Saturday, October 13, 2007

Genentech Pulls the Plug on Avastin®

On October 11th, Genentech wrote the retinal community that “Genentech will no longer allow compounding pharmacies to purchase this product from wholesale distributors.” The product in question is Avastin®. Susan Desmond-Hellman, the President of Product Development, stated the reason for this change was that “some” physicians were using Avastin to treat wet AMD and that “the drug had not undergone any formal, random, controlled clinical trials for ocular use.” She also state that Lucentis® was FDA approved for wet AMD. The goal of this decision is to force ophthalmologists to use Lucentis rather than Avastin for wet AMD.

The New York Times wrote that Lucentis was used in about 50% of patients with AMD which means that probably Avastin was used in the other 50%. At Iowa the trend has been back to using Avastin in lieu of Lucentis. Other ophthalmologists whom I’ve talked to are also using Avastin more and more. I suspect that Lucentis was losing market share to Avastin. Genentech, of course, make far more profit from the $2000 dollar a dose Lucentis than from the wholesale Avastin that, even after the compounding pharmacy add its charges, costs the patient around $100.

The Complications of AMD Treatment Trial will compare Lucentis to Avastin. Avastin has been used however, by thousands of retinal doctors in hundreds of thousands patients. These doctors and their patients have concluded that Avastin is a very good treatment for AMD. Most doctors can’t tell a difference between the two drugs. Most doctors use a dosing schedule of every four weeks for Lucentis and every six weeks for Avastin. Patients like this fifty percent increase in the time between injections.

The Genentech letter states that, “no patient should go without one of our approved medicines due to financial barriers alone.” The support system they mention, The LUCENTIS Commitment™ program, involves the completion of a lot of forms and costs the patient and doctor’s office hours of time. The statement implies that Genentech will pay for the drug when in reality they pay for just the part not covered by Medicare or any additional insurance. Americans pay for Lucentis either through taxes or premiums. The Wall Street Journal says that curbing Avastin could cost taxpayers $1 to $3 billion dollars a year.

Genentech is entitled to earn as much money as they can. The American taxpayer is entitled to the best medical care and the lowest price. The problem is that it is not a free market. Congress keeps throwing the wrench into capitalism and seems perfectly willing to give drug companies whatever they want at the expense of their constituents.

The real problem though is that Genentech is now practicing medicine. By restricting access to Avastin, the company is putting itself squarely between the doctor and his patient. The company is telling the doctor what drug he can use and what drug he cannot use. This is a very bad precedent. Genentech should reverse their decision.

3 Comments:

Anonymous Anonymous said...

Dr. Folk,

I'm not following your logic about "Congress throwing a monkey wrench into capitalism". It seems to me that this whole problem is Genetech's doing, not that of any federal or government agency.

7:46 AM  
Blogger MedRounds Publications said...

Dr. Folk responded to the above comment here.

7:11 PM  
Anonymous Anonymous said...

Dr. Folk --
I'd like to highlight your point: "Most doctors use a dosing schedule of every four weeks for Lucentis and every six weeks for Avastin. Patients like this fifty percent increase in the time between injections."

My mother has wet ARMD in both eyes. While legally blind in one eye, the second eye was only subjected to one round of PDT damage before we switched to Avastin in Dec. 2005. She's experienced great results with Avastin.

However as with the PDT, she's one of the subset of patients that just doesn't stabilize with treatment. So for nearly 2 years, she's received injections in both eyes every 6 - 8 weeks.

The overwhelming economic argument aside, I think any policy-maker advocating a pharmacologically unwarranted change to 4 week treatment intervals vs 6 - 8 weeks should be expected to join the fun by having sham injections on the same schedule.

Then it might dawn on them that, though equivalent treatment outcomes may be realized, 50 - 100% more needle sticks HAS to increase the risk of adverse events. This is NOT like switching from once-a-day to twice-a-day dosing of an oral medication.

Thanks for the heads-up on the changing availability of Avastin -- we're scheduled for treatment on 19 Oct.
-- JBB, DVM
Cincinnati, OH

9:45 AM  

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