A New Drug Must Prove It Is Better

Since 1 January 2011, every drug with a new active substance in Germany must prove its Zusatznutzen, its added benefit, when it comes on the market. The manufacturer submits a dossier. The Federal Joint Committee, the highest self-governing body of German health care, then decides whether the drug is better than the established treatment it chose for comparison. If no added benefit is shown, statutory health insurance pays a price based on comparable drugs that already exist. New treatment methods face a similar test. In outpatient care, the Social Code allows them to be billed to statutory insurance only after the committee has recognized their benefit, auch im Vergleich zu bereits zu Lasten der Krankenkassen erbrachte Methoden, also in comparison with the methods the insurers already pay for.

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