Calls for NICE to change how it assesses treatments

NICEThe Association of the British Pharmaceutical Industry (ABPI) is calling for NICE to reform the way it assesses treatments for its guidelines[1], echoing the views I’ve read on social media from health professionals, academics and frustrated patients with long-term conditions such as M.E., fibromyalgia and vitamin B12 deficiency, amongst many others.

In an opinion piece in the Pharmaceutical Journal, the Acting CEO of ABPI, Alison Clough, acknowledges that NICE performs well in some areas but says that it also stifles innovation, which is causing the UK to lose its place as the global leader in pharmaceutical innovation. This has the knock-on effect of new drugs not reaching patients in desperate need of treatments.

Clough states that several vital cancer drugs and medicines for rare diseases have not been approved for use in the UK and that the way NICE approves treatments needs urgent reform so that guidelines keep up with the fast pace of research.

The “one-size-fits-all” approach of NICE is criticised, along with its failure to update guidelines quickly enough when the evidence base for treatments is built upon. The ABPI would like to see treatments approved at an earlier stage so that patients have quicker access to novel treatments, updated with clinical evidence as it comes to light. For the processes involved in licensing in the UK, read How long does it take a new drug discovery to be licensed in the UK?

An aside before I carry on…

  • I know we don’t like the term CFS/ME but this is what the guideline is called at the moment, so I have to refer to it as that.
  • Many people seem to think that in calling something a treatment we mean a cure but it is really defined as “medical care given to a patient for an illness or injury”[2].

Clough’s criticisms are also applicable to CG53, the NICE guideline for CFS/ME, which was published way back in 2007. In February 2014, it was reviewed but NICE decided not to update it and moved it to the “static” list[3]. This means the guideline won’t be reviewed again for another 5 years instead of updating it as the evidence-base for M.E. treatments evolves with published research findings. The reasons given for guidelines being moved to the static list are

“at that time no major ongoing studies/research was identified as due to be published in the near future (that is within the next 3-5 years)”

Thanks to the M.E. charities and the M.E. Twitter bringing our attention to all the research going on, I think it would be fair to say that this assumption was incorrect.

Here’s a link that carries out a search query for M.E. and CFS. Clicking the link runs a PubMed query and a bar chart on the right hand side on the results page under “Results by year”, shows how many papers have been published each year. There has been so much research coming out recently into bio-markers for possible use in blood tests and potential drug targets and drug candidates, such as rituximab and we’re only just over 1 year into the 5 years we’ll have had to wait for another review.

I think this shows that the decision to shelve CG53 has stifled innovation in M.E. treatments and diagnostics. There would be no benefit in drug companies developing new drugs or repositioning existing ones when they will never be approved for use or recommended in the NICE guideline. This is possibly why research has had to rely on donations to the ME charities and crowdfunding campaigns.

Evidence from 8 years ago wouldn’t have been acceptable in coursework during my degree – if I used anything more than 3 years old I was told to check that the evidence is still up to date and provide a more recent reference – so why is this acceptable in the evidence-based treatment of patients? It surely wouldn’t be for other physical illnesses.

It’s a problem generally with having guidelines. They try to standardise care but can stop doctors trying other treatments and not reviewing often enough causes problems. They were supposed to just be “guidelines” but have gradually come to be seen as compulsory.

My point is that we’re not the only people annoyed by the NICE guidelines. If big pharma is also unhappy, with their influence – money talks, something is likely to happen to improve the situation.

So, do you agree with the ABPI? What barriers do you see for the advancement of treatment of M.E. in the UK?

Feel free to leave your thoughts in the comment section below but there’s also an opportunity for UK patients to have our say in a government review, which I’ve written about with a links to it in the article, Patients invited to engage in government review to speed up use of new treatments and tests. Although the review is about all illnesses in general I think it’s an opportunity not to miss.


1 Clough A. NICE’s assessment process is stifling pharmaceutical innovation. Pharmaceutical Journal. 2015. (accessed 16 Jul 2015).
2 treatment – definition of treatment in English from the Oxford dictionary. 2015. (accessed 16 Jul 2015).
3 NHS England. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) | Guidance and guidelines | NICE. 2007. (accessed 16 Jul 2015).
4 NHS England. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) | Guidance and guidelines | NICE. 2015. (accessed 17 Jul 2015).

9 thoughts on “Calls for NICE to change how it assesses treatments

  1. For me, the key word is ‘major’. There are a lot of smaller scale research projects in hand – but surely nothing on the scale of FINE or PACE?

    Maybe that provides a justification for moth-balling the NICE guideline? I’d be interested to know what else has been dumped onto the ‘static’ *read ‘neglected’* list.

    Liked by 1 person

    • The static list is one of the references but here’s the link and I’ll link to it in the text as well. Research is coming out at such a pace (if you’ll excuse the pun) that 5 years is a long time. Prescribers also seem highly reluctant to try anything other than what’s recommended in the guidelines, compared with before they existed, when I remember being prescribed all sorts of things to try out by consultants. “Guidelines” has gradually changed to “rules”. My other point is that perhaps the reason there has been no “major” research (also depends what they call “major”), is that there has been very little point in the drug companies bothering with M.E. if the guidelines aren’t going to be reviewed to include what they come up with, hence all the crowdfunding that’s having to be done.


    • Also, it’s the whole NICE system that the CEO of the ABPI is concerned about, not just CG53. If big pharma is unhappy, there’s hope for change because Cameron is desperate to keep drug companies working within the UK, so they will likely call the shots.


  2. Emily in my role as a patient I get the impression that the CCG dictates what my GP can and cannot prescribe. Is it CCGs that have turned NICE guidelines into absolute rules, at primary care level at least?

    Liked by 1 person

    • I’d say yes, that’s probably been the route to what we currently have with prescribing. With the recommendations being partly based upon cost-effectiveness to the NHS and with prescribing costs being squeezed and squeezed it’s probably what has lead to sticking so rigidly to them – pressures from CCGs (and previously Primary Care Trusts towards the end of them) to reduce prescribing costs. I’m no expert in commissioning and CCGs but I was taught that the guidelines are only guidelines and that clinical judgement, previous patient response to treatment etc (common sense!) are supposed to over-ride them on a case-by-case basis. Sticking so rigidly to them there’s no breathing room for specialists to move treatment forward by what they’re actually prescribing – often off-label – which is how many advancements in treatments were often made prior to the guidelines. I’ve also noticed this myself as a patient. Just trying something to see whether it helps doesn’t happen anymore. Some would argue that this a good thing for standardising care and it possibly is but has the downside of hampering innovative use of existing drugs.


  3. My GP is very up front with me about CCG rationing and prescribing rules. Her computer flashes up ‘Computer Says No’ [or words to that effect] when the CCG has said such and such is not allowed to be prescribed any more.

    So basically at primary care level, my sense is that individual clinical judgement is very much curtailed.

    I cannot speak for consultant level treatment, as all my bipolar meds are standard or indeed ‘gold standard’ so it wasn’t a surprise that the consultant psychiatrist was happy to prescribe them.

    Charles Shepherd (from my unreliable memory) has spoken of professional indemnity exposure if doctors are prescribing experimental drugs for ME. That is, if something goes wrong with a drug used off-label [speculatively] and against NICE guidelines, the doctor would not have a leg to stand on if the patient sought redress!


    • Neither would the pharmacist, who would share the litigation for dispensing it. The occasional prescription (I’m not saying in ME specifically) when a drug has been initiated by a specialist for an off-license use then continued by the GP but also ones started by GPs in the past. I’m not necessarily talking about the unpleasant drugs some suggest for ME though. Getting off-topic anyway!


    • Incidentally, a treatment not recommended by NICE doesn’t necessarily make it off-label. It’s MHRA that does the licensing. The litigation aspect of going off-NICE is definitely something that has also evolved far from “guidelines” as they were originally intended to be. I remember reading some frustration at our extra layer of prescribing “rules” (NICE) in the UK compared with the FDA in the US.


  4. Yes, I do understand that NICE does not licence medicines. MRHA I guess does, sponsored by the Dept of Health. But it had never occurred to me that USA does not have a NICE equivalent body. I looked at CDC, and no they are not the US version of NICE. Anyway, I’ll stop de-railing!!

    MY gut feel is that there has been ‘mission-creep’ since NICE was first set up!

    Liked by 1 person

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