Surrey and sussex policy recommendation committee

Surrey and Sussex Policy Recommendation Committee
Policy Recommendation
PR2006/05: Rimonabant for the treatment of obese, or overweight
patients with associated risk factors
Issue Date:
November 2006
Review Date:
December 2008
Recommendation:
The Surrey and Sussex Policy Recommendation Committee has considered evidence of clinical and cost-effectiveness, information on current activity, impact on costs and opinion of key stakeholders in Surrey and Sussex with regard to whether rimonabant should be used as an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m²), or overweight patients (BMI 27 kg/m²) with associated risk factors, such as type 2 diabetes or dyslipidaemia, and if so what its place in therapy should be, and recommends: 1. A cautious approach to the introduction of rimonabant 20mg into practice. Its use should only be considered for the treatment of obese patients (BMI 30 kg/m²), or overweight patients (BMI > 27 kg/m²) with associated risk factors, such as type 2 diabetes or dyslipidaemia, when all of the following criteria are fulfilled. Patients have tried a combination of other available non-surgical measures, including behavioural management, exercise and diet, without pharmacotherapy, but have failed to lose 5-10% body weight in 6 months. Both orlistat and sibutramine have been tried and not tolerated due to side effects or are contraindicated. Specific clinical contraindications for its use and special warnings and precautions for use have been taken into account*. In particular clinicians have assessed patients to exclude those with depression, a history of depression or other forms of mental illness and to provide a baseline for future assessments during the course of treatment. Patients are fully informed of the known risks and those areas where more evidence is required to assess the risks, and patients are monitored throughout treatment. It is prescribed as an adjunct to diet and exercise as part of a treatment plan for the management of obesity. Clinicians adhere to the special reporting requirements related to ‘black triangle’ drugs. *It is to be noted that Rimonabant In Obesity (RIO)-North America, RIO-Europe and RIO-Lipids trials excluded individuals with type 1 and 2 diabetes, and RIO-Diabetes only included diabetics taking metformin or sulphonylurea monotherapy. The Summary of Product Characteristics and further details on exclusions from the trials can be found in Annex 1. This policy recommendation will be reviewed in light of new evidence or guidance from NICE. Primary Care Trusts in Surrey and Sussex will always consider exceptional cases according to individual need.
Key findings and conclusions of the Rimonabant Working Group:
The use of rimonabant 20mg after one year produces modest weight loss of approximately 5%. Treatment needs to be continued to maintain weight loss. No clinically relevant effects on plasma lipids and blood pressure were found. There is evidence that for every 15 patients treated for one year, one will experience adverse effects of a general or serious nature. The long-term adverse effects of rimonabant are unknown. There are no trials comparing rimonabant against other anti-obesity drugs and long-term effects are unknown. There are no studies available that demonstrate cost-effectiveness of rimonabant. Clinicians would support a cautious approach to the introduction of rimonabant into practice and would be unwilling to prescribe rimonabant 20mg for patients with depression, a history of depression or other forms of mental illness. Careful patient selection taking account of contraindications and special precautions is essential. There could be over 700,000 individuals that meet the indications for treatment with rimonabant. The total annual spend on orlisat and sibutramine in Surrey and Sussex is £1.7 million. Use of rimonabant as a third line option will incur additional costs of £640,750 per year. Routine use of rimonabant would incur additional costs of approximately £4 million per annum for every 1% of the eligible population treated. Restricting prescription to secondary care would incur additional costs of approximately £6 million per annum for every 1% of the eligible population treated.
References:

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Source: http://oldweb.sash.nhs.uk/tf/trust_guidelines/Ch4CNS/HPURimonabant.pdf