Germany's pricing watchdog is extending its spread to cover reviews into the cost-effectiveness of a number of blockbuster products, including diabetes, cardiovascular and rheumatoid arthritis treatments.
The country's Federal Joint Committee (G-BA) issued a statement saying it is looking at drugs of "economic importance" with a high volume of sales in a number of therapeutic areas. The review is being carried out using the controversial AMNOG pricing structure which came into force in January 2011 and the move represents the first time it has appraised already-marketed drugs.
The G-BA has published a list of six areas and ten drugs it is evaluating. Making the list are Johnson & Johnson/Gruenenthal's painkiller Nucynta (tapentadol), Amgen's osteoporosis therapy Prolia (denosumab) and two antidepressants, Servier's Valdoxan (agomelatine) and Eli Lilly's Cymbalta (duloxetine). In the RA arena, the agency is looking at J&J's Simponi (golimumab), Roche's RoActemra (tocilizumab) and UCB's Cimzia (certolizumab pegol).
As for diabetes, the G-PA is going to look at the cost-effectiveness of Novo Nordisk's Victoza (liraglutide) and Byetta (exenatide), the Amylin-developed drug which is now going to be marketed by Bristol-Myers Squibb and AstraZeneca. It is also investigating the value of new bloodthinners from Bayer and Boehringer Ingelheim, namely Xarelto (rivaroxaban) and Pradaxa (dabigatran),
These cost-benefit analysis could very well result in price cuts and pharmaceutical companies have regularly voiced their concerns that the AMNOG system is flawed.