Avastin/Lucentis Update 20: Genentech Rescinds Clampdown on Avastin
As reported this morning on the WSJ Health Blog, Genentech has rescinded its declaration to stop supplying Avastin to compounding pharmacies as of November 1st. The company said it would delay this policy until January 1st and might rescind it all together if the FDA gave the company "legal and regulatory authorization to do so."
Here is the full story as reported on the WSJ Health Blog, followed by the letter announcing the change in policy posted by Genentech, and the letter from the AAO/ASRS following their meeting last Friday with Genentech's principals:
Genentech Delays Avastin Clampdown
WSJ Health Blog
Posted by Jacob Goldstein
October 30, 2007, 8:52 am
To appease upset M.D.s and patients, Genentech is putting off a plan that would make it more difficult for physicians to use the company’s cancer drug Avastin as an inexpensive treatment for eye diseases.
And, the company suggests, it could reverse its stance against Avastin for ophthalmic use altogether if the FDA gives its blessing.
Avastin isn’t approved for use in the eyes, but it’s very similar to the company’s eye drug Lucentis. Both block the growth of blood vessels. Doctors often substitute Avastin for Lucentis to treat wet age-related macular degeneration and other eye diseases, because Avastin’s much cheaper. Avastin runs about $40 a shot each month versus $2,000 a dose for Lucentis. To use Avastin to treat vision loss, many M.D.s rely on compounding pharmacies to re-package vials of Avastin into small doses for injection into the eyes.
Genentech said earlier this month that it wouldn’t allow distributors to sell Avastin to compounding pharmacies as of Nov. 30. But in an open letter posted on its Web site (read it here) yesterday, the company took a softer tone, agreeing to supply compounding pharmacies with Avastin until Jan. 1.
And, the company added, it would reinstate the supply after that “if the FDA gave the company legal and regulatory authorization to do so.” (It’s not clear whether Genentech is actively seeking such authorization, or what would be required to receive it.) The company also explained that it had destroyed 350,000 vials of Avastin because of FDA concerns that the product didn’t meet the standards that apply to drugs used in the eye.
Lucentis is approved only for wet AMD, but doctors are finding that Lucentis and Avastin may help in other eye conditions. Avastin’s lower price makes it especially useful in treating those diseases, when reimbursement by insurance can be spotty. Yesterday’s letter addressed this issue explicitly, promising that Genentech’s program to deliver Lucentis to AMD patients who can’t afford it would also apply to patients with other eye diseases.
The Genentech letter says these shifts came as a result of a meeting between Genentech senior executives and leaders of the American Academy of Ophthalmology and the American Society of Retina Specialists.
The doctors groups sent their own letter to members yesterday saying they met with Genentech executives including CEO Arthur Levinson on Friday. “We are encouraged by the meeting results and hope our optimism will be justified by future actions,” the doctors’ letter says.
Also, for completeness, here is the letter about the change in policy from Genentech to the ophthalmic community:
Here is the full story as reported on the WSJ Health Blog, followed by the letter announcing the change in policy posted by Genentech, and the letter from the AAO/ASRS following their meeting last Friday with Genentech's principals:
Genentech Delays Avastin Clampdown
WSJ Health Blog
Posted by Jacob Goldstein
October 30, 2007, 8:52 am
To appease upset M.D.s and patients, Genentech is putting off a plan that would make it more difficult for physicians to use the company’s cancer drug Avastin as an inexpensive treatment for eye diseases.
And, the company suggests, it could reverse its stance against Avastin for ophthalmic use altogether if the FDA gives its blessing.
Avastin isn’t approved for use in the eyes, but it’s very similar to the company’s eye drug Lucentis. Both block the growth of blood vessels. Doctors often substitute Avastin for Lucentis to treat wet age-related macular degeneration and other eye diseases, because Avastin’s much cheaper. Avastin runs about $40 a shot each month versus $2,000 a dose for Lucentis. To use Avastin to treat vision loss, many M.D.s rely on compounding pharmacies to re-package vials of Avastin into small doses for injection into the eyes.
Genentech said earlier this month that it wouldn’t allow distributors to sell Avastin to compounding pharmacies as of Nov. 30. But in an open letter posted on its Web site (read it here) yesterday, the company took a softer tone, agreeing to supply compounding pharmacies with Avastin until Jan. 1.
And, the company added, it would reinstate the supply after that “if the FDA gave the company legal and regulatory authorization to do so.” (It’s not clear whether Genentech is actively seeking such authorization, or what would be required to receive it.) The company also explained that it had destroyed 350,000 vials of Avastin because of FDA concerns that the product didn’t meet the standards that apply to drugs used in the eye.
Lucentis is approved only for wet AMD, but doctors are finding that Lucentis and Avastin may help in other eye conditions. Avastin’s lower price makes it especially useful in treating those diseases, when reimbursement by insurance can be spotty. Yesterday’s letter addressed this issue explicitly, promising that Genentech’s program to deliver Lucentis to AMD patients who can’t afford it would also apply to patients with other eye diseases.
The Genentech letter says these shifts came as a result of a meeting between Genentech senior executives and leaders of the American Academy of Ophthalmology and the American Society of Retina Specialists.
The doctors groups sent their own letter to members yesterday saying they met with Genentech executives including CEO Arthur Levinson on Friday. “We are encouraged by the meeting results and hope our optimism will be justified by future actions,” the doctors’ letter says.
Also, for completeness, here is the letter about the change in policy from Genentech to the ophthalmic community:
Open Letter
October 29th, 2007
Genentech recently informed the retinal community that our company would no longer allow compounding pharmacies to purchase Avastin® (bevacizumab), a Genentech-manufactured drug, from authorized wholesale distributors. Avastin is an infused medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with certain forms of cancer, though some ophthalmologists have been using it to treat various ocular diseases, including neovascular (wet) age-related macular degeneration (AMD).
The decision we communicated was not made lightly. In fact, it was guided by our company's strong commitment to take actions that are scientifically and clinically sound and in the best long-term interest of patients, while at the same time adhering to government regulations and remaining mindful of the retinal community's views.
We understood that some would disagree with our decision to stop supplying Avastin to compounding pharmacies and would accuse Genentech of making profit, not patients, its priority. Genentech's decision was not motivated by a desire for increased profits. We did not and do not expect that this change in policy toward compounding pharmacies will lead to any increase in LUCENTIS® (ranibizumab injection) sales. Further, we expect Avastin to be available and that physicians will continue to prescribe it for ocular indications.
A series of FDA actions contributed to our decision. First, the FDA raised concerns related to the sterility and repackaging of the drug for ocular use in a Warning Letter to a compounding pharmacy. Subsequently, during a routine inspection of our South San Francisco manufacturing facility, FDA inspectors raised concerns related to the ongoing ocular use of Avastin, because it is not manufactured for that use. In order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin deemed unsuitable for use in the eye due to a higher visual inspection standard. (These lots would have been entirely suitable for its approved use as an intravenous cancer medication.) The action resulted in the loss of more than 350,000 vials of Avastin with a market value of more than $200 million. The implication of this event was that future supplies of Avastin would likewise be at risk of having to be destroyed. In our judgment, these FDA actions — and the potential for future similar actions — necessitated a change in our policy toward compounding pharmacies.
Genentech and the retinal community share a commitment to patients and have been working to help ensure the transition does not unduly impact patient care. To this end, Genentech senior executives met with American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS) leadership to discuss the company's decision and areas for collaboration. Among the outcomes of that conversation was our agreement to make January 1, 2008, rather than November 30, 2007, the date on which Genentech discontinues the supply of Avastin to compounding pharmacies. We made this change so that affected physicians will have sufficient time to develop and implement transition plans to assure that patient care is not adversely affected. Genentech also agreed that it would reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so. Further, we discussed ways to establish an even more effective access program for non-AMD patients who seek anti-VEGF therapy.
It is important to highlight that Genentech has always believed that no eligible patient should go without one of our approved medicines due to financial barriers alone and that the necessary steps to obtaining assistance should be as easy as possible. Specific to Lucentis, we offer The LUCENTIS Commitment™, a comprehensive support program dedicated to facilitating timely reimbursement. In addition, the Genentech Access to Care Foundation (GATCF) provides Lucentis at no cost not only to qualified patients with wet AMD, but also to qualified patients with other ocular diseases that can lead to blindness. Genentech is working in conjunction with GATCF to make the process more efficient and to speed patient access to treatment. You should expect to see process improvements implemented by year-end. We look forward to working with the ASRS and AAO to identify other opportunities for improving the ease of access to and speed of patient assistance programs.
If physicians or patients have any questions related to our access and reimbursement services, please contact us toll-free at 1-866-724-9394.
For more than 30 years, Genentech has been and remains committed to high standards of integrity in contributing to the best interest of patients. We believe our current course of action underscores that commitment, and ensures that patients and physicians will continue to have access to safe and effective treatments.
And, last but not least, the letter posted by the AAO/ASRS to its membership:
Genentech Agrees to Delay Action on Avastin Sales
October 29, 2007
October 29th, 2007
Genentech recently informed the retinal community that our company would no longer allow compounding pharmacies to purchase Avastin® (bevacizumab), a Genentech-manufactured drug, from authorized wholesale distributors. Avastin is an infused medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with certain forms of cancer, though some ophthalmologists have been using it to treat various ocular diseases, including neovascular (wet) age-related macular degeneration (AMD).
The decision we communicated was not made lightly. In fact, it was guided by our company's strong commitment to take actions that are scientifically and clinically sound and in the best long-term interest of patients, while at the same time adhering to government regulations and remaining mindful of the retinal community's views.
We understood that some would disagree with our decision to stop supplying Avastin to compounding pharmacies and would accuse Genentech of making profit, not patients, its priority. Genentech's decision was not motivated by a desire for increased profits. We did not and do not expect that this change in policy toward compounding pharmacies will lead to any increase in LUCENTIS® (ranibizumab injection) sales. Further, we expect Avastin to be available and that physicians will continue to prescribe it for ocular indications.
A series of FDA actions contributed to our decision. First, the FDA raised concerns related to the sterility and repackaging of the drug for ocular use in a Warning Letter to a compounding pharmacy. Subsequently, during a routine inspection of our South San Francisco manufacturing facility, FDA inspectors raised concerns related to the ongoing ocular use of Avastin, because it is not manufactured for that use. In order to resolve the concerns raised by the FDA, we destroyed four batches of Avastin deemed unsuitable for use in the eye due to a higher visual inspection standard. (These lots would have been entirely suitable for its approved use as an intravenous cancer medication.) The action resulted in the loss of more than 350,000 vials of Avastin with a market value of more than $200 million. The implication of this event was that future supplies of Avastin would likewise be at risk of having to be destroyed. In our judgment, these FDA actions — and the potential for future similar actions — necessitated a change in our policy toward compounding pharmacies.
Genentech and the retinal community share a commitment to patients and have been working to help ensure the transition does not unduly impact patient care. To this end, Genentech senior executives met with American Academy of Ophthalmology (AAO) and American Society of Retina Specialists (ASRS) leadership to discuss the company's decision and areas for collaboration. Among the outcomes of that conversation was our agreement to make January 1, 2008, rather than November 30, 2007, the date on which Genentech discontinues the supply of Avastin to compounding pharmacies. We made this change so that affected physicians will have sufficient time to develop and implement transition plans to assure that patient care is not adversely affected. Genentech also agreed that it would reinstate its supply of Avastin to compounding pharmacies if the FDA gave the company legal and regulatory authorization to do so. Further, we discussed ways to establish an even more effective access program for non-AMD patients who seek anti-VEGF therapy.
It is important to highlight that Genentech has always believed that no eligible patient should go without one of our approved medicines due to financial barriers alone and that the necessary steps to obtaining assistance should be as easy as possible. Specific to Lucentis, we offer The LUCENTIS Commitment™, a comprehensive support program dedicated to facilitating timely reimbursement. In addition, the Genentech Access to Care Foundation (GATCF) provides Lucentis at no cost not only to qualified patients with wet AMD, but also to qualified patients with other ocular diseases that can lead to blindness. Genentech is working in conjunction with GATCF to make the process more efficient and to speed patient access to treatment. You should expect to see process improvements implemented by year-end. We look forward to working with the ASRS and AAO to identify other opportunities for improving the ease of access to and speed of patient assistance programs.
If physicians or patients have any questions related to our access and reimbursement services, please contact us toll-free at 1-866-724-9394.
For more than 30 years, Genentech has been and remains committed to high standards of integrity in contributing to the best interest of patients. We believe our current course of action underscores that commitment, and ensures that patients and physicians will continue to have access to safe and effective treatments.
And, last but not least, the letter posted by the AAO/ASRS to its membership:
Genentech Agrees to Delay Action on Avastin Sales
October 29, 2007
Last Friday, the leadership of the Academy (AAO) and the American Society of Retina Specialists (ASRS) met with three of Genentech’s top leaders: the company’s chairman/CEO, president and chief medical officer. We had a frank and open discussion about Genentech’s decision to stop sales of Avastin® to compounding pharmacies and impressed upon them our deep concern for its impact on patients’ access to this treatment option. We are encouraged by the meeting results and hope our optimism will be justified by future actions.
Genentech has agreed to:
* Delay the Avastin sales embargo to compounding pharmacies until Jan. 1, 2008, which allows us more time to help our members find work-around solutions;
* Not impede physicians or other legal agents (e.g., group purchasing agents) from ordering Avastin or using compounding pharmacies after the embargo is in place;
* Seek advance comment from the Academy and ASRS on any direct-to-patient or -physician communications on Avastin versus Lucentis®;
* Work with appropriate parties to make anti-VEGF therapy available for eligible low-income or under-insured patients;
* Ensure that an anti-VEGF agent (Avastin or Lucentis) can be made rapidly available for patients with time-critical needs in a way that minimizes in a legally appropriate manner the financial risk to the physician; and
* Send Susan Desmond-Hellmann, Genentech’s president of product development, to the Academy’s Retina Subspecialty Day program and the upcoming ASRS meetings, where she will discuss this issue with our membership.
Genentech reaffirmed its position that its actions were a result of communications from the FDA. The company has agreed to share the specifics of this information, which we in turn will share with our members. More importantly, however, Genentech said that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.
On our part, the Academy and ASRS will continue all efforts to protect the physicians’ right and ability to use off-label drugs.
While it is hard to overlook Genentech’s initial decision, we cannot ignore the fact that the company has given ophthalmologists and patients a breakthrough treatment for macular degeneration and other eye diseases. We trust and will continue to seek verification that Genentech is committed to addressing our concerns in a reasonable and timely manner.
Sincerely,
C. Pat Wilkinson, MD
Academy President
H. Dunbar Hoskins, Jr., MD
Academy Executive Vice President
Julia Haller, MD
ASRS President
Genentech has agreed to:
* Delay the Avastin sales embargo to compounding pharmacies until Jan. 1, 2008, which allows us more time to help our members find work-around solutions;
* Not impede physicians or other legal agents (e.g., group purchasing agents) from ordering Avastin or using compounding pharmacies after the embargo is in place;
* Seek advance comment from the Academy and ASRS on any direct-to-patient or -physician communications on Avastin versus Lucentis®;
* Work with appropriate parties to make anti-VEGF therapy available for eligible low-income or under-insured patients;
* Ensure that an anti-VEGF agent (Avastin or Lucentis) can be made rapidly available for patients with time-critical needs in a way that minimizes in a legally appropriate manner the financial risk to the physician; and
* Send Susan Desmond-Hellmann, Genentech’s president of product development, to the Academy’s Retina Subspecialty Day program and the upcoming ASRS meetings, where she will discuss this issue with our membership.
Genentech reaffirmed its position that its actions were a result of communications from the FDA. The company has agreed to share the specifics of this information, which we in turn will share with our members. More importantly, however, Genentech said that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.
On our part, the Academy and ASRS will continue all efforts to protect the physicians’ right and ability to use off-label drugs.
While it is hard to overlook Genentech’s initial decision, we cannot ignore the fact that the company has given ophthalmologists and patients a breakthrough treatment for macular degeneration and other eye diseases. We trust and will continue to seek verification that Genentech is committed to addressing our concerns in a reasonable and timely manner.
Sincerely,
C. Pat Wilkinson, MD
Academy President
H. Dunbar Hoskins, Jr., MD
Academy Executive Vice President
Julia Haller, MD
ASRS President
posted by Irv Arons @ 12:30 PM
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