England: Ignoring NICE Guidelines Can Be Unlawful

Pharmaceutical Executive

A CCG had denied funding for oocyte preservation for a woman with Crohn’s disease before she had bone marrow transplant and chemotherapy.

An administrative court has said that a Clinical Commission Group (CCG, a local budget holder for the National Health Service in England) can’t just disagree with guidance from the UK’s National Institute for Health and Clinical Excellence (NICE) - that’s unlawful.

A CCG had denied funding for oocyte preservation for a woman with Crohn’s disease before she had bone marrow transplant and chemotherapy. That was despite NICE setting out when oocyte preservation could take place in their February 2013 Clinical Guideline on Fertility. (Although it seems to be focused on oocyte preservation in cancer, rather than Crohn’s). The CCG denied an exceptional case for funding, and the woman appealed.

Finding it’s unlawful to depart from guidance such as a Technology Appraisal (TA) wouldn’t be a surprise. Recommendations from these must be followed, according to statutory Directions, with funding provided within 3 months of NICE guidance. But it is surprising when it applies to other forms of guidance, and in this case, a clinical guideline. There’s no statutory requirement to fund them.

Why not follow NICE guidance?
You might wonder why, given all the time, effort, and money spent on guidelines, they aren’t followed. Part of the reason could be simply the financial impact. Could it have been the cost in this case? Egg freezing can cost something in the region of £3,000 (US$5,000), according to the media.

Money is stressed by NHS England as a potential reason not to follow NICE guidance -  the NHS’s interim Commissioning Policy on Implementation and Funding of Guidance produced by the National Institute for Health and Clinical Excellence, from April 2013, says:

Guidance issued to the NHS is non-binding advice which is intended to assist the NHS in the exercise of its statutory duties. It recommends steps which might be taken,    factors which could be taken into account and procedures which could be followed to deliver specified steps of administration or policy. NHS bodies are entitled to take decisions which do not follow Guidance (other than NICE’s Technology Appraisals) if they have a good reason to do so. The availability of resources and competing priorities can be a good reason.

And in relation to its own commissioning, which covers specialized services like genetics, the NHS: “reserve[s] the right to depart from NICE Guidance…if [it has] a good reason to do so.”

Will this ruling change anything?
It’s pretty tricky to know whether NICE appraisals, which are underpinned by the Directions, are followed in any case. Much effort has gone into exploring this by the Health and Social Care Information Centre and industry through the Innovation Scorecard (the latest version of which is from March 2014 and available here). And often the best answer is simply, we don’t know.

If it’s hard to know if Technology Appraisals are followed, you can imagine how difficult it is to know if specific clinical guidelines (or the other thousands of pieces of guidance generated by NICE) are followed. Some are audited locally or nationally by Royal Colleges. But that all depends on their priorities.

The finding that a CCG can’t just disagree with NICE general guidance may give a few CCGs pause for thought, and perhaps NHS England too. But it will probably rest on other patients resorting to court to make NICE guidance a ‘must do’. That will depend on a whole host of issues, not least whether patients are well enough to go through that.

Leela Barham is an independent health economist. You can find out more about on her website and contact her at leels@btinternet.com