Abstract
BackgroundAlthough current beta cell replacement therapy is effective in stabilizing glycemic control in highly selected patients with refractory type 1 diabetes, many hurdles are inherent to this and other donor-based transplantation methods. One solution could be moving to stem cell-derived transplant tissue. This study investigates a novel stem cell-derived graft and implant technology and explores the circumstances of its cost-effectiveness compared to intensive insulin therapy.MethodsWe used a manufacturing optimization model based on work by Simaria et al. to model cost of the stem cell-based transplant doses and integrated its results into a cost-effectiveness model of diabetes treatments. The disease model simulated marginal differences in clinical effects and costs between the new technology and our comparator intensive insulin therapy. The form of beta cell replacement therapy was as a series of retrievable subcutaneous implant devices which protect the enclosed pancreatic progenitors cells from the immune system. This approach was presumed to be as effective as state of the art islet transplantation, aside from immunosuppression drawbacks. We investigated two different cell culture methods and several production and delivery scenarios.ResultsWe found the likely range of treatment costs for this form of graft tissue for beta cell replacement therapy. Additionally our results show this technology could be cost-effective compared to intensive insulin therapy, at a willingness-to-pay threshold of $100,000 per quality-adjusted life year. However, results also indicate that mass production has by far the best chance of providing affordable graft tissue, while overall there seems to be considerable room for cost reductions.ConclusionsSuch a technology can improve treatment access and quality of life for patients through increased graft supply and protection. Stem cell-based implants can be a feasible way of treating a wide range of patients with type 1 diabetes.
Highlights
Current beta cell replacement therapy is effective in stabilizing glycemic control in highly selected patients with refractory type 1 diabetes, many hurdles are inherent to this and other donor-based transplantation methods
In our study we aimed to explore the circumstances under which a stem cell-based graft tissue would be cost-effective, given its effectiveness is comparable to state of the art islet transplantation aside from immunosuppression drawbacks
Our analysis shows that the use of stem cells for beta cell replacement therapy can be an effective use of health budget funds
Summary
Current beta cell replacement therapy is effective in stabilizing glycemic control in highly selected patients with refractory type 1 diabetes, many hurdles are inherent to this and other donor-based transplantation methods. Islet cell transplantation is effective for treating certain type 1 diabetes patients, some hurdles are inherent to this and other donor-based transplantation methods [1,2,3,4]. As of 2017 clinical trials are ongoing in Canada and the United States that use a thin removable device which is implanted under the skin [7, 16] This device has hES cell-derived pancreatic progenitor cells within a casing to shield the tissue from the immune system [15]. The long term goal of research into beta cell replacement therapy is to reverse diabetes and completely avoid the need for immunosuppressive medication
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