Genentech decision expands access to bevacizumab

Key Points

The decision was announced after months of negotiations with the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS), as well as a vociferous outcry by retina specialists.

The decision allows Genentech to remain true to its Oct. 11 announcement that it no longer would sell its drug to compounding pharmacies, in part over liability concerns about maintaining the drug's sterility. Compounding pharmacies are used by a majority of retina specialists to break down the large vials of bevacizumab packaged for cancer treatments into single-dose injections for off-label treatment of wet age-related macular degeneration (AMD).

Wholesale prices of the medications ranged from $1,950 per dose for ranibizumab to about $5.50 per dose for bevacizumab, according to Genentech spokeswoman Dawn Kalmar. Most patients require monthly doses.

After ophthalmologists' initial outcry, the company agreed to extend its initial Nov. 30 cut-off date to sell to compounding pharmacies to Jan. 1, to allow time for a solution to be devised. Under the agreement announced Dec. 20, physicians can purchase bevacizumab directly from authorized wholesale distributors, and physicians can designate a destination: hospital pharmacy, compounding pharmacy, or physician's office.

"This process is one that the [AAO] and ASRS believe addresses the needs of most of their members," the medical groups said in a joint statement. "It is a significant step forward."

C.P. Wilkinson, MD, a retina specialist and AAO president at the time the decision was announced, said he believes the company genuinely is trying to do what's right for patients, physicians, and shareholders.

"This is a good company, and I don't think [it's] really out to [hurt] anybody," he said. "There are certain realities here that you have to respect. I don't think this is a smoke-and-mirrors or bait-and-switch kind of deal."

Genentech said it believes that the decision reflects the "collaborative approach" taken by the company and physician groups.

"Genentech continues to believe [that ranibizumab] is the most appropriate treatment for patients with wet [AMD] because it was specifically designed, formally studied, approved by the U.S. FDA and manufactured for intraocular delivery for the treatment of wet AMD," the company said in a prepared statement. "At the same time, Genentech does not interfere with physicians' prescribing choices and believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients."

Dr. Wilkinson cautioned that implementation of this solution may vary because laws regarding compounding pharmacies differ from state to state. The AAO and ASRS recommended that physicians consult their legal advisers.

The company and the organizations all said that they would continue to work together to develop additional programs to "more efficiently facilitate and expedite patient access and physician reimbursement for [ranibizumab]."

Genentech spokeswoman Krysta Pellegrino said that new program details still were being determined. "We really want to ensure that all patients who need our therapies have access to it," she said.

Dr. Wilkinson said the company intends to expand the number of patients eligible for financial assistance for ranibizumab and to speed up physician reimbursement from weeks or months to a matter of days.

"I have no doubt that the original process was, indeed, very, very cumbersome and time-consuming and I don't think it solved the problem at all," he said. "I'm sure it will be vastly improved."