AAO, ASRS, Genentech reach compromise on bevacizumab

South San Francisco, CA-Genentech, the American Academy of Ophthalmology (AAO), and the American Society of Retina Specialists (ASRS) have agreed to a compromise related to the distribution of bevacizumab (Avastin).

South San Francisco, CA-Genentech, the American Academy of Ophthalmology (AAO), and the American Society of Retina Specialists (ASRS) have agreed to a compromise related to the distribution of bevacizumab (Avastin).

The organizations and company have been working together since October, when Genentech announced that soon it no longer would allow compounding pharmacies to purchase bevacizumab directly from authorized wholesale distributors. The ophthalmic groups believed that this change in distribution could have negatively affected patient and physician access to off-label treatment using the drug for wet age-related macular degeneration (AMD), diabetic retinopathy, macular edema, and other conditions.

Bevacizumab is approved by the FDA only for oncology-related indications. Ophthalmologists who use it to treat eye disorders rely on compounding pharmacies to divide vials of the drug into smaller doses.

Genentech issued a statement that in part said: “Working together, we have determined that physicians can prescribe [bevacizumab] and purchase it directly from authorized wholesale distributors, and wholesalers can ship to the destination of the physician’s choice, including to hospital pharmacies, compounding pharmacies, or directly to the physician’s office. This process is one that the AAO and ASRS believe addresses the needs of their members. It is a significant step forward.” The AAO issued a statement that included almost identical wording.

“Because laws differ from state to state, the implementation of this solution may vary,” the AAO statement said. “The [AAO] and ASRS recommend that physicians check with their legal advisers when considering this new option.”

The physician organizations also are working with Genentech to develop additional programs to facilitate and expedite patient access and physician reimbursement for ranibizumab (Lucentis) regardless of patients’ ability to pay, according to the AAO and the company.

“Genentech continues to believe [ranibizumab] is the most appropriate treatment for patients with wet [AMD] because it was specifically designed, formally studied, approved by the [FDA], and manufactured for intraocular delivery for the treatment of wet AMD,” according to Genentech. “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.”

Physicians or patients who have questions related to the ranibizumab access and reimbursement services offered by Genentech may call the company at 866/724-9394. For questions about Genentech’s authorized wholesale distributors, ophthalmologists may contact Genentech at 800/551-2231 or e-mail csordermgmnt-d@gene.com.