Tweaks To German Pharma Law Require Firms to Prove Drugs' Value Within a Year
Last-minute tweaks to Germany's pharmaceutical sector restructuring laws (AMNOG) require drug firms to provide evidence of a product's value within 12 months of launch – or risk having it struck off the reimbursement list.
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German elections have led to the possibility of several coalition government constellations, but none are particularly good for the pharmaceutical industry.
Withholding Tresiba from Europe’s biggest drug market seems counterintuitive in view of the ultra-long-acting insulin’s spreading acceptance elsewhere. But in doing so, Novo avoids having Germany’s reimbursement authorities questioning its benefits and demanding a price cut.
Despite overall economic growth, the German health ministry refuses to lift the pharmaceutical price freeze or obligatory rebate to health insurers, saying industry is coping well with them; firms say they have already sacrificed more than had initially been asked.