Highlights of G-BA’s annual report 2020

The G-BA has recently published its annual report from last year, 2020.

Key statistics on the early benefit assessments

• The number of dossier submissions has steadily increased every year, since the benefit assessments were introduced in 2011 (with the exception of 2012). Last year saw a record high of 116 submissions.
• However, out of 444 early benefit assessments that were completed by 31 Dec 2020, the G-BA assigned the highest additional benefit rating, “major”, in only 10 cases. That’s only 2.6%.
• In 2020, the sales of 5 orphan drugs exceeded €50 mn within a 12 months period. Therefore, the guaranteed additional benefit rating for these orphan drugs was no longer valid. Instead, the G-BA conducts full benefit assessments, and the manufacturers were required to submit a full dossier.

Did you know that the AMNOG law has been amended 7 times?

• The AMNOG process is often called a “learning system”, since there were 7 changes to the law (SGB V §35a) so far since its introduction in 2011. The law changes introduced in 2020, covered by the GKV-FKG regulation, included 3 important updates:
  1. Now, ATMPs automatically will undergo a benefit assessment and therefore are reimbursed in the outpatient setting from launch. Previously, the G-BA decided on a case-by-case basis whether the ATMP should be assessed as a method.
  2. “Reserve antibiotics” can be exempt from the benefit assessment upon request by the manufacturer. These “reserve antibiotics” are those antibiotics that
     • are effective against infections caused by multi-resistant bacterial pathogens
     • are used in strictly defined indications
     • have only limited alternative therapy options.
  3. The G-BA now has to consult medical societies and the Drug Commission of the German Medical Association when determining the appropriate comparator therapy.

The full report (in German only) can be accessed here.