Nature Medicine: Drug companies should stay out of AMD prescribing decision

New York-Ophthalmologists should be able to consider prescribing bevacizumab (Avastin) instead of ranibizumab (Lucentis) to treat neovascular (wet) age-related macular degeneration (AMD) without interference from pharmaceutical companies, maintained the writers of an editorial published online June 6 in Nature Medicine.

The United Kingdom’s National Health Service (NHS) could save an estimated $133 million a year if bevacizumab were used instead of the approved drug, ranibizumab, to treat AMD, they wrote, in “beyond cost considerations.”

“These attempts of drug companies to protect their revenue stream seem hard to swallow,” the authors wrote.

Ranibizumab is marketed for the treatment of wet AMD by Genentech in the United States and by Novartis in the rest of the world. Bevacizumab, a cancer drug, is marketed by Genentech in the United States and by Roche elsewhere. Genentech is a Roche company.

Novartis recently sought a legal review to prevent reimbursement for the off-label use of bevacizumab for AMD. The NHS has allowed the reimbursement since 2011. According to Nature Medicine, ranibizumab costs about $1,960 per injection, whereas bevacizumab costs $47 to $78 per injection.

The company maintains that bevacizumab’s use for AMD could result in patient safety issues; trials comparing the two drugs have demonstrated a higher incidence of side effects in patients treated with bevacizumab. The editorial authors, however, wrote: “But it's unclear whether these differences can be attributed to the treatments, as the trial was carried out in patients with a median age of over 80 years old, who may be prone to other medical problems.”

Novartis previously attempted to prevent German health-care providers from using bevacizumab off-label to treat AMD, the authors note, and in the United States, Genentech tried to prevent the supply of the drug to pharmacies that were reformulating it for use against AMD.

Genentech also has offered rebates to U.S. doctors who administer large numbers of ranibizumab injections, to discourage the use of bevacizumab. This tactic prompted the American Academy of Ophthalmology to remind members of its ethics policies.

If bevacizumab routinely becomes available as an off-label treatment for AMD in the United Kingdom, the authors wrote, then health-care providers, health-care information technology assessors, and perhaps even professional societies together will need to help design a regulatory structure to ensure accountability for the drug’s safety and efficacy, and they’ll also want to develop guidelines to help clinicians and patients choose treatments.

“Although drug regulatory agencies could have a potential role in devising such frameworks, under the current system, it is difficult to see how they can intervene to evaluate off-label use without a pharmaceutical sponsor submitting its product for expanded licensing,” they said.

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