HCP Terms Trodelvy HR+ G.Access Program
Patient Enrolment Terms and Conditions
These terms and conditions apply to the Trodelvy HR+ G.Access Program (HR+AP) for Trodelvy.
1. HR+AP patient enrolment will open on the 27th February 2023 and terminate on 1st January 2026 unless Trodelvy is listed on the PBS with respect to the same indications as HR+AP, before this date..
2. Before enrolling a patient in the HR+AP, you represent and warrant that you have:
a) read a copy of the Trodelvy Product Information and understand its indications and contraindications;
b) explained the HR+AP (including in respect of the costs of the Product to the patient) to the patient in sufficient detail to obtain their informed written consent in the form specified by Gilead and you agree to keep this consent on file. To maintain patient privacy, this consent is not to be provided to Gilead; and
c) obtained the patient’s consent to share their patient data with Gilead for the purposes of the collection of real world evidence associated with the use of Trodelvy in HR+ HER2- patients.
3. No patient can be enrolled unless and until they meet the HR+AP Patient Eligibility Criteria.
4. There is no restriction on the number of patients that each clinician can enrol, however, Gilead reserves the right to refuse further enrolments from any clinician or group of clinicians in the event of excessive numbers of enrolments to ensure the continued viability and sustainability of the program.
5. Before a patient is provided with any dose, confirmation of the patient meeting the HR+AP Patient Eligibility Criteria is required.
6. You agree that you have obtained all necessary approvals, including from your employer and all relevant institutions, to use the G.Access program and to enrol patients in the HR+AP.
7. Gilead anticipates that patients on the HR+AP when PBS reimbursement occurs will transition to access under the PBS, provided the PBS listing covers the same indication.
8. Subject to continuing to meet the HR+AP Patient Eligibility Criteria, any patient treated on the HR+AP will be guaranteed treatment until progression or transition to access under the PBS when PBS reimbursement occurs. If a patient was being treated on the HR+AP, continues to meet the HR+AP Patient Eligibility Criteria, and has not progressed, but does not meet any PBS restrictions that apply to Trodelvy, Gilead will continue to provide access under the HR+AP.
9. Subject to 8 above, Gilead may terminate enrolment in the HR+AP at any time in its absolute discretion, acting reasonably.
10. Gilead will not cover any costs associated with any treatment associated with Trodelvy whether those costs are hospital costs, dispensing fees or any other cost associated with the patient’s treatment.
11. You agree to provide all reasonable assistance upon receipt of a reasonable request from Gilead for the purposes of compliance with applicable laws and relevant regulatory obligations.
12. You agree to notify Gilead within one working day of receipt of any communication from a regulatory authority in relation to Trodelvy and provide Gilead with copies of any such correspondence, unless to do so would be unlawful.
HR+AP Patient Eligibility Criteria
13. Each patient must only be enrolled in the HR+AP if, at the time the patient is enrolled, the patient meets the HR+AP Patient Eligibility Criteria outlined below:
a) that the patient’s condition is unresectable locally advanced or metastatic breast cancer;
b) the condition must be hormone receptor (oestrogen and progesterone receptor) positive (HR+);
c) the condition must be human epidermal growth factor receptor 2 negative (HER2-); and
d) the patient must have received endocrine-based therapy (including a CDK4/6 inhibitor) and at least two additional systemic therapies in the locally advanced or metastatic setting.
Ordering and payment
14. You and the institution are responsible for placing any orders for Trodelvy under the HR+AP.
15. Each order must take into account any dose adjustments by weight or other clinical reasons so that only the correct number of vials is ordered.
16. Each dose is delivered separately, and no stockpiling of the drug is permitted by institutions. Where Gilead becomes aware that additional vials have been supplied, Gilead may adjust deliveries against future of orders to account for these additional vials.
17. Each patient order will require confirmation of:
a) the patient’s ongoing and informed consent;
b) that the patient continues to meet the Patient Eligibility Criteria; and
c) your agreement to comply with the terms and conditions of the G.Access Program at the time of the order.
18. Where the patient is enrolled in the HR+AP, you or the institution are responsible for making all payments in accordance with these terms and conditions. Any arrangement for payment by the patient is a matter between the patient, and you or the institution. If payment is not made in accordance with these terms and conditions, Gilead reserves the right to discontinue supply.
Drug Safety Reporting
19. To comply with pharmacovigilance regulations, you will within 1 business day of becoming aware, report all safety information to Gilead via prescribed form to Safety_FC@gilead.com including, but not limited to, all adverse events, serious adverse events or special situation reports (as defined in Exhibit A) of which you become aware during the period in which your patient is enrolled in the HR+AP. For alternative contact details, please telephone 1800 806 112 to report an adverse event.
20. You will alert Gilead Patient Safety of any potential safety issues arising from the use of the Product within twenty-four (24) hours of becoming aware of such information.
21. Gilead is responsible for any regulatory reporting obligations that arise from any report made by you to Gilead.
22. When sending any adverse events and/or safety information by email, to the above address, you will ensure an acknowledgement is received from Gilead (to confirm receipt) and document the acknowledgement. If not received within 2 business days, the safety report should be resent.
23. Gilead may request additional information related to the use of the Product. Such request will be addressed to the patient’s physician. You will provide all reasonable assistance upon receipt of a reasonable request from Gilead for the purposes of compliance with applicable laws and relevant regulatory obligations. You will ensure that there will be no directly identifiable patient information (e.g., name, address, etc.) in any report you send to Gilead in accordance with these HR+AP Trading Terms, except as required or permitted by law or regulation or as authorized in the applicable informed consent form. Gilead will retain all information provided under these HR+AP Trading Terms for as long as required to meet regulatory obligations related to the Product.
24. Pregnancy reports. Reports of pregnancy following maternal or paternal exposure are applicable to all products to support the monitoring of the safety of Gilead products in pregnant people. Where a Gilead product is supplied for use and the person is, or becomes pregnant, the requesting physician will complete a pregnancy report form, to be provided by Gilead, when they become aware of that treatment during pregnancy. The requesting physician will provide the HCP contact details on the form such that Gilead can follow-up on the pregnancy outcome directly with the HCP at an appropriate timeframe. The pregnancy report form will be reported directly to the Gilead PS department at the contact information specified below for safety reports.
AU-TRO-0303 Date of preparation July 2024
Exhibit A:
Drug Safety Definitions
Abuse: Persistent or sporadic intentional excessive use of a medicinal product by a patient or clinical study subject.
Adverse Event (“AE”): Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event (AE) can therefore be any unfavourable and/or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also include pre- or post-treatment complications that occur as a result of protocol mandated procedures, lack of efficacy, Overdose or drug Abuse/Misuse reports. Pre-existing events that increase in severity or change in nature during or as a consequence of participation in the clinical study shall also be considered AEs.
Adverse Reaction (“AR”): An untoward medical occurrence (unintended or noxious responses) considered causally related to an investigational or authorized medicinal product at any dose administered. Adverse Reactions may arise from Medication Errors, uses outside what is foreseen in the protocol or prescribing information (off-label use), Misuse and Abuse of the product, Overdose or Occupational Exposure where applicable.
Drug Interactions: Any report of drug/drug, drug/food, or drug/device interactions.
Counterfeit or Falsified Medicine: Any medicinal product with a false representation of: a) its identity, including its packaging and labeling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients: b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder: or c) its history, including records and documents relating to the distribution channels used. This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights. Note: Counterfeit or Falsified Medicine will not apply in clinical studies.
Exposure via breastfeeding: Reports of any exposure to a medicinal product during breastfeeding. Note: Such reports are not expected from clinical studies, however if they occur should be reported as an SSR.
Lack of Effect (LOE) Report: A report of a situation where there is apparent failure of the medicinal product or medical technology to bring about the intended beneficial effect on individuals in a defined population with a given medical problem, under ideal conditions of use. NOTE: Lack of Effect reports from clinical studies refer to situations where the product is administered within the authorized indication and use. Lack or Effect reports do not apply to clinical studies where LOE is an endpoint.
Medication Error: Any unintentional error in the prescribing, dispensing, preparation for administration or administration of a medicinal product while the medication is in the control of a healthcare professional, patient or consumer. Note: Medication Errors may be classified as a) Medication Error without an AE, which includes situations of missed dose b) Medication Error with an AE c) Intercepted Medication Error or d) Potential Medication Error.
Misuse: Use of a medicinal product that is intentional and inappropriate and not in accordance with its authorized product information.
Occupational Exposure: Exposure to a medicinal product as a result of one’s professional or non-professional occupation.
Off-label Use: Where a medicinal product is intentionally prescribed by a health care professional for a medical purpose not in accordance with the authorized product information with respect to indication, dose, route or patient population (e.g. the elderly). NOTE: Off- Label Use will not apply in clinical studies.
Overdose: Administration of a quantity of a medicinal product given per administration or cumulatively which is above the maximum recommended dose as per the protocol or in the product labelling. The Parties agree that in the course of conducting a clinical study, the terms of the clinical study protocol (as fully approved by all applicable bodies) overrides the local product labelling.
Pregnancy Reports (Maternal Pregnancy and Partner Pregnancy): Reports of pregnancy following maternal or paternal exposure to the product. Note: For clinical studies the collection of partner pregnancy reports is dependent on the safety profile of a product and determined at the project level.
Product Complaints: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, safety, or effectiveness of a medicinal product after it is released for distribution.
Safety Documentation: All records in any form (including, but not limited to, written, electronic, magnetic and optical records and scans, radiographs and electrocardiograms) that describe or record safety data and safety related activities covered by this Agreement.
Serious Adverse Event (“SAE”) / Serious Adverse Reaction (“SAR”): An event or any untoward medical occurrence that at any dose either:
a) Results in death; or
b) Is life-threatening
NOTE: The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe; or
c) Requires in-patient hospitalisation or prolongation of existing hospitalisation; or
d) Results in persistent or significant disability/incapacity; or
e) Results in a congenital anomaly/birth defect; or
f) Results in a medically important event or reaction.
Special Situation Reports (“SSR”): One of:
· Pregnancy Reports (Maternal Pregnancy and Partner Pregnancy)
· Exposure via breastfeeding
· Abuse,
· Misuse
· Medication Error: actual or potential
· Off-Label Use
· Overdose
· Lack of Effect
· Occupational Exposure
· Drug Interactions
· Unexpected Benefit
· Counterfeit or Falsified Medicines
· Transmission of infectious agents via the product
Transmission of infectious agents via the product: Any suspected transmission of an infected agent through a Gilead medicinal product.
Unexpected Benefit: an unintended therapeutic effect where the results are judged to be desirable and beneficial.
