Pharmaceutical Executive Europe - November/December 2007 - (Page 25) Pharmaceutical Executive Europe Nov/Dec 2007 Health Economics 25 members, and treatment guidelines. In addition, based on an IQWiG assessment and according to the law, the head association of the sick funds must set a maximum reimbursement price. The IQWiG assessment will be based on its own predefined criteria, which, together with its data sources, will be set out early on in the process in a ‘report plan’. This is published as part of IQWiG’s operational procedures, which also involve a ‘draft report’ ahead of a ‘final report’ for the G–BA. The G–BA then conveys its recommendations to the Ministry of Health (BMG), which considers whether the decisions taken by the G–BA are legally robust. IQWiG is consulting a number of international experts regarding the potential methodology — although again it is unclear on what basis these ‘experts’ were selected. The new imperative: demonstrating value To succeed in the reformed German healthcare market, pharma companies must focus on a range of short- and long-term solutions providing a clear pathway through an IQWiG assessment. In particular, they will need to revisit reimbursement and market access processes. In the past, pharma companies could, following market authorization, market a product, set the price and receive full reimbursement. This will change. With the new processes in place, companies can still set the price but they will need to assess the likelihood of an IQWiG/G–BA approval. Developing health economic information, including a health technology evaluation, and preparing thoroughly for an IQWiG assessment is therefore essential. For some companies, it will call for a new set of skills and techniques. The opportunity for pharma managers to engage with IQWiG during the assessment process, which will begin with IQWiG conducting a scoping workshop and inviting stakeholders to comment on the extent of the assessment, is emerging. Consultations on the report plan will be held, followed by hearings on the draft reports. In between, evidence available to be included in the assessments will be discussed informally. To be prepared for these ‘encounters’ pharmaceutical companies should compile the evidence available and potentially produce their own parallel Health Technology Assessment (HTA), based on internationally accepted standards (INAHTA or DAHTA) and written by specialist authors. Judging by the proposed IQWiG ‘report plan’ for the assessment of a particular treatment, pharma managers will need to compare the suggested population, intervention, comparator and outcomes of mortality, morbidity and quality of life with their own notions about their product. They should also evaluate the criteria for the study/article evaluation selected, as well as the deployed search algorithm. This can be done best by comparing the report plan with an HTA. IQWiG’s assessment process may last 12 months or longer; managers will need to follow this closely, especially with regard to publication of the draft report, which is issued with an invitation for comments to be discussed subsequently at a private hearing with IQWiG. Thorough preparation is essential, but the timescale for turnaround is short — a mere four weeks. IQWiG’s final report should take into account revisions agreed at the draft report stage, but at this point there will be no scope for a further appeal to IQWiG regarding the final report it submits to the G–BA. The next opportunity for an appeal is directly to the G–BA once their decision has been made. Appeals can challenge the The current situation At the time of going to press, IQWiG was preparing its new assessment methodology paper and is expected to announce the selected methodologies (Version 3) in Q4 2007. This will allow pharma companies very little time to prepare for assessments beginning in 2008. Statements emanating from IQWiG and G–BA officials suggest that, as before, the new process may involve a health benefit assessment as the first step. If no such benefit is perceived, then no cost-benefit assessment will be conducted. If, however, there is believed to be benefit over existing treatments, a costeffectiveness analysis will be conducted. To determine whether any new drug offers a health benefit gain, comparisons will be made with the current care regimen for patients within the SHI sector defined in the report plan. Based on current IQWiG practice, many health benefit assessments, but only a few cost-benefit assessments, can be expected — mainly because (so far) very few evaluations have revealed additional benefits from new therapies. New treatments that are innovative, high-profile, expensive, and likely to be in demand by a large number of patients are the most likely G–BA targets for an IQWiG assessment. Staying ‘off the radar screen’ of the G–BA and other institutional players in healthcare may therefore become a strategic necessity for some pharma companies in Germany. Quite what constitutes ‘expensive’ is not defined by IQWiG, but it is likely to be a fluid threshold. Cost-effectiveness according to IQWiG It is also unclear precisely what form IQWiG’s technical cost-benefit analysis will take. However, the following ‘good practice’ guidelines can be expected to influence its final shape: ● Recommendations of the Panel on Cost-effectiveness in Health and Medicine. ● Published guidelines for authors and peer reviewers of economic submissions to the British Medical Journal. ● The New England Journal of Medicine policy on costeffectiveness analyses. ● Set of German recommendations on the conduct of economic 1 evaluations.
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