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Will local prescribing formularies survive the reforms?

With the scrapping of PCTs, prescribing formularies were all set to pass to CCGs. But the original plans for CCGs and prescribing were much bigger than simply passing the baton. CCGs, instead of NICE, would recommend which drugs were cost-effective while NICE's role became advisory only.

But concerns about the doctor-patient relationship being compromised and CCGs finding themselves in the firing line over rationing decisions prompted a Government U-turn.

CCGs will continue to maintain a local formulary to ensure some local control and ownership over prescribing budgets, but developments in recent weeks have started to make clearer just how circumscribed these local formularies will have to be.

Tackling variation

A report in February by Sir Ian Carruthers, head of the Department of Health's innovation review team, on tackling variation in the NHS highlighted the fact that not all local formularies currently include all NICE technology appraisals, leading to a postcode lottery where patients miss out on NICE-approved drugs.

The report also found in some cases local formularies were duplicating NICE assessments and challenging appraisal recommendations, again acting as a barrier to the uptake of NICE-approved medicines.

The upshot of this is to be a major NICE-led review of local formularies. NICE will then produce a best-practice guide to help NHS trusts and CCGs develop local formularies – along centrist lines.

The report also recommended technology appraisal recommendations be automatically incorporated into local formularies within 90 days of their publication.

According to Dr Gillian Leng, deputy chief executive of NICE: ‘NICE-approved drugs should not be excluded from local formularies on the grounds of cost.

‘We want all patients to have access to medicines that we consider to be effective.' 

In a further range of measures aimed at reducing variation in prescribing, Sir Ian's report outlines plans to introduce a NICE compliance regime for the funding direction attached to NICE technology appraisals ‘to ensure rapid and consistent implementation throughout the NHS' in the next couple of months.

The DH will also establish a NICE Implementation Collaborative – made up of the NHS Commissioning Board, NICE, the chief pharmaceutical officer, the main industry bodies, the NHS Confederation, the Clinical Commissioning Coalition and the royal colleges – to support the implementation of NICE guidance.

Observers are in no doubt that prescribing is moving to a centre-led approach that will constrain local formularies and potentially force GPs to prescribe expensive new drugs their CCGs can ill afford.

But a further major change could be still to come – last month, it emerged the Future Forum is to re-examine the NHS Constitution's guarantee to patients of access to all NICE-approved therapies.

The right balance?

So will formularies survive?

Dr Charles Alessi, chair of the NAPC – one half of the Clinical Commissioning Coalition – says he will be pressing ministers to ensure CCGs have flexibility to address local priorities: ‘There needs to be some flexibility. Some processes are mandatory, but everything can't be mandatory – otherwise, what are CCGs for? There is going to be a lot of debate about where to draw that line.'

The cumulative effect of the standardisation of formularies along with ‘carrots and sticks' in the system will lead to greater rigidity in prescribing, according to Conservative Medical Society chair Dr Paul Charlson.

‘There will be less flexibility overall, especially over the big things like statins and PPIs. If GPs and CCGs don't toe the line, the quality premium might not come their way. A CCG that's overspent probably isn't going to be first in line for any benefits.'

Dr Bill Beeby, chair of the GPC clinical prescribing subcommittee and a GP in Middlesbrough, believes the combination of external pressures to save money and increased control from NICE will ‘create havoc' for GPs, and that postcode prescribing will still emerge.

‘We're all working hard to ensure that we prescribe efficiently and cost-effectively, but one recommendation from NICE that an expensive drug should be adopted could cause big problems at a local level,' he points out. ‘When NICE was brought in, the idea was that whatever it recommended, funding would be made available to support those decisions. We're told that funding is reflected in baseline funding. But more often than not, it's impossible to say whether it is or not. The fear is we are going to end up with certain areas saying no and others saying yes – with the results recorded in the daily press. These are emotive subjects and the emotional impact is massive. We're going to see CCGs being blamed for the shortfall. We're going to see NICE giving guidance on best practice and CCGs not necessarily following it, because of affordability. The criticism will come back onto the CCGs.'

Dr Beeby adds: ‘Our view at the BMA is that we don't want to see CCGs go through their own evaluations when it comes to spending money and affordability. In an ideal world, we'd like to see NICE do a proper job, participating in choosing treatments, to provide that guidance at a national level so it doesn't need to be expected down at a local level. And then it would be nice to see appropriate funding for NICE's guidance made available. Then implementation at the local level becomes about good-quality, effective treatment.' 

So if local formularies look set to survive, albeit containing more central guidance, does this mean GPs will be under increased pressure to follow NICE recommendations?

Dr Paul Charlson says it will still be for individual clinicians to decide what to prescribe: ‘There will no compulsion to follow NICE guidance or national policy. For individual GPs, it will depend on how much pressure their CCGs put on them – which will vary around the country.

‘If you're sitting with a patient and there's a good clinical reason for prescribing something different from what NICE recommends, then nobody's going to criticise you. But if you do it every time, questions will be asked.'

Alisdair Stirling is a freelance journalist