Abstract
Cranioplasty surgery has many impacts to patients’ physical and mental health, for example, restoration of the mechanic of fluid flow inside the brain which protect from external danger with the reconstructive patient appearance that affected socialization emotional well-being. In the current years, Polymethylmethacrylate (PMMA) material has been famously used for the surgery for more than 50 years with the cost effectiveness and the inclusion in most of the government welfare in many countries. However, this material is not the best options for this surgery in term of strength and anti-infection, in other word, the PMMA may has a stellate pattern when receive a curtain point of external force that can lead to the death of the patient. The METICULY Patient-specific titanium mesh implant, model CraniMesh, was introduced in 2017 with the 3D printing technology and personalized design for the cranioplasty surgery. This product overcomes the strength and anti-infection problems of PMMA with additional properties of surgical time reduction. Despite the increased benefits and cost, the CraniMesh has not been listed in the Thai government welfare yet, also no evidence of the comparative pharmacoeconomic study between the CraniMesh and the PMMA cranioplasty plate to facilitate the listing process. This study has objectives to evaluate the safety and performance of the Cranimesh and the retrospective clinical study of usage between these 2 products in cranioplasty surgery, which comprises of 3 parts, as follow. The performance testing of the CraniMesh according to the accepted standard compliance utilize the requirement of the United States Food and Drug Administration (USFDA) for medical device control and registration. This study has shown the complied test protocols and reports of all the necessary tests required by the USFDA to confirm with one of the most restrictive standards. The results showed that the CraniMesh has equivalent safety and effectiveness in both the product and the manufacturing process in international level, and this can be used as the pathway for Thai medical device manufacturer to achieve the USFDA standard. In the retrospective clinical study for the implantation of the CraniMesh and the PMMA cranioplasty plate for 28 and 30 samples, respectively, with 6-month follow-up period in multicenter to confirm the safety and effectiveness of the device, the reoperation and infection rate of the PMMA plate is 16.7% while the CraniMesh had 0%. The CraniMesh had surgical time 169.3±71.4 minutes, while the PMMA plate had surgical time at 247.0±111.7 minutes. This data was considered with the statistical methods with p-value<0.05. The pharmacoeconomic study of the CraniMesh and the PMMA cranioplasty plate utilizing the comparative utility cost analysis with economic decision tree model for 10 years analysis showed that the Incremental cost-effectiveness ratio (ICER) has negative value in the social point of view. In other word, cranioplasty surgery with the CraniMesh will have decreased cost -11,990 baht with the increased Quality Adjust Life year (QALYs) 0.04 which is more dominant and cost-saving when compared with the PMMA cranioplasty plate. In the public point-of-view, ICER will equal to 91,330 baht for annually increased QALYs. These results showed that in the social point-of-view, the CraniMesh has 77% worthiness probability to the specified worthiness at 160,000 baht for annually increased QALYs in the context of Thailand, while the PMMA cranioplasty plate has 23% worthiness probability in the same context. For the public point-of-view, the CraniMesh has 56.3% worthiness probability and the PMMA plate has 43.7% worthiness probability. All the results from every parts of this project showed the efficiency of the CraniMesh in the phase of pre-clinical study, retrospective clinical study, and pharmacoeconomic study of medical device. This results will be lead to the decision-making support for the policy to add the CraniMesh in the medical device listing in the near future to help decrease the status quo gap in public health system of Thailand.
