Using health technology assessment for informing coverage decisions in Thailand
Abstract
This article aims to illustrate and critically analyze the results from the 1-year experience of using health technology assessment (HTA) in the development of the Thai Universal Coverage health benefit package. We review the relevant documents and give a descriptive analysis of outcomes resulting from the development process in 2009–2010. Out of 30 topics nominated by stakeholders for prioritization, 12 were selected for further assessment. A total of five new interventions were recommended for inclusion in the benefit package based on value for money, budget impact, feasibility and equity reasons. Different stakeholders have diverse interests and capabilities to participate in the process. In conclusion, HTA is helpful for informing coverage decisions for health benefit packages because it enhances the legitimacy of policy decisions by increasing the transparency, inclusiveness and accountability of the process. There is room for improvement of the current use of HTA, including providing technical support for patient representatives and civic groups, better communication between health professionals, and focusing more on health promotion and disease prevention.
Health technology assessment (HTA) has been described as “A multidisciplinary field of policy analysis…[that] studies the medical, economic, social and ethical implications of development, diffusion and use of health technology” [1]. Although in theory, HTA potentially covers the evaluation of all dimensions of the value of health interventions, decision-makers from a variety of jurisdictions expressly demand information on the effectiveness and cost–effectiveness of health technologies [1–4]. Besides the recognized scarcity of health resources and inefficiency in their use [101], other key reasons for this attention to cost–effectiveness are rapidly aging populations and the ever-increasing availability of high-cost innovations, which further jeopardize system sustainability, especially in countries with publicly funded health schemes [102,103]. As a consequence, health economic evaluation is accepted as a tool to address a wide array of health policy issues, including the pricing and reimbursement of health technologies, development of practice guidelines, planning of specialist facilities, design of payment schemes and promotion of competition in the health system, among others [5].
The development of health benefit packages (i.e., the set of goods, services and actions covered by health insurance schemes) is a particular area where cost–effectiveness studies have acquired significance in recent years [6,104]. Although some health plans develop the list of health benefits to which their covered populations are entitled in implicit ways – usually driven by lobbying from influential stakeholders – there is a rising trend towards the use of transparent and rational criteria for the making of coverage decisions [6,105]. Typical information for decision-making includes scientific and technical data (e.g., cost–effectiveness or disease burden) and value judgments of a social and ethical nature (e.g., questions of equity, solidarity or autonomy). The weight given to each criterion depends on the contextual characteristics of the particular health system [1,7].
All empirical evidence from high-, middle- and low-income countries suggests an urgent need to develop more transparency and consistency in decision-making processes for health benefit package development. For example, Schreyogg et al. compared regulatory frameworks for defining health benefit packages in nine European countries and found that the decision-making process in many study settings is instead guided by lobbying activities of certain stakeholders, especially in countries with explicit benefit packages and lacking transparency of decision criteria [6]. This finding is consistent with the analysis of Greb et al. on procedures and criteria for benefits decisions in Switzerland and Germany, which found that consistency of decision-making can further be improved by providing information on the entire decision-making process, including prioritization of assessments and the information on the final decisions necessarily needed by patients [8]. They also maintain the need to grant other stakeholders representation apart from decision-makers and health professionals in the decision-making bodies in both countries. Although there is scarce evidence in middle- and low-income countries, Shewade et al. studied coverage decision-making in Bosnia and Herzegovina, Georgia, Ghana, India, Mexico, Peru, Thailand and Uganda, and found that coverage decision-making processes often lack a systematic process to identify interventions to be considered in the package [9]. In addition, there is no consensus on criteria for making coverage decisions but the majority of study countries use multiple and rather subjective criteria.
In Thailand, the Universal Health Coverage Scheme (UC) has offered a package of healthcare interventions to all Thai citizens who are not covered by other health insurance schemes since 2001 [106]. The Subcommittee for the Development of the Benefit Package and Service Delivery (SCBP) is the body that recommends to the Board of the National Health Security Office (NHSO) which health benefits should be included in the package. Pressure on the SCBP to broaden stakeholder participation, and the imperative to make an optimal resource allocation of limited resources led eventually to the development of an explicit mechanism for coverage decisions in 2009. With this task, two health policy research institutes under the aegis of the Thai Ministry of Public Health – the International Health Policy Program (IHPP) and the Health Intervention and Technology Assessment Program (HITAP) – embarked on devising a system, based on the principles of HTA, that would enhance not only the inclusiveness but also the transparency and use of scientific evidence in the process [10].
This article aims to describe and critically analyze the outcomes of the 2009–2010 HTA process employed in the development of the Thai UC benefit package, in particular the patterns and performance of topic submission and topic prioritization, the characteristics and results of economic evaluation studies, and the extent to which the SCBP’s appraisal recommendations are concordant with the economic evidence.
The UC benefit package development process
The development of the UC benefit package follows the Thai HTA methods guidelines and detailed process guidelines based on the governance arrangements of seven HTA agencies in Europe and North America. Overall, the following major steps are followed in the process [10]:
▪ Nomination of health topics: representatives of several groups of stakeholders (four for each group of policy-makers, health professionals, academics, patient associations, civic groups and lay citizens; and three for the healthcare industry group) can propose six topics each annually to the IHPP and HITAP. Topics must be accompanied by supportive information indicating the procedure used to determine their importance and the rationale for submission according to established criteria;
▪ Prioritization of health topics: a panel comprising representatives of four stakeholder groups (health professionals, academics, patient and civic groups) select at least ten topics yearly for assessment according to six prioritization criteria: size of the affected population, severity of problems, effectiveness of interventions, variation in practice, economic impact on household expenditure, and ethical and social implications. Topic selection is facilitated by the information provided by the IHPP and HITAP’s research staff. Each criterion has been identified through an explicit scoring approach with well-defined parameters and thresholds. Based on the scoring system, the proposed interventions are ranked and their order is adjusted through deliberation;
▪ Technology assessment: after the selected topics are approved by the SCBP, economic evaluation and budget impact analysis are conducted by two health policy research institutes – the IHPP and HITAP – in collaboration with external experts, following the Thai HTA methods guidelines. The guidelines recommend the quantification of marginal costs and health outcomes, expressed in terms of quality-adjusted life years (QALYs), of new interventions versus standard practice (the so-called incremental cost–effectiveness ratio [ICER]) [11]. In some cases where cost–benefit analysis is more appropriate for evaluation (e.g., antenatal screening for Down syndrome), the researchers calculate cost–benefit ratios. Relevant stakeholders participate in the scoping of research questions, validation of results and elaboration of preliminary recommendations;
▪ Appraisal: technology assessment findings and recommendations are subsequently presented to the SCBP for appraisal. This procedure does not have any written guidelines. The subcommittee, which consists of multidisciplinary members, except industry representatives, are selected by the NHSO Board from several stakeholder groups. Appraisal criteria may include the assessment results as well as feasibility and social value judgments. In terms of determining exactly what constitutes good value for money, the SCBP considers a threshold of one per-capita gross domestic product (GDP; US$4800 in 2011 [107]) per QALY gained;
▪ Decision-making: although the SCBP is not the formal decision-maker, their recommendations on the inclusion or exclusion of assessed interventions are, in practice, endorsed by the NHSO board.
Materials & methods
A document review was performed on the meeting minutes and research reports related to the development of the UC benefit package of 2009–2010. For the descriptive analysis of topic submission and prioritization, health technologies covered in the submitted topics were divided into different categories according to their material nature and purpose following the classification developed by Goodman [108], and also according to the cause of the target health problem. The data were cross-tabulated against the different groups of stakeholders who participated in the process. Meanwhile, results of HTA studies were extracted and compared with the health coverage recommendations made by the SCBP. Assessment results were simultaneously classified in two ways as follows: according to per-capita GDP per QALY gained, as proposed by the SCBP; and according to an arbitrary threshold of Thai baht 200 million (US$6.4 million in 2011) chosen for the purposes of this study, at and above which interventions were considered to have a high budget impact and below which a low budget impact, and then cross-tabulated against three different types of appraisal recommendations according to Dakin et al. (recommended, recommended with restriction and not recommended) [12].
Results
In 2009–2010, a total of 30 topics were submitted by seven eligible stakeholders to IHPP and HITAP. Groups of policy-makers, healthcare industry and lay citizens reached their quota of topic nomination (at a maximum of six topics per group annually), while health professionals submitted only one topic during the period of this study.
Table 1 presents the distribution of health interventions covered in the submitted topics classified into different categories. Regarding the nature of interventions, 12 out of 30 submitted topics were medicines (including drugs and biologics, such as anti-IgE). Among these 12 medicines, eight were submitted by policy-makers and the healthcare industry. Some topics covered medical devices/equipment/supplies (four topics), such as diapers for incontinence, and four topics were medical/surgical procedures (e.g., implant dentures). In addition, ten topics were related to organizational or managerial systems, such as a smoking cessation program that covered health education, case-finding, medical and nonmedical treatment and rehabilitation, of which six were submitted by groups of academics and lay people.
The submitted topics covered a wide range of interventions with different purposes including: prevention (a topic of folate and iodine supplementation for reproductive women); screening and diagnostics (seven topics, including antenatal screening for Down syndrome); treatment (16 topics, including treatment for severe lupus nephritis); and rehabilitation (two topics, including implant dentures). In addition, there were four topics submitted as a combination of different interventions to confront a health problem, such as the development of a package for the screening, treatment and rehabilitation of alcoholism. More than half of the topics submitted by groups of academics, the healthcare industry and civil society in 2010 were for curative purposes.
Of the 30 submitted topics, the most common target of interventions covered was noncommunicable diseases (25 topics), for example mental illness, which has traditionally been neglected. Another four topics targeted communicable diseases, such as chronic hepatitis B, which is the most common cause of the leading cancer in Thailand – hepatocellular carcinoma. The other topics targeted diseases that can be identified as either communicable or noncommunicable.
In the process of health topic prioritization, the 30 submitted topics were ranked according to the six prioritization criteria. Table 2 presents the prioritization scores and results of the assessments in terms of value for money and budget impact analysis. Upon deliberation and consensus on the appraisal process, the SCBP recommended six out of 12 interventions to be adopted in the Thai UC benefit package.
Table 3 shows the relationship between the results of technology assessment and those of appraisal. Two out of 12 interventions were analyzed in terms of cost analysis (one of them was recommended by the SCBP); therefore, their results were not included in Table 3, which presents the assessment results in terms of ICER. From Table 3, five out of ten interventions were recommended to be adopted in the package, of which two interventions were recommended with restrictions. Four out of five interventions with an ICER less than one per-capita GDP and relatively low budget impact were recommended by the SCBP; meanwhile, one out of four interventions with an ICER less than one per-capita GDP and relatively high budget impact was accepted. No intervention that yields more than one per-capita GDP for ICER was recommended.
Discussion
This article shows how Thailand’s UC developed its health benefit package in a systematic, participatory, transparent and evidence-based manner. Results from a 1-year experience indicate that policy-makers, lay citizens and the healthcare industry welcomed and exercised their right to participate fully. However, this is not the case for health professionals, who used to be key players in the past development of the package. Many may not be aware of or do not pay attention to this mechanism. A major problem is the inadequate communication, not only between the four royal colleges representing medical professional groups in this project, but also among members of particular royal colleges. Moreover, autonomy as an obvious characteristic of the medical profession may have a role in the lack of harmony and cooperation. It is possible that some individual specialists have sought to influence the nomination of new technologies through other eligible groups, as an alternative to the formal pathway. By contrast, other interests introduced effective communication strategies among members. The information dissemination and also interorganization collaborations had been well established before the reform initiative was inaugurated in 2009. For instance, the civic associations not only worked together under the NHSO’s auspices for almost 10 years, but also supported each other in many health campaigns such as those for access to essential medicines, ensuring the rights of HIV patients and their families, and consumer protection [13,14].
Patient associations and civic groups, even though they show great interest in this initiative, have a constraint capacity to gather the information required for topic nomination. For instance, the IHPP and HITAP suggest that each topic should be submitted accompanied by relevant and supporting information, such as disease burden, household economic impact or intervention effectiveness. Since this problem was identified during the beginning phase, a mechanism was developed to provide technical support to these groups by procuring information for internal prioritization and submission. Sometimes, however, these groups are allowed to submit topics without comprehensive information. In addition, the nomination of topics allows stakeholders to submit health problems rather than specific interventions, which would involve more technical knowledge. We found that almost all topics submitted by patient associations, civic groups and lay citizens were health problems in comparison with the intervention topics submitted by the healthcare industry. It is interesting to note that lay citizens reached their maximum quota for topic nomination in comparison with patient representatives and civic groups. The characteristics of the lay citizen representatives – who are the most active participants in the annual National Health Assembly for the development of healthy public policies [14] – may be the reason why they seem to be more familiar with and capable at this kind of process.
Concerning the purposes of interventions, treatment dominates over prevention and screening because treatment usually provokes more concern among stakeholders. In 2002, when the UC was established, the budget was set at approximately 14% for prevention and health promotion. Although the total budget for the UC has increased over the past 9 years, the budget allocated for prevention and health promotion has not been enhanced proportionally, resulting in a relative reduction in the percentage of the budget for this category. This fact activated an urgent action by the board of the NHSO in order to increase the investment on prevention and health promotion. As a consequence, the SCBP demands that stakeholders nominate more topics related to prevention and health promotion. For 2011–2012, stakeholders agreed that each group needs to submit at least two out of six topics for this category.
Our findings reveal that not only is value for money important for the selection of interventions to be included in the benefit package, but so too are budget impact, equity or feasibility issues. For example, even though the implant dentures were found to be very cost effective in the Thai setting, the SCBP recommended to not include them in the benefit package due to the fact that the standard complete dentures have not yet been widely accessible among the eligible population, especially those marginalized groups. Thus, approval of the more sophisticated implant dentures in the benefit package would diminish the effort of health providers to provide complete dentures to those without access [15]. As a result, they suggested improving the service provision of complete dentures instead. Furthermore, diapers offer good value for money but, due to high budget implications, they were not recommended for the package. For the treatment of chronic hepatitis B, tenofovir is recommended only for those who develop lamivudine resistance. The practice of liver biopsy before prescribing tenofovir and the scarcity of sub-specialists who can perform this procedure led to the recommendation of restricting its use as a second-line treatment [10].
It may be difficult to generalize this approach to other settings given the differences in governance and HTA capacity. The political will of decision-makers to make transparent and participatory coverage decisions is crucial. Fortunately, key decision-makers at the NHSO are former scholars with a record of support for evidence-based policy [106]. At the same time, HTA capacity in Thailand has reached a critical level to produce a considerable number of high-quality HTA studies [16]. For instance, by the time this program was initiated, Thailand already had national methodological HTA guidelines and the use of HTA for the development of the national essential drug list [17]. As a consequence, it is recommended that resource-poor settings invest more on HTA capacity building and use the research outputs for setting priorities on health investment that address local needs in the initial stages.
Conclusion
HTA is useful for informing coverage decisions of health benefit packages. HTA includes prioritization of topics for assessment, assessment and, finally, appraisal. HTA enhances the legitimacy of policy decisions by increasing the transparency, inclusiveness and accountability of the process.
Future perspective
Given the global movement to achieve universal healthcare coverage, there will be increasing demand for health benefit package development. The balance between technical and social aspects of the decision-making process as well as adopting particular technologies is needed. Finally, institutionalization of HTA when this approach is generally known and accepted by society is believed to help strengthen and sustain its application.
Interventions’ classification | Stakeholders who submitted health topics | Total topics submitted | Selected topics for assessment | ||||||
---|---|---|---|---|---|---|---|---|---|
Policy-makers | Academics | Health professionals | Healthcare industry | Civic groups | Patient associations | Lay citizens | |||
Number of submitted topics | 6 | 5 | 1 | 6 | 3 | 3 | 6 | 30 | 12 |
Nature of interventions | |||||||||
Medicines† | 4 | 2 | – | 4 | 1 | 1 | – | 12 | 5 |
Devices, equipment and supplies | – | – | – | 1 | 2 | – | 1 | 4 | 2 |
Medical and surgical procedures | 1 | – | – | – | – | 1 | 2 | 4 | 1 |
Organizational and managerial systems | 1 | 3 | 1 | 1 | – | 1 | 3 | 10 | 4 |
Purposes of interventions | |||||||||
Prevention | 1 | – | – | – | – | – | – | 1 | – |
Screening and diagnosis | – | 1 | 1 | 1‡ | – | 1 | 3 | 7 | 3 |
Treatment | 3 | 3 | – | 5 | 2 | 1 | 2 | 16 | 6 |
Rehabilitation | 1 | – | – | – | 1 | – | – | 2 | 2 |
Combination | 1 | 1 | – | – | – | 1 | 1 | 4 | 1 |
Target disease of interventions | |||||||||
Noncommunicable diseases | 4 | 4 | 1 | 5 | 3 | 3 | 5 | 25 | 8 |
Communicable diseases | 2 | 1 | – | 1 | – | – | – | 4 | 4 |
Both | – | – | – | – | – | – | 1 | 1 | – |
Selected topics for assessment | 4 | 3 | 1 | 2 | 1 | 1 | – | – | 12 |
Interventions | Submitted by | Methods | Prioritization score | Assessment results | Policy recommendations | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Size of afflicted population | Severity of problems | Effectiveness of interventions | Variation in practice | Economic impact on household expenditure | Ethical and social implications | Total | Incremental cost–effectiveness ratio | Budget impact (million baht) | |||||
Treatment for severe lupus nephritis | Patient associations | CUA | 2 | – | 4 | 2 | 5 | 1 | 14 | THB -436,000/QALY (cost saving) | 110 | The most cost-effective intervention (intravenous cyclophosphamide plus azathioprine) has already been covered under the benefit package | |
Smoking cessation program | Academics and healthcare industry | CUA | 5 | – | 3 | 2 | 1 | 3 | 14 | THB -38,958/QALY (cost saving) | 1.5 | Recommended for further consideration to be adopted in the benefit package | |
Treatment for people with chronic hepatitis B | Policy-makers | CUA | 5 | – | 4 | 2 | 3 | 3 | 17 | THB -14,000/QALY (cost saving) | 100 | Both lamivudine and tenofovir are cost effective | |
Implant dentures for people who have problems with conventional complete dentures | Policy-makers | CUA | 5 | – | 2 | 2 | 5 | 1 | 15 | THB 5147/QALY | 150 | Not recommended because problems of access to standard treatment of dental care were still unsolved | |
Absorbent products for urinary and fecal incontinence among disabled and elderly people | Civic groups | CUA | 4 | – | 2 | 2 | 4 | 1 | 13 | THB 54,000/QALY | 4800 | Not recommended because of high budget impact | |
Treatment for people with chronic hepatitis C | Academics | CUA | 3 | – | 5 | 2 | 3 | 1 | 14 | THB 86,600/QALY | 2400 | Not recommended because of high budget impact | |
Monitoring patients with sepsis by using FloTrac™, PreSep™ or PediaSat™ | Healthcare industry | CUA | 4 | 5 | 5 | 2 | 2 | 3 | 21 | THB 122,000/QALY | 5200 | Not recommended because of the limited information in the Thai setting for decision-making | |
Anti-IgE for severe asthma | Healthcare industry | CUA | 4 | – | 3 | 5 | 5 | 1 | 18 | THB 414,503/QALY | 54,000 | Not recommended because it is not a cost-effective intervention | |
Diagnostics and treatment for multidrug-resistant and extensively drug-resistant tuberculosis | Policy-makers | CBA | 1 | 2 | 5 | 1 | 5 | 4 | 18 | 0.76† (cost saving) | 30 | Recommended for further consideration to be adopted in the benefit package because the cost of health services would be greatly reduced through the diagnosistic tests | |
Screening for Down syndrome in the second trimester of pregnancy | Health professionals | CBA | 5 | 4 | 5 | 2 | 1 | 1 | 18 | 0.81† (cost saving) | 1180 | Recommended for further consideration to be adopted in the benefit package because the cost of health services would be greatly reduced through the screening tests | |
System for screening, treatment and rehabilitation of alcoholism | Policy-makers | N/A | 5 | – | 5 | 4 | 1 | 1 | 16 | N/A | – | Not recommended because of inadequate information; the SCBP request more information on its cost–effectiveness to make coverage decisions | |
Screening for risk factors for leukemia in people living in industrial areas | Academics | Cost of illness | 4 | – | 3 | 5 | 1 | 2 | 15 | N/A | – | Recommended for further consideration to be adopted in the benefit package because the problem causes considerable loss in terms of cost of illness at 3500 million THB in 30 years |
In 2012, 1 US dollar is approximately 30.8 Baht [109].
†Cost–benefit ratio.
CBA: Cost–benefit analysis; CUA: Cost–utility analysis; N/A: Not applicable; QALY: Quality-adjusted life year; SCBP: Subcommittee for the Development of the Benefit Package and Service Delivery; THB: Thai baht.
Data taken from [10,18].
Assessment results† | Budget impact | Recommended (n) | Recommended with restrictions (n) | Not recommended (n) |
---|---|---|---|---|
ICER ≤1 per-capita GDP/QALY | Low | 2 | 2 | 1 |
High | 1 | – | 3 | |
ICER >1 per-capita GDP/QALY | Low | – | – | – |
High | – | – | 1 |
†Two cost analysis studies are not included in this table.
High budget impact >200 million Thai baht per annum; low budget impact ≤200 million Thai baht per annum.
GDP: Gross domestic product; ICER: Incremental cost–effectiveness ratio; QALY: Quality-adjusted life year.
Data taken from [10,18].
Financial & competing interests disclosure
The authors of this paper, except P Jongudomsuk, are supported financially by the National Health Security Office for the development of the Universal Coverage health benefit package. The design, interpretation and presentation of results are independent from the funding organization. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
References
Papers of special note have been highlighted as: ▪ of interest ▪▪ of considerable interest
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Using health technology assessment for informing coverage decisions in Thailand. (2012) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer.12.10
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