Pharmacist Information
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Pharmacist Information
Dear Pharmacist,
AstraZeneca has announced that after discussions with the U.S. Food
and Drug Administration (FDA), the company is making a labeling
change to IRESSA® (gefitinib tablets). Based on the
lack of survival benefit in the Phase III Trial 709 (ISEL)
comparing IRESSA to placebo in advanced recurrent NSCLC and the
availability of other drugs that do prolong life, the revised label
indicates that IRESSA is only to be used in patients who are
benefiting or have benefited from IRESSA. After September 15, 2005,
no new patients will be allowed access to IRESSA unless they are
being enrolled into a clinical trial that was approved by an IRB
(Institutional Review Board) prior to June 17, 2005, or they are
part of a clinical study that is being conducted under an
investigational new drug application (IND). Clinical trials
approved by an IRB after June 17, 2005, must be conducted under a
valid IND, subject to prior review and approval of the proposed
protocol by AstraZeneca to ensure drug supply.
Following this label change, AstraZeneca will be initiating the
IRESSA Access Program (“Program”). Effective on
September 15th,2005, IRESSA will only be obtainable through the
Program by approved patients under the revised labelling using a
single Specialty Pharmacy Provider.
Please note that IRESSA will continue to remain available through
the usual channels until the Program is implemented and
prescriptions can be filled as they have in the past. Beginning
September 15, 2005, by agreement with FDA, IRESSA should be
dispensed exclusively through the IRESSA Access Program and
not in the retail setting. AstraZeneca will begin to remove IRESSA
from retail distribution channels immediately following the
IRESSA Access Program launch on September 15, 2005. More
information specific to the process for returning unused IRESSA
following September 15, 2005 will be sent to you at a later date.
As we have consistently communicated to our customers, AstraZeneca
is committed to ensuring that patients who are benefiting or have
benefited from IRESSA have appropriate access to the product. We
request that you continue to balance IRESSA inventories within your
network and evaluate overall need before placing orders for
additional product. We recognize the important role pharmacies play
in providing patient access to IRESSA, and we are committed to
working closely with you to insure inventories are maintained at
appropriate levels.
At this time, the current return goods policies are in effect for
IRESSA and we will contact you if an exception to this policy is
warranted.
If you have any additional questions please contact AstraZeneca.
Trade Customer Service. Our Trade Customer Service number is
1-800-842-9920. Our hours of operations are 8:00 to 5:00 Eastern
Standard Time. You may also access Trade Customer Services via our
web site at www.azcos.com.
Pharmacist Q&A
Q: Will pharmacies be reimbursed for the full cost of the
inventory they return?
A: Yes. AstraZeneca is currently developing a process for
Pharmacies and others to obtain reimbursement for Iressa following
the launch of the Iressa Access Program on September 15,
2005. At this time, the current AstraZeneca returns policy remains
in effect. Further information regarding the process of returning
unused Iressa after September 15, 2005 will be communicated at a
later date.
Q: How soon can pharmacies return their inventory?
A: After September 15, 2005 pharmacies will be instructed on how to
return any remaining supply of IRESSA to AstraZeneca.
Q: For how long can local pharmacies continue to fill
prescriptions for IRESSA?
A: Pharmacies may continue to fill prescriptions for IRESSA through
September 15, 2005. After this date, please refer patients to the
IRESSA Access Program at 1-800-601-8933 for information on how to
fill their prescriptions.
Q: What should pharmacies do if a patient brings them a
prescription for IRESSA after September 15, 2005?
A: After September 15, 2005 pharmacies should not fill any
prescription for IRESSA. After this date, please refer any patient
with an IRESSA prescription to the IRESSA Access Program for
assistance. The toll free number is: 1-800-601-8933. Patients can
also be referred to AstraZeneca for assistance at 1-800-601-8933 or
from this website.
Q: Can pharmacies enroll patients in the IRESSA Access
Program?
A: Pharmacies cannot enroll patients into the IRESSA Access Program
due to the patient and physician consent/certification forms that
are required by the program. After September 15, 2005, please refer
patients to the IRESSA Access Program at 1-800-601-8933 for
information on how to fill their prescriptions
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