Boehringer Ingelheim and partner Eli Lilly have decided to delay the launch of their new once-daily diabetes treatment Trajenta in Germany, despite winning EU approval last month, because they are waiting for the outcome of pricing negotiations with the German government.
Moreover, if the government decides to set Trajenta's pricing too low under the recently-introduced Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance (AMNOG), the companies may decide not to introduce the drug in Germany at all. Launches in other European markets are in the process of being organised, they said in a statement.
The European Commission approved Trajenta (inagliptin) for use as a monotherapy and in combination with metformin and sulphonylurea drugs on August 25, following the lead of the US Food and Drug Administration which cleared it in May.
Lilly chief executive John Lechleiter criticised Germany's healthcare reforms earlier this year, saying that the AMNOG was overly-complex and tried to determine the value of a new drug before there was any real-world experience with its use.
In a harbinger of the current decision, Lechleiter said that AMNOG raised the risk that new medicines which can benefit patients "will be delayed or withdrawn."
The decision about whether to launch Trajenta in Germany hinges on how the pricing authorities decide to make that assessment, and specifically which comparator drugs will be used in determining its price.
This so-called functional comparison could mean that Trajenta will be compared to older, less effective treatments, compromising its ability to command a price that reflects its innovative nature.
Trajenta is a dipeptidyl peptidase-4 inhibitor will compete against Merck & Co's Januvia (sitagliptin) first launched in 2007, and line extension Janumet (sitagliptin and metformin), as well as Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin) and Novartis' Galvus (vildagliptin).
Boehringer Ingelheim and Lilly maintain that unlike its peers, Trajenta can be given at a single (5mg) daily dose with no adjustment needed to cater for patients with impaired kidney or liver function.
Around 6.8 million people in Germany have type 2 diabetes, and two thirds of them exhibit some level of kidney dysfunction.
Boehringer Ingelheim and Lilly are concerned that not only will the comparison be inappropriate, but also that there will be little transparency about the decision-making process.
"Ongoing talks with payers suggest there is no readiness to set appropriate prices for innovative new medicines," commented Engelbert Guenster, head of Boehringer Ingelheim 's German operations.