On October 11th, Genentech issued a letter to physicians stating that as of November 30, 2007, the company will no longer allow compounding pharmacies to purchase Avastin directly from wholesale distributors. This raises two questions: "Why?", and "Is this a big deal?".
There may be many reasons for this – who is liable for complications following off-label use of a medication? Is it the physician, compounding center, or drug company? Genentech has gone to great lengths to make the community aware that Avastin’s use in AMD is off-label, and is conducting trials of Lucentis for non-AMD retinal diseases. Is this not enough awareness?
What is the role of a drug company? Traditionally, they have developed a drug and seen it through FDA approval for a specific indication. Physicians can then use the drug at their discretion. I do not recall an instance where a company has refused to sell its product directly to a compounding pharmacy for fear it might be used for another indication. Even with the more serious concerns about sterile endophthalmitis with intravitreal kenalog, Bristol-Myers-Squibb issued a warning letter to ophthalmologists stating that its use in the eye is off-label and its ocular safety is of concern. Appropriate warning.
Furthermore, the letter from Genentech states “Most important among these events is the FDA approval and broad availability of Lucentis for patients with wet AMD.” Agreed, there is an FDA-approved alternative product for AMD. But even for AMD, many patients are not eligible for subsidized costs through the Lucentis Commitment program. Others simply do not wish to pay such high co-pays. And, third-party payers are not covering Lucentis for non-AMD patients. So physicians are left with little choice but to use Avastin for retinal vein occlusions, diabetic retinopathy, and choroidal neovascularization from other causes.
The bottom line is this: how will Genentech’s decision affect patients and practices? It probably won’t. The retina community will look for other ways around this problem. We won’t allow our patients to be put at risk by aliquoting doses of Avastin ourselves. I expect that many retina specialists will now order Avastin directly from the wholesaler and then have the drug shipped to a compounding pharmacy. Supplies will be kept at the pharmacy, and syringes prepared as needed. Just a little more paperwork, but patients will still be getting the drug.
Drug companies have to be careful not to alienate physicians. We need industry to develop new drugs for our patients. Industry needs us to trial their medications and prescribe them. What we don’t want is a battle between industry and the physician. Is this an industry-physician battle, or an Avastin-Lucentis battle? According to market surveys, we are prescribing 50% Lucentis and 50% Avastin for our AMD patients. We do what is in the best interests of our patients. Is it better that an 80 year old lady is treated with Avastin, or goes without treatment because she doesn’t meet the criteria for the Lucentis Commitment program, and won’t pay the co-pay out of pocket? As physicians, we have all made a pledge: Primum non nocere.
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