Financial Times (01/24/12) Smith-Parker, Jennifer
Pharmaceutical companies that hope to gain higher reimbursement in Germany must show that a new drug is not only effective, but an improvement on standard care. On Jan. 1, 2011, a law known as AMNOG mandated that companies introducing new drugs submit a cost-benefit dossier to G-BA, the ultimate decision-maker in German healthcare. G-BA can then consult with the Institute for Quality and Efficacy in Health Care (IQWiG). AstraZeneca’s heart drug Brilique, the first drug evaluated under the new pricing process, is an example of Germany's requirements that drug makers boost trial-design efforts. Although AstraZeneca compared Brilique to four different comparators in four patient populations, IQWiG only issued a moderately positive preliminary assessment. Essentially, payers in Germany said that the Phase III trial design was enough for regulatory purposes, but not for reimbursement purposes. Companies must consider adding patient outcome measures as trial endpoints since Germany is the largest market in Europe and the reimbursement it sets could be considered in other countries. Adherence to these requirements would force pharmaceutical companies to spend added months or even years designing trials. Many companies are forced to choose between less patient outcome data and faster market entry with low price point, or paying millions more for long-term studies with the possibility of garnering a better price point that could lose them market share.

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