New drug for type 2 diabetes is no better than older, cheaper treatments, says institute

BMJ 2012; 345 doi: (Published 19 December 2012) Cite this as: BMJ 2012;345:e8593
  1. Ned Stafford
  1. 1Hamburg

The agency responsible for evaluating the effectiveness of drugs in Germany has for a second time concluded that linagliptin, a new drug used to treat type 2 diabetes, offers no added benefit over older, less expensive treatments already on the market.1

The agency, the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Healthcare), widely known as IQWIG, is evaluating linagliptin as part of a complex process to determine the reimbursement price paid by Germany’s public health insurance system to drug companies to cover the cost of treatment with the drug.

Linagliptin was approved in 2011 for use in the European Union and the United States. It was developed under an alliance between the drug companies Boehringer Ingelheim and Eli Lilly and has been introduced in more than 30 countries under the trade names Trajenta or Tradjenta.

In its most recent assessment of linagliptin, announced on 3 December, IQWIQ said, “No added benefit of the drug over the appropriate comparator therapy (ACT) can be determined, because the pharmaceutical company has not submitted any relevant studies.” The appropriate comparator therapy includes treatment with the sulfonylureas glibenclamide and glimepiride.

Boehringer Ingelheim Germany issued a statement the same day as IQWIG’s announcement, disagreeing with the assessment.2 The company said that it and Eli Lilly had provided evidence that the drug had “clear additional benefits” in the treatment of patients with type 2 diabetes. The company’s statement also cited a study published in the Lancet that found that linagliptin was associated with significantly fewer cardiovascular events than glimepiride.3

The institute’s negative assessment is not the final decision in the process but only a recommendation to the Federal Joint Committee, which has the last word on the issue.

Thomas Mueller, head of the pharmaceuticals department at the committee, told the BMJ that drug companies, medical associations, and any other clinical experts interested in the issue can give written statements until 24 December. A hearing will be held in January at which oral statements can be given.

A final decision from the committee is expected by the end of February, Mueller said. If the Federal Joint Committee found that linagliptin had additional benefits, then the drug company would be able to negotiate a reimbursement price with the umbrella organisation of public health insurers. If no agreement on price were reached, an arbitration commission would set the price.

He added that if the committee decided that linagliptin had no additional benefit, a price would be set whereby the annual treatment cost was no higher than the cost of the appropriate comparator treatment.

In its first assessment of linagliptin in January this year IQWIQ was not able to find any added benefit because Boehringer Ingelheim had chosen sitagliptin as the comparator therapy instead of a sulfonylurea. In March the Federal Joint Committee agreed with IWQIG’s assessment. Boehringer Ingelheim then applied for a new assessment of linagliptin and submitted a new dossier to IQWIG.


Cite this as: BMJ 2012;345:e8593