Health technology assessment pdf

To assess this, a comparison of costs and consequences such as health outcomes associated with all technologies in question is made. The outcomes are typically expressed in life-years gained when adopting a new technology compared with life-years gained with existing technologies. Cost—utility analyses are essentially cost-effectiveness analyses in which gains in health-related quality of life HRQoL are considered and assessed.

The ICER is then compared to a threshold value below which a technology is deemed cost-effective use of resources, or, put more simply, value for money. Finally, cost—benefit analyses evaluate both costs and consequences in monetary terms ie, for example, in euros. For this, it is necessary to assign a monetary value to any consequences associated with the alternative health technologies. To design an economic evaluation within HTA, we ask a set of standard questions that, when addressed, form the scope of the study.

Under Population, we define the patient population that can potentially be helped with the new health technology. In Intervention, we specify not only which intervention but also the dosage, mode of administration and anything else that is relevant, in line with the marketing authorisation. The same level of precision is required in Comparators, where this should be provided for each potential comparator. Here it is advisable to be broad in the inclusion of comparators and not to discard any at this stage based on, for example, lack of evidence.

In the definition of Outcomes, we consider anything that may be relevant to the patients with the condition in question, as well as the effects on costs, and the organisation. In Time horizon, we define the length of time for which the new technology will have an impact on costs and consequences. Typically, a patient lifetime horizon is used. Finally, the question of the Perspective defines whether the economic evaluation is conducted from a health service perspective, a societal perspective, or the perspective of an organisation, such as a hospital.

The perspective is important as it determines which comparators and outcomes are to be included and what time horizon is appropriate. There are two commonly used approaches to economic evaluation: a trial-based approach versus a decision-analytic modelling-based approach. If this is a randomised controlled trial RCT , this approach offers the advantage of high internal validity, that is, randomisation means that estimates of effectiveness and costs are relatively unbiased for that group of patients in that setting.

However, there are drawbacks and these include, among others, that the RCT may not be generalisable to the population that is relevant to policy-makers and that trial follow-up may be shorter than the time horizon of interest, and indeed too short to capture all effects that a health technology can have on patients.

An approach using decision-analytic modelling can address some of these issues, allowing for long-term prediction of outcomes, and consideration of uncertainty. Damian Walker. Yot Teerawattananon. Sort by Post date Total views. Order Asc Desc. Blog Post. Ursula Giedion and Javier Guzman. November 29, Y-Ling Chi et al. Samantha Hollingworth et al. Cassandra Nemzoff et al. The result is similar to the use of HTA in India [ 34 ]. It is not surprising that public health programs, medicines and vaccines were the most identified as being critical areas for HTA.

This is likely due to the high costs associated with these technologies and the ability to address major disease burdens by developing these areas. However, surprisingly public health programs were prioritized over medicines and vaccines that are usually the exclusive domain of HTA. Decision makers are usually interested in two different financial forces less budget for more demand and more supply at a higher price and as a result they tend to channel each request for new investment through an evaluation process, assessing the effectiveness of the new programmes or products in real-life situations and whether the money spent is good value for health and for the healthcare programme as opposed to efficacy from randomised clinical trials; and whether it is worth buying the new asset given the limitations that exist [ 35 ].

The WHO road map for access to medicines, vaccines and other health products, —, aligns with the outputs that have been identified within the WHO framework including provision of authoritative guidance and standards on the quality, safety and efficacy of health products, access to essential medicines, vaccines, diagnostics and devices for PHC [ 36 ]. Improving the quality of health care, allocative efficiency and equity issues were the most identified attributes for HTA use in policy making and this is line with the core principles of UHC.

It is interesting and of significance that the quality of health care was considered the most important component of HTA. In most HTAs and economic analyses, allocative efficiency have been considered most important in technology adoption. Yet it has been noted that allocative efficiency may not be the only, or the most important, issue to be considered in technology adoption [ 37 ]. It is important to note that HTA emphasizes that the approach seeks to be comprehensive and multidisciplinary.

A good HTA therefore will always include a solid review of the clinical efficacy of a technology, and would attempt to understand safety issues from the evidence available. It is also important to assess other external factors that could be impacted by the use of such technology or policy like equity and fairness, budgetary control and transparency in decision making. Equity considerations as mentioned by the respondents is also important as integrating equity consideration in HTA can help decision-makers and policy-makers to better understand the distributional impact of health interventions.

Equity consideration in economic evaluations have been conducted on some health technology intervention programmes such as vaccines [ 38 ]. These prioritized attributes for HTA use in policy making by the respondents therefore underscores the fact that HTA attributes should be context specific.

Further research should therefore focus on more informed contextualized categories for scoring HTA attributes. The use of HTA to address safety issues, such as low quality medicines and value for money concerns, was seen as important, perhaps reflecting problems in Nigeria related to service quality, safety of patients and healthcare providers and efficiency and use of cost effective technology interventions. The efficacy concerns were linked to quality of care and assuring efficacy before implementation of the programme.

The explicit use of evidence by incorporating safety, efficacy, cost effectiveness, budget impact, and social and ethical considerations were also noted in India [ 39 ] and Thailand [ 40 ].

Dang et al. The perceived availability and accessibility of suitable local data to support HTA varied widely but in many instances was considered inadequate and limited. There are often data on the burden of disease but its application may be limited due to incomplete or unreliable documentation [ 42 ].

The availability of information on burden of diseases and data pertaining to particular population subgroups for which a technology may be applicable is important for HTA.

Data on medicines and medicine prices is also important, as availability of medicines has been noted to be a major determinant of use of health facilities in Nigeria [ 43 ]. Without these data, the evidence base for HTA will be limited. The respondents identified a range of topics where further research is needed. In prioritization of health technology assessment topics and commissioning of HTA projects, the research topics derived from key stakeholders should be given preferences instead of using globally derived topics that are not context-specific.

It has been noted that using information routinely available in the literature and from the vignettes to select HTA topics could not be used to estimate the absolute value of HTA with any certainty in the selection and prioritization of HTA topics [ 46 ].

Most HTA programs have criteria for topic selection, although these criteria have been known not to be always explicit [ 47 ].

Therefore, qualitative methods of gathering this information, like surveying stakeholder perspectives, should be considered. Similarly, the areas of greatest training need for HTA generators and users identified by the participants were broad. Building technical capacity for HTA can take place in-country, in institutions that have the capacity to do so. This can also occur at both the federal and state level since health policies are decided and implemented at the state level as well as federal levels.

However, literature on HTA capacity building in resource-poor countries suggests that political will, involvement of stakeholders, technical and financial support from international partners are crucial in developing training programmes [ 48 , 49 , 50 ]. The main limitations of this study include that the survey participants were mainly stakeholders in MNCH issues; their expertise in this area may have biased the responses. We also did not also collect information from patients and other health care workers who are also users of healthcare system as they were not part of our study population.

Information from them may have given a more comprehensive information towards policy making. This is a gap for future studies. These findings illuminate the current situation, the opportunities including potential HTA topics , and challenges in using HTA in Nigeria. Introducing evidence-informed priority setting in Nigeria and other LMICs will require support from several stakeholders who produce and use HTA evidence.

Stakeholder participation in identifying HTA topics and conducting research will enhance the use of HTA evidence for decision making. There is demand for use of evidence in specific policy areas so, long-term capacity development to encourage evidence-informed priority setting will be worth the effort. Organization WH. Tracking universal health coverage: first global monitoring report: World Health Organization; Accessed 28 Jan FOMH Abuja: Federal Ministry of Health; Federal Ministry of Health Nigeria.

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Int J Health Policy Manag. Introducing health technology assessment in Tanzania. In the fifth and final stage the technology has become old- fashioned and should be abandoned. One speaks of obsolete technology here.

Finally, in addition to the stages mentioned above, the study of the diffusion or spread of health technologies in health care systems has been a long-standing tradition in health technology assessment, as outlined in the textbook by Rogers Other factors like test availability, ease of implementation, regulatory considerations, and prices should be considered in deciding the methods used for testing. Health Needs Assessment HNA is used as an objective and evidence-based method of tailoring health services.

HNA aims to match the specific health needs of people to benefit population health. HNA also addresses health inequalities and identifies - non-recipients of beneficial health interventions, - recipients of ineffective health care, - recipients of inefficient health care, - recipients of inappropriate health care Thus, health needs can be understood as issues that would benefit from changes in health care or from wider social and environmental changes HNA uses epidemiological, qualitative and comparative methods to describe health problems, to identify inequalities in health and access to services, and to determine priorities for the most effective development or use of services.

Timely and accurate information is essential if health services are to meet the changing and different health needs of their populations, subpopulations, and individuals. Routine health information can provide data for epidemiologically based assessments of ill health and help target what health services are needed. Alternatively, the global burden of disease can be represented by disability adjusted life years DALYs , which can be used to identify current and future health needs, and plan essential health services.

To achieve this aim, HNA is carried out in two steps: 1. Case managers of randomised selected clients were interviewed with a standardised assessment instrument Colorado Client Assessment Record. In total 1, clients case managers of three different care programs participated. The results of the needs assessment were distributed to all stakeholders, including clients, family members, mental health professionals, community support staff and managers and directors.

Both unmet needs and over met needs were identified. Examples of recommendations are as follows: 1 match care to clients needs, 2 increase capacity of assertive case management, 3 bridge levels of care including primary care and improve flow-through, 4 provide more educational and vocational services, 5 enhance service for clients with substance abuse, 6 improve client and family collaboration in care.

Health Impact Assessment Indirectly, HIA has its legal basis on the European level in the Amsterdam treaty which states that "a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities" Article HIA can be used to assess policies on local, regional, national or supra-national level It aims to identify the potential health consequences of a policy on a given population, including the positive health outcomes as well as potential adverse effects on health and health inequalities Thereby, HIA strives to influence decision making by raising awareness of the relationship between health and physical, social, and economic environments, by producing estimates of the impact of a variety of decision on the health of the population, and by supporting stakeholder participation, including that of lay people.

Methodologically speaking, HIAs can be based on a participative approach or on expert opinions; they can be qualitative or quantitative or a mixture of both The four options differ in the extent to which the provision of services and facilities change, ranging from no change in provision and only essential refurbishment to a wide range of new community facilities and the replacement of hospitals by a new one.

It covers a rapid desktop exercise using readily available information and professional knowledge to predict positive and negative impacts around ten broad determinants of health.

These are employment and economy, education, transport, housing, visual amenity environment , access to services, crime, lifestyle, pollution, and family and social cohesion.

Interim results and the final report were presented to relevant stakeholders and decision makers of the project. Across the four options, 90 potentially positive and 84 potentially negative impacts were identified.

In summary, the first option had only limited potential but the three others offered a high to maximum opportunity for a whole system change, for improved access and service delivery, and to link wider modernization initiatives. It can be said that highlighting positive and negative impact according to the broad variety of determinants raises awareness of decision makers to the range of potential effects on the health and wellbeing of the local population.

Furthermore, the decision making process became more transparent as a result of the involvement of stakeholders. The role of HTA, HNA and HIA for translational research in genomic medicine Health technology assessment The development of HTA is mainly influenced by methodological streams of policy analysis, evidence-based medicine, health economic evaluation and social and humanistic sciences In the process of HTA, the activity of horizon scanning or early warning aims at identifying and assessing relevant emerging and new health technologies, thereby contributing to promote the adoption of beneficial and cost-effective technologies and to prevent the undesirable consequences of the unorganised haphazardous introduction of high-impact technologies The concepts of early identification and assessment have gained considerable support and about a third of all HTA agencies worldwide have established a horizon scanning system.

Since , several agencies are collaborating in EuroScan, an international network for exchange of information and evaluation of new health technologies Recently, results of a horizon scanning exercise focusing on genetic tests has been published, showing that there are yet only a limited number of clinical applications, predominantly in oncology and cardiovascular disease Systematic literature reviews and quality assessment of published research are at the core of HTA and evidence—based medicine alike.

Furthermore, peer review plays a significant role in HTA to assure high quality and independence of the assessment.

HTA is thus in a position to tackle translational research needs in phases two to four where evidence-based guideline development, research on implementation, dissemination and diffusion as well as outcomes research becomes relevant. Two Canadian research teams 43, 44 who work on HTA methodologies have contributed in particular to specific requirements for the assessment of genome-based technologies including genome-based health information.

Giacomini et al. The domains identified 1 criteria for decision making, 2 the definition of cut-off points for each criterion, and 3 guidance for conditional coverage decisions Rather, what must be assessed for coverage is the testing service: the laboratory technology, plus a target population, plus a clinical context. The first criterion for decision making was defined as the intended purpose of the technology 43 , analogous to the afore mentioned definition of test purpose suggested by Zimmern and colleagues 6.

The second criterion is effectiveness, which for genetic tests is redefined as clinical utility. Clinical utility is regarded as a function of five nested features including e. One of the other criteria is cost-effectiveness. Interestingly, a systematic review of health economic evidence on genome-based information of new screening tests found that tests for eight conditions have been subjected to economic evaluation and although evidence is still limited, decision makers were recommended to consider the introduction of selective genetic screening for FAP familial adenomatous polyposis and HNPCC hereditary non polyposis colorectal carcinoma The author added that as genetic test costs are declining the existing evaluations may warrant updating, which fits with the concept of health technology assessment as an iterative process of assessing all relevant aspects in different phases of the life cycle of a health technology.

Blancquaert also developed an innovative HTA framework applicable to genome-based health applications see figure 1 In addition, economic analysis can be performed for each dimension or globally The evaluation of the organisation of health care may be seen as a necessary step prior to phase three, where clinical guidelines are transferred to health practice.

Figure 1 HTA framework for genetic tests 46 A limitation of the conventional HTA approach is that the dynamics of technology development are not taken into account. Constructive technology assessment CTA has been advocated as a means to address this issue By acknowledging the socio-dynamic processes of technology development CTA can influence the development and implementation of the technology.

The foundations for these processes have to be laid in phase one of the translational research process, but could continue until the final stages. Close contacts between researchers, innovators and decision makers early in the process are a prerequisite for the success of the approach, guiding and steering the process according to the decision making needs of a specific group of clinicians and patients for instance. Diagnostic methods of CTA include among others traditional social sciences techniques and also socio- technical mapping techniques to identify the past and possible future scenarios of technological dynamics.

An example is a study in the Netherlands where a socio-technical analysis of preconceptional carrier screening for cystic fibrosis and haemoglobinopathies was carried out to elucidate the preconditions for successful implementation Intervention methods in CTA include among others action techniques like awareness initiatives, controlled experimentation, consensus conferences, and dialogue workshops, to influence technological development and application Ideally, a clinical need may be the starting point for basic research and the subsequent development of a new health technology.

This, however, is a relatively rare sequence of events. Additionally to the fact that this HTA framework encompasses dimensions of genetic test evaluation as described by ACCE and beyond it has a clear policy orientation. Thus, decision making can be grounded on a more informed level, it reduces the amount of uncertainty and it can specify the conditions for the use and the implementation of new technologies It builds the basis for the effective and efficient implementation and diffusion of a proven technology and supports research, since evidence is needed to give specific recommendations and support the decision making process in the field of genomics.

Health Needs Assessment As health needs assessment aims to identify the health needs of a local population it supports translational research with tools for prioritisation and identification of areas for needed professional and service development as well as needed requirements of genome-based health applications. Furthermore, education and training needs can be identified for those who are going to apply genome-based health applications 50 as well as for the population health literacy.

As Wright et al.