Senator Eyes Cost Of Genentech Drugs
6 CommentsBy Ed Silverman // October 22nd, 2007 // 4:30 pm
Herb Kohl, the Democrat from Wisconsin who chairs the Senate’s Special Committee on Aging, is suspicious about Genentech’s reasons for ending sales of its Avastin cancer drug to compounding pharmacies. And he’s worried that the biotech’s decision, which was announced two weeks ago, will wind up costing Medicare a great deal of money.
You may recall Avastin is widely used to treat wet macular degeneration, but the biotech never sought FDA approval for that purpose. Why? Well, its much newer Lucentis drug, which happens to cost about 40 times more, was approved for that use. In explaining its move, Genentech cited FDA concerns about contamination when an Avastin vial is split into different doses; the agency issued a warning letter to a compounder recently.
But opthamologists say the decision will likely make treatment much more expensive for some patients - a vial of Lucentis is about $2,000, while Avastin costs between $40 and $50. A Genentech spokeswoman told us that docs can continue to obtain Avastin vials from other sources, such as hospitals, but she objected to the idea that Genetech is trying to promote Lucentis at the expense of Avastin.
Kohl doesn’t buy that argument. In a letter he sent last week to Medicare, which estimates the Genentech move could cost taxpayers between $1 billion and $3 billion, Kohl wrote “most troubling about this proposed plan is the fact that may be, in part, due to an effort to boost sales of…Lucentis.” He also cited recent testimony about “Genetech’s refusal to allow further studies on the use of Avastin in combating many serious eye ailments - including wet macular degeneration - many of which occur in the elderly.” The NIH, by the way, is undertaking such a trial.
Hat tip to the WSJ Health Blog
Paul
So what exactly is Senator Kohl suggesting? That people be treated with a drig for a condition where it has not been studied and no one has a clue whether or not it works?
They are speaking with both sides of their mouths when one day they insist on more safety studies and the other day they insist on treatment without any studies - efficacy or safety.
Paul
So what exactly is Senator Kohl suggesting? That people be treated with a drug for a condition where it has not been studied and no one has a clue whether or not it works?
They are speaking with both sides of their mouths when one day they insist on more safety studies and the other day they insist on treatment without any studies - efficacy or safety.
sea
Can the government really mandate an off-label use? I’m very curious to see how this ends up.
Paul
Another one of their inconsistencies. Senators are all over the news complaining that industry drives off-label use; yet here they are doing it themselves.
Will government accept the liability if something goes wrong for a patient based on the government telling people to use an unproven drug?
Anon
It never seems to be brought up that Lucentis, as a Fab, doesn’t have an Fc region that can cause inflammation (unlike Avastin, which is an IgG), and that was a key *safety* feature in the design of Lucentis - as getting inflammation in the retina of an AMD patient is not going to make anything better..
J. F. Kadlec, M.D.
There is tremendous empirical evidence that Avastin does the same job for people going blind from macular degeneration as Lucentis. The only difference is that Lucentis is two thousand dollars an injection as opposed to Avastin at forty dollars.
Many thousands of people have been treated with the affordable Avastin without any more adverse effects than Lucentis, however, Genentech, the manufacturer of both drugs is trying to restrict the use by imposing onerous conditions, causing people to either come up with the large amount of money (and large amount of profit for Genentech) for Lucentis or go blind.
No…………Senator Kohl is absolutely right. He is concerned that the corporate greed of Genentech is being put ahead of letting people go blind. Let us hope he is successful in keeping Avastin available for treatment of macular degeneration, similar to the way it is utilized in the rest of the world.