Part 1: Defining unproven cellular therapies

Given the potential of cell-based products, including stem/progenitor cells and immune cells, there is a global effort to introduce these therapies into the clinic to correct organ dysfunctions, to treat cancer and to abrogate autoimmune diseases and a wide variety of pathological conditions [1–3]. Relatively easy access to these cells, obtained from marrow, adipose, cord blood and other human tissues, provides tremendous opportunity for translational research, particularly for indications with no satisfactory medical solution for patients with “unmet medical needs.” Prenatal and adult stem cells (including induced pluripotent stem cells have significant potential to rebuild tissues and correct dysfunctional organs in human diseases

Encouraging Smokers to Quit: The Cost Effectiveness of Reimbursing the Costs of Smoking Cessation Treatment

Background: Smoking cessation should be encouraged in order to increase life expectancy and reduce smoking-related healthcare costs. Results of a randomised trial suggested that reimbursing the costs of smoking cessation treatment (SCT) may lead to an increased use of SCT and an increased number of quitters versus no reimbursement. Objective: To assess whether reimbursement for SCT is a cost-effective intervention (from the Dutch societal perspective), we calculated the incremental costs per quitter and extrapolated this outcome to incremental costs per QALY saved versus no reimbursement. Methods: In the reimbursement trial, 1266 Dutch smokers were randomly assigned to the intervention or control group using a randomised double consent design. Reimbursement for SCT was offered to the intervention group for a period of 6 months. No reimbursement was offered to the control group. Prolonged abstinence from smoking was determined 6 months after the end of the reimbursement period. The QALYs gained from quitting were calculated until 80 years of age using data from the US. Costs (year 2002 values) were determined from the societal perspective during the reimbursement period (May-November 2002). Benefits were discounted at 4% per annum. The uncertainty of the incremental cost-effectiveness ratios was estimated using non-parametric bootstrapping. Results: Eighteen participants in the control group (2.8%) and 35 participants in the intervention group (5.5%) successfully quit smoking. The costs per participant were _291 and _322, respectively. If society is willing to pay _1000 or _10_000 for an additional 12-month quitter, the probability that reimbursement for SCT would be cost effective was 50% or 95%, respectively. If society is willing to pay _18_000 for a QALY, the probability that reimbursement for SCT would be cost effective was 95%. However, the external validity of the extrapolation from quitters to QALYs is uncertain and several assumptions had to be made. Conclusion: Reimbursement for SCT may be cost effective if Dutch society is willing to pay _10_000 for an additional quitter or _18_000 for a QALY.Cost-effectiveness, Cost-utility, Reimbursement, Smoking-cessation-therapies, Smoking-withdrawal