Genentech sparks fallout with physicians over Avastin supply

Due to the company’s refusal to supply compounding pharmacies, the AAO and the ASRS seek information for physicians, patients.

ByJessica Loughery

In the wake of Genentech’s announcement that it will stop selling bevacizumab to compounding pharmacies, ophthalmology groups such as the American Society of Retina Specialists and the American Academy of Ophthalmology attempted to interpret how the restriction might affect patient care.

In the company’s Oct. 11 letter to physicians, it announced that, as of Nov. 30, Avastin (bevacizumab, Genentech) will only be available directly to physicians and hospital pharmacies through authorized wholesale distributors. The anti-VEGF drug has been approved by the U.S. Food and Drug Administration for oncology indications only but is widely used off-label by ophthalmologists to treat wet age-related macular degeneration.

“We anticipate that [physicians] will find alternate means of accessing Avastin so that this does not interfere with their prescribing choice, nor does it interfere with their ability to prescribe and use Avastin as they see appropriate,” Dawn Kalmar, spokesperson for Genentech, told Ocular Surgery News in a telephone interview.

She said some physicians will not have to find alternate means of accessing bevacizumab because hospital pharmacies will continue to have access to the drug after Nov. 30 and many physicians order the drug through this channel already.

“I think that what they’ve done is ask physicians to essentially jump through one more hoop to get their patients Avastin,” said Jay S. Duker, MD. “The patients will get the Avastin anyway, and all [the company] ends up doing is making it more difficult for the physicians and engendering more ill will amongst the physicians.”

Decision sparks concerns

The American Society of Retina Specialists (ASRS) and the AAO echoed some private practitioners’ concerns about what this decision will mean for physicians and patients.

The AAO believes that Genentech’s decision could significantly affect the care of patients with AMD, the organization said in a press release. Ophthalmologists need compounding pharmacies to divide vials of the drug into small doses for treating AMD and other eye disorders, according to an AAO statement.

Both the AAO and the ASRS are seeking additional information to determine an appropriate and safe solution for patients and their physicians.

“Our first effort here is to strongly express our unhappiness to Genentech and very rapidly to assess what all our options are,” Julia A. Haller, MD, president of the ASRS, told OSN in a telephone interview. “To that end, we’re approaching the FDA, we’re approaching our congressional representatives, and we are also retaining top legal counsel for advice.”

“Knowing that this was going to require adjustment on the part of physicians, ... we offered 7 weeks advance notice so that they could discuss how they were going to address this,” Ms. Kalmar said. “In addition, we’ve had conversations with both leadership at the AAO and the ASRS to make sure they are addressing this from the community standpoint.”

Sterility, repackaging issues

In Genentech’s letter to physicians, the company noted the FDA’s recent concern over the sterility and repackaging of bevacizumab because the drug is not approved for ocular indications. However, some believe the company’s decision stems from monetary, rather than sterility, concerns.

“There’s the belief in the investment community that off-label use of Avastin is going to continue to hurt Lucentis (ranibizumab, Genentech) sales,” John Pollack, MD, told OSN. “From my perspective, Genentech has taken a decidedly adversarial stand against the retinal community by attempting to limit their access to Avastin. I don’t think that anyone in the retina community believes for a second that Genentech’s move is related in any way to FDA concerns related to sterility and repackaging of Avastin by compound pharmacies because they’re regulated and licensed on the state level.”

Steven J. Cosentino PD, RPh, CRA, of Rockwell Compounding Associates in Rye, N.Y., agreed.

“I’ve been compounding Avastin since August of 2005 at an accelerating rate, and I have dealt with up to 17% of the retina specialists in the country,” Mr. Cosentino said. “I have not had one reported case of contamination.”

Head-to-head trial

Genentech points to bevacizumab’s molecular cousin, ranibizumab, as an appropriate, available replacement treatment for wet AMD. Both drugs share a similar method of VEGF-blocking action, but ranibizumab was approved by the FDA for use in wet AMD in June 2006.

A head-to-head clinical trial, the Comparison of Age-Related Macular Degeneration Treatments Trials, is scheduled to begin in early 2008. The randomized trials will be conducted at 40 sites throughout the United States and will involve about 1,200 patients with 2 years of follow-up.

“I think the best solution is always to get as much data as we can, and therefore, the Avastin vs. Lucentis trial is critical to really see how good is Avastin and how well does it compare to Lucentis,” Dr. Duker said.

For more information:

Steven J. Cosentino PD, RPh, CRA, can be reached at Rockwell Compounding Associates, 350 Theodore Fremd Ave., Rye, NY 10588, U.S.A.; +1-914-925-2304; e-mail: scosentino@rockwellcompounders.com.

Jay S. Duker, MD, can be reached at New England Eye Center, 750 Washington St., Box 450, Boston, MA 02111, U.S.A.; +1-617-636-4604; e-mail: jduker@tufts-nemc.org.

Julia A. Haller, MD, can be reached at 600 N. Wolfe St., Baltimore, MD 21287, U.S.A.; +1-410-955-4714; e-mail: jhaller@jhmi.edu.

Dawn Kalmar can be reached at Genentech, 1 DNA Way, South San Francisco, CA 94080, U.S.A.; +1-650-225-5873; e-mail: kalmar.dawn@gene.com.

John Pollack, MD, can be reached at Illinois Retina Associates, 300 Barney Drive, Suite D, Joliet, Ill 60435, U.S.A.; +1-815-744-7515; e-mail: pollackjs@aol.com.

Jessica Loughery is an OSN Staff Writer who covers all aspects of ophthalmology. She also writes daily updates for OSNSuperSite.com.