Avastin/Lucentis Update 38: The Controversy Continues “Across the Pond”

It seems that the Brits also want to use Avastin instead of Lucentis in treating AMD, and the UK’s cost-effectiveness body of NICE (the National Institute for Health and Clinical Excellence) is taking the first steps to appraise the off-label use of Avastin to replace the already approved use of Lucentis in AMD. As reported by Nick Smith of APM Health Europe, it appears that Lucentis’ high cost is beginning to effect the UK’s NHS and thus a look at the lower-cost anti-VEGF version, Avastin.

(I have written about the Brits (and others in Europe) wanting to use Avastin in the past – please see the references at the end of this report.)

Here, with permission of the  publisher, is the latest story from Europe.

NICE set to examine cost effectiveness of Avastin off-label in ophthalmology

APM Health Europe

LONDON, May 4 (APM) - UK cost-effectiveness body NICE is taking the first steps in appraising the cost-effectiveness of Roche's cancer drug, Avastin (bevacizumab) in off-label use for ophthalmology, on the instructions of Britain's Department of Health. NICE indicated to APM it has not yet concluded if such an appraisal is possible but, presuming it is, the likely end result of Avastin proving a lot more cost-effective than Novartis' Lucentis (ranibizumab) looks likely to put a dent in the sales of Lucentis internationally.

Citing restrictions on what can be communicated in the run up to the UK's general election, NICE refused to expand on its exploratory findings but pointed to an earlier unheralded statement on its website. In short, this says NICE has been asked by the DoH to look at the feasibility of conducting such a study (the usual process) and, while the request is unusual, it is within its remit.

Nice notes that it gave the green light to the use of Lucentis by the National Health Service in 2008 for use in age-related macular degeneration but also that read-out on head-to-head trials of it and Avastin in ophthalmology are expected late 2011 and 2102. NICE concluded that it will report back to the DoH, including the opinions of stakeholders it has garnered, in early summer.

SAFETY?

Speaking to APM on Tuesday, both Roche and Novartis said NICE had not yet approached them for an opinion on the assessment. Neither were positive on the move, with Roche pointing out clearly that Avastin was not indicated in ophthalmology and that even if the drug worked in "fundamentally the same way" the development of Lucentis, particularly its stronger binding properties, made it significantly different.

Roche, via its subsidiary Genentech which developed Avastin and Lucentis, retains the rights to Lucentis in some markets including the U.S. and first quarter sales were worth $327 million, up a reported 27%.

Novartis told APM it had been made aware of the instructions to NICE by the government but also that NICE had not indicated how it intends to take the issue forward. However, the company said it is "concerned" by the direction given by health ministers, given the "availability of a licensed and NICE approved treatment, ranibizumab."

Novartis stressed the trial data supporting Lucentis' use and its NICE approval, specifically noting it had to come up with a special pricing scheme to gain the green light for NHS funding.

On the issue of Lucentis versus Avastin in AMD trials, Novartis said these "will not deliver the robust safety data available for ranibizumab." Novartis did not specifically give an opinion on whether Avastin was safe in ophthalmology but stressed it was developed and approved as a cancer drug.

PROBLEMS

Nevertheless this latest development highlights the problems faced by Novartis in Lucentis' relatively short history with the company needing to come up with various special pricing schemes to get it accepted in several markets. That achieved - even if margins may have been squeezed - with first quarter sales of $364 million, up 59%, the drug was beginning to move in the direction of the earlier big sales targets of some analysts.

However, data published in Ophthalmology in December suggesting equivalent efficacy will not help Novartis and, given NICE's well-established international influence, a positive opinion on Avastin looks like it would at best dampen the upward sales path. Even ahead of this, many countries are already known to use Avastin in AMD - including some UK hospitals, as NICE itself acknowledges.

Roche does not have a clear run either, with head-to-head trials of the two being conducted in the world's biggest market. (The CATT Study)

(Editors Note: According to Dr. Daniel Martin, in charge of the CATT Study (Comparison of AMD Treatments Trials) in the U.S., there are at least five other large comparative studies, in addition to CATT, underway around the World. For the list, see: Avastin/Lucentis Update 34: More on the Comparative Studies.)

From NICE's point of view, its earlier thinking that patients should be blind in one eye before being eligible for treatment in the other is one of the most derided decisions it has ever made.

Other writings on this topic:

Avastin/Lucentis Update 15: The Brits Join in on the Fight

Avastin/Lucentis Update 16: And Now the Germans Join the Battle

Avastin/Lucentis Update 25: Comparative Studies Proliferate – France Joins the Fray

Avastin/Lucentis Update 34: More on the Comparative Studies