Genentech is notifying ophthalmologists of a change to the distribution of Avastin (a cancer drug also being used to inhibit AMD associated retinal bleeds). Avastin sells for about $50 per dose vs. Lucentis, the new Ocular-specific version of Avastin being used in new AMD clinical studies, which we're told will cost the patient somewhere in the range of $2,000 per dose.
Beginning November 30th, the Lucentis compound must be ordered directly from Genentech, rather than purchased from a compounding pharmacy.
Both versions of this drug have been linked to increased risk of stroke.
The FDA and Genentech claim to be concerned about sterilization issues involved when compounding pharmacists divide Avastin into tiny portions for ocular use.
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8 comments:
At $2000. per dose, wouldn't it be more appropriate to focus on lifestyles, including diet and supplements to prevent this disease in the first place? Seems like a much safer/less expensive way to go.
What's the point of developing a drug treatment so expensive that it's not affordable to most AMD patients. How will medicare ever cover the cost of Lucentis?
$2,000 per dose sounds high - I was under the impression that Lucentis shots were about half that amount.
Hi Barbara,
Unfortunately, the price per injection of Lucentis is about $2,000 or more. Apparently, the wholesale cost is over $1,900.
Ownership of the two drugs by one company that is unwilling to license the cheaper one for AMD use speaks to the important need for the FDA to step up to the plate and address the problem of differential pricing of similar drugs for different diseases.
Even if a clinical trial showed the two drugs to have equivalent efficacy for the AMD patient, Avastin could still not be authorised for AMD use given the refusal by Genentech to license it for that purpose.
What's even more interesting is the timing of the cut off date -- the day before the CATT Study to compare Avastin vs. Lucentis is set to begin.
For more on this controversy, please take a look at my web Journal -- I've been following and writing about this controversy for over a year:
http://irvaronsjournal.blogspot.com
Irv Arons
Irv,
Thanks so much for providing a link to your most interesting blog. I promise to spend some time over the weekend reading a number of your well written articles.
One wonders how these money hungry people face themselves in the mirror?
It's reasonable to make a nice profit, but it's not reasonable to price drugs out of the reach of the people who most need them.
The American Academy of Ophthalmology believes that Genentech’s decision to stop sales of Avastin® (bevacizumab) to compounding pharmacies could have a significant impact on the care of patients with age-related macular degeneration (AMD).
“Our main concern is for our patients with macular degeneration, who have come to rely on Avastin in their fight against potential vision loss,” said Charles “Pat” Wilkinson, MD, president of the Academy. “Together with the retinal community, the Academy is evaluating how this decision will affect patient care.”
Both Avastin and the FDA-approved Lucentis® (ranibizumab injection), another drug sold by Genentech, share a similar method of action by inhibiting vascular endothelial growth factor (VEGF). However, Lucentis was designed and tested specifically for treatment of wet AMD, while Avastin has only been FDA-approved for oncology indications. Prior to Lucentis’ approval, many ophthalmologists had been using Avastin to treat wet AMD, and many doctors continue to use it, citing good clinical results for patients. The National Institute of Health is sponsoring a head-to-head trial between the two drugs starting this year.
“The primary concern of ophthalmologists is preserving the sight of our patients. Because Avastin has also been used off-label to treat diabetic retinopathy, macular edema and various other sight-threatening disorders, Genentech’s decision to restrict availability of the drug has much wider implications than just for AMD patients,” said H. Dunbar Hoskins Jr., MD, executive vice president of the Academy.
The Academy is seeking information from the FDA and Genentech to determine an appropriate and safe solution for patients and their doctors.
According to Genentech, Avastin will continue to be made available directly to physicians and hospital pharmacies through authorized wholesale distributors. However, ophthalmologists need compounding pharmacies to divide vials of Avastin into smaller doses for the treatment of AMD and other eye disorders.
Source: AAO
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