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vbloc Therapy

Study concludes vagal nerve blocking Therapy is cost-effective

vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally invasive procedure that does not alter or remove any patient anatomy

EnteroMedics has announced that a cost-effectiveness study analysing vBloc Therapy for the treatment of obesity was published in the American Journal of Managed Care. The study, ‘Cost-Effectiveness Analysis of Vagal Nerve Blocking for Morbid Obesity’, concludes that vBloc Therapy for Class II and III obese patients with diabetes and Class III obese patients without diabetes, is likely to be a cost-effective alternative to conventional weight loss therapy and that vagal nerve blocking represents good value for the money from the perspective of a US payer.

vBloc Therapy works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally invasive procedure that does not alter or remove any patient anatomy. The vBloc System is designed to give the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss while also reducing comorbidity factors related to obesity.

"Demonstrating health economics and financial benefits with vBloc therapy is imperative for prospective payers as they consider coverage decisions," said Dan Gladney, Chairman, President and CEO of EnteroMedics. "This publication brings us one step closer to increasing the accessibility to vBloc for the thousands of individuals who are seeking vBloc as a solution for obesity and associated comorbidities, but for whom the cost of the technology is prohibitive."

The study, led by Boston Health Economics in Waltham, MA, assessed the lifetime cost-effectiveness of intermittent, reversible vagal nerve blocking (via the implantable weight loss device vBloc) therapy versus conventional therapy as treatment for patients who are class 2 obese with diabetes and for those who are class III obese with or without diabetes, who have found pharmacotherapy and behavioural therapies ineffective, but are not prepared or willing to undergo current bariatric surgical options.

The researchers designed a cost-effectiveness model to simulate weight loss, diabetes remission, and costs in patients with obesity undergoing vagal nerve blocking therapy versus conventional therapy.

Using Monte Carlo simulation, patients entered the model one at a time and could transition between health states by experiencing BMI change. The model focused on change in BMI and diabetes remission as predictors of healthcare costs, health-related quality of life, and survival. Inputs for vagal nerve blocking effectiveness were obtained from the ReCharge trial; however, remaining inputs were estimated from published literature. Incremental cost-effectiveness ratios (ICERs) were evaluated in terms of cost per quality-adjusted life-year (QALY) gained.

The outcomes showed that ICERs for vagal nerve blocking versus conventional therapy in patients who were class II and class III obese were estimated to be US$17,274 and US$21,713 per QALY gained, respectively. Sensitivity analyses showed results to be robust to reasonable variation in model inputs, with the upper limit of ICERs remaining below US$30,000 for all sensitivity analysis scenarios assessed.

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