Evaluation methods
In principle, assessments should always be made with reference to the present Standard of Care in Switzerland.
The potential (added) benefit of interventions should be comprehensively evaluated; this includes not only clinical/therapeutic effects and quality of life from the individual (patient) perspective, but also benefits from the individual perspective of third parties (involved/uninvolved: “public health benefits”, for example with vaccinations; the latter should in principle be restrictively interpreted).
Socio-economic benefits (including “indirect” consequences for the economy) are included in the evaluation under the criterion of cost-effectiveness (analyses of cost implications and possibly also analyses of efficiency).
Clinical therapeutic effects (including improvements in quality of life) are assessed in relation to their relevance and their magnitude; in addition, the available level of evidence relative to the best level of evidence that can be expected under the circumstances, the practical relevance with regard to the Swiss health system and the quality of the existing studies are also taken into account. This serves to determine the degree of confidence as to whether (and, if so, to what extent) future research is likely to alter the observed effects.
If the outcome of the assessment falls below the (possible) level of evidence to be expected and/or the relevance and/or the quality of the study, this leads to a downgrading of the intervention in the comparative benefit rating.
The intervention may be downgraded by up to two notches, one if
- the documented formal level of evidence is lower than the context-related, best possible level of evidence to be expected; and one if
- the quality of the data is not sufficiently persuasive, either because of methodological deficiencies in the studies or because of the limitations of the empirical data available.
In exceptional cases, a downgrading may be compensated by up to one notch if very major positive effects of an intervention have been observed, if there is an unequivocal dose-response relationship, and if all conceivable sources of bias have been attenuated by the observed effect.
The (added) benefit assessed integratively and categorically from an individual perspective in this way is a basis not only for assessing the suitability and cost-effectiveness of the intervention, but also – together with the latter – for the subsequent decisions of the FOPH on reimbursement and maximum price.
Assessment of suitability
The assessment of suitability adds a social perspective to the individual perspective of the cost-effectiveness assessment. It consists of an examination for conformity with the priority objectives of solidarity-based healthcare within the limits covered by compulsory health insurance. Essential elements for this are not only normative premises, but also empirically demonstrable expectations, including the willingness of Swiss insurers to accept trade-offs (so-called social preferences); for this there is further need for research (see above, “Operationalization of criteria of efficacy, suitability and cost-effectiveness”), especially with regard to the offered validation of the assumptions made on the basis of national and international studies concerning the objectives of a jointly financed healthcare and thus the criteria for suitability, including their ranking and weighting.
Assessment of cost-effectiveness
Analyses of the cost implications for the starting point for any assessment of cost-effectiveness in the context of the HTA process. The aim of these analyses is to establish transparency on the short, medium and long-term consequences of a decision for all payers (including the compulsory health insurance and patients) and, where applicable, for costs to the economy. They include (amongst other things) scenarios with different price assumptions.
If critical budget sums are exceeded for the compulsory health insurance (projected within the subsequent five years in the case of new interventions, actual or projected in the case of existing technologies) formal efficiency analyses are necessary.
Such a universal benchmark would also be only theoretically conceivable if the hypothesis were true that the primary objective of jointly financed healthcare was to maximize the number of QALYs “produced” with a given allocation of resources. From today’s perspective, it has to be seen as empirically false for this assumption (the “QALY maximization hypothesis“) to be squared with the social preferences of the insured person.
According to the principle of a pluralism of methods the economic method of evaluation that should be selected in the HTA process is the one most suitable for a meaningful differentiation of the evaluated intervention(s) in the individual case. This gives rise at the same time to the need for Early Consultations (in the rHTA process) and Scoping (in the cHTA process).
Need for setting limits
The need for setting limits is acknowledged. The limits are derived from the operationalized criteria of efficacy, suitability and cost-effectiveness and include the following:
- with regard to the criteria of efficacy, the demand for a demonstrable added benefit, the relevance and magnitude of effects, the level and quality of the existing evidence,
- with regard to the criteria of suitability, the exclusion of “bagatelles” (based on the triviality of the disorder or the self-financing that can be reasonably expected of the insured person; basis of judgment: analysis of cost implications from insured person’s perspective) from the services covered by compulsory health insurance
- with regard to the criteria for cost-effectiveness, the possible influence of all cost implications (scale of program) on appropriate decisions regarding reimbursement and prices and
- the exclusion (or adequate cost reduction) of technically and productively inefficient technologies.
Potential for further development of method
Building on the agreed principles, there is potential for a targeted further development of the limit-setting method by the addition of an efficiency criterion, which meets the needs of suitability. In this context, promising options appear to be
- in the sense of an approximation] variable cost/QALY benchmarks as a function of the severity and frequency of a disorder and
- [prospectively] direct methods of measuring relative social willingness to pay.
From today’s viewpoint, further research and development are needed for this. Concrete proposals for the next steps will be submitted.
Dealing with uncertainty
HTAs do not eliminate uncertainty, but identify and characterize uncertainty and lack of evidence. A distinction is to be drawn here between clinical and economic evidence that is in principle not (yet) available and evidence that has not been generated but can be expected. Dealing with uncertainty includes the use of modeling techniques (without probative value), including scenario and sensitivity analyses, on the one hand, and of managed entry strategies (fixed-term conditioned reimbursement and reevaluation, coverage with evidence development and risk sharing agreements) on the other.