Avastin/Lucentis Update 17: The Controversy Heats Up Once Again
Genentech Restricting Avastin Sales To Curb Eye Use
Posted by Jacob Goldstein
WSJ Health Blog
October 11, 2007, 2:39 pm
The toughest competitor for Genentech’s eye drug Lucentis has been Avastin, a Genentech cancer drug.
Today, though, Genentech said it wouldn’t let wholesalers sell Avastin to compounding pharmacies, which have been taking Avastin out of vials and putting it into pre-packaged syringes for eye treatment.
Avastin isn’t approved for use in the eyes, but it’s very similar to Lucentis, which the FDA cleared last year to treat an eye disease called wet macular degeneration. Some doctors substitute Avastin for Lucentis because a dose of the cancer medicine used for the eye disease is a lot cheaper. Avastin used that way costs about $40 a month compared with $2,000 a month for Lucentis. (Physicians are free to prescribe drugs for unapproved uses.)
In a letter explaining the decision (see below), Genentech pointed out that Lucentis was developed expressly for use in the eyes, and that the FDA has expressed safety concerns over the re-packaging of Avastin.
In the first six months of this year, U.S. sales of Avastin were $1.1 billion, and Lucentis sales were $420 million.
Avastin, which is sold through wholesalers, will still be available to hospital pharmacies and directly to doctors after the company ends sales to compounding pharmacies at the end of next month.
But Anne Fung, a San Francisco ophthalmologist, said she worries that some doctors, unable to buy the drug from compounding pharmacies, may do the re-packaging work themselves without the proper safety equipment. “This move is taking it out of a regulated environment into an unregulated environment,” she told the Health Blog. That could increase the risk of contamination and serious eye infections.
Fung, who said Avastin and Lucentis are split roughly 50-50 among macular degeneration patients, said she would likely try to get Avastin from a hospital pharmacy, which might charge her more than the compounding pharmacy.
Genentech spokeswoman Dawn Kalmar pointed out that most wet macular degeneration patients are covered by Medicare, and said the company helps connect patients who can’t cover their copay (which can be $400 a month for Lucentis) with charities that help with payment.
Here is a copy of the Genentech letter:
Letter to Physicians
October 11th, 2007
Dear Retinal Community Member:
On behalf of Genentech, manufacturer of Avastin® (bevacizumab), I am writing to inform you of a change to the distribution of this product. Like all of Genentech's FDA-approved oncology products, Avastin is distributed directly to physicians and hospital pharmacies through authorized wholesale distributors. Genentech has also permitted compounding pharmacies to purchase Avastin from authorized wholesale distributors. As of November 30, 2007, Genentech will no longer allow compounding pharmacies to purchase this product directly from wholesale distributors. This change does not otherwise impact the distribution of Avastin nor will it remove Avastin from the marketplace or otherwise limit a physician's prescribing choice. Physicians can still order Avastin directly from authorized wholesale distributors.
Avastin is an infused medication approved by the U.S. Food and Drug Administration (FDA) for use in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum and in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
Despite the availability of LUCENTIS® (ranibizumab injection), an FDA-approved treatment for neovascular (wet) age-related macular degeneration (AMD), some ophthalmologists are using Avastin for the unapproved treatment of this and other ocular indications. Avastin is not FDA-approved for ocular uses and is not manufactured to meet U.S. Pharmacopoeia (USP) ophthalmic standards. This change will not go into effect until November 30, 2007 to allow for physicians and compounding pharmacies to adjust to this change in distribution.
A series of events have contributed to our decision to make this change to our distribution of Avastin. Most important among these events is the FDA approval and broad availability of Lucentis for patients with wet AMD. Subsequent to the approval of Lucentis, the FDA raised concerns related to the sterility and repackaging of Avastin for ocular use in a Warning Letter to a compounding pharmacy and, separately, during a routine FDA inspection of our South San Francisco manufacturing facility, concerns were raised by inspectors related to the ongoing ocular use of Avastin because it is not designed, manufactured or approved for this use. In addition, we note that Avastin has not undergone any formal, randomized, controlled clinical trials for ocular use.
We recognize this change may require some adjustment on your part and are acknowledging this by notifying you seven weeks prior to the change taking effect. In addition, I would like to reiterate Genentech's commitment to patient access to our approved products. We have always believed that no eligible patient should go without one of our approved medicines due to financial barriers alone. As such, we have invested in a dedicated support services organization to assist with providing patients access to our medicines. Specific to Lucentis, we offer The LUCENTIS Commitment™, a comprehensive support program dedicated to facilitating timely reimbursement. If you or your patients have any questions related to our access and reimbursement services, please contact us toll-free at 1-866-724-9394.
Should you have questions or comments about this distribution change, I encourage you to contact us at firstname.lastname@example.org. We will do our best to respond to your inquiry by the end of the next business day. Thank you for your patience and understanding as we move forward with implementing this change.
Susan Desmond-Hellmann, M.D.,M.P.H.
President, Product Development