Following NICE's technical appraisal authorising Nalmefene (Selincro) last year, local areas have been developing protocols to ensure prescribing adherence - see below for examples.
Nalmefene was authorised as a drug to support a reduced drinking goal amongst mildly dependent drinkers, although has been considered controversial in some respects. To be eligible, drinkers must be assessed as alcohol dependent, but not be physically dependent (i.e needing a detox).
In addition drinkers must be exceeding 5 units in a drinking day if female and 7.5 units in a drinking day if male, described as a high 'Drinking Risk Level' (DRL). Once prescribed, the drug is to be taken 'as needed', for instance if a person anticipates a drinking occasion. However patients can only be prescribed Nalmefene if they still meet this criteria two weeks after initial assessment and agree to psychosocial interventions for the length of treatment.
Local pathways
As a result, local areas have been developing pathways to ensure that where Nalmefene is prescribed, it is done so in adherence with NICE guidelines. Concerns about Nalmefene being prescribed without psychosocial interventions may be in some part be driven by media reports or coverage neglecting to highlight or emphasise the key requirement for psychosocial intervention.
As highlighted in a detailed guest post by Dylan Kerr, a number of issues need careful consideration, including how 'dependence' is assessed, and the role of brief intervention and psychosocial support. The effects of the latter are hard to extrapolate from the effects of the drug, and indeed the research trials showed only relatively small differences between those receiving psychosocial support and a placebo (control group) and those receiving psychosocial support plus Nalmefene.
In addition, Nalmefene can only be prescribed if a patient is still drinking at high 'DRL' two weeks after an initial assessment. In the studies, many patients had cut down significantly as a result of the brief intervention alone, and thus no longer drinking at a high DRL.
Local areas may also be carefully considering the cost as austerity continues to bite. At £3.03 a pill it will not be considered a cheap drug by CCGs, although presently Nalmefene represents only a fraction of the spend on alcohol prescriptions - albeit likely to rise. However Lundbeck, producers of the drug and sponsors of a range of alcohol activity in recent years, have announced major restructuring suggesting a change in priorities.
One positive indirect effect of Nalmefene's availability could be regraded as increasing 'help-seeking' amongst a population of mildly dependent drinkers who would otherwise not have sought help. The issue may be ensuring that the role Nalmefene plays is one in which it is always as part of psychosocial support within a robust pathway, with further evaluation of its benefit outside research conditions.
Some examples of local pathways are below.
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