NICE bars obesity pill from routine NHS use

The National Institute for Health and Care Excellence has published a final appraisal determination not recommending use of Mysimba (naltrexone/bupropion) as an adjunct to a reduced-calorie diet and increased physical activity for the management of weight in adult patients meeting certain criteria.

"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 Institute said.

The drug would cost £2.61 per day per person for however long they need to take it, but cost effectiveness calculations were uncertain because more robust evidence is needed to show how effective the drug is in the long term, it noted.

However, Ahmed Al-Derzi, chief executive of Consilient Health, which bought rights to commercialise and distribute Mysimba in the UK and Ireland from Orexigen back in December, insists that the drug has an important role to play in the management of obesity, complex, multifactorial chronic disease."

"Obesity is a significant and growing issue in the UK, and Mysimba is an important new therapy in the management of this complex, multifactorial chronic disease," insisted Ahmed Al-Derzi, chief executive of Consilient Health, which bought rights to commercialise and distribute Mysimba in the UK and Ireland from Orexigen back in December.

"Mysimba costs just £2.61/day; the annual direct costs of obesity to the National Health Service are currently estimated at £6.1 billion".

Professor John Wilding, who leads research into obesity in the Institute of Ageing and Chronic Disease at the University of Liverpool, was also critical of NICE’s decision.

"The data show that Mysimba provides an innovative option to help patients lose weight in conjunction with lifestyle measures. As a clinician who helps support many people in their efforts to lose weight as part of the treatment of long-term illnesses such as type II diabetes, I think many will be disappointed by this decision as they find it impossible to achieve and maintain weight loss with lifestyle alone," he said.

Mysimba has a novel mode of action that is not fully understood, but thought to target the central nervous system pathways responsible for hunger and eating, helping patients feel less hungry and resist food cravings.

The drug was approved for use in Europe in 2015 for adults who are obese/overweight and have one or more weight-related co-morbidities, such as type II diabetes or hypertension, with the condition that patients should only be allowed to continue taking the drug if they have achieved at least 5 percent weight loss after after 16 weeks’ treatment.