1.1 Naltrexone–bupropion is not recommended within its marketing authorisation for managing overweight and obesity in adults alongside a reduced-calorie diet and increased physical activity.
1.2 This recommendation is not intended to affect treatment with naltrexone–bupropion that was started in the NHS before this guidance was published. Adults having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Obesity is very common in England, affecting about 30% of the population. Current management for overweight and obesity is lifestyle measures alone, lifestyle measures with orlistat or bariatric surgery.
Clinical trial evidence shows that naltrexone–bupropion with lifestyle measures is more effective than lifestyle measures alone, but its long-term effectiveness is unknown.
The estimate of cost effectiveness for naltrexone–bupropion with lifestyle measures, compared with lifestyle measures alone, is highly uncertain because of uncertainties in the modelling assumptions. Large numbers of people could be eligible for treatment which could potentially be long-term, leading to high overall costs for naltrexone–bupropion. Therefore, in these circumstances more certainty is needed that naltrexone–bupropion will provide value for the NHS.