Not so NICE for Victoza®
This morning we learned that the United Kingdom’s National Institute For Health and Clinical Excellence (NICE) recommend Victoza®, Novo Nordisk’s (NYSE:NVO) daily GLP-1, as add on therapy for poorly controlled patients with type 2 diabetes. According to their web site; “NICE has recommended the use of liraglutide (Victoza), a once-daily injection, for the treatment of type-2 diabetes as part of triple therapy regimens, under latest draft guidance.”
However all was not so nice when you read the entire statement which includes the following passage; “Under the draft guidance, liraglutide is not recommended for use in dual therapy or in the 1.8mg daily dosage.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “We are pleased to recommend liraglutide, 1.2 mg daily, as a clinically and cost effective treatment option as part of triple therapy regimens for some patients under restrictions.
“However we felt that there was not sufficient evidence to recommend it in dual therapy regimens for type-2 diabetes mellitus. The Committee concluded that there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual therapy regimens for this type of diabetes. The next step for the manufacturer is to consider the committee’s comments and respond to its concerns.” Highlighting added by Diabetic Investor.
This news by NICE is in sharp contrast to the recent decision by the FDA to allow Byetta from Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) to be used as a monotherapy. It should also be noted that Novo originally was seeking approval for Victoza as a monotherapy from NICE. It’s even more interesting that this recent news from NICE is not even mentioned on the Novo web site nor did the company issue a press release on this news. Diabetic Investor assumes that the folks at Novo aren’t celebrating President’s Day and are working today. But then again one should never assume anything when it comes to what Novo does or does not do.
The fact is, try as they might to down play all the issues with Victoza the folks at Novo are facing a major marketing problem with the drug. It seems the more we learn about Victoza the more questions that come to mind. While this is not all that unusual for a new drug, it should send a message to everyone who believes Byetta and Victoza just because they are from the same class of drugs work the same way. The fact is unlike Victoza, the concerns surrounding Byetta and its sister compound Byetta LAR, have been very consistent.
Victoza and Byetta are both GLP-1’s but as we learning what applies to Victoza does not necessarily apply to Byetta. Or put more simply, while Novo continues to use the term “class effect” when trying to explain the many issues with Victoza, all publicly available data does not support their assertion.
The real proof will come soon enough as the PUDFA date for Byetta LAR is fast approaching. Should LAR gain approval on time and without a black box warning as Diabetic Investor expects then the real fun begins. It will also be interesting to see how Novo responds as their claims of a “class effect” will largely go down the drain. This is where Victoza could find itself if the company isn’t careful.