Nuvigil (armodafinil) Patient Bridging Programme

Terms and Conditions

General terms

1. The Nuvigil Patient Bridging Programme (‘The ‘Programme’) is the primary means for accessing patient starter packs of Nuvigil. Previous Nuvigil sampling programmes have been discontinued.
2. Teva Pharma Australia has retained the services of a third party web services, warehouse and distribution company to manage The Programme on its behalf. Any references to Teva also means Teva or this third party on its behalf.
3. The Programme is subject to a limit of 14 days of consecutive treatment for the enrolled patient (i.e. 2 starter packs maximum, for either strength). This is strictly fixed at 14 days and cannot be extended or repeated using a different Nuvigil strength.
4. Health Care Professionals (HCP’s) may receive a quantity of Nuvigil starter packs as a “balance” to securely hold in a medical practice, for the purpose of issuing to eligible patients when they present for treatment. This balance can be ordered via your local Teva representative, who upon HCP request will take a signed order using approved Teva ordering methods only. 
5. A maximum of 10 units of 7-tablet packs of Nuvigil 150mg and 250mg may be requested for this “balance” at a frequency of no more than one order per month (via the Teva representative).
6. As each patient is enrolled by the HCP and a number of starter packs is assigned to this patient, the balance will be adjusted and reflected on the patient enrolment website. When the balance of either strength reduces to a quantity of 2 units, the local representative will be automatically notified and they will arrange to meet the requesting HCP for a new order to be placed.
7. Every patient who receives a Nuvigil starter pack must be enrolled in The Programme. If patients are provided starter packs without being enrolled into The Programme, this will not reflect on the balance in the database, so the HCP will be unable to place a new order to replenish with new starter packs until the previous balance is properly reconciled against patient enrolments. The patient enrolment form must be completed in-full to be valid. 
8. Teva may extend or cancel this programme at any time at its sole discretion. Teva will communicate any changes to the offer to the HCP. 
9. No party is under any obligation to participate in this programme. The patient and prescribing doctor may cease participating in the programme at any time. 
10. Teva does not and will not provide any HCP involved in this programme with any incentive or transfer of value, apart from providing the HCP with a balance of Nuvigil starter packs at no cost, to dispense to the patient under the terms of The Programme. 
11. A HCP's participation in this programme is not intended to be, in any way or manner, an inducement for that HCP to prescribe, supply, administer, recommend, promote, buy or sell any particular medicinal products, including Teva’s products. 
12. Each enrolment of a patient is done via entering their initials (only) as a step in the enrolment page. No other information that could be identifiable to the patient is to be used. A record number is applied by the system upon updating of this entry into a secure database for the purpose of managing the programme. The purpose of this database is solely to validate the enrolment of patients against the balance of Nuvigil starter packs for each HCP. The database will not be used for any other purpose.
13. Nuvigil starter pack units provided by Teva as part of this programme must not be on-sold, distributed to another HCP or any other party (other than the intended patient), or otherwise disposed of, except in accordance with this programme or as required by law. 
14. Teva reserves the right, in its sole discretion, to disqualify a participant from this programme for failure to comply with any of these terms.

Patient eligibility:

To be eligible for this programme, a patient must:

1. Have a diagnosis consistent with the three TGA-approved indications for Nuvigil, as described in the drop down box in the patient enrolment page
2. Comply with either of the reasons for needing the bridging programme, as described in the drop down box in the patient enrolment page
3. Not have been previously enrolled in the Nuvigil Patient Bridging Programme
4. Not be currently treated with Nuvigil for the same condition and dose at which they may be enrolled in the programme.

Adverse Event Reporting

Privacy information

1. Teva collects and uses basic contact, AHPRA and enrolment information from HCPs to manage and administer the Nuvigil Bridging Programme, including to complete HCP validity checks, respond to HCP queries or requests or otherwise communicate with the HCP in respect of the programme. 
2. By filling in the order form, Teva collects the following information directly:
1. Doctors: Surname and AHPRA number, and will also use the HCP contact information already on file to mail the balance of starter packs and/or to email (where permitted) information pertaining to the programme, either directly or from your local Teva representative.
2. Patients: Initials and a random record number (thereby de-identified), the reason for requiring the Nuvigil starter packs, the strength given and their clinical indication for treatment.
3. Teva will be unable to provide the offer to the HCP and patient if the HCP does not permit the use of the information described above.
4. Teva may collect, use, store and otherwise handle the personal information as required or authorised by applicable law, including to assess, record and report actual or suspected adverse events and safety issues, and (if applicable) to seek additional information in connection with such adverse events or safety issues, and other purposes with consent.
5. This information may be disclosed to third parties that help Teva deliver its services (including but not limited to website providers, mailing partners and parties which administer the programme). 
6. You may receive communications from Teva or its partners which are factual in nature, or which relate to the administration of this programme. Teva’s Privacy Policy explains how it collects, uses and handles your personal information, how you may access and correct such personal information, how to lodge a complaint regarding the handling of your information, and how Teva will deal with such a complaint. If you have any queries or would like further information about Teva’s privacy practices, contact us at privacy.au@tevapharm.com  or view our privacy policy at https://www.tevapharma.com.au/general-pages/Privacy_Policy/  https://www.tevapharma.com.au/general-pages/phv_privacy_policy/ and our Privacy Collection Notice at https://www.tevapharma.com.au/general-pages/privacy-collection-notice-teva-pharma-australia/. 

Patient information

Patients should speak with their HCPs if they have any questions about this program, Nuvigil, or any aspect of their health.

Program information for healthcare professionals

Please contact the Nuvigil Team (Senior Brand Manager, WAKE) via email at angus.hastie@tevapharm.com.au, or 0406 517 897 for more information. Alternatively, please contact your local Specialist Sales Representative.

TEVA Pharma Australia Pty Ltd, ABN 41 169 715 664, Level 1, 37 Epping Road, Macquarie Park, Sydney, NSW 2113. Phone: 1800 AU TEVA (1800 28 8382). Fax: +61 2 8061 9999. www.tevapharma.com.au . NUVIGIL^® is a registered trademark of Teva Pharmaceutical Industries Ltd. Date of preparation: May 2021. NUV-AU-00413