Pharmaceutical Executive Europe - November/December 2007 - (Page 24) 24 Health Economics Nov/Dec 2007 Pharmaceutical Executive Europe Working with IQWiG Frank-Ulrich Fricke examines the implications of Germany’s changing healthcare landscape and explains how pharma managers can prepare for the imminent economic reforms. tarting in February 2006, a wave of healthcare cost-containment reforms have been sweeping through Germany. These measures were designed to deliver savings of €1.0 billion in 2006, rising to €1.3 billion in 2007 and 2008. In July 2006, a further package to restructure the financing of healthcare and create a more cohesive, uniform system was agreed. These reforms impact the German pharmaceutical market in a number of ways and include a stronger role for IQWiG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) in the evaluation of new drugs and technologies. From 2008, after the amendment of its methodologies and in addition to its previous remit for evaluating clinical benefit, IQWiG will be able to conduct cost-benefit assessments of ‘high-profile’ drugs. From that point on, Germany will join a growing number of countries wherein pharmaceutical products are measured with an economic slide-rule before a cent of statutory health insurance funds is made available to procure them. In Germany, however, a product will first gain market access and will then be assessed for subsequent restrictions or withdrawal of prescribability. IMS currently estimates that up to €140 billion of annual global pharmaceutical sales are subject to some form of economic evaluation. Currently and in the future, by satisfying IQWiG’s criteria, a drug can be prescribed via the statutory health insurance, thereby allowing access to a wider prescription market. Failure to S demonstrate efficiency gains is likely to limit the market to those citizens and private health funds that are willing and able to pay up to the full prescription price. IQWiG carries out its work at the behest of der Gemeinsame Bundesausschuss (G–BA), or Federal Joint Committee. The G–BA — part of the self-governing body that oversees the German health care system — is institutionalized as a legal entity under public law. However, it does not have responsibility for the licensing of drugs, which is the preserve of the Federal Institute for Drugs and Medical Products (BfArM). G–BA likens its role to being the “eye of the needle” through which a new drug or method must pass to gain a positive evaluation in terms of benefit and efficiency, before qualifying for reimbursement in outpatient care from the statutory health insurance (SHI) funds. Together, IQWiG and the G–BA act as the muscular gatekeepers of the healthcare market in Germany. Convincing these organisations that a new treatment offers improved value for money over existing interventions has become the key to commercial success. IQWiG assessments of new drugs, other interventions, currently marketed drugs and additional measures that may have a relevant budgetary impact on the SHI are typically commissioned by the G–BA and serve as a basis for a number of important decisions. These include whether to include a drug in a reference pricing group, the prescribability of drugs for SHI
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