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Independents' Day

NICE recommends introduction of 10% statin threshold into QOF despite GP opposition

NICE has given the green light to a new QOF indicator rewarding practices for how many patients they treat with statins at the 10% primary prevention threshold, despite unease among GP members on the independent advisory panel.

The introduction of the 10% threshold for prescribing statins to patients newly diagnosed diabetes and hypertension was discussed this afternoon at the first meeting of the newly convened QOF committee.

The indicator will now be put forward for GPC and NHS Employers to negotiate its introduction into the contract for 2015/16.

It comes after the RCGP, the GPC and the former chair of the QOF advisory panel all strongly spoke out against the introduction of the indicator.

Several GP members of the panel voiced concerns about the proposed indicator rewarding practices only for treatment with statins and not lifestyle advice - which they said goes against the NICE lipid modification guidelines which emphasise lifestyle advice should be offered before statin therapy.

They argued for the indicator to be reworded to reward offering lifestyle advice and other interventions as appropriate, including statins, to allow GPs room to discuss the option of statins with patients. They also proposed the term ‘offer’ a statin be used rather than ‘treated with’ a statin to allow more room for GPs to give patients the option of a statin rather than be paid only if the patient ended up with a prescription.

However, other committee members, including one GP, argued that NICE guidelines were clear that GPs should be prescribing statins at the 10% threshold, and that GPs would be able to exception report patients who chose not to take the drug option.

The panel agreed instead to introduce a new indicator incentivising lifestyle advice in these groups, as well as a new indicator incentivising statin treatment at the 10% threshold - and to introduce new business codes to allow for the exception reporting.

NICE QOF Committee chair Professor Danny Keenan said patients in these risk groups at the 10% risk threshold ‘should be on a statin’.

He added: ‘We have very clear guidelines, they couldn’t be clearer - and we’ve been over and over this. We’ve introduced the lifestyle indicator and allowed for exception reporting and we should go ahead with this.’

Dr Andrew Green, chair of the GPC prescribing committee, said it was ‘obviously disappointing that NICE have chosen to ignore the views of both the body that represents GPs as well as our royal college’.

However, he added, ‘whether this eventually becomes part of QOF remains subject to negotiation’.

Dr Green said: ‘I have no doubt the proposed indicator 11a [the proposal to measure the prescription of statins] will be a measure of prescribing activity but not of the quality of patient care, which depends on many more factors than a simple tablet-count. As general practice becomes more complex it is vital that measures of performance are sophisticated enough maintain validity, and have the confidence of GPs; this proposal meets neither of these requirements.’

Pulse revealed today, the former chair of the committee - Dr Colin Hunter, a GP in Westhill, Aberdeenshire - said that NICE had ‘lost the plot’ to consider introducing the new indicators.

He said: ‘I personally am completely against the 10%. I don’t think there is enough evidence to support it and I think it’s a societal question.

‘I think it is where NICE has lost the plot – when you end up with the majority of people over 65 needing a statin because the economics tell you that. The economics are far from a good science.’

Dr Hunter’s intervention followed those of the RCGP and the GPC, who both strongly opposed the proposals in their consultation responses.

The GPC said that it was ‘vital for the credibility of QOF’ that indicators have a robust evidence base, make significant difference to patients and are backed for the profession, adding that these proposals ‘fail on all these counts’.

The RCGP warned that the proposals risked ‘the loss of professional confidence in the healthcare targets they are being asked to meet’.

Proposed wording of new indicators

  • IND-11: % of patients aged 25-84, with a new diagnosis of hypertension or type 2 diabetes* who have a recorded cardiovascular risk assessment score of 10% or greater who have been given lifestyle advice;
  • IND-11a: % of patients aged 25-84, with a new diagnosis of hypertension or diabetes* who have a recorded cardiovascular risk assessment score of 10% or greater who are currently treated with statins.

* this may include ‘three months either side of diagnosis’


Readers' comments (44)

  • Samuel Lewis

    Statins are cost-effective down to ten-year cvd risk of 10% . The higher the risk the lower the nnt., and the greater the chance of individual benefiting. Trust me - NICE are the experts at this.

    But we GPs are the experts on patients, and will only treat consenting adults. I recommend Simva or Astorva at 10mg to minimise sideeffects and maximise cost-benefit reduction in morbidity. It's true that at 10% risk threshold mortality reduction has not reached statistical significance.

    But that also means that most women will not qualify. Only hypertension and diabetes patients are included.. and if they live heart attack free, and do not have a prolonged life into dementia, then that objection is also invalid.

    Offer 10mg, repeat script, no tests, no followup. Workload will reduce as you cut your heart attacks. Wake up and smell the coffee.

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  • 10mg sounds a placebo dose.Why bother ? What dose were all the trials using ?

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  • How many heart attacks do statins prevent? Given that statins increase calcification and have a number of other effects that could make CHD worse:

    Several people have also commented on the cost effectiveness of statins, however the cost effectiveness calculation NICE did is a complete joke. If you read the report you will find that the cost of adverse effects is completely ignored. In addition, the lack of any reduction in ACM of course indicates that the statin is just as likely to cause another serious condition, even if a heart attack was 'prevented'. If you do a calculation only looking at the up side of course you will come out with a number that is favourable to mass treatment.

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  • Any half intelligent 80yr old is going to question our motives when we suggest a statin might prolong their life, when they've just complained about their arthritis, poor sight and hearing, having to get up 6x a night to pee.... Who decided we should all be living longer anyway? Old age is not for cissies

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  • Has anyone on NICE asked patients what they want? I bet they haven't and I bet they would say no to this if given the NNTs.

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  • My patients do not believe the "no side effects" mantra, and I am very unconvinced that the small benefit would be considered worthwhile if explained with proper NNT tables for individuals at the lower end of risk. We should prescribe very cautiously to healthy individuals. Our patients, once convinced that a statin is good will want to consider rosuvastatin if they experience side effects. This is not cost effective, but once convinced that a statin is beneficial, the patients won't care about that- "surely you're not going t let me have a heart attack or stroke just because of cost?"

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  • Samuel Lewis

    Justin smith asks how many heart attacks will be prevented.

    Answer = one third of them.

    100 people with 10 to 20% risk will have about 15 heart attacks in ten years. So 5 will be prevented.

    The arthritic nocturic octogenarian and the fit 50 year old should have the right to decide ..

    Next question?

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  • Samuel Lewis

    In answer to anonymous of 12.42

    Statin has a plateau dose- response curve. The first 10mg of simva produces 30% cholesterol lowering. Each dose doubling adds a mere 6%.

    SEARCH compared 20mg versus 80mg = no significant difference in benefits, but 25-fold less risk of myopathy.

    10 20 40 all cheap.

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  • Samuel Lewis clarified the reduction in heart attacks as 5 prevented if 100 people are treated over 10 years.

    Of course, none of the trials have been 10 years long so we don't really know. I think there are a number of reasons to be sceptical about the long-term suggested cardio-protective role of statins. However, assuming that 5 are prevented (or postponed). How many of the 100 people treated will develop type 2 diabetes or suffer one of the many unknown fates of statin use?

    Obviously, the current system makes it impossible to know the harms. Quite simply, the commercial interest is not in pursuing that part of the equation with full openness. One example being that the Cochrane heart group highlighted the fact that around half of all the trials did not report on adverse effects at all. Another example would be Professor Collins industry supported CTT group who refuse to let anyone have access to their data, for commercial reasons.

    Its conceivable that the 5 prevented heart attacks could easily be countered by the increased diabetes risk in the longer term, yet alone the many unknowns.

    In my mind, the numbers don't add up for mass use. And the general belief that lowering cholesterol can only be a good thing ignores the consistent finding of low cholesterol and significantly increased mortality - which studies have shown is not reverse causality as was previously suggested.

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  • Samuel Lewis

    dear justin.

    i fear your mind is closed to any evidence i offer, since you do not seem to subscribe to the credo of RCT trumping all other evidence. 'none of these trials have been ten years long' ? wrong. check it out. even if it were true, then a five year trial showing significant delay in heart attack and death , would be enough evidence for me !

    Another example :- "the general belief that lowering cholesterol can only be a good thing ignores the consistent finding of low cholesterol and significantly increased mortality" is entirely irrelevant, even if it were true. The RCT evidence that taking a statin reduces CVD events by 30%, and all-cause death by upto 20% regardless of age , cholesterol level, or CVD risk trumps that argument, ever since the 4S trial (and consistently repeated in all RCTs since). I thought as you did, until I attended Pederson's 4S launch over 20 years ago in Portugal ( paid for by big Pharma, I admit, but VERY educational). When the facts changed, I changed my mind ( Maynard-Keynes). The diabetes risk is small. and clearly outweighed by the improved net outcomes of death and disability. Whether CTT are driven by Big Pharma became irrelevant when simva and atorva went off-patent cheap as chips.

    but if i have mistaken you, and "the current system makes it impossible to know the harms". why not look at your own practice experience to judge the acceptability and harm rates of statin ? you must have hundreds of cases ??

    in our practice a half of people at lower end of risk refused statin, with many citing Daily Mail 'putative side-effects'. As risk increased , our patients are much more inclined to stick with their statin. After a heart attack nearly all of them tell me they take their statin. the pharmacist confirms they do collect it!

    what does your audit tell you?

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