Schuster stick to your last: IQWiG and health economics

The GKV-WSG has given the IQWiG an additional task: It is supposed to prepare cost-benefit analyzes for medicines, on the basis of which the umbrella association of the Federation of Health Insurance Funds sets maximum reimbursement amounts. The legislature wants these analyzes to be prepared “according to the international standards of evidence-based medicine and health economics recognized in the respective specialist circles” (§ 35 b SGB V). It is becoming increasingly clear that IQWiG is neither willing nor able to fulfill this mandate. The latest evidence is an essay by IQWiG director Peter Sawicki together with the senior IQWiG editor and a pharmacist employed by IQWiG with additional economic training (Dintsios et al. 2009).

>> The article explains once again why the IQWiG method paper on cost-benefit analysis (IQWiG 2008) largely deviates from health economic standards and presents a concept that is not in line with all previous approaches to economic evaluations of health services. Again, it is met with incomprehension that “many statements, especially from German health economists, were particularly critical” (Dintsios et al. 2009: 32). What remains unmentioned is that foreign economists have without exception expressed criticism of the methods paper and even the Scientific Advisory Board of IQWiG has joined this criticism, even though there are hardly any specialist economists on it. In addition, the authors mock the legislature: The legal requirement to “link “internationally recognized standards of evidence-based medicine (ebM)” and “authoritative international standards, especially health economics” places special demands on future health economic methods” (Dintsios et al. 2009 : 34). And this means, the authors conclude, that the IQWiG must set the standards of health economic evaluation itself, largely ignoring the health economic experts and their findings.
According to the IQWiG authors, who do not belong to these specialist groups, this is primarily due to three things: Firstly, the “standards of evidence-based medicine ... have been in development for 50 years and have now matured to such an extent that they are no longer seriously controversial internationally are” (Dintsios et al. 2009: 34), while this apparently does not apply to the health economic evaluation methods that have been in development for 40 years. Secondly, the German healthcare system is completely different from the rest of the world as “it is not subject to any fixed national budgeting” (Dintsios et al. 2009: 33); a fallacy that has become clear since the introduction of Section 71 SGB V (principle of contribution rate stability) and at the latest since the establishment of the health fund and the uniform health insurance contribution. Thirdly, “the IQWiG proposal is an attempt to preserve the … principle of solidarity” (Dintsios et al. 2009: 32). “Health economics should ultimately help create a living environment that is important to a solidarity-based society” (Dintsios et al. 2009: 34). And in the opinion of IQWiG, internationally recognized health economic standards are not sufficient.
Did the apparently completely naive legislator not see this when he formulated Sections 35b and 139a? And do health insurance companies and health care decision-makers need the IQWiG to “preserve the principle of solidarity anchored in German social law” (Dintsios et al. 2009: 32) and to determine “what a society considers to be ‘just’” (Dintsios et al. 2009 : 34)? In order to still meet the legal requirements and maintain the integrity of our welfare state, “the institute has commissioned a committee of international experts in health economics and related subject areas to specify such standards” (Dintsios et al. 2009: 34). What the IQWiG authors do not mention is that the majority of this committee was made up of non-specialist economists, one of the best-known international health economists, a Dutchman, left the committee in anger, a second one left in the meantime and one of the few health economists on the national scientific advisory board of the IQWiG also abdicated.
An increase in health economics expertise is unlikely to be expected at IQWiG in the future. According to the advertisement, IQWiG is looking for a doctor with experience in health services research for the position of head of the health economics department.
Resolving paradigms
The evaluation of health services should always be carried out on an interdisciplinary basis, but this does not mean that the disciplines patronize each other and set new standards in their respective foreign fields. How would it be received by medical professionals if a commission made up of a majority of non-medical professionals were to question the “holy grail” of EbM? The image of Don Quixote striving for justice and solidarity in the form of the IQWiG in the fight against the evil spirit of “objective utilitarianism” of the health economists (Dintsios et al. 2009: 32) seems to be very worn out after all the discussion that has taken place. Wouldn't it make sense if each discipline cared about the methods for which it has the specialist knowledge and was open to discussion towards other disciplines? This is now the basis of an interdisciplinary health technology assessment (HTA) worldwide, which IQWiG is apparently still having a very difficult time with.
The task of developing an efficient and targeted method paper for cost-benefit assessment for the German statutory health insurance is not difficult at all. It helps if you break away from the paradigm: “Looking at other countries only helps to a limited extent.” (Dintsios et al. 2009: 34). For example, the English National Institute for Health and Clinical Excellence (NICE) has 10 years of experience in the field of HTA, including the economic evaluation of health services. It is worth looking at the NICE methods (National Institute for Health and Clinical Excellence 2008) and adapting them to national circumstances (Redwood 2008;schulenburg et al. 2007).
Then we might have achieved what was missing from the IQWiG method paper in the first attempt:
• Consistency (e.g. in the IQWiG method paper, the interpretation of the legal situation differs in the main part and the cost appendix, as well as the information on the sensitivity analysis and the discount rate to be used)
• Clear separation of value judgments and factual statements (the derivation of the cardinal measurement of benefit remains completely obscure. Instead of adapting the internationally common concept of QALYs, which has been researched for 40 years, IQWiG speaks vaguely of a sum score that has yet to be developed and the need for willingness -to-pay studies)
• Clear guidelines for studies (the methods paper contains neither clear statements on cost nor benefit measurement nor on the treatment of long-term effects and uncertainties)
• Compatibility of the general foundations of economic theory (the extension of the efficiency frontier is a normative and arbitrary IQWiG invention)
• Transparency (the evaluation process has so far remained obscure or arbitrary)
• Readability and clarity in the language (many sentences are not understandable or have been poorly translated from English. The central terms such as costs, yield, benefits, effect of benefits and value of benefits are not defined)
NICE has developed a method paper that represents a solid basis for a systematic HTA program in the form of the technology appraisal system and enables a comprehensive and targeted assessment of the clinical and health economic evidence according to the current state of science. The cost-effectiveness or cost-utility of the technology to be evaluated is calculated, whereby the preferred outcome measure - IQWiG would speak of a sum score - is quality-adjusted life years (QALYs) (Gafni/Birch 2003). This measure, which was developed in large population studies with many thousands of people around the world using the latest scientific methods, is flexible and adaptable to the needs of the respective decision-maker.
When evaluating new medical technologies, NICE attaches great importance to a high level of transparency and participation of the relevant interest groups. As the figure makes clear, six phases can be identified in the evaluation process (Rothgang et al. 2004): Phase 1 characterizes the prioritization or selection of technologies for the evaluation process by the Ministry of Health. A technology is considered a priority if a high additional benefit or a high cost burden is to be expected. The NICE selection team includes representatives from the public and external organizations. (National Institute for Health and Clinical Excellence 2008)
Phase 2 concerns the actual creation of the HTA report by one of currently seven independent academic research institutions. The creation of the HTA report is divided into two crucial sub-points: the so-called scoping and the assessment. During scoping, the essential parameters for the assessment are determined together with external interest groups: among others. the target population, alternatives and benefit parameters. During the assessment, the evidence underlying the technology is systematically recorded and evaluated. As an important end result, cost-effectiveness is expressed as an incremental cost-benefit ratio wherever possible. If necessary, a suitable model will be created to synthesize the clinical and economic evidence. Manufacturers and other external stakeholders have the option of submitting their own data and models, which, however, must correspond to a specified standard, the so-called reference case (Fig. 1.).
On the basis of the HTA report, the actual conclusion for the NHS system is drawn in the third phase: whether and, if so, in what form (generally, in studies, for subpopulations) a technology will be offered by the National Health Service. At this point, among other things, the so-called threshold value comes into discussion. Up to what cost-to-benefit ratio should a new intervention be reimbursed? While IQWiG would like to calculate its own threshold for each indication based on cost and benefit data from products already on the market using a methodologically and scientifically unsound procedure, NICE works with a corridor of £20,000 to £40,000 per additional given for all indications QALY, although deviations occur. If an intervention is rejected by the NICE Appraisal Committee, all stakeholders involved in the assessment process (consultees) have the opportunity to object. Once the appraisal is valid, the report is published in the fourth phase of the assessment process.
In the fifth and sixth phases of the evaluation process, the short- and long-term conclusions of the HTA report are implemented and evaluated. In the fifth phase, NICE formulates its guidelines, which are highly relevant to clinical practice, as these are binding for local primary care trusts. The sixth phase concerns the Healthcare Commission's evaluation of the impact of the NICE Guidance. A so-called health check is carried out annually, which is intended, among other things, to evaluate the local situation of the implementation of NICE guidelines and the general performance of the NHS.
If studying and adapting well-founded methods for evaluating health services that have been tried and tested abroad is too laborious, there is still a pragmatic way forward. This is even more recommended because “IQWiG prefers a pragmatic approach” (Dintsios et al. 2009: 33). It could have simply adapted the third revised version of the Hanover Consensus (Schulenburg et al. 2007). This consensus is a methodological guideline for the cost and benefit assessment of health services in Germany, which was signed by over 70 representatives of the health economy, the medical profession, health insurance companies, state institutions and industry. Instead of providing an unscientific approach that never achieves the recognition of health economics experts and those affected, a consensus that has already been achieved offers many advantages. <<