1. Only Australian residents who are prescribed LUCRIN (leuprorelin acetate) for the treatment of metastatic or locally extensive prostate cancer (Stage C and D), are eligible to participate in The Man Plan program (Program).
2. The Program is sponsored by AbbVie Pty Ltd (ABN 48 156 384 262) (AbbVie) and managed and administered by AbbVie’s nominated third party providers (Service Providers). Service Providers facilitate the provision of all communications, including phone calls, mail, emails, SMS and any future digital communication channels that may become available for the Program.
3. Participation in a Program is designed to complement and support the prescribing instructions of a healthcare professional who is responsible for prescribing LUCRIN for prostate cancer (Prescribing Specialist). All services offered under the Program are optional, allowing patients to opt into all or a selection of the available services.
4. The Program does not replace the advice of a Prescribing Specialist or other healthcare professional (HCP). Patients should speak to their Prescribing Specialist if they have any questions or concerns about their treatment. Patients should also refer to LUCRIN’s Consumer Medicines Information available at https://secure.guildlink.com.au/gc/ws/ve/cmi.cfm?product=veclucrx or by calling AbbVie Medical Information on 1800 043 460 if they have any further questions or concerns.
5. The maximum duration of the Program is two years from the date of confirmed enrolment into the Program.
7. AbbVie reserves the right to cease funding a Program and/or terminate the Program with reasonable notice at any time.
8. AbbVie reserves the right to change and/or cease providing any of the services within the Program with reasonable notice at any time.
9. The Program consists of the following services:
10. Service Providers may make additional contact with patients from time to time if new or pilot services (Services) are introduced while they are enrolled in the Program. AbbVie may introduce Services with the view to improve or provide additional patient support. Participation in these Services is voluntary and patients have the right to decline any or all of these Services.
11. Patients may opt out at any time of any part of the Program or the whole Program at any time by contacting the Service Provider either by phoning 1800 626 752, writing to The Man Plan, Reply Paid 751, North Sydney, NSW 2059 (no stamp required) or by faxing 1800 219 836.
How to enrol in the Program
12. A patient can opt in to participate in the Face-to-Face Exercise program, Virtual Exercise Program or the At Home Exercise Program. Participation in the service will be based on the patients: (1) proximity to an EP; (2) medical history; (3) any issues identified by their HCP or the EP; and (4) their current level of fitness.
13. Patients (or a patient’s HCP on behalf of the patient) may enrol the patient in the Program by:
PATIENT RISK WARNING, DISCLAIMER AND INDEMNITY
1. The exercises depicted in the At Home Exercise Program materials are provided as examples and are for demonstration and informational purposes only. The At Home Exercise Program is not a form of medical advice and should not be considered as such.
2. If at any point during the exercise activities patient begin to feel faint, dizzy, or have any discomfort, they should stop immediately and consult their HCP.
3. Patients should be aware that a common side effect of hormone therapy (including LUCRIN) is a reduction in bone mineral density which may result in increased bone fracture risk. Patients acknowledge the specific contraindications, precautions and adverse effects of LUCRIN generally, in the Consumer Medicine Information included in the LUCRIN packaging. Patient’s participation in the Program is at their sole discretion and at their own risk. Patients assume all risk and responsibility in respect of any injury arising from their participation in the selected exercise activities or other Program activities for the duration of the Program.
4. To the maximum extent permitted by law, each patient agrees to indemnify the Service Providers, AbbVie, their assigned EP/HC/Dietician and any premises from which the Face to Face Exercise is conducted, from any and all damages, actions, claims, judgments, costs of litigation and legal costs which may result from; (1) their of, or presence upon, the property or facilities of their assigned EP; and (2) their participation in the Virtual Exercise Program or At Home Exercise Program.
5. Patients acknowledge that neither AbbVie, the Service Providers nor their assigned EP/HC will make any assessment of a patients health, ability, capacity or suitability to participate in the exercise activities in the Program. The Face-to-Face/Virtual Exercise Program will be tailored to each patients needs by their assigned EP. To the maximum extent permitted by law, patients agree that they will bring no claim, legal or otherwise against AbbVie, the Service Providers or their assigned EP/HC as a result of any death, bodily injury or loss or damage arising out of their participation in the Program or use of the services associated with the Program, or otherwise relating to the provision of the training by the EP or HC.
Service Providers will collect, use, store and/or disclose personal information relating to a patient in connection with their participation in a Program. Service Providers use personal information primarily to manage a patient’s participation in a Program and for other purposes as notified to the patient. Service Providers will not use personal information for any other purposes unless Service Providers have consent to do so or is required to do so by law. If a patient does not provide personal information when requested, Service Providers will not be able to manage a patient’s participation in a Program and, as a result, the patient may not be able to participate.
Before submitting any information and agreeing to enrol in the Program, patients should be aware of and consent to the following:
By providing personal information (including your name, age, contact details; as well as, sensitive information relating to the medical condition being treated with Lucrin, patients consent to Service Providers using their personal information for the following purposes:
- program administration and delivery of products and services;
- contacting healthcare professionals and providing them with information about Lucrin and a patient’s participation and activities undertaken in the Program;
- tailoring a Program to a patient;
- providing a patient with materials relating to their treatment and the Program;
- contacting patients to inform them of changes in a Program and to collect their feedback on a Program;
- for safety monitoring, reporting and auditing and responding to enquiries or issues in relation to their Medication.
Collection and Use of Personal Information:
Service Providers will collect personal information directly from patients and their Prescribing Specialist/Delegate. Service Providers may also disclose personal information to other persons involved with the Program for the purposes described above. Service Providers may use personal information to assess a patient’s interest in participating in market research or AbbVie sponsored research projects related to a Program.
Data Sharing with AbbVie:
Any self-reported safety events (including adverse events, special situations and product complaints) that arise from taking Lucrin will be reported to AbbVie for the purpose of reporting this information to the appropriate regulatory notification body and/or in accordance with AbbVie’s Safety Information reporting processes. AbbVie may also use the personal information to contact a patient and/or their healthcare professional to obtain additional information relating to the safety event (including adverse events, special situations and product complaints). AbbVie may also grant access for the purpose of information technology services for system administration only. De-identified information relating to a patient’s participation in the Program may be collated into a report for AbbVie. AbbVie may use this information to:
- help to develop and evaluate the Medications, the Programs, services, materials and treatment
- enable research, including future scientific research and publications to help future patients
- promote awareness of the Programs AbbVie may also share de-identified information with its parent company AbbVie Inc. or its affiliates regarding how the Programs are working on an aggregated basis.
Before agreeing to refer a patient for enrolment in a Program, Prescribing Specialists and other HCPs (collectively referred to as HCPs for the purposes of the below) should be aware of and consent to the following:
FOR PRESCRIBING SPECIALISTS AND HEALTHCARE PROFESSIONALS (together, HCPs)
By completing an enrolment to participate in a Program, HCPs consent to Service Providers collecting and using the personal information provided (e.g. name and contact details) to contact them in relation to the Program, including patient-related updates, and otherwise as necessary to undertake participation in the Program.
Collection and Use of Personal Information:
Service Providers may collect HCP personal information directly from the HCP or may source such information from AbbVie’s use of third-party databases (e.g. OneKey) to complete their registration details for a Program. Personal information held about an HCP will be linked to the patients under that HCP’s medical care. HCP personal information will be used for the purposes of administering the Program, including but not limited to safety event reporting, and may be disclosed to other third parties involved in the delivery of the Program.
Personal Data of Patients:
By completing an enrolment to participate in a Program, HCPs and their Delegate/s confirm that they are authorised to collect a patient’s personal information (including email address and phone number), and that they have provided the necessary notifications to each patient (or their guardian) that they are nominating for enrolment into the Program. HCPs and their Delegate/s confirm that they have informed their patient that Service Providers may need to contact them to complete their enrolment into the Program.
How to Contact Us:
If there are any questions in relation to privacy, please contact a Service Provider on 1800 626 752, or by writing to the Man Plan team at email@example.com or The Man Plan, Reply Paid 751, North Sydney, NSW 2059 (no stamp required) or fax to 1800 219 836.
AU-LUCR-200030. February 2021