Germany's IQWiG angers Novo Nordisk with Tresiba rejection
This article was originally published in Scrip
Germany's IQWiG, the country's health technology appraisal institute, has rejected Novo Nordisk's Tresiba (insulin degludec) for "formal reasons," claiming it was unable to reach a conclusion on the drug's additional benefit. Novo Nordisk has objected to the assessment's outcome.
IQWiG said that Novo Nordisk's submission was incomplete, which was why the institute rejected Tresiba to treat type 1 diabetes mellitus. One of the three studies IQWiG had identified as relevant to the evaluation, NN1250-3585, was not included in Novo Nordisk's submission.
In addition, there are five modules in an IQWiG submission, but in this case only information from modules 1-4 was included in the analysis. This was because Novo Nordisk objected to IQWiG publishing the information in module 5, meaning that IQWiG was unable to use the information at all because of transparency rules.
"IQWiG cannot include any data in the assessment which should not be published in the report or would have to be blackened. The result would no longer be transparent and understandable," explains Matthias Heck, who heads up the Brussels office of the BPI, a German association representing pharmaceutical firms. IQWiG said there was not enough information in modules 1-4 to conclude the assessment.
Novo Nordisk, however, said that it disagreed with IQWiG's decision. The company said it submitted "comprehensive data and background information," and that IQWiG could find all of the missing information in module 5.
The company said it had good reason to object to the publication of the information in module 5, which it says contained confidential data. "It is not normal practice to make raw data from clinical trials public in the way IQWiG asks for," the company told Scrip. "Novo Nordisk has a publicly available code of conduct for the disclosure of clinical trial information in compliance with the Declaration of Helsinki, and applicable laws and guidelines."
"This move is certainly not easy for us," commented Krisja Vermeylen, managing director of Novo Nordisk in Germany. "On one side is our transparency in the handling of trial data in the first place. On the other hand, we must protect our operating and business secrets."
Nevertheless, Novo Nordisk said it is confident that it can come to a solution with the German authorities. The IQWiG assessment is the first step in the German reimbursement process, and there are still opportunities for the company to turn things around.
Novo Nordisk originally boycotted the German market with Tresiba, amid fears that an assessment in the country would not acknowledge the drug's benefits (scripintelligence.com, 22 August 2013). The company was afraid that it would have to sacrifice too much on price. Other innovative diabetes drugs have also fared badly under Germany's AMNOG process (scripintelligence.com, 17 December 2013).