Pharmaceutical Executive Europe - November/December 2007 - (Page 26) 26 Health Economics Nov/Dec 2007 Pharmaceutical Executive Europe reference pricing group set, the treatment guidelines laid down and any prescribing exclusions from SHI funds. If this proves unsuccessful, a final challenge can be made and the case heard before the Social Courts. A successful challenge may mean referral 2 back to the G–BA for reconsideration. Throughout the appeals process, the product in question may remain on the market and the manufacturer can establish the brand. Thus, although the delay of the assessment can benefit the product, the process will nevertheless incur additional costs. Early planning critical Companies hoping to supply pharma products in Germany need to start looking for the positive economic impact of their new healthcare intervention early in the development process. In doing so, companies should consider patient potential, current pathways of care, and the financial impact of the illness. From this analysis, they will need to develop strong value hypotheses as well as demonstrate the clinical difference their new treatment will make. All this will need to be translated into financial terms. For the major international pharma companies, such a process is likely to fit in with current best practice; for others, some procedural adjustments will be required. But even such a rigorous approach might not be sufficient to secure prescribability, potentially resulting in the need to consider discount pricing. This may not, however, be quite as damaging as it first sounds. reduce the choice of treatment for patients. This, in turn, may further differentiate the quality and quantity of care, with those who are privately insured and/or willing to pay more out of pocket having access to those treatments which are more in line with their individual preferences and are potentially more expensive. Public reaction to the reforms will in part depend on the media attention attracted by IQWiG’s work and the strength of the patient lobby. The patient’s perspective — particularly in terms of health endpoints that describe a patient ‘feeling better’ — is not fully considered by IQWiG. Over time, such neglect may lead to public dissatisfaction with the changes to the healthcare system, putting reforms once again on the German health policy agenda. ■ References 1. Recommendations on the conduct of evaluations can be issued by everybody. IQWiG will most likely take into account the recent update of the Hanover Consensus Guidelines for its own methodology paper. 2. Social Courts cannot overrule the G–BA without referral. Discounting The Social Code makes provision for manufacturers and sickness funds to agree discount contracts; most statutory health insurance funds have these contracts in place, which do not affect public or reference prices across the rest of Europe. In other words, a discount in Germany does not mean a discount elsewhere in Europe. Recent experience in Germany shows that such discount contracts can be an effective way of either staying on the market (as in the case of short acting insulin analogues) or entering the market (as with generics). By establishing a discount contract with a sickness fund, those companies marketing generics have been able to gain market share and, in some cases, gain a handsome dividend. Patients, too, benefit from the discount schemes, not only in terms of access to treatments they would not otherwise have had, but also because the presence of a discount contract enables sick funds to release their patients from co-payments. About the Author Frank-Ulrich Fricke is principal, Health Economics and Outcomes Research at IMS Health, based in Germany. He has a particular focus on health economic evaluations (cost analysis, economic modelling, cost effectiveness analysis), market access strategies and health policy. Formerly co-founder and managing director of Fricke & Pirk, Frank-Ulrich previously worked for several years in the pharmaceutical industry in health economics, pricing and health policy, latterly as head of health economics at Novartis Pharma in Nuremberg. His professional experience encompasses health economic evaluations across a range of markets and therapeutic areas, and his main professional interests are health economic modelling, health technology assessment, health policy and healthcare system research. Frank-Ulrich holds a Masters degree in Business Administration and a PhD in Economics from Bayreuth University. Patients and prescribers: an alternative scenario Where pharma companies are unwilling or unable to negotiate a discount contract, one effect of the economic belt-tightening reforms may be to limit the toolkit available for prescribers and
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