Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Modelling the health benefits of smoking cessation in Japan.

BACKGROUND: In Japan, tobacco smoking is one of the main avoidable causes of disease and death. Although the benefits of smoking cessation for reducing disease risk and increasing longevity have been extensively documented, a relatively low proportion of Japanese smokers currently express a willingness to quit. This study attempted to quantify future reduction in the burden of smoking-attributable disease that could result from increases in smoking cessation. METHODS: A simulation model was developed to project changes in mortality in Japan associated with increased quit attempts and use of nicotine replacement therapy (NRT) among smokers, incorporating data on smoking prevalence, cause-specific mortality rates, quitting behaviour and NRT use and effectiveness. RESULTS: Approximately 46 000 lung cancer deaths and 56 000 cardiovascular disease deaths could be avoided over 20 years if the proportion of smokers making a quit attempt per year gradually increased to current US levels over 20 years. If each of these quit attempts were aided by NRT, the estimates of avoidable deaths would increase to 64 000 for lung cancer and 78 000 for cardiovascular disease. In this model, negligible deaths were avoided due to decreased smoking initiation over the 20-year simulation. CONCLUSION: Smoking cessation can have measurable short-term impacts on the smoking-related mortality burden in Japan. However, to achieve these gains, tobacco control policies should focus both on increasing smokers' willingness to quit and providing the support and therapies to increase the likelihood that smoking cessation attempts will succeed.