G-BA updates Rules of Procedure in line with adjusted AMNOG legislation
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
With the adjusted "AMNOG-rules” the G-BA now again has the possibility of an early benefit assessment of pharmaceuticals marketed before the introduction of the AMNOG process. This new rule may apply to active substances which are newly introduced into the German market in an indication that differs from the one previously launched. While the original version of the AMNOG process already provided the option of such an assessment, the legislator repealed the legal basis for the evaluation of medicines in the so-called “existing market (Bestandsmarkt)” in April 2014. Now the about-face: with the adoption of the Rules of Procedure, the G-BA will again be able to carry out a benefit assessment for drugs with active substances that were first marketed before 1 January 2011, if the drug will be authorized in a new indication and covered by a new data protection period.
The two further amendments to the Rules of Procedure allow a streamlining of the AMNOG process. With shortening the waiting period for a reassessment according to §35a SGB V due to new scientific findings, the new regulation offers pharmaceutical entrepreneurs a more rapid assessment of new evidence. So far, an application for a reassessment was only possible after one year; now the application can be timed that with expiration of the one year waiting period the G-BA will immediately start the new evaluation procedure.
In addition, the Rules of Procedure adjustment leads to more flexibility for the G-BA in respect of bundling several benefit assessments of the same active substance. Upon request of the pharmaceutical manufacturer, the statutory deadline for submitting the required evidence for an AMNOG process may be postponed by up to 6 months, if the authorization of at least one new area of application is to be expected within that period. The application must be submitted no later than three months before the actual legal deadline.
In summary, the amendments to the G-BA Rules of Procedure imply both an extension of the competences of the G-BA in the context of the possibilities of starting an early benefit assessment of pharmaceuticals as well as a flexibilization of the way how the assessment procedure will be carried out.