After two months of anger and controversy, Genentech has struck a deal with opthamologists over distribution of the cancer med, which many docs use to treat wet macular degeneration, even though it was never approved for that use. The agreement comes shortly after US Sen. Herb Kohl, a Democrat from Wisconsin, called for an investigation into Genentech's decision to halt supplies to compound pharmacies over concerns Medicare costs could rise by $3 billion annually. (Here's the Genentech
statement).
The backdrop: Genentech planned to restrict sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into smaller doses and repackaged for docs. Opthalmologists complained that would hurt patients, because the alternative treatment is Genentech’s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. Lucentis sales haven't taken off, because docs continue to use Avastin.
The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech won’t study Avastin for the eye disease (but the NIH is doing so). At the American Academy of Opthalmology annual meeting last month, one doc called Genentech's move eggregious during a panel featuring a Genentech exec.
The truce calls for allowing docs to buy Avastin from wholesalers, which will ship Avastin to compounding pharmacies. However, a Genentech spokeswoman, Krysta Pellegrino, tells us that issues related to sterilization at a compounding pharmacy processing Avastin is an ongoing concern. Nonetheless, "we're trying to abide by all the regulations and the spirit of the law while at the same time recognizing" that doctors seek access to Avastin for eye use, she says.
An American Academy for Ophthalmology spokeswoman, Siobhan Bunaes, tells Reuters the deal should work for most of its docs, although it could make paperwork cumbersome. She adds, however, that Genentech assured the group it would not raise the price of Avastin. Here's a statement from the group, which calls the deal a "significant step forward."
4 Comments
This case always cracked me up. Here we have a bunch of people up in arms because Genentech was trying to steer people away from an "off-label" indication of a cancer drug and towards a legitimate opthalmic drug. These same people (more than likely) are the ones complaining that pharma companies try to market drugs for off label indications. What hipocrits. People are willing to "bend the rules" a bit whenever it helps thier bottom line -- whether it's consumers or big pharma.
Now that physicians have been successful in gaining access to Avastin for WMD, are they also required, in plain English, to explain to their patients they have decided to administer them a drug that is NOT FDA-approved for safety, efficacy or sterility for WMD, because it's cheaper?
Will they explain there IS an FDA-approved drug for this purpose but they don't like the price?
For patients on Medicare and other insurance, the FDA-approved drug, Lucentis, is covered, as it should be, and physicians place patients at unnecessary risk when using Avastin instead.
We should all be greatly concerned these physicians have now created a precedent where insurers will NOT reimburse for an FDA-approved drug because a pharmacy company can make something cheaper, even though they cannot guarantee the safety, efficacy or sterility of every product they make themselves.
Recent headlines from Oregon where three patients died from a 'mistake' made in a compounding pharmacy begs the question, "How do we justify increased risk based on cost saving efforts as being 'best for the patient?"
Sandra, very good arguement. You stated it much more eloquently that I was able to.
Your article does not mention that Lucentis coverage by OHIP is limited for those diagnozed in the last three months with AMD. I have dry AMD in one and 2 years ago I started treatment for wet. In the last 2 years I spennt close to $10,000 of my savings for the treatment that was to be supplement my little pentionin in later years. The OHIP decision is cruel, insane and discriminatory. What would you say if cancer, parkinson hearth etc. patients would be denyed access to new, more effective drugs because they are not "new" patients. By the way the treatment greatly improved my sight as you can see I could wright to you. Sincerely Marta Guttman