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IRESSA Access Program
Dear Physician,
AstraZeneca announced on June 17, 2005 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
Institutional Review Board (IRB) 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.
To implement the new label, as of September 15th,2005,
AstraZeneca will initiate the IRESSA Access Program to fill
renewal prescriptions for IRESSA through a single mail order
pharmacy (Priority Healthcare) for patients meeting the criteria
set forth by the label. IRESSA will remain available in the US
through the IRESSA Access Program pending availability of new data
that would support an additional revision to the label, or possible
future withdrawal.
Prior to September 15, 2005, patients can continue to obtain IRESSA
by prescription from local pharmacies. The IRESSA Access
Program will become effective on September 15, 2005, after
which date commercial supply of IRESSA will be provided only
through Priority Healthcare. Non-commercial (investigational)
supply of IRESSA for clinical trials is not impacted by this
program. Patients enrolled in ongoing IRB approved clinical trials
using commercially available IRESSA can obtain IRESSA through the
IRESSA Access Program.
For IRESSA to be dispensed by Priority Healthcare on or after
September 15, 2005, the following steps must be completed for
each individual patient:
Physician must certify via the Physician Certification Form
that
-
Physician is familiar with the ISEL results and revised
labeling
-
Individual patient qualifies to receive Iressa according to
revised labeling or is in or will be enrolled in a clinical
trial approved by an IRB prior to June 17, 2005
-
Individual patient has been informed about IRESSA and other
treatment options
Patient must review and sign Patient Consent Form, and call
Priority Healthcare with insurance/payment information
Physician/staff must fax or mail prescription and completed,
signed physician and patient forms to:
Priority Healthcare
250 Technology Park
Lake Mary, FL 32746
ATTN: IRESSA ACCESS PROGRAM
FAX: 1-888-792-9831 TEL.: 1-800-601-8933
IRESSA will be mailed to the address requested by the patient.
Future prescriptions for the patient must be sent to Priority
Healthcare. Prescription refills/repeats for the same individual
will not require repeat signed Physician Certification or Patient
Consent forms.
The Physician Certification Form, Patient Consent Form and revised
Iressa labeling are enclosed as attachments to this letter. For
more information, please contact the IRESSA Access Program at
1-800-601-8933 or from this website.
Physician/Nurse Q&A
Q: I have several patients on IRESSA now, what will I need to do
to continue them on IRESSA?
A: After September 15, 2005, in order to write a prescription for
IRESSA in the U.S. Physicians will need to sign a Physician
Certification Form for each individual patient stating that:
-
You are familiar with the ISEL (trial 709) results and
the revised IRESSA labeling
-
The individual named patient you are writing the
script for qualifies to receive IRESSA according to the revised
labeling or is in or will be enrolled in a clinical trial
approved by an IRB prior to June 17, 2005
-
The individual named patient has been informed about
IRESSA and other treatment options and has signed the Patient
Consent Form.
The Physicians Certification Form, the Patient Consent Form and a
signed prescription will then need to be sent to the IRESSA
Access Program. Once the forms are on file with the program,
patients can call Priority Health Care and process renewal
prescriptions as needed. Forms are available by calling AstraZeneca
at 1-800-601-8933 or from this website.
Q: I have a patient that was on IRESSA a few months ago, taken
off the drug for other medical reasons and I now want to restart
them on IRESSA—after September 15, 2005 will this patient be
considered a ‘new’ IRESSA patient and ineligible to
receive the drug?
A: This patient would be considered an existing patient as long as
the patient previously received IRESSA (any time prior to September
15, 2005) and the physician felt the patient benefited from the
treatment and should now continue with IRESSA.
Q: After September 15, 2005 will patients that receive their
prescriptions through the IRESSA Access Program receive the drug
free from AstraZeneca?
A: The IRESSA Access Program is not a free drug program, it is a
distribution program put in place to administer the revised label.
IRESSA remains a commercially available, FDA approved drug.
Priority Healthcare, a large national mail order pharmacy, will
administer the IRESSA Access Program. They take all forms of
insurance and will help patients with their insurance coverage
questions.
Q: What will IRESSA cost through the IRESSA Access Program?
A: Prescriptions filled through the IRESSA Access Program will be
priced in line with what pharmacies are charging for IRESSA today.
Q: What if I want to put a new patient on IRESSA after September
15, 2005?
A: Per the FDA labeling for IRESSA, only patients who are
benefiting or have benefited from IRESSA may continue to receive
IRESSA after September 15, 2005. The only new patients for whom a
prescription can be written are patients enrolling in an IRB
approved clinical trial using commercial product which had approval
prior to June 17, 2005.
Q: Will AstraZeneca keep its Patient Assistance Program to help
uninsured patients of low income maintain their access to
IRESSA?
A: Yes. The AstraZeneca Patient Assistance Program will remain in
place for IRESSA patients. Patients currently enrolled in the
program will continue to receive free medication from AstraZeneca.
AstraZeneca will also continue to take new applications for
financial assistance from patients who are benefiting or have
benefited from IRESSA and find themselves without insurance and
needing assistance.
Q: How do AstraZeneca and/or the FDA define
“benefit” as outlined in the revised labeling and in
the Physician Certification Forms?
A: The determination as to if a patient is benefiting or has
benefited from IRESSA can only be made by a patient and his/her
physician. AstraZeneca will not in any way try to influence this
decision on a patient-by-patient basis.
Q: Do I have to fill out a certification form for each of my
patients that I wish to keep on IRESSA?
A: Yes. Each patient must have a signed Patient Consent Form, a
Physician Certification Form, and a renewal prescription submitted
to the IRESSA Access Program to fill prescriptions after September
15, 2005. No additional paperwork is needed for subsequent
prescription renewals and these may be phoned into Priority Health
Care, administer of the IRESSA Access Program, as needed.
Q: I am a clinical trial investigator participating in an IRESSA
trial. Study drug is shipped to me from AstraZeneca—will this
announcement change the way investigational study drug is handled
in the future?
A: This program does not affect clinical trial study drug
(investigational drug) supplied by AstraZeneca for clinical trials
currently underway. For new trials that have yet to receive IRB
approval, the investigator must first gain approval from
AstraZeneca on the protocol, and then the study must be conducted
under a valid IND.
Q: I am in the process of getting a clinical trial with IRESSA
approved by my Institutional Review Board (IRB)—how does this
announcement effect our plans for future trials with IRESSA?
A: All clinical trials not IRB approved by June 17, 2005, will need
to be approved by AstraZeneca and conducted under a valid IND.
Q: How can I get more information on the Iressa Access
Program?
A: Your AstraZeneca sales representative can answer questions about
the program and information is also available by calling
AstraZeneca at 1-800-601-8933 between the hours of 8am and 6pm EST
Monday through Friday. Forms and written information about the
program can be accessed from this website. Forms are to be sent to:
Priority Healthcare
250 Technology Park
Lake Mary, FL 32746
ATTN: IRESSA ACCESS PROGRAM
FAX: 1-888-792-9831
TEL.: 1-800-601-8933
IRESSA Access Program Physician Certification Form
Click here to download the IRESSA
Access Program Physician Certification Form.
IRESSA Access Program Patient Consent Form
Additional information about IRESSA®
(gefitinib tablets) has recently become available.
As a result of that information, the IRESSA Access Program is
being implemented effective September 15, 2005. The IRESSA
Access Program places limitations on the types of patients who
can take IRESSA and the way qualifying patients can receive
their supply of IRESSA.
You may be eligible to obtain IRESSA through the IRESSA Access
Program. For you to be able to decide whether you want to
sign up for the IRESSA Access Program, you should understand
enough about the risks and benefits of IRESSA therapy to make
an informed decision. This process is known as informed
consent. Once you have been informed and have had any
questions you may have about IRESSA answered, you will be asked
to sign this consent form if you wish to receive IRESSA through
the IRESSA Access Program. You do not have to sign this consent
form. If you do not sign this consent form, you will not be
able to receive IRESSA after September 15, 2005.
Click here to download the patient consent form for the IRESSA Access Program
Please click here for Full Prescribing Information
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