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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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April 4, 2011

Update on Avastin and Lucentis

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Posted by Derek

The Lucentis/Avastin story is going to get more complicated as the year goes on. Next month the results of a head-to-head study of the two drugs (one far less costly than the other) in cases of macular degeneration will be revealed, and it's widely thought that they'll come up as basically equivalent in efficacy.

But as this Wall Street Journal article makes clear, they may not be equal in safely. The same meeting that will see the trial results presented will also feature an analysis of Medicare claims for both drugs, which looks like it'll show that Lucentis has a better safety profile. This is exactly what Roche/Genentech would like to hear, naturally. We'll have to wait until May to see which message wins out. . .

Comments (13) + TrackBacks (0) | Category: Clinical Trials | Drug Prices


COMMENTS

1. pete on April 4, 2011 12:37 PM writes...

Derek, for those of us w/o a WSJ subscription, how about some details from this story. For example, does the story cite the statistical difference seen between the two WRT stroke incidence ? Thanks.

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2. Hap on April 4, 2011 12:47 PM writes...

Well, if there's a safety difference, then I think people are stuck trying to pay for Lucentis over Avastin, and the FDA is going to have to deal with compounding Avastin. If safety is only a showstopper when it doesn't cost the gov't money, well, I think the people that oppose the Democrats' health care reform (let alone single payer options) would have a pretty powerful claim as to why such reforms would be a bad idea.

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3. Mark on April 4, 2011 12:54 PM writes...

#1: Pete

Just look up the WSJ article through google news, you'll get full content.

Mark

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4. pete on April 4, 2011 4:53 PM writes...

@3 Mark
Good point, thanks. Here are a few of the major messages from the article:
- "11% higher risk in overall mortality and a 57% higher risk of hemorrhagic cerebrovascular accident"
- "the findings in the studies are somewhat limited due to incomplete information on potential confounding factors, such as smoking and baseline lipid and blood pressure levels"
- More data to come

As far as I can see, the risks for hemorrhagic stroke and death are already quite rare with Lucentis (Tolentino, M. 2011 Systemic and ocular safety of intravitreal anti-VEGF therapies for ocular neovascular disease. Surv Ophthalmol.Mar-Apr;56(2):95-113.).

So, I wonder, given the 30-FOLD difference in cost/injection between Lucentis vs Avastin -- is this level of added risk with use of off-label Avastin really going to be a show stopper for most eye physicians & their patients ?

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5. Anonymous on April 4, 2011 6:20 PM writes...

That's Roche..it's all about spin, spin , spin! Tweak the data....hummmm...looks like another accutane on the horizon...

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6. RickW on April 5, 2011 6:35 AM writes...

@4 - Most of the time the eye physicians and patients are not paying the 30 fold difference.

Depending on how the NIH trial turns out, could insurance companies decide to pay only for Avastin in these cases?

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7. Connie on April 5, 2011 8:22 AM writes...

As someone who has had multiple Avastin shots in my eye due to a Vein Occlusion and heavy bleeding, I can tell you I had NO problems with the drug, and in my case, it saved my sight. I went from 20/400 to 20/20 or 20/30 corrected, which is what I had been before the bleed. My retinologist, published, and highly respected in his field ALWAYS recommends Avastin over Lucentis. Lucentis is way over-priced ($2,000 or more per shot) compared to Avastin (approx. $600 a shot.) Most insurances won't pay - but I'd spend the money all over again! As far as safety - it is a minute dosage straight into the vitreous in the eye - NOT going into the blood stream as used in chemo treatments. The chances of stroke or high blood pressure from this would be almost non-existent. (I have high blood pressure - it did NOT affect mine at all.) Lucentis company will ALWAYS try to stir up trouble to increase their sales, as the only way most doctors will prescribe is if they can no longer use Avastin.

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8. pete on April 5, 2011 9:25 AM writes...

@7 Connie
Many thanks for your response -- it's always key to hear from someone on the front lines.

Regarding the 30-FOLD cost differential I cited, I based it on the WSJ article:
"Many physicians in the U.S. have started to give patients Avastin rather than Lucentis for the treatment of advanced age-related macular degeneration because of the high price of Lucentis. The drug, which has been designed to treat eye ailments, costs about $1,500 per injection compared to about $50 for an Avastin treatment."
I'm surprised to hear that you're paying as much as $600/injection. It'd be interesting to hear if that's a new pricing trend in response to continued pressure by Eye Docs to allow off-label Avastin ?

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9. Anonymous on April 5, 2011 11:36 AM writes...

Interesting data; 11% sounds like 10 vs. 9 deaths and 57% increase could be 11 vs. 7 strokes. In a sample size of 1200, neither would touch statistical significance. I look forward to the results, with accompanying adjustment for risk factors.

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10. Connie on April 5, 2011 2:58 PM writes...

Not sure how he arrived at the $600 figure. But he charges about $2000 for Lucentis. A couple of years earlier I had another more minor bleed. At the time, I was referred to another retinologist, who had been on the front lines fromt he beginning. He charged approx. $500 at that time (about 3 - 3 1/2 years ago.) So I did not question the $600 charge. Fortunately, my husband's company was self-insured, and their administrating insurance company approved the Avastin shots. Most are not that fortunate. I would have taken out a loan to get the shots if necessary. If I understand the history my original retinologist told me - Lucentis wasn't even developed until good results started coming in from Avastin. They then started to harp on the "sterile qualities" of Avastin vs Lucentis, and saw a good way to ramp up the profits. As probably most of the macular degeneration patients are Medicare or Medicaid - there is a different situation there. In my case - I am a LONG way from that age, and if I have any more bleeds, will probably end up paying out of pocket - WILLINGLY!

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11. pete on April 5, 2011 5:24 PM writes...

@ 10 Connie
Best wishes for the future.

In defense of Lucentis, there was a compelling scientific basis for substituting it for Avastin in opthalmic uses. But it now appears (maybe) that the real-life difference between the Lucentis vs Avastin is not so great in terms of the safety/efficacy relationship. We'll see (pun alert).

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12. Amy S. Patel on April 11, 2011 4:14 PM writes...

There are additional details in this article http://www.baysidesolutions.com/blog/2011/04/avastin-cost-controvers/ about using Avastin for cancer and AMD as well as information on Roche & Novartis.

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13. Judith Delgado on April 11, 2011 6:13 PM writes...

Just to set the record straight regarding Connie's comment, "Lucentis wasn't even developed until good results started coming in from Avastin."

Lucentis was going through the FDA approval process (on a fast track basis). Avastin was used at that time because Lucentis was not available and some retinal specialists recognized that the anti-VEGF properties of this colon cancer treatment might work in the eye as well. Lucentis underwent 7-8 years of development and use in thousands of patients before approval.

It will be interesting to see the CATT results. I know many patients who have benefited from Avastin. I am still concerned about the safety issues of Avastin, particular in relation to particulate matter.

BTW, that $600 Avastin charge probably includes the physician charge, sterile tray, etc. The drug itself is only approximately $50.

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