AMNOG Germany’s new drug re-imbursement law
According to §35a SGB V (German Social Security Code) reimbursable drug products with new drug substances are now subject to a benefit assessment by the Joint Federal Committee. This requires that the marketing authorization holder needs to submit a cost-benefit dossier (“value dossier”) parallel to the market introduction, if they want to obtain reimbursement of the full price for the first year , which substantiates the additional benefit of the drug product.
Dr Regenold GmbH is able to assist clients with the preparation and submission of the “value dossier”.