My Notes
Lucentis -
Macular degeneration is the leading case of blindness in patients over the age of 55 in the United States. It affects about 10 million Americans.
Lucentis, manufactured by Genentech is the number one approved drug for the treatment of neovascular or "wet" AMD, a condition that if left untreated leads to blindness.
Treatment with Lucentis is not a cure,for it merely stabilizes the wet form of macular degeneration, and in many patients prevents the condition from worsening.
This means that it must be administered as a maintenance drug.
At a cost of $2,000/dose and a once-a-month dosing schedule, the cost to treat the half-million "wet" AMD patients in the U.S. would be greater than $10 billion per year!
This is more than the entire Medicare budget ($4.77 billion in 2006) for all of ophthalmology (cataracts, diabetes, glaucoma, and everything else) combined. In 2004, the entire Medicare Part B budget for all drugs for all medical fields was $12 billion!
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My Math: --------------------
Lucentis Math for Wet AMD: -------------------------- $2,000 * 12 months = $24,000 $2,000 * 24 months = $48,000 $2,000 * 36 months = $72,000
Avastin Math for Wet AMD: -------------------------- $60 * 12 months = $700 $60 * 24 months = $1,400 $60 * 36 months = $2,160
One practitioner said that he uses Lucentis much more now because his office has streamlined reimbursement issues. Does the extra $80 income per dose (and the likely need for more frequent injections) influence practice patterns?
Lucentis Practioner for Wet AMD: ------------------------------- $80 * 12 months = $960 $80 * 24 months = $1,920 $80 * 36 months = $2,880
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This was not good news for Genentech, because although treating AMD with Avastin® is an off-label use (Avastin® is approved for treating colon and certain lung cancers), the cost of the treatment is between 1% and 3% of the cost of Lucentis® treatment ($20-60 per dose versus $2,000/dose).
patentdocs.typepad.com
The drug has not been without controversy, however, since it is not a cure for AMD but merely stablizes the wet form, and in many patients prevents the condition from worsening.
This means that the drug must be administered like insulin or other maintenance drugs. At a cost of $2,000/dose and a once-a-month dosing schedule, the cost to treat the half-million "wet" AMD patients in the U.S. is greater than $10 billion per year.
According to Dr. Edward Chaum, Plough Foundation Professor of Ophthalmology, University of Tennessee, this is more than the entire Medicare budget for all of ophthalmology (cataracts, diabetes, glaucoma, and everything else) combined.
patentdocs.typepad.com
With Avastin and Lucentis, things are not always as they appear. This is more than a simple case of off-label prescribing. Both Avastin and Lucentis are produced by the same pharmaceutical company, Genentech.
Lucentis is a direct derivative from the original drug Avastin, with both being almost identical in molecular makeup.
amdsupport.ca
In a retrospective chart review published in the British Journal of Ophthalmology, it appears that Lucentis or Avastin are equally effective at decreasing macular thickness and volume. Avastin appears to last longer than Lucentis.
Another paper published in the Graefes Archive of Clinical and Experimental Ophthalmology reveals that Avastin accumulates within retinal pigment epithelial (RPE) cells. Lucentis however, does not accumulate.
Thus, the study concluded that there are substantial differences in the pharmacokinetics of these two macular degeneration drugs.
A third study published in Investigative Ophthalmology and Vision Science reported that higher does of Avastin resulted in higher cell death of photoreceptors. This study compared Avastin treatments with Macugen treatments. Lucentis was not considered as part of this study.
Researchers concluded that the destruction of photoreceptors may be important for patients suffering from a variety of eye diseases, including macular degeneration and diabetic retinopathy, especially if Avastin treatments were continuing for a period of time.
amdsupport.ca
Like other injections given into the eye, serious eye infection (endophthalmitis) and detached retina have occurred with LUCENTIS.
Increases in eye pressure have been seen within 1 hour of an injection. Your eye doctor should monitor your eye pressure and eye health during the week after the injection. lucentis.com
LUCENTIS - WET AMD - Efficacy The figues below show the Lucentis Trial Results in terms of efficacy agingeye.net
Ranibizumab (Lucentis®) 0.5 mg Increases Stroke Risk February 2, 2007
Ranibizumab 0.5 mg intravitreally significantly increased the incidence of stroke (1.2%) in patients with neovascular, age-related macular degeneration compared to the 0.3 mg dose (0.3%, p = 0.02) in an interim safety analysis of the ongoing SAILOR study. These stroke rates are both lower than the stroke rate observed in previous clinical trials. The risk for recurrence appears to be higher in patients with a prior stroke. A complete safety analysis will be available later in 2007. Use ranibizumab with caution in patients with a history of stroke.
healthcare.utah.edu agingeye.net
Feb 11, 2009 Lucentis increases risk of stroke
A meta-analysis of data from three large clinical studies finds that intravitreal injection of Lucentis (ranibizumab) is associated with increased risk of stroke, also known as cerebrovascular accident (CVA).
A total of 859 subjects were treated with monthly Lucentis, and 434 subjects were sham-treated. During the 2-year observation period, 19 of the Lucentis-treated subjects (2.2%) were found to have CVA, whereas 16 (1.9%) were found to have MI. Of the sham-treated subjects, 3 (0.7%) were found to have experienced CVA, whereas 13 (3.0%) were found with MI during the period. According to the current meta-analysis, intravitreal Lucentis was associated with the incidence of CVA (Odds Ratio: 3.24), whereas there was no apparent association between intravitreal Lucentis and MI.
These results indicate an association between intravitreal injections of Lucentis and the subsequent incidence of CVA. The authors recommend that patients be made aware of this complication before treatment.
An earlier meta-analysis found a nonsignificant trend toward a higher risk of stroke with Lucentis use.
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