An agreement has finally been reached between Genetech and American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS) regarding the company’s non willingness to sell the medicine to compounding pharmacies.
Genentech is a San Francisco based Biotech Company which manufactures medicine to treat muscular degeneration, a leading cause of blindness among the elderly. The FDA approved medicine for this treatment is Lucentis, which costs $2000 for each injection.
Avastin also functions in the same way as Lucentis by restricting blood flow to abnormal new blood vessels beneath the retina. If left untreated, those vessels can leak blood and fluid, resulting in severe vision loss.
The whole problem arose when the compounding pharmacies started dividing vials of Avastin under sterile conditions into smaller portions which can be used in the eye. This way the cost of each dosage came down to a range of around $20 to $100.
In October, the company announced that it won’t supply Avastin to compounding pharmacies which repackaged it, thus affecting the business of Lucentis which earned revenues of about $200 million in the third-quarter. The company said its sales have been hampered by use of Avastin for macular degeneration.
Doctors and other critics opposed this move by the company as they think it’s a move to protect Lucentis sales and company is not willing to provide cheaper treatment to the people.
The company denied all these charges and maintained its stand stating that Lucentis is the most appropriate treatment for patients with wet age-related mascular degeneration and was specifically designed, formally studied, approved by the U.S. Food and Drug Administration (FDA). Avastin is not made for use in the eye.
Another concern raised by the company was the sterile conditions at a compounding pharmacy processing Avastin. This severely hampers the quality of the drug and makes it unsuitable for use.
“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, company spokeswoman Krysta Pellegrino said.
According to the agreement, physicians can prescribe Avastin 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 will increase a little bit of paperwork but it caters to the concerns of everyone.