The backdrop: Genentech planned to restrict sales to compounding pharmacies, citing FDA concerns about contamination when an Avastin vial is split into smaller doses and repackaged for docs. Opthalmologists complained that would hurt patients, because the alternative treatment is Genentechâ€™s newer Lucentis, which is approved for the eye disease, but costs 40 times as much, or about $2,000. Lucentis sales haven't taken off, because docs continue to use Avastin.
The decision renewed criticism that Genentech is trying to steer business toward Lucentis at the expense of patients, especially since the biotech wonâ€™t study Avastin for the eye disease (but the NIH is doing so). At the American Academy of Opthalmology annual meeting last month, one doc called Genentech's move eggregious during a panel featuring a Genentech exec.
The truce calls for allowing docs to buy Avastin from wholesalers, which will ship Avastin to compounding pharmacies. However, a Genentech spokeswoman, Krysta Pellegrino, tells us that issues related to sterilization at a compounding pharmacy processing Avastin is an ongoing concern. Nonetheless, "we're trying to abide by all the regulations and the spirit of the law while at the same time recognizing" that doctors seek access to Avastin for eye use, she says.
An American Academy for Ophthalmology spokeswoman, Siobhan Bunaes, tells Reuters the deal should work for most of its docs, although it could make paperwork cumbersome. She adds, however, that Genentech assured the group it would not raise the price of Avastin. Here's a statement from the group, which calls the deal a "significant step forward."