The following terms and conditions (‘Terms’) apply to your registration in, and use of, a program that facilitates patient access to BLENREP® (belantamab mafodotin) and supports the coordination of required eyehealth examinations (the ‘MyeCare Program’). The MyeCare Program is sponsored by GlaxoSmithKline Australia Pty Ltd (‘GSK’) and managed by Partizan Worldwide Pty Ltd (‘Partizan’) (together, ‘us’, ‘we’ or ‘our’). References to the ‘MyeCare Program team’ in these Terms mean Partizan staff and authorised subcontractors acting on its behalf.
Please read these Terms and the MyeCare Program Privacy Notice available at www.myecare.com.au/privacy-notice. It is your right to refuse to agree to the terms and conditions outlined here; however, if you do not agree, you and your patients may not be able to enrol or participate in the MyeCare Program. If you have any questions or require additional information, please contact the MyeCare Program team on 1800 140 272.
Your registration in the MyeCare Program shall constitute acceptance of the following terms and conditions:
You may only access and use the MyeCare Program in accordance with these Terms and any instructions provided by the MyeCare Program team.
You will use the secure online MyeCare Portal (the online referral and program-management platform) to submit patient referrals and manage MyeCare Program interactions.
For each patient referral, you must actively indicate your agreement to these Terms within the MyeCare Portal (via the required onscreen declaration/checkbox) before submitting the referral. This affirmative selection confirms your acceptance of these Terms for that patient and enables the patient enrolment to proceed.
You confirm that you are a medical practitioner registered to practise in Australia under the Health Practitioner Regulation National Law, including current specialist registration in haematology or medical oncology (‘Health Professional’).
You acknowledge and agree that:
Patients are eligible to be enrolled in the MyeCare Program only if all the following criteria are met:
The condition must be confirmed by a histological diagnosis,
AND
The treatment must be as a part of triple combination therapy in combination with bortezomib and dexamethasone,
AND
Patient must have progressive disease* after at least one prior therapy, following one or two prior lines of therapy (i.e. BLENREP must be used as second or third line treatment),
AND
Patient must not have previously received treatment with another B-cell maturation antigen (BCMA) directed therapy for this condition.
AND
Australian resident with a valid Medicare card.
You acknowledge that patient enrolment in the MyeCare Program will remain open until one of the following occurs:
3.1 Eligibility Confirmation
Before submitting a referral, you confirm that the patient meets the MyeCare Program eligibility criteria as outlined in Section 2 and meets the indications in the current BLENREP Product Information. A consent form for the supply of BLENREP through the MyeCare Program is available for you and your patient to sign and keep with your medical records. You must notify the MyeCare Program team if the patient becomes ineligible at any time. If you select assistance with eye‑test coordination, the patient will be required to provide a separate digital consent as per Section 3.3.
3.2 Patient Understanding and Verbal Consent
You must ensure the patient understands the (i) MyeCare Program and the services provided, and (ii) what treatment with BLENREP will entail, including potential adverse effects and the requirement for regular eye examinations. You must obtain the patient’s verbal consent to be referred to the MyeCare Program.
3.3 Electronic Consent and Enrolment
Following referral, the patient will receive the MyeCare Program Terms and Conditions and Privacy Notice electronically via SMS. Enrolment for the MyeCare Program can only be completed once the patient provides electronic consent via the secure link.
You agree to report any Adverse Events (“AE”) or Human Safety Information (“HSI”) associated with BLENREP® through the appropriate reporting channels, including your local hospital processes. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems or GSK Medical Information on 1800 033 109.
Where an AE or HSI involving a GSK product is reported, the MyeCare Program team, on behalf of GSK, may contact you to request followup information to support regulatory reporting obligations.
Services provided under the MyeCare Program may include Healthcare Professional services and Patient services. Not all services are required for, or provided to, every patient. Supply of BLENREP may occur independently of other MyeCare Program services, subject to patient enrolment.
Healthcare Professional Services
The following services are provided to support Healthcare Professionals in coordinating patient access and treatment planning:
Patient Services
The following services may be provided directly to patients who enrol in the MyeCare Program and provide the required consents:
Services provided under the MyeCare Program may vary depending on:
We reserve the right to alter or cancel any services under the MyeCare Program, or the MyeCare Program itself, at any time.
Partizan administers the MyeCare Program. By providing your personal information and/or registering to use the MyeCare Program, you consent to Partizan collecting, using, storing, transferring and disclosing your personal information in accordance with these Terms and the MyeCare Program Privacy Notice available at www.myecare.com.au/privacy-notice and the Privacy Act 1988.
Patient personal information is not shared with GSK except where required, and with patient permission, for AE or HSI reporting. In such cases, only the information required to fulfil GSK’s regulatory obligations will be disclosed. Deidentified and aggregated data may be provided to GSK for governance and compliance purposes.
If you have any questions, concerns, or a complaint regarding the treatment of your privacy or your patient’s privacy, please contact the MyeCare Program team by phone on 1800 140 272 or by email at support@myecare.com.au.
Your registration on the MyeCare Program system will continue for the duration of the MyeCare Program or until you opt out. You may opt out at any time by calling 1800 140 272 or writing to the MyeCare Program team at support@myecare.com.au.
We may suspend or cancel your access to the MyeCare Program if required for regulatory, safety, operational or MyeCare Programrelated reasons. We will use reasonable efforts to provide you with notice wherever practicable.
If you need to opt out of your registration with the MyeCare Program or otherwise transfer a patient’s care to another Healthcare Professional, please contact the MyeCare Program team on 1800 140 272 or at support@myecare.com.au (Monday to Friday, 9am–5pm AEST) to update your details and facilitate the transfer. Where a patient is transferred, the new treating Healthcare Professional will be required to register to the MyeCare Program, by reading and agreeing to these Terms before the MyeCare Program supply and support services can continue.
If your registration to the MyeCare Program ends for any reason, the MyeCare Program team will contact your patient to explain what this means for their ongoing support and supply arrangements and will assist with a safe and timely transition of care in line with your clinical direction.
We reserve our right to modify these Terms at any time, including the MyeCare Program eligibility requirements. We will use reasonable endeavours to ensure that you are alerted to changes, such as by contacting you via email. Your subsequent continued use of the MyeCare Program after such changes have been made will constitute acceptance of the new Terms.
We may also update, improve or otherwise modify the software, services and the MyeCare Program from time to time.
The MyeCare Program may be terminated at any time at the direction of GSK, for regulatory or safety reasons or any other reason GSK deems necessary. No new patients will be enrolled after MyeCare Program termination.
If legally permitted following MyeCare Program termination, your patients already enrolled at the time of termination may continue to receive MyeCare Program support and BLENREP supply in accordance with your clinical direction, until treatment is clinically discontinued, the patient no longer meets eligibility criteria, or disease progression occurs.
If regulatory or safety requirements prevent continuation of MyeCare Program support or supply, GSK will provide reasonable notice (where possible) and will assist in facilitating a safe transition of care if required.
If you have any questions about the MyeCare Program or these Terms, please contact us by phone on 1800 140 272 or by email at support@myecare.com.au.
For product information or AE/HSI reporting for BLENREP (belantamab mafodotin), contact GSK Medical Information: 1800 033 109.
Progressive disease is defined as at least one of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M-protein (monoclonal protein); or
(b) at least a 25% increase in 24-hour urinary light chain M-protein extraction, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo-secretory** and non-secretory myeloma patients only, at least 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).