What are the impacts of increasing cost-effectiveness Threshold? a protocol on an empirical study based on economic evaluations conducted in Thailand

Abstract

Background Economic evaluations have been widely used to inform and guide policy-making process in healthcare resources allocation as a part of an evidence package. An intervention is considered cost-effective if an ICER is less than a cost-effectiveness threshold (CET), where a CET represents the acceptable price for a unit of additional health gain which a decision-maker is willing to pay. There has been discussion to increase a CET in many settings such as the United Kingdom and Thailand. To the best of our knowledge, Thailand is the only country that has an explicit CET and has revised their CET, not once but twice. Hence, the situation in Thailand provides a unique opportunity for evaluating the impact of changing CET on healthcare expenditure and manufacturers’ behaviours in the real-world setting. Before we decide whether a CET should be increased, information on what happened after the CET was increased in the past could be informative and helpful. Objectives This study protocol describes a proposed plan to investigate the impact of increased cost-effectiveness threshold using Thailand as a case study. Specifically, we will examine the impact of increasing CET on the drug prices submitted by pharmaceutical companies to the National List of Essential Medicine (NLEM), the decision to include or exclude medications in the NLEM, and the overall budget impact. Materials and designs Retrospective data analysis of the impact of increased CET on national drug committee decisions in Thailand (an upper middle-income country) will be conducted and included data from various sources such as literature, local organizations (e.g. Thai Food and Drug Administration), and inputs from stakeholder consultation meetings. The outcomes include: (1) drug price submitted by the manufacturers and final drug price included in the NLEM if available; (2) decisions about whether the drug was included in the NLEM for reimbursement; and (3) budget impact. The independent variables include a CET, the variable of interest, which can take values of THB100,000, THB120,000, or THB160,000, and potential confounders such as whether this drug was for a chronic disease, market size, and primary endpoint. We will conduct separate multivariable regression analysis for each outcome specified above. Discussion Understanding the impact of increasing the CET would be helpful in assisting the decision to use and develop an appropriate threshold for one’s own setting. Due to the nature of the study design, the findings will be prone to confounding effect and biases; therefore, the analyses will be adjusted for potential confounders and statistical methods will be explored to minimize biases. Knowledge gained from the study will be conveyed to the public through various disseminations such as reports, policy briefs, academic journals, and presentations.

Cost-effectiveness of tenofovir prophylaxis during pregnancy for the elimination of mother-to-child transmission of the hepatitis B virus: real-world analysis from Thailand

“…The HBIG-free intervention with TDF prophylaxis was the most cost-effective option . +Cost-effectiveness threshold in Thailand is 160 000 THB per QALY, 18 and QALY of chronic HBV infection was 13.6 years. 19 ICER, incremental cost-effectiveness ratio; TDF, tenofovir disoproxil fumarate.…”

“…The cost per infection averted results were compared against Thailand’s cost-effectiveness threshold that explicitly defined since 2013 that they are willing to pay 160 000 THB per quality-adjusted life year (QALY). 18 QALY gained for chronic HBV infection in Thailand was 13.6 life-years from previous publication, calculated by modelling of direct (medical and non-medical) and indirect costs in Thailand of patients aged 30 years old who would be giving standard chronic hepatitis B treatment that could have 13.6 QALYs gained. 19 We selected the best two cost-effective interventions to test for impact of each of the stated parameters on ICER.…”

“…Figure 2 ICER of three TDF-based interventions comparing to Thailand's willingness to pay threshold (160 000 THB per QALY). +Cost-effectiveness threshold in Thailand is 160 000 THB per QALY,18 and QALY of chronic HBV infection was 13.6 years 19. ICER, incremental cost-effectiveness ratio; TDF, tenofovir disoproxil fumarate.…”

Establishing cost-effectiveness threshold in China: a community survey of willingness to pay for a healthy life year

“… 6 A recent systematic review found that 17 countries have officially recognised CETs. 7 Among these countries, England (£20 000–30 000 per QALY), 8 Thailand (160 000 Thai baht per QALY), 9 Ireland (€45 000 per QALY) 10 and Norway (500 000 Norwegian krone) 10 have explicit CETs. For most of the countries which lack formal thresholds, indicative CETs gauged by gross domestic product (GDP) per capita are often used alternatives, 11 especially in low-income and middle-income countries.…”