Health technology assessment of medical devices

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5 Methods in health technology assessmentAs stated in a policy brief by the EuropeanObservatory on Health Systems and Policies,“in order to give an evidence-basedsolution to the problems outlined in thepolicy question, the researchers undertakingthe assessment will need to specifythe policy question in terms of safety, efficacy,effectiveness, psychological, social,ethical, organizational, professional andeconomic aspects. These research questionsdetermine how the rest of the assessmentwill be conducted, the aspectsthat will be evaluated and those that willnot ... Formulating research questions is acrucial part of the assessment, since theytranspose the original decision-makingproblem, the policy question, into questionsthat can be answered by evaluatingscientific evidence”(5). Depending on thespecific context of the decision-making,the dimensions needed by the decisionmakermay vary. For example, hospitalbasedHTA tends to focus much moreon specific organizational dimensions,compared with HTA for decision-makingby a ministry of health.The Health technology assessmenthandbook by the Danish Centre forHealth Technology Assessment providesan excellent overview of most of themethods needed and used internationallyin HTA (7). It is important to note thatan economic analysis is often, but notalways, part of an HTA. The economicdimensions may include cost-benefitanalysis, cost-utility analysis, costeffectivenessanalysis, cost-minimizationanalysis, and also budget impactanalysis and other forms of economicassessments. As always in HTA, themethod must be appropriate for thedecision-making process to be informedby the HTA. Quality-adjusted life years(QALYs) and disability-adjusted life years(DALYs), as used in cost-utility analyses,are often seen as the hallmarks of HTA,but in many situations budget impactis much more important and useful fordecision-makers.Formal methods for using HTAs producedin one setting and putting them into thecontext of another setting are receivingincreasing attention. One example isthe HTA adaptation toolkit developed aspart of the European Network for HTA(EUnetHTA) collaboration (8).12Health technology assessment of medical devices
6 Links between health technology regulation,health technology management and healthtechnology assessmentHealth technology regulation (HTR),health technology assessment (HTA) andhealth technology management (HTM)are complementary functions to ensurethe appropriate introduction and use ofmedical devices.While the regulatory processes concernall medical devices and drugs to somedegree, HTA is usually reserved for complexproblems. Table 1 summarizes someof the differences and complementaryroles of health technology regulationand HTA.Table 1. Comparison of health technology regulationand health technology assessmentCharacteristicsPerspectiveHealthtechnologyregulationSafety andefficacyHealthtechnologyassessmentEfficacy,effectiveness andappropriatenessRequirement Mandatory Recommendationon complextechnologiesRole Prevent harm Maximizeclinical and costeffectivenessPractitioners from HTM and HTA have hadonly very limited interactions in the past.However, as requested in the World HealthAssembly resolution WHA60.29 on healthtechnologies, Member States are urged“to formulate as appropriate nationalstrategies and plans for the establishmentof systems for the assessment, planning,procurement and management of healthtechnologies in particular medicaldevices, in collaboration with personnelinvolved in health-technology assessmentand biomedical engineering”(9).It is useful to compare the dimensionsof HTM and HTA to gain an appreciationof their respective contribution to policydecisions that ensure the most appropriatediffusion of health-care technologies,such as medical devices. Table 2compares HTM and HTA along severalvery broad dimensions. Understandingand supporting the synergy between HTMand HTA will be a major factor for thesuccess of national health technologypolicies.Table 2. Comparison of health technologymanagement and health technology assessmentDimensionHealthtechnologymanagementHealthtechnologyassessmentPerspective Health facility SocietalOrientation Community served Population healthMethodCriteriaProjectmanagement,technology lifecycleNeeds analysis,alternatives,specificationsSystematic criticalreview, metaanalysisClinicaleffectiveness, costeffectiveness,appropriatenessOutcome Decision Policy/decision/practiceHTR, HTA and HTM are distinctactions for enabling the best use ofhealth technologies, especially medicaldevices, for better health care and betterpopulation health. Close links need tobe established between the three, butit is essential to keep these activitiesseparate. For example, in order to supportdecision-making for complex problems,HTA examines all significant intendedas well as unintended consequences ofWHO Medical device technical series13
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