Division of application areas possible?

19.06.2012 09:35

In the newsletter of the Federal Joint Committee for the month of May, its impartial chairman, Dr. Rainer Hess that as an amendment in the hearing on the “16. AMG amendment” a consideration has not yet been brought forward

This is to allow the pharmaceutical company to exclude areas of application for which it cannot prove any additional benefit from the ability to prescribe as uneconomical in order to negotiate a higher reimbursement amount for those areas of application for which it believes it can demonstrate an additional benefit. In this respect, Section 34, Paragraph 1b, Sentence 9 of SGB V allows the G-BA to determine the inefficiency of the regulation for areas of application of a medicinal product that can be used for fixed amounts if the medicinal product has been removed from a group for fixed amounts due to a proven therapeutic improvement in another area of application .
According to Hess, the same would have to apply if the National Association of Statutory Health Insurance Funds agreed a correspondingly appropriate reimbursement amount with a pharmaceutical company based on a proven additional benefit - for an area of application of a new active ingredient limited to the corresponding patient group - because then the regulation does not have an additional benefit documented area of application would be uneconomical. However, a manufacturer cannot force such a decision with a correspondingly restricted application. Rather, the dossier must be submitted in full and remain fully verifiable by the G-BA with regard to proof of benefit