Pharmacoeconomic Guidelines: Thailand
Country/Region: Thailand
Submission Guidelines
Guideline for Health Technology Assessment in Thailand Updated Edition: 2019
Submission Guidelines Source:
Information current as of Tuesday, April 11, 2023
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | Guideline for Health Technology Assessment in Thailand Updated Edition: 2019 |
| Affiliation of authors | Universities, Foundation, HITAP (Health Intervention and Technology Assessment Program), Ministry of Public Health |
| Purpose of the document | Provide the important principle and updated recommendation of HTA research in Thailand |
| Standard reporting format included | Yes |
| Disclosure | Yes |
| Target audience of funding/ author's interests | Decision makers, researchers, pharmaceutical companies |
| Perspective | Societal perspective should be used as primary perspective and other perspectives could be used as secondary perspectives. |
| Indication | Researchers should clearly review the health problems of interest including the principle of the health problem, disease progression, prevalence, and incidence, impacts of the health problem on several aspects, diagnosis and treatment guidelines, efficacy, effectiveness, and efficiency of treatments for the health problem |
| Target population | Target population should be defined from health problems and details of population should be described |
| Subgroup analysis | Pre-specified subgroup analysis could be performed. |
| Choice of comparator | Researchers should identify all possible comparators. The process and reasons of selecting actual comparators should be clearly provided. Details of all comparators must also be clearly described. |
| Time horizon | The time horizon should be long enough to capture the full costs and effects of the health technology. |
| Assumptions required | Yes |
| Preferred analytical technique | Cost-utility analysis should be firstly considered. If utility data is not available, cost-effectiveness analysis (avoiding using intermediate outcome) or cost-benefit analysis could be used depending on characteristics of interventions of interest. |
| Costs to be included | Costs to be included depend on the study perspective. Cost of intervention, cost of adverse event or cost of illness due to treatment failure should be included. Direct medical, direct non medical and indirect costs should be included if societal perspective is used but indirect cost should not be included in CUA from societal perspective. |
| Source of costs | Primary data collection from medical records for direct medical cost and interview patients or caregivers from direct non-medical cost and indirect cost. |
| Modeling | Yes |
| Systematic review of evidences | Relative treatment effect should be derived from the meta-analysis of RCTs with direct comparison. Relative treatment effect should be adjusted to reflect effectiveness relevant to the target population in Thai context. In instances where several alternatives are being compared or even if there is only 1 alternative but there is an opportunity to consider comparing further alternatives in the future, network meta-analysis that covers all possible alternatives can be used. |
| Preference for effectiveness over efficacy | Yes. Health outcome for health technology assessment should reflect effectiveness rather than efficacy. Effectiveness data should be derived from efficacy data by identifying the factors that may differ between real-world settings and trial environments such as adherence. |
| Preferred outcome measure | Final outcome should be used. Surrogate outcome should be translated into final outcome if possible. In instances where the surrogate outcome was used, justification should be provided along with the evidence on the association between the surrogate and final outcome |
| Preferred method to derive utility | For primary data collection, the EQ-5D-5L using hybrid model is recommended. However, when the EQ-5D-5L is not appropriate to that health state, other utility methods such as SG, TTO, VAS, EQ-5D-3L, HUI, or SF-6D can be employed but justification should be made. |
| Equity issues stated | Yes. HTA agency and decision-makers should develop a systemic process to assess transparency, credibility, and stakeholder engagement. |
| Discounting costs | In base-case analysis, cost and outcome should be discounted at the same rate because the local threshold in Thailand remains unchanged. The appropriate discount rate is recommended at 3%. Sensitivity analysis should be performed in 2 scenarios. o First scenario: if the time horizon of health economic evaluation is equal to 30 years or less. Sensitivity analysis should be performed using a uniform discount rate ranging from 0-6% for cost and outcome. o Second scenario: if the time horizon of health economic evaluation is longer than 30 years. In addition to performing sensitivity analysis similar to the first scenario, different rates of discounting cost and outcome should be conducted. Outcome should be discounted with a lower magnitude rate than cost by the percentage of growth rate of threshold. In other words, the outcome should be discounted at a 2.5% lower rate than cost. |
| Discounting outcomes | In base-case analysis, cost and outcome should be discounted at the same rate because the local threshold in Thailand remains unchanged. The appropriate discount rate is recommended at 3%. Sensitivity analysis should be performed in 2 scenarios. o First scenario: if the time horizon of health economic evaluation is equal to 30 years or less. Sensitivity analysis should be performed using a uniform discount rate ranging from 0-6% for cost and outcome. o Second scenario: if the time horizon of health economic evaluation is longer than 30 years. In addition to performing sensitivity analysis similar to the first scenario, different rates of discounting cost and outcome should be conducted. Outcome should be discounted with a lower magnitude rate than cost by the percentage of growth rate of threshold. In other words, the outcome should be discounted at a 2.5% lower rate than cost. |
| Sensitivity analysis-parameters and range | A DSA to identify key parameters affecting sensitivity of the results should be illustrated using a tornado diagram. Possible ranges of the parameter variation should include 95% CI with data sources. Otherwise, a reasonable variation between +10-25% of the base-case values could be used. |
| Sensitivity analysis-methods | A DSA to identify key parameters affecting sensitivity of the results should be illustrated using a tornado diagram. Possible ranges of the parameter variation should include 95% CI with data sources. Otherwise, a reasonable variation between +10-25% of the base-case values could be used. If the base-case ICER was higher than the CE threshold, a threshold analysis should be conducted in order to determine the cost-effective price of health technology under evaluation. A PSA should declare data distribution of the parameters upon statistical models assumed. |
| Presenting results | Results should be presented in a defined form. Both discounted and undiscounted cost, LY, QALY, ICER/LY, and ICER/QALY per capita should be presented. ICER should not be presented if it is a negative value but use "dominant" or "dominated" instead. Sensitivity analysis results should be presented. |
| Incremental analysis | Yes |
| Total costs vs effectiveness (cost/effectiveness ratio) | Cost-effectiveness ratio is not recommended. |
| Portability of results (Generalizability) | The patient population to which the pharmaco-economic evaluation applies should be consistent with the patient population defined in the clinical part of the reimbursement request submission. |
| Financial impact analysis | The data set for BIA should comprise the same data set as CEA. However, there are the difference in some issues for BIA: 1) the estimate of eligible population using open-cohort approach; 2) using budget holder perspective; and 3) no discounting for future cost. Notably, the reporting format of BIA should be clearly detailed to enable third party validation of the results or for a further reanalysis. |
| Mandatory or recommended or voluntary | Mandatory |
Acknowledgement: