July 2017 – NEW TREATMENT FOR OBESITY – NICE SAYS NO – DECISION CHALLENGED

Consilient Health is extremely disappointed that the National Institute for Health and Care Excellence (NICE) has not recommended the use of Mysimba▼® (naltrexone hydrochloride/bupropion hydrochloride), its oral, anti-obesity medicine.

Mysimba is indicated as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g. type 2 diabetes, dyslipidaemia, or controlled hypertension)1.

Commenting on the NICE decision, Ahmed Al-Derzi, Chief Executive Officer, Consilient Health said: “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. Mysimba costs just £2.61/day; the annual direct costs of obesity to the National Health Service are currently estimated at £6.1 billion2”.

NICE based its recommendations on a single technology appraisal review, instigated in April 2017, of the clinical and economic evidence.

Professor David Haslam, a GP with a special interest in obesity and cardiometabolic disease, and a physician in Obesity Medicine at the Centre for Obesity Research at Luton and Dunstable Hospital said: “In the UK almost two-thirds of adults are either overweight or obese, which increases the risk of many serious illnesses such as type 2 diabetes, high blood pressure, heart disease, stroke and cancer3,4. Mysimba has demonstrated clinical efficacy and a new treatment option is key in general practice”.

Professor John Wilding, who leads research into obesity in the Institute of Ageing and Chronic Disease at the University of Liverpool said: “The data show that Mysimba provides an innovative option to help patients lose weight in conjunction with lifestyle measures5-7. 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 2 diabetes, I think many will be disappointed by this decision as they find it impossible to achieve and maintain weight loss with lifestyle alone”.

ENDS

References
1. Mysimba Summary of Product Characteristics May 2017.
2. Public Health England (2016c) Economics of Obesity.
https://www.noo.org.uk/NOO_about_obesity (accessed February 2017).
3. www.gov.uk/government/uploads/system/uploads/attachment_data/file/613532/obesphys-
acti-diet-eng-2017-rep.pdf (accessed July 2017).
4. 2. http://www.nhs.uk/Livewell/loseweight/Pages/statistics-and-causes-of-the-obesityepidemic-in-the-UK.aspx (accessed March 2017).
5. Greenway FL et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376 (9741):595-605. doi: 10.1016/S0140-6736(10)60888-4. Epub 2010 Jul 29.
6. Apovian CM et al. A Randomized, Phase 3 Trial of Naltrexone SR/Bupropion SR on Weight and Obesity-related Risk Factors (COR-II). Obesity (2013) 21, 935-943. doi:10.1002/oby.20309.
7. Hollander P. Effects of Naltrexone Sustained-Release/Bupropion Sustained-Release Combination Therapy on BodyWeight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes. Diabetes Care 2013 36: 4022–4029.
8. Billes SK, Sinnayah P, Cowley MA. Naltrexone/bupropion for obesity: an investigational combination pharmacotherapy for weight loss. Pharmacol Res 2014;84:1-11.

Notes to editor
Mysimba
Mysimba’s novel mode of action is not fully understood but it is thought to target the Central Nervous System pathways responsible for hunger and eating, helping patients feel less hungry and resist food cravings5,8.

Consilient Health
Consilient Health was established in 2005 and has its headquarters in Ireland. The company is an independent, dynamic and rapidly growing pharmaceutical company with a successful portfolio in Women’s Health, Bone Health and generic products. In December 2016, Consilient Health signed an agreement with Orexigen Therapeutics Ireland Ltd to commercialise and distribute Mysimba in the UK and Ireland.

For further information, please contact:
Louise Blakeborough, Chapter Five
T: +44 (0) 1483 892773
M:+44(0) 7831 444789

 

UK/MYS/0617/0082a July 2017