Daiichi Sankyo Expanded Access Form
Section I: Description of Daiichi Sankyo Expanded Access
The Daiichi Sankyo Expanded Access program provides Physicians an opportunity to request access to a Daiichi Sankyo unapproved investigational product for a patient who suffers from a serious disease or condition where no other treatment option in that indication for that patient population exists.
All requests must be submitted using the Expanded Access form. All requests will be reviewed by Daiichi Sankyo medical personnel. Should the request be approved, the requestor must enter into an Expanded Access Agreement with Daiichi Sankyo.
Daiichi Sankyo, Inc. cannot approve Expanded Access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.
For approved requests, Daiichi Sankyo will provide the investigational product at no charge to the requestor for a duration and frequency determined by the company. The requestor is responsible for reporting any safety issues associated with the use of the investigational product to Daiichi Sankyo. Daiichi Sankyo is not accountable for securing local ethics committee approval for use of such investigational product.
Section II: Overview of process and anticipated timelines:
Physicians must complete the Expanded Access form and submit it via this web site using the SUBMIT button at the bottom of the form.
Daiichi Sankyo medical personnel will review the form for completeness and make a decision on the request.
If a decision is made not to provide access to an investigational product, Daiichi Sankyo will notify the requestor within 10 business days from receipt of the completed form.
If a decision is made to provide access to an investigational product, the requestor will be notified by Daiichi Sankyo with instructions for executing the Expanded Access Agreement within 10 business days from receipt of the completed form.
Upon full execution of the Expanded Access Agreement, drug shipment coordination with the Physician’s office will be scheduled.
Section III: Instructions for Expanded Access form
Please do not submit any patient protected information
1. Complete all questions relating to Patient Eligibility criteria.
2. Complete the Physician Section.
3. Please include your medical opinion about the medical benefit the investigational product may provide to the patient.
All incomplete and/or illegible applications will be returned to the Physician for completion.
PLEASE DO NOT INCLUDE ANY PATIENT MEDICAL INFORMATION/RECORDS WITH THIS APPLICATION.
1. Patient Eligibility
2. Physician Information
3. Medical Rationale for Request
I certify that the information provided in this application is complete and accurate to the best of my knowledge, and that once the investigational product requested under the Daiichi Sankyo Expanded Access Program is approved for release to this patient, I will be responsible for supervising the patient’s treatment. I understand and certify that all units of any investigational product shipped to me pursuant to this application will be provided to the above-named patient only, for his or her treatment, and will not be sold or otherwise distributed and that no patient or third party (including, but not limited to, Medicare and any other governmental programs) shall be charged for such product. Additionally, no units of this investigational product will be submitted for Medicare, Medicaid, or any public or private third party reimbursement, or returned for credit. I understand eligibility under this program is subject to the Daiichi Sankyo Expanded Access Program’s approval and the patient’s continuing compliance with all eligibility requirements, as set by Daiichi Sankyo, Inc. I agree to allow the Daiichi Sankyo Expanded Access Program or its authorized agent(s) to review the medical, financial, and insurance records for this patient at any time for the purposes of verifying the patient’s eligibility status for the program and the patient’s receipt of any investigational product(s) provided to him or her through the program.