Saturday, December 02, 2006

Avastin/Lucentis Update 9: A Disturbing Report about the Upcoming Trial Between Avastin and Lucentis

In my ongoing efforts to keep the public informed about the status and availability of Avastin and the upcoming clinical trial comparing Avastin to the already approved Lucentis for battling age-related macular degeneration, I have received permission from the editors of Executive Laser Report to reprint their disturbing findings about these drugs from the recently concluded American Academy of Ophthalmology meeting held in Las Vegas.

Retina Report from the 2006 AAO meeting in Las Vegas, November 12-14, 2006
Published in the November 30th issue of Executive Laser Report

Industry entities (pharmaceutical and device companies in general – not just Genentech) reportedly are attempting to prevent the newly announced head-to-head trial sponsored by the National Eye Institute (NEI) of Genentech’s Lucentis and Avastin in AMD. Dr. William Rich, an American Academy of Ophthalmology legislative expert, said, “We are very concerned about an intervention of industry into getting this trial carried out…We are monitoring it very carefully…We do anticipate some interference with the start of this trial by industry…Industry is going to petition not to see this trial carried out…I wouldn’t be surprised (to see the trial stopped). And public interest groups (e.g., AARP) around the country are going to be watching carefully, too.”

Asked how industry could interfere with the NEI trial, Rich said there may be petitions that (1) the trial is not necessary, so the government shouldn’t pay, or (2) the government shouldn’t pay because the treatment (Avastin) is experimental. He added, “I think Genentech is classy enough that I don’t think they would interfere in Washington. The company is known for its ethics, but the entire pharmaceutical and device industry is threatened (by the trial). I would be shocked if there aren’t discussions going on in Washington now about this trial.”

There was a strong emphasis at AAO on the price differential between Lucentis and Avastin and the impact of that cost difference on the US economy (about $5 billion more than if Avastin were used). Other countries simply will not use Lucentis, experts emphasized, so Avastin has to be studied as a public health issue, because that is what other countries will use. Dr. Rich emphasized that the NEI trial is not a “cost-based” trial because cost is not a factor in Medicare coverage today, rather the trial is to resolve “public health issue” because of the non-US countries that will be using Avastin.

Currently, Avastin is covered by Medicare for AMD in 48 states. The co-pay cost to a Medicare patient is roughly $60 for Avastin vs. about $440 for Lucentis. Most retina surgeons said they are giving patients a choice between the two drugs, asking them what they want to pay or how often they want to come in (monthly with Lucentis or once every 6-8 weeks with Avastin).

How many patients are choosing Avastin? Sources indicated the split is about 50/50. That was also the finding of a Retina Society survey. So, why are Lucentis sales strong? There are doctors who don’t want to use an off-label product. There could be some stocking, but retina specialists didn’t think that was a major factor.

Genentech has created a lot of ill will in the ophthalmology community. There is a definite negative attitude by retina specialists toward Genentech. Their attitude is reminiscent of the way interventional cardiologists felt several years ago toward Johnson & Johnson because of its monopoly (and perceived high price) for the Palmaz-Schatz cardiac stents – and for which they punished J&J for years after competitors were available.

This article was reprinted with permission from the November 30th issue of Executive Laser Report, published by Emerging Trends in Medicine. For information on subscribing to Executive Laser Report, please contact Emerging Trends in Medicine, by clicking on the connecting link.

Author’s Note on Avastin

Since posting the original article on January 31, 2006, I have now posted ten updates on this important drug for treating age-related macular degeneration. In addition to the posting you are reading, here is a listing (with links) to the others:

Avastin: A New Hope for Treating AMD (January 2006)

Avastin Update: Medicare not Likely to Cover its Use (March 2006)

Avastin Update II: AAO supports Medicare Coverage for Off-label Avastin Use (April 2006)

ARVO 2006: A Further Update on Both Avastin and Lucentis for Treating AMD (May 2006)

Avastin/Lucentis Update 4: FDA Approves Lucentis for Treating Wet AMD (July 2006)

Avastin Update 5: NIH Considers Comparing Lucentis and Avastin (August 2006)

Avastin/Lucentis Update 6: Latest Results Published in NEJM and Another Call for a Trial Between Them (October 2006)

Avastin/Lucentis Update 7: BREAKING NEWS – NEI/NIH Will Fund Comparative Study (October 2006)

Avastin/Lucentis Update 8: A Report of the Latest News from the 2006 AAO Meeting (November 2006)