German regulator assesses more drugs
pharmafile | April 22, 2013 | News story | Sales and Marketing | AMNOG, Bayer, Germany, Pradaxa, Xarelto
A new raft of drugs which will be subject to potentially stringent cost/benefit analysis in Germany has been announced.
The country’s pharma watchdog, the Federal Joint Committee (G-BA), is to decide whether big-name brands including Novo Nordisk’s once-daily GLP-1 analogue Victoza (liraglutide) for type II diabetes, should remain at their current price on the market.
Blood thinners such as Bayer’s Xarelto (rivaroxaban) and Boehringher Ingelheim’s Pradaxa (dabigatran), Johnson & Johnson’s painkiller Nucynta (tapentadol) and Lilly’s antidepressant Cymbalta (duloxetine) are also on the list for potential price cuts.
Pharma will be looking on with some apprehension since the controversial AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) pricing measure, introduced in early 2011, has been heavily criticised – for linking the price of new medicines to generics among other things.
AMNOG states that currently-marketed products can be reviewed as well as new ones, and it seems likely that the companies involved in the latest round of reviews could see drops in the prices they are able to charge for their medicines.
Europe’s pharma industry has been strident in its calls for a re-think on pricing in Germany, saying that it may cause huge damage if current structures remain in place.
Three years ago the German government – looking to cut its drugs bill by more than €2 billion – produced shockwaves in pharma by proposing that mandatory price reductions should be imposed one year after a drug’s launch.
Pharma has been in a bind over this: Germany is Europe’s largest pharma market and therefore highly lucrative – yet its rhetoric and action on pricing is putting considerable pressure on companies.
Boehringer Ingelheim and Lilly went so far as to say they would not launch diabetes drug Trajenta in the country, making it clear that Germany’s pricing controls were to blame for the decision.
Seen in this context, the G-BA’s latest announcement is a continuation of a well-publicised policy – yet that does not make it any more comfortable for pharma.
Adam Hill
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