lavery said: “We acknowledge that these decisions are not easy. However, it is not acceptable to treat people whose lives are so dependent on a decision so callously with a series of broken promises.”
- In a separate development, the charity said yesterday that Vimizim manufacturer BioMarin had reinstated free provision of the treatment for a set of patients who had been on a clinical trial for it, but from whom it had recently been withdrawn, until NICE makes a decision expected in October.