• Specialised commissioning is “very hard to probe”, resulting in “unusual decisions”, stakeholders warn
  • NHS England made funding U-turn on two treatments it had previously deemed “unaffordable” but provided little detail about why
  • FOI request for minutes of specialised commissioning funding body denied
  • ABPI says “major reassessment” of whole process may be necessary

Charities, an MP and the pharmaceuticals industry have heavily criticised NHS England’s specialised commissioning process for “lacking transparency” about how it makes “life and death” funding decisions.

The comments come after NHS England’s advisory groups recently changed its mind over funding for two treatments it previously deemed “unaffordable”.

Mark Tami, MP for Alyn and Deeside, has previously spoken in Parliament about NHS England’s decision to refuse funding for a specialised transplant treatment. He told HSJ: “We need a more transparent approach to what the national processes are. How are decisions arrived at or are they just making it up as they go along? This is a life and death decision-making body; this is about people’s lives.”

Proposals for new or revised treatments or medications are coordinated by NHS England’s 41 clinical reference groups representing specialised condition areas such as immunology, spinal services and respiratory. Each CRG can write clinically evidenced treatment proposals.

These then feed into six national programmes of care boards: cancer; mental health; women and children; trauma; blood and infection; and internal medicine. Each board decides which proposals should feature in its annual work programme and carries out an impact analysis of each proposal.

Final funding decisions are then made by three “governance gateways”: the clinical priorities advisory group; the specialised commissioning oversight group; and the specialised services commissioning committee.

Nick Meade, policy director at the charity Genetic Alliance UK, said that while there was strong patient representation at CRG level, it was “very hard to probe” how final funding decisions are being made by the CPAG and SSCC. He added: “At present some unusual decisions are being made.”

In June, the CPAG said it was “not currently affordable” to fund everolimus, a drug that could help patients with tuberous sclerosis complex, a rare genetic illness that causes tumours to be developed in organs including the brain, heart and kidneys.

When the review was re-run, due to the need to factor in the funding for the prophylactic HIV drug PrEP, everolimus moved from the lowest priority ranking to the second highest ranking, meaning it was automatically funded.

NHS England told HSJ the drug manufacturer provided further clinical evidence and a reduced price, which led it to being awarded higher priority. It refused to disclose the discount offered or details of how the changes were analysed by the CPAG.

In December, the CPAG decided to refuse funding for second stem cell transplants for people with relapsed cancer, which was widely condemned by cancer experts. At the time, one said: “There is a consensus of opinion by responsible expert haemato-oncologists in the UK and across the world saying this [treatment] is important but we having a funding process that flies in the face of that.” The treatment had been widely funded before 2013.

However, in February the CPAG announced it would fund the procedure, despite previously saying that to be commissioned the treatment would have to be considered by its spring prioritisation committee. NHS England would not say if the committee met early or, if not, how the decision to fund that treatment was made.

Mr Meade said: “There was no clear message as to why that happened. It came as a surprise, a welcome one for patients but one would like there to be fewer surprises in the commissioning of rare diseases in England.”

HSJ submitted a freedom of information request to see the minutes of the CPAG but it was dismissed under section 14 of the FOI Act. NHS England said the request was “vexatious”. It said it held over 10,527 pages of information relating to the minutes of CPAG meetings but releasing them would cause an “unjustified level of disruption” and place the organisation under a “grossly obsessive [sic] burden”. It said it would take “115 working days” to read, redact print and scan the documents.

NHS England does not publish the dates when this group meets or its agendas.

Within the specialised commissioning structure there is also a Rare Diseases Advisory Group that advises on medicines going through the specialised commissioning funding process. As part of its own terms of reference it is meant to publish its agenda and minutes of its meetings. However, it has failed to do since 2014 and even these minutes are no longer available on its website.

The Association of the British Pharmaceutical Industry has raised concerns about many elements of the specialised commissioning process.

Mike Ringe, ‎NHS Strategy and market access manager at ABPI, said: “The annual work plan completely lacks transparency and the whole [CPAG] process is opaque. Companies work their way through the process by intuition. [It is] currently not fit for purpose.”

Paul Catchpole, ABPI’s director of value and access, said: “It’s a very long and convoluted process, with multiple stages, multiple committees and multiple submissions. It’s impossible to attribute what’s going on where…

“The process has been changing a bit every year and people still aren’t happy with it, so we have to ask the question at some point – is it worth continually tinkering? Or is it now worth a major reassessment?”

NHS England had not responded to HSJ at the time of publication.