Assessment of drugs in the established market
In June 2012 the G-BA applied the previous Section 6 of §35a of Social Code Book V (“AMNOG paragraph”) for the first time and specified that drugs of the established market were to undergo a benefit assessment (“call-up” of established drugs). This referred to patent-protected drugs that had already been on the market before January 2011, i.e. before AMNOG came into effect. In February 2014 the legislator backpedalled and stopped all planned assessments of the established market by changing the law (14th Social Code Book V Amendment Act).
The first assessment of drugs of the established market referred to the class of gliptins. These drugs are used to treat people with type 2 diabetes, largely in combination with other drugs. The individual drugs investigated were saxagliptin, sitagliptin, and vildagliptin, in each case also in fixed combination with metformin. They were approved between 2007 and 2009 and were all competitors of linagliptin, which entered the market in 2012. In the early benefit assessment, the added benefit of linagliptin was classified as “not proven”. In order to ensure equality of competition between the older gliptins and the newer linagliptin and to give consideration to their relevance in health care, in June 2012 the G-BA also called up the older gliptins for early benefit assessment and requested the pharmaceutical companies to submit dossiers.
The company Novartis, whose drugs vildagliptin and vildagliptin/metformin were to be assessed, took legal action at the Higher Social Court of Berlin-Brandenburg. Novartis could only achieve an extension of the deadline for dossier submission, but could not prevent the procedure of benefit assessment.
Storm of protest
Of all gliptins assessed, IQWIG could determine an added benefit only for sitagliptin as mono- or combination therapy. In addition, the G-BA determined a hint of a minor added benefit for saxagliptin, also as mono- or combination therapy. The assessments by IQWiG and the G-BA caused a storm of protest from diabetes specialists and pharmaceutical companies. However, there were also positive reactions, for example from the Drug Commission of the German Medical Association.
Pros and cons regarding the end of the assessment of the established drug market
It was then not surprising that political efforts were made from autumn 2013 onwards to stop the regulation of the established market. On 20 February 2014 the 14th Social Code Book Amendment Act was passed in the German Bundestag, sealing the end of the procedure. Not all of those involved agreed with this change in the AMNOG procedure. Whereas it was welcomed by the G-BA and the German Association of Research-Based Pharmaceutical Companies (VfA), Wolf-Dieter Ludwig, the Chairman of the Drug Commission of the German Medical Association (AkdÄ) as well as patient representatives emphasized that, in view of the numerous pseudo-innovations, how important it was also to subject older drugs to a benefit assessment. IQWiG’s Director Jürgen Windeler also regards the assessment of older drugs to be indispensable. However, in his opinion this does not necessarily have to be regulated in AMNOG.