Terms & Conditions
EVENITY® Co-Pay Program: Healthcare Professionals
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EVENITY® (romosozumab) will be prescribed by you to your patient for an indication for which EVENITY® is registered for therapeutic use in Australia.
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By virtue of enrolling a patient in the Program, you have deemed it appropriate, based upon your independent medical evaluation of the patient, and the requirements for Program eligibility, to treat the patient with EVENITY®.
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You have read and are familiar with the EVENITY® Approved Product Information (PI), including precautions and the recommended dosage regimen and method of administration. The approved PI is available from Amgen Australia Ph: 1800 803 638 or at www.amgen.com.au/Evenity.PI.
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The patient's treatment with EVENITY®, including understanding of and compliance with all requirements is wholly the responsibility of you.
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You shall be wholly responsible for explaining the relevant information to the patient. Amgen make no warranties, express or implied, regarding EVENITY® or its use in the patient.
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Amgen, in its sole discretion, has the right to cease providing free product under the EVENITY® Co-Pay Program at any time.
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You are required to obtain all appropriate consents for the patient to participate in the Program. Such consents shall permit Amgen and/or their third party suppliers, including Atlantis Health to collect, use, disclose and store the patient health information to administer the Program and their regulatory requirements such as reporting adverse events, as permitted by law. All patient personal information shared with Amgen will be de-identified except where Amgen has notified the physician that personal information that identifies one or more patients is required in order to comply with legal obligations in the state or territory in which the patient is being treated.
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As part of the informed consent process, you must provide the patient and/or their authorised caregivers or guardians with:
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An explanation of whom to contact in the event of a treatment-related question or injury;
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A description to which confidentiality of records identifying the patient will be maintained, explaining the possibility that applicable regulatory authorities may inspect such records;
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A statement that there could be unanticipated circumstances in which the patient's participation in the Program could be terminated by the physician or Amgen, without regard to the patient's consent;
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Information on the costs that may result from taking EVENITY®; and
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Any information that the patient specifically requests.
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You have read and understood the privacy statement provided and you agree with it. You understand that information relating to an adverse event, other safety finding or product quality complaint with an Amgen product that is identified during this activity will be forwarded to Amgen's Pharmacovigilance department, and possibly to health authorities when required.
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You consent for Amgen's Pharmacovigilance department to contact you for follow-up in case an adverse event, other safety finding or product quality complaint is identified as part of this activity. You acknowledge that you must check with your patient before providing the requested follow-up information.
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You represent and warrant that you have not been debarred as a physician pursuant to any applicable laws or regulations. Furthermore, there are no proceedings against you that could lead to your debarment. You also agree to immediately inform Atlantis Health in writing if any such proceeding is threatened or commenced.
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Atlantis Health and/or Amgen reserve the right to change the Program Terms and Conditions at any time.
Repatha® Co-Pay Program: Healthcare Professionals
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Repatha® (evolocumab) will be prescribed by you to your patient for an indication for which Repatha® is registered for therapeutic use in Australia.
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By virtue of enrolling a patient in the Program, you have deemed it appropriate, based upon your independent medical evaluation of the patient, and the requirements for Program eligibility, to treat the patient with Repatha®.
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You have read and are familiar with the Repatha® Approved Product Information (PI), including precautions and the recommended dosage and mode of administration. The approved PI is available from Amgen Australia Ph: 1800 803 638 or at www.amgen.com.au/Repatha.PI.
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The patient's treatment with Repatha®, including understanding of and compliance with all requirements is wholly the responsibility of you.
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You shall be wholly responsible for explaining the relevant information to the patient. Amgen make no warranties, express or implied, regarding Repatha® or its use in the patient.
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Amgen, in its sole discretion, has the right to cease providing free product under the Repatha® Co-Pay Program at any time.
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You are required to obtain all appropriate consents for the patient to participate in the Program. Such consents shall permit Amgen and/or their third party suppliers, including Atlantis Health to collect, use, disclose and store the patient's personal information to administer the Program and meet their regulatory requirements such as reporting adverse events, as permitted by law. All patient personal information shared with Amgen will be de-identified except where Amgen has notified the physician that personal information that identifies one or more patients is required in order to comply with legal obligations in the state or territory in which the patient is being treated.
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As part of the informed consent process, you must provide the patient and/or their authorised caregivers or guardians with:
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An explanation of whom to contact in the event of a treatment-related question or injury;
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A description to which confidentiality of records identifying the patient will be maintained, explaining the possibility that applicable regulatory authorities may inspect such records;
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A statement that there could be unanticipated circumstances in which the patient's participation in the Program could be terminated by the physician or Amgen, without regard to the patient's consent;
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Information on the costs that may result from taking Repatha®; and
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Any information that the patient specifically requests.
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You have read and understood the privacy statement provided and you agree with it. You understand that information relating to an adverse event, other safety finding or product quality complaint with an Amgen product that is identified during this activity will be forwarded to Amgen's Pharmacovigilance department, and possibly to health authorities when required.
•
You consent for Amgen's Pharmacovigilance department to contact you for follow-up in case an adverse event, other safety finding or product quality complaint is identified as part of this activity. You acknowledge that you must check with your patient before providing the requested follow-up information.
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You represent and warrant that you have not been debarred as a physician pursuant to any applicable laws or regulations. Furthermore, there are no proceedings against you that could lead to your debarment. You also agree to immediately inform Atlantis Health in writing if any such proceeding is threatened or commenced.
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Atlantis Health and/or Amgen reserve the right to change the Program Terms and Conditions at any time.
IMDELLTRA® Private Pay Program: Healthcare Professionals
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IMDELLTRA® will be prescribed by you to your patient for an indication for which IMDELLTRA® is registered for therapeutic use in Australia.
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By virtue of enrolling a patient in the Program, you have deemed it appropriate, based upon your independent medical evaluation of the patient and the requirements for Program eligibility, to treat the patient with IMDELLTRA®.
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You have read and are familiar with the IMDELLTRA® Approved Product Information (PI), including precautions and the recommended dosage and mode of administration.
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Decisions regarding the patient's treatment and ongoing management, including communication of Program requirements to the patient, remain the responsibility of you as the treating physician.
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You shall be wholly responsible for explaining the relevant information regarding the Program to the patient, including all payment obligations associated with participation.
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Prior to enrolment, you must ensure that the patient understands and acknowledges:
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participation in the Program requires ongoing payment by the patient;
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invoices must be paid by the due date to ensure medication can be dispatched in time for treatment;
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delayed payment may impact treatment schedules;
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except where required by law, no refunds, credits or reimbursements will be provided where treatment is discontinued, interrupted or ceased for any reason;
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Except where medication expressly supplied at no charge under the Cost-Share benefit in accordance with these Terms and Conditions, Amgen does not provide compassionate, bridge, emergency or ongoing free stock under this Program.
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You must ensure that the Program consent form is completed, signed and returned to Atlantis Health prior to patient enrolment.
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'At no charge' stock will only be supplied upon receipt of evidence that all previous doses supplied under the Program have been paid for in accordance with the applicable payment terms.
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If a patient fails to make payment by the invoice due date, Atlantis Health may notify you of the potential treatment delay so that appropriate clinical management can be considered.
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You are required to obtain all appropriate consents for the patient to participate in the Program.
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Neither Amgen nor Atlantis Health accepts responsibility for treatment delays, missed doses, changes to treatment schedules or associated clinical outcomes resulting from delayed or non-payment.
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Amgen may amend, suspend or terminate the Program or these Terms and Conditions at any time. Where reasonably practicable, Amgen will give prior notice. Any amendment, suspension or termination will not affect a Patient Payment already accepted for Product that has not been supplied; in that circumstance, Atlantis Health will arrange a refund of the applicable Patient Payment if Product cannot be supplied.
EVENITY® Co-Pay Program: Pharmacy/Pharmacists
As the nominated pharmacy/pharmacist (You), you agree to request EVENITY® for this patient through a pharmaceutical wholesaler. In order to claim back the cost of EVENITY® through the EVENITY® Co-Pay Program, EVENITY® should be ordered through your wholesaler subject to their standard trading terms.
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EVENITY® is only intended for and supplied to the patient enrolled in the Program, and the patient must have a valid prescription for the product.
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You agree that the treatment duration is at the discretion of the prescribing physician, and you will not dispense EVENITY® to any patient without a valid prescription.
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You agree to be reimbursed monthly for any at no cost EVENITY® that has been dispensed as part of this Program, and only for the product for which a dispensing record has been lodged by the end of the preceding month.
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You acknowledge that you will be reimbursed and agree to the rebate amount for your services in participating in the Program (as agreed and in accordance with the Program requirements). You must accurately report on any provision of services and product under this Program on the forms provided.
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By participating in this Program, you confirm that you accept full responsibility for, and shall take all steps to maintain, appropriate records and ensure appropriate supply, storage, handling, distribution and usage of EVENITY® for this Program in accordance with any applicable laws and regulations.
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You confirm that you will release your dispensing records for audit purposes to Atlantis Healthcare should we request it, within 30 days of the date of request.
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You agree to promptly notify Atlantis Health in the event of a regulatory audit or inspection that relates to the administration of the product for this Program to a patient under this Program.
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You agree to take any action necessary, as reasonably requested by Atlantis Health, to properly correct or address any deficiencies noted in the dispensing record for the Program or as a result of any regulatory inspection or audit of your records related to this Program.
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By participating in this Program, you warrant that you have obtained consent from your pharmacy staff, or any other persons relating to this request, to forward their personal information to Atlantis Health, and to service providers or affiliated companies that assist us, on their behalf and that their information will be treated the same as outlined in the Privacy Statement.
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By supplying your contact details, you also consent for Atlantis Health and/or Amgen to contact you for follow-up information if a safety report is identified. You agree that Atlantis Health and/or Amgen can contact you via email or telephone to seek further information regarding adverse events.
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By participating in this Program, you acknowledge that you have read and understood the Australian Product Information for EVENITY®, and you understand that you can seek information for this product from the Consumer Medicine Information and the Product Information.
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You agree to report all adverse events, other safety findings and product quality complaints immediately to Amgen's Pharmacovigilance team, and to obtain patient consent before providing personal information when making a report.
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You represent and warrant that you have not been debarred as a pharmacist pursuant to any applicable laws or regulations. Furthermore, there are no proceedings against you that could lead to your debarment. You also agree to immediately inform Atlantis Health in writing if any such proceeding is threatened or commenced.
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Atlantis Health and/or Amgen reserve the right to change the Program Terms and Conditions at any time.
Repatha® Co-Pay Program: Pharmacy/Pharmacists
As the nominated pharmacy/pharmacist (You), you agree to request Repatha® for this patient through a pharmaceutical wholesaler. In order to claim back the cost of Repatha® through the Repatha® Co-Pay Program, Repatha® should be ordered through your wholesaler subject to their standard trading terms.
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Repatha® is only intended for and supplied to the patient enrolled in the Program, and the patient must have a valid prescription for the product.
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You agree that the treatment duration is at the discretion of the prescribing physician, and you will not dispense Repatha® to any patient without a valid prescription.
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You agree to be reimbursed monthly for any at no cost Repatha® that has been dispensed as part of this Program, and only for the product for which a dispensing record has been lodged by the end of the preceding month.
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You acknowledge that you will be reimbursed and agree to the rebate amount for your services in participating in the Program (as agreed and in accordance with the Program requirements). You must accurately report on any provision of services and product under this Program on the forms provided.
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By participating in this Program, you confirm that you accept full responsibility for, and shall take all steps to maintain, appropriate records and ensure appropriate supply, storage, handling, distribution and usage of Repatha® for this Program in accordance with any applicable laws and regulations.
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You confirm that you will release your dispensing records for audit purposes to Atlantis Healthcare should we request it, within 30 days of the date of request.
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You agree to promptly notify Atlantis Health in the event of a regulatory audit or inspection that relates to the administration of the product for this Program to a patient under this Program.
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You agree to take any action necessary, as reasonably requested by Atlantis Health, to properly correct or address any deficiencies noted in the dispensing record for the Program or as a result of any regulatory inspection or audit of your records related to this Program.
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By participating in this Program, you warrant that you have obtained consent from your pharmacy staff, or any other persons relating to this request, to forward their personal information to Atlantis Health, and to service providers or affiliated companies that assist us, on their behalf and that their information will be treated the same as outlined in the Privacy Statement.
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By supplying your contact details, you also consent for Atlantis Health and/or Amgen to contact you for follow-up information if a safety report is identified. You agree that Atlantis Health and/or Amgen can contact you via email or telephone to seek further information regarding adverse events.
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By participating in this Program, you acknowledge that you have read and understood the Australian Product Information for Repatha®, and you understand that you can seek information for this product from the Consumer Medicine Information and the Product Information.
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You agree to report all adverse events, other safety findings and product quality complaints immediately to Amgen's Pharmacovigilance team, and to obtain patient consent before providing personal information when making a report.
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You represent and warrant that you have not been debarred as a pharmacist pursuant to any applicable laws or regulations. Furthermore, there are no proceedings against you that could lead to your debarment. You also agree to immediately inform Atlantis Health in writing if any such proceeding is threatened or commenced.
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Atlantis Health and/or Amgen reserve the right to change the Program Terms and Conditions at any time.
IMDELLTRA® Private Pay Program: Pharmacy/Pharmacists
As the nominated pharmacy/pharmacist (You), you acknowledge that Atlantis Health provides program administration services in connection with the Program and medication supplied under this Program will be distributed by DHL, on behalf of Amgen for the Program.
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IMDELLTRA® supplied under this Program is intended solely for the enrolled patient for whom it has been ordered and approved.
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Medication supplied under the Program is allocated to a specific enrolled patient and cannot be transferred, reassigned, exchanged, sold or used for any other patient.
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Atlantis Health will coordinate supply of medication to the nominated pharmacy once Program requirements have been met. For the purposes of this program only, Atlantis will be taking payment for, and facilitating the order and delivery of IMDELLTRA®, on behalf of Amgen Australia.
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No reimbursement payments will be made to participating pharmacies under this Program.
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You agree to maintain appropriate records relating to receipt, storage, handling, dispensing, administration and destruction of Program medication in accordance with all applicable laws and regulations.
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Any medication supplied through the Program that is not administered to the enrolled patient remains ineligible for reimbursement, return or credit.
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Any medication supplied through the Program that is not administered to the enrolled patient, including expired, damaged or otherwise unusable stock, must be destroyed in accordance with applicable institutional policies, local procedures and regulatory requirements.
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Where the 'at no charge' medication supplied under the Program is not administered and is subsequently destroyed, the treating pharmacy should retain appropriate destruction records and make them available to Amgen upon request.
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Upon request, you agree to provide records relating to Program medication for audit and compliance purposes.
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You agree to promptly notify Atlantis Health of any product discrepancy, product loss, stock destruction, medication error, adverse event or product quality complaint associated with Program medication.
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Amgen may amend, suspend or terminate the Program or these Terms and Conditions at any time. Where reasonably practicable, Amgen will give prior notice. Any amendment, suspension or termination will not affect a Patient Payment already accepted for Product that has not been supplied; in that circumstance, Atlantis Health will arrange a refund of the applicable Patient Payment if Product cannot be supplied.
EVENITY® Co-Pay Program: Patients
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You have been advised by your doctor that you are suitable for EVENITY® (romosozumab) treatment and agree to participate in the Program.
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You have been informed by your doctor about the EVENITY® Co-Pay Program, treatment with EVENITY®, including how to administer and its potential benefits and side effects, and any questions have been answered.
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You understand that you will only be eligible to receive product at no cost† through a participating pharmacy once you meet the eligibility criteria, including proof of dispense history from your selected pharmacy.
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Amgen, in its sole discretion, has the right to cease providing the EVENITY® Co-Pay Program at any time.
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You are aware that in order to manage the Program, your doctor will be required to provide personal information to Atlantis Health (the Program administrator) who will collect and store your information in accordance with the privacy statement and for the purposes of administering the Program.
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If you report an adverse event, with your consent, your personal information will be provided to Amgen and Amgen may need to contact you for more information. If consent is not provided, the adverse event will be reported in a de-identified manner.
† Note: pharmacies may charge a dispensing fee. These fees are not included in the Program.
Repatha® Co-Pay Program: Patients
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You have been advised by your doctor that you are suitable for Repatha® (evolocumab) treatment and agree to participate in the Program.
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You have been informed by your doctor about the Repatha® Co-Pay Program, treatment with Repatha®, including how to administer and its potential benefits and side effects, and any questions have been answered.
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You understand that through the Program, you will be eligible to receive one Repatha® prescription (which includes x2 SureClick® pens) at no cost† when you have purchased two Repatha® prescriptions for the duration determined by your doctor or expanded PBS listing, whichever comes first.
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Amgen, in its sole discretion, has the right to cease providing the Repatha® Co-Pay Program at any time.
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You are aware that in order to manage the Program, your doctor will be required to provide personal information to Atlantis Health (the Program administrator) who will collect and store your information in accordance with the privacy statement and for the purposes of administering the Program.
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If you report an adverse event, with your consent, your personal information will be provided to Amgen and Amgen may need to contact you for more information. If consent is not provided, the adverse event will be reported in a de-identified manner.
† Note: pharmacies may charge a dispensing fee. These fees are included in the Program up to the value of $18.00. Amgen does not cover any additional non-drug related costs such as consultation fees.
IMDELLTRA® Private Pay Program: Patients
You, as the patient, acknowledge and understand that:
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You have been advised by your doctor that you are suitable for IMDELLTRA® treatment and agree to participate in the Program.
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You have been informed by your doctor about the IMDELLTRA® Private Pay Program, including the costs associated with treatment, and have had the opportunity to ask questions.
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To participate in the Program, the consent form provided by your prescribing healthcare professional must be completed, signed and returned to Atlantis Health via email at imdelltra@amgencostshare.com.au
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You acknowledge that participation in the Program requires payment of invoices by the due date specified to ensure medication can be dispatched and delivered in time for your treatment schedule.
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Payment is deemed received only when cleared funds have been received by Atlantis Health or its nominated payment provider. For the purposes of this Program only, Atlantis will be taking payment for, and facilitating the order and delivery of IMDELLTRA®, on behalf of Amgen Australia.
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You understand that medication cannot be dispatched until payment has been received and processed.
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If payment is not received by the due date, medication will not be dispatched, and your prescribing healthcare professional will be notified of the potential treatment delay.
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You acknowledge that delayed payment may result in postponement of scheduled infusions.
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Continued supply of medication under the Program is conditional upon payment of all applicable invoices by the due date and compliance with Program requirements.
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You acknowledge that, except where required by law, no refunds, credits or reimbursements will be provided for medication that has been ordered, allocated, supplied or paid for under the Program, including where treatment is discontinued, interrupted or ceased for any reason.
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You acknowledge that except for medication expressly supplied at no charge under the Cost-Share benefit in accordance with these Terms and Conditions, Amgen does not provide compassionate, bridge, emergency or ongoing free stock under this Program.
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By agreeing to participate in the Program, you acknowledge that you will be responsible for funding treatment costs for as long as treatment continues.
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The Program contributes only towards the cost of the medication and does not cover any other treatment-related expenses, including but not limited to infusion fees, hospital charges, clinic charges, consultation fees, nursing services, consumables, administration materials, parking, travel expenses or any other costs associated with treatment.
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Neither Amgen nor Atlantis Health accepts responsibility for treatment delays, missed doses, changes to treatment schedules or associated clinical outcomes resulting from delayed or non-payment.
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Participation in the Program does not guarantee availability of the product. Supply remains subject to product availability and Amgen's ability to supply the product. If a Patient Payment has been made but Product cannot be supplied, Atlantis Health will arrange a refund of the applicable Patient Payment.
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Amgen may amend, suspend or terminate the Program or these Terms and Conditions at any time. Where reasonably practicable, Amgen will give prior notice. Any amendment, suspension or termination will not affect a Patient Payment already accepted for Product that has not been supplied; in that circumstance, Atlantis Health will arrange a refund of the applicable Patient Payment if Product cannot be supplied.
