Transparency Issues Floor Novo Nordisk's Tresiba At IQWiG
This article was originally published in The Pink Sheet Daily
Executive Summary
IQWiG has said that Novo Nordisk's refusal to make public part of its dossier for its diabetes therapy Tresiba represents a lack of transparency and makes the drug impossible to recommend.
Germany's junior reimbursement watchdog IQWiG is blaming Novo Nordisk AS's determined secrecy for the failure of its diabetes therapy Tresiba (insulin degludec) to secure a high assessment grade. With IQWiG now saying that Tresiba offers no added benefit over existing therapies, the Danish manufacturer is going to find it difficult to secure a decent price in a market in which it refused to launch last year.
In a decision published Aug.1, IQWiG's official stance is that Novo Nordisk's Tresiba dossier was simply incomplete. The reimbursement watchdog says certain studies were excluded for no recognizable reason, and that studies included in the dossier lacked important information concerning methodology and results.
A spokesperson for Novo Nordisk said that the company disagreed with IQWiG's assessment. “While we submitted comprehensive data and background information, IQWiG still considers our dossier incomplete,” the company said.
Problems relating to the dossier are more complex than these IQWiG and Novo statements indicate.
IQWiG is required to publish its findings and the justifications for them, including modules 1 to 4 of the dossier submitted by the pharmaceutical manufacturer. In the case of Novo Nordisk and Tresiba, IQWiG said it was in these modules that vital information was missing.
IQWiG did concede that the information required was all contained in module 5 of the dossier. Still, the entire contents of module 5 are subject to commercial confidentiality. This means that IQWiG cannot put this information into the public domain if the manufacturer refuses to allow this.
The legal framework behind the reimbursement process – contained within the law on the restructuring of the pharmaceutical sector, AMNOG – does not permit IQWiG to include in its assessment information that it is not able to publish in its final report, or which has been censored or obscured. If such information were included without having been published, IQWiG explains that this would lack transparency and make the result incomprehensible.
IQWiG confirmed that Novo Nordisk had refused to permit the publication of the details contained in module 5 of the Tresiba dossier.
The manufacturer stressed that it is not normal practice to make raw data from clinical trials public in the way IQWiG wants.
Indeed, the debate over what should and should not be made public has been raging across Europe for years. While the European Parliament voted in favor of the Clinical Trials Regulation in April 2014, which includes legislation on wider transparency, the European Medicines Agency announced in July that it would postpone the publication of its policy on sharing data from clinical trials until October (Also see "MEPs Pass Clinical Trials Laws But Implementation Will Be Troublesome" - Pink Sheet, 3 Apr, 2014.).
Novo Nordisk spokesperson said the Danish company 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. “We have an established and very open process for making clinical data available to researchers. Access can be granted to datasets from Novo Nordisk sponsored clinical trials completed after 2001 for product indications approved in both the EU and U.S.,” they said.
Tresiba Trials And Tribulations
It is not the end of the drug in Germany - even if the manufacturer refuses to budge on the transparency issue -because it is the senior reimbursement body, G-BA, and not IQWiG that has the last word on the matter. However, if G-BA confirms IQWiG’s decision, it is hard to see how the drug will make it to the pricing negotiation stage with the statutory health insurers.
Still, the Novo Nordisk spokesperson said: “IQWIG assessment is the first step in a longer reimbursement process in the German market, and we are still confident that we will come to a solution with the German authorities to the benefit of people with diabetes in Germany.”
The IQWiG decision is just one of a number of stumbling blocks encountered by Tresiba.
Ironically, Novo Nordisk was reluctant to launch in Germany precisely because it believed that the AMNOG-based reimbursement assessment would not give the drug a fair chance (Also see "Novo Nordisk Withholding Tresiba From German HTA Process" - Pink Sheet, 20 Aug, 2013.).
In August last year, Novo Nordisk CEO Lars Rebien Sørensen said of the German reimbursement authorities in an interview with “The Pink Sheet DAILY”: “They have been very restrictive recently on all new drugs and so we’re concerned that if we launch we would be forced by their non-acceptance to withdraw the product.” If G-BA backs IQWiG's stance, this might still happen.
The company already had a foretaste of the German situation when, in April this year, the French reimbursement authority, the Transparency Commission, decided that while Tresiba was effective for diabetes patients, it offered no additional benefit compared with existing therapies.
On the other side of the Atlantic, Tresiba is faring little better. In February 2013, FDA said it found a cardiovascular signal in its evaluation of clinical data involving Tresiba and wanted additional CV data from a dedicated outcomes trial before completing the NDA review (Also see "Novo Nordisk Dismayed By “Complete Response” Letter For Insulin Degludec" - Pink Sheet, 11 Feb, 2013.).