Plans drawn up by NICE to get GPs to switch to prescribing cheap tablets for asthma instead of a combination inhaler have been criticised by GP experts, who have warned the move ‘could cost lives’.
Under the NICE proposals, GPs would be expected to offer a course of leukotriene receptor antagonist (LTRA) tablets to patients whose asthma is poorly controlled with a low-dose inhaled corticosteroid (ICS), instead of stepping up therapy by adding a long-acting beta-agonist (LABA) – usually done with a combination LABA/ICS inhaler.
NICE has argued that the benefits of the LABA/ICS combination are only ‘marginal’ and that trying out the LTRA tablets rather than going straight to a combination inhaler could save the NHS ‘tens of millions’ of pounds a year.
However, GP respiratory experts from the Primary Care Respiratory Society (PCRS) and the RCGP have rejected the idea, warning that it could lead to patients neglecting their steroid medication – and therefore potentially increasing their risk of an acute exacerbation.
In their official response to the consultation, the PCRS said that while some evidence suggests patients may adhere to the LTRA tablets better than they do to LABA, ‘the risk that people will stop using ICS may be greater with LTRA because it is not a combined treatment’.
The response continued: ‘This could costs lives if people stop using their ICS inhaler in preference for taking a tablet.’
A survey of PCRS members, also seen by Pulse, revealed that more members disagreed with the proposal than agreed with it – and that it would mean ‘virtually all’ GPs changing their current practice to stepping up therapy in adults and children over five.
The same concern was also raised by RCGP experts who warned in their submission to the consultation: ‘We would worry in real world clinical practice of the impact of compliance if the patient received LTRA they may stop the basic treatment for a steroid responsive inflammatory condition.’
RCGP council member Dr Steve Holmes, who contributed to both the PCRS and RCGP official consultation responses, explained: ‘The danger would be that people use an ICS and then if prescribed a LTRA decide to discontinue the ICS – which would not happen in combination.’
Both the consultation submissions also raised particular concern at the new advice to step up with LTRAs in children, which they said was based on ‘very low quality evidence’ and also carried the risk that children, or their parents, may inadvertently favour the tablets because they are easier to take than an inhaler.
They stated: ‘One unintended consequence of the recommendation is that children/parents may continue with the therapy with the higher adherence, ie, the LTRA, at the expense of the more effective but less patient-friendly ICS therapy. When patients use an ICS/LABA combination, adherence to ICS may be higher due to the symptomatic benefit felt from the LABA component.’
Dr Duncan Keeley, policy lead at the PCRS, said NICE’s proposed change was based on the same evidence used by the established ‘gold standard’ asthma guidance from the British Thoracic Society/Scottish Intercollegiate Guidelines Network (BTS/SIGN) to recommend stepping up LABA/ICS – but that NICE’s cost-effectiveness analysis favoured adding LTRAs because the tablets are cheaper.
Dr Keeley said: ‘Because there is a relatively small difference between the outcomes with these two options, NICE is of the opinion LTRAs, the tablets, which are now inexpensive and off-patent, should be tried first because this would represent a substantial cost saving.’
Professor Mark Baker, director of the NICE centre for guidelines said: ‘We recognise that these new recommendations represent a change to current practice. However it is a change that is likely to save the NHS millions each year.
‘We are actively seeking views on the draft recommendations and any relevant comments submitted via the NICE website will be considered by the committee before the final guideline is published.’
It comes after Pulse revealed NICE is having to consult the public and stakeholders for a second time about related guidelines on asthma diagnosis – publication of which has already been delayed for around 18 months because of objections from the GP profession.
How NICE plans to shift GP asthma prescribing
The major change concerns initial step-up therapy in patients whose asthma is not adequately controlled with a low-dose inhaled corticosteroid (ICS) on top of short-acting beta-2 agonist (SABA) therapy.
NICE says GPs should first consider adding a leukotriene receptor antagonist (LTRA) to the ICS, in both adults and children of any age.
NICE says that ‘purely based on the clinical evidence, the Guidelines Committee considered the addition of LABA to be marginally more effective than the addition of LTRA’ but that ‘given the size of the asthma population the movement to LTRAs at this point in the pathway could save tens of millions each year’ and that ‘the clinical efficacy of low dose ICS + LABA was not sufficient to justify such a large spend’.
It said that an economic evaluation showed that stepping up to ICS plus an LTRA was the most cost-effective of any option, while stepping up to an ICS/LABA combination would cost an extra £56,480 per quality adjusted life year (QALY) gained.
However, this contrasts with existing practice in line with current ‘gold standard’ guidelines from BTS/SIGN, which recommends initial step-up therapy with a LABA in adults – specifying that this should be done through use of a combination LABA/ICS inhaler to ensure adherence to the steroid component.
In children, GPs can choose either a LABA or LTRA as initial add-on therapy in children.
BTS/SIGN says that ‘on the basis of current evidence, LABA are the first choice initial add-on therapy in adults’, while in children ‘there is insufficient evidence to support one over the other’.