Abstract
Adaptive health technology assessment (aHTA) is a structured approach to select and evaluate appropriate and effective technologies. Although aHTA processes have been developed in many countries, the formal aHTA decision-making process has not been developed in Thailand. Therefore, studies are needed to strike a balance between data quality and timeliness for policy decisions. This study aimed to gather and analyze information from a literature review and interviews with health economics researchers and expert meetings consisting of representatives of health economics researchers, representatives of the Health Economics Working Group, representatives of the National Health Security Office, cardiologists and an endocrinologist. The final model of aHTA was summarized in 4 steps. Step 1 constitutes the urgency of the situation. Step 2 comprises basic clinical and economic information of the technology, which is divided in the following 5 sub steps: 2.1 evidence of efficacy and safety, 2.2 feasibility, 2.3 certainty of efficacy/safety, 2.4 existing local CEA/BIA and 2.5 critical appraisal. Step 3 is budget impact and alternative options, and lastly, step 4 consists of health Economic Value (cost-effectiveness analysis). If medicines or technologies have incomplete or inappropriate information and no study has been conducted of the health economics and budgetary impacts, the researchers may refer the information to the decision makers to proceed with the full HTA study or may consider a final decision. When SGLT2 inhibitors (dapagliflozin and empagliflozin) were evaluated regarding patients with heart failure using an algorithm based on the aHTA model, drugs in this group were not used for emergencies. Therefore, step 1 could proceed to step 2, which is to consider the clinical and economic background of the technologies in 5 sub-steps. SGLT2 inhibitors could pass 4 sub-steps to step 2.5 which is critical appraisal. The researchers believed that the existing local CEAs do not correspond to the scope of national policy decisions. Therefore, it was forwarded to step 3, which involves a quick budget impact analysis. The analysis indicated that the SGLT2 inhibitors group, concerning both dapagliflozin and empagliflozin, have a budget impact of more than 300 million THB and 500 million THB yearly. Therefore, an analysis was performed by setting a ceiling (threshold analysis), and found that drug prices had to be negotiated. Dapagliflozin and empagliflozin’s price should be reduced by 57.13 - 58.72 % and 52.07 – 53.85 %, respectively. When considering the characteristics of alternative technology, SGLT2- inhibitor is the 4th main drug to be added to the other three main drugs. Therefore, patients still retain other options. The SGLT2 inhibitors did not reach step 4 (Rapid CEA) according to the algorithm based on the adaptive HTA model. Thus, the pathway was forwarded to the step of conducting a full HTA evaluation for the National Drug List.
