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Drug switching - the debate concludes

The debate moves on to the evidence base for switching, whether the switches being suggested are concordant with NICE guidance and whether drugs other than statins will be targeted next.

The debate moves on to the evidence base for switching, whether the switches being suggested are concordant with NICE guidance and whether drugs other than statins will be targeted next.

Pulse: Let's move on to the assessment of evidence base and who decides if there's evidence to justify switching drugs?

Dr Peter Fellows (PF): Can I be a bit inflammatory about NICE guidance because NICE is not universally accepted, and many of our local consultants are highly critical of judgments from NICE. We've seen some fundamental reversals of its decisions in the last couple of years, and I think it's unfortunate NICE is tied up with cost, and cost effectiveness. I would far rather see a body that looks at clinical effectiveness without being linked to the Government's attempts to drop the cost of the NHS.

Dr Gillian Leng (GL): Well it was interesting because ten minutes or so ago you said that you really didn't like the postcode prescribing, and you didn't think that was appropriate.

PF: NICE was designed to do away with it.

GL: Well of course, of course. And you need a national body to eliminate postcode prescribing, because postcode prescribing is about a decision here in place A, as different from place B, so you have to have a national mechanism to do that.

PF: But that's medical not cost effectiveness.

GL: The health service has a defined budget, so difficult decisions have to be made about prioritising spend, and you have to do it at a national level if you want to avoid postcode prescribing. I don't think there's another solution if you want those things, and it isn't an easy thing to do, and I don't think anybody, any organisation is going to ever do that without arousing controversy. We've changed our minds, we have a consultation process where we listen to what people are saying and if we didn't ever change our minds we'd be told you don't listen.

Dr Neal Maskrey (NM): I think its essential advice is pragmatic and cost-effective, and I'm really worried that you want to have advice that doesn't take into consideration the cost.

PF: I think a lot of people don't trust the advice because they think its been tainted by a government whose motive is cost.

David Fisher (DF): Actually, we're bandying around the term ‘cost effective' but you know, if we are really honest most of the mechanisms we've talked about are about reducing cost, they're not actually about driving cost effectiveness. The National Audit Office made a really key point about this, and said of course we have to live within a budget, we have to prescribe lowest cost options where they exist, but freedom and flexibility still has to be in the system to allow doctors to prescribe the best medicine for their patient to get the best outcome, and outcomes are being lost in this whole discussion, its all about reducing costs.

Dr David Russell (DR): Well I trust what NICE comes out with and that its not Government-led. I don't look at the advice it gives and think it's rubbish. I'm really pleased that it looks into cost as well.

Pulse: Are all the drug classes that have been widely switched in accordance with NICE guidance?

Professor Mike Kirby (MK): There is actually very little literature on the safety of switching.

Sue Ashwell (SA): Very little published but probably a lot of experience.

DR: Which is where something like ScriptSwitch worked bloody fantastically because before you have to make the switch you get the best advice before you click on that button.

MK: There's two sides to this equation, there's the evidence base that drives the decision in the first place, and then there's the evidence base that doesn't yet exist which says what happens further down the track, and some of the very significant cost savings generated by these switch programs does need to be seriously reinvested in tracking what the results of this programme are further down the line.

Martyn Carroll: We don't decide what switches the software shows, the PCTs do that, but we analyse the results and do see huge uptake of NICE guidance in users. Quite often that will be not a switch, it will just be an information message that relates a prescribing linked element of NICE guidance.

DR: What Peter was saying he's got loads of consultants that don't agree with NICE. If you can have good kind of protocols with the backing of local consultants you might wish to hear different advice.

Pulse: So does anyone seriously question the evidence base for it being sensible to switch from atorvastatin to simvastatin?

DF: I do. Because I think we've only ever got half of the evidence base, and that's the front end. We don't have an evidence base for what happens.

SA: I feel that that's one area where we do have some evidence but one of the challenges about collecting the evidence is around outcomes. Measuring outcomes relating to prescribing interventions is notoriously difficult. I acknowledge a proxy outcome, which is, what is the lipid level? And we measure that through so the QOF.

MK: I don't think we have good evidence of this and I think it is a concern and that we should be being much more academic about researching it.

SA: I think that's an important point, but we stratify different patient groups, so we have a different protocol for high risk patients.

DF: Well that's an example of best practice risk stratification, and how often does that happen?

MK: And you know, I don't think risk scoring is that good. And I do think the evidence base isn't good – we need to look at it really carefully.

NM: Well we have to be clear about this, there is a good evidence base for simvastatin 40mg, there's a good evidence base for atorvastatin 10mg, there isn't a good evidence base within a randomised controlled trial for moving patients from one to the other in terms of outcomes. There's very good data in terms of cholesterol level. Now, yes, you're right, we need more research, but there is a stronger evidence base for this than there is for many other things that we do in medicine.

PF: There are side effect issues. I was on simvastatin 10mg and developed a very severe peripheral neuropathy. And many diabetologists are now saying the QOF cholesterol target of 5 is ridiculous and we should be looking for a target of around about 3.5, and quite honestly I don't think that's achievable with simvastatin.

NM: Peter, there has to be a randomised control trial in people with diabetes that shows lowering people's cholesterol to certain levels makes them live longer or better. We don't currently have that. We barely have it in high risk groups such as those close to a cardiovascular event. So the jury's definitely out in terms of an aggressive approach to this.

MK: The problem is though that 10mg atorvastatin was equivalent to about 27 or 28 mg of simvastatin, so if you put patients on 20mg simvastatin there's a possibility cholesterol will go up.

SA: My experience is that GPs put the doses back up. But my understand is that these drugs have a very flat dose response curve, so doubling the dose of atorvastatin I believe only increases its effectiveness by 10%.

PF: When atorvastatin goes generic will all these simvastatin patients be transferred to generic atorvastatin? I think that is an ethical issue because what happens if you do a switch and when the drug is switched suddenly it gets cheaper?

SA: We've done it with the PPIs, the patients understand, it's something you work through.

NM: Some of this switch programme actually puts a bit of emphasis on reviewing patients. Some of the improvements in cholesterol levels might be because patients were actually taking their medicine more regularly than they were before.

MK: We saw equivalence in terms of cholesterol and blood pressure actually fell. And I think your point's well made, these patients were carefully monitored and followed up and they have been for two years, and that gets put into the equation, but that is a cost to the practice.

Pulse: We've dissussed statins, but switching has moved on, with data suggesting ARBs and PPIs and bisphosphonates are all being targeted for switching. Does the evidence base extend to these drugs?

MC: One thing to clarify is that for the products you've mentioned the data has come from scripts, but that's not all necessarily down to switching. A lot may just be a change in drug selection at the start of treatment.

DR: We've looked at ACE inhibitors and switching those with ARBs, we've looked at statins, looked at bisphosphenates. But also we try and prevent it happening in the first place, by using schemes such as Scripswitch to prevent having to do switches in the first place.

DF: How much of those, you know, what proportion of those types of schemes have got the goal of improving outcomes? None of these schemes are about outcomes.

NM: I'm sorry, I don't think that's true. There are many many examples of incentive schemes where components within that scheme have got nothing to do with cost and everything to do with safety or effectiveness.

SA: It's not about reducing costs it's about releasing funds to spend on something else.

Pulse: Would we expect to have Department of Health Better Care Better Value indicators in these areas?

NM: Well, there was a consultation, which closed some time ago, and we are waiting to hear whether those initial indicators are going forward or not.

GL: But David was mentioning outcomes and when we look at particular guideline topic, we will look at all the drugs and compare effectiveness, but often the information just isn't there to say that was is significantly more effective than another, so what do you do, other than say well there's no evidence so you prescribe the cheapest.

MK: And the evidence will never be there because the numbers of people in a study required to show a difference would be so great it would be impossible to recruit and fund that sort of trial, so inevitably we end up with uncertainty about whether one medicine in one therapeutic category is better or worse than another because that evidence is never going to be available to us.

MC: I think with bisphosphonates one thing that we've seen with GPs is not necessarily a switch but maybe a prompt about a patient having an adequate intake of calcium and vitamins, which actually might result in another drug being prescribed.

DF: My parting shot on the better care, better value indicators is that the next round will actually be seeing worse care lower cost indicators unfortunately, and therefore we're missing a huge opportunity to actually improve truly cost effective prescribing.

PF: But I think we tend to beat ourselves up in terms of inefficient use of medicines. Let's not forget we're the most frugal users of medicines in Europe. Some 80% of our prescriptions are generic, we buy those generics at the lowest cost in Europe, and the number of prescriptions that are written per consultation is tiny in comparison with other countries.

Richard Hoey, deputy editor, Pulse: I'm going to wind up….thanks ever so much for coming along, its been a really interesting discussion.

The debate was organised by ScriptSwitch

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