Fintepla - UCB, Inc.

UCB, Inc. must ensure that healthcare providers, patients, pharmacies, and wholesalers‑distributors comply with the following requirements:

UCB, Inc. must provide training to healthcare providers who prescribe FINTEPLA.

The training includes the following educational materials: Prescriber Training, REMS Program Overview, and Prescriber Knowledge Assessment. The training must be available online and in hard‑copy format via fax and mail.

UCB, Inc. must provide training to pharmacies that dispense FINTEPLA.

The training includes the following educational materials: Pharmacy Guide and REMS Program Overview. The training must be available online and in hard-copy format via fax and mail.

To support REMS operations, UCB, Inc. must:

1. 1.Authorize dispensing for each patient based on receipt of the Patient Status Form on the following schedule: prior to initiation of treatment, and for subsequent dispensing, within 270 calendar days from the date of receipt of the last Patient Status Form. If a complete Patient Status Form is not received within 270 calendar days, the patient is not authorized to receive the drug until a completed form is received.
2. 2.Establish and maintain a REMS website, www.FinteplaREMS.com. The REMS website must include the capability to complete prescriber certification, pharmacy certification, and enroll and manage patients online, to obtain authorization to dispense online, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include REMS-specific prominent links to the REMS website. The REMS website must not link back to any promotional product websites.
3. 3.Make the REMS website fully operational and make all REMS materials available through the REMS website and call center by the date FINTEPLA is first commercially distributed.
4. 4.Establish and maintain a REMS call center for REMS participants at 1-877-964-3649.
5. 5.Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the FINTEPLA REMS.
6. 6.Ensure prescribers are able to complete the certification process online, by fax and mail.
7. 7.Ensure prescribers are able to enroll their patients in the REMS online, by fax and mail.
8. 8.Ensure pharmacies are able to complete the certification process online, by fax and mail.
9. 9.Ensure prescribers are able to submit the Patient Status Form to the REMS online, by fax, and by mail.
10. 10.Ensure prescribers are able to report adverse events suggestive of valvular heart disease and pulmonary arterial hypertension via the Patient Status Form online, by fax, and by mail.
11. 11.Ensure pharmacies are able to obtain authorization to dispense online and by phone.
12. 12.Provide the Prescriber Training, REMS Program Overview, Prescriber Enrollment Form, Patient Enrollment Form, and Prescribing Information to healthcare providers who (1) attempt to prescribe FINTEPLA and are not yet certified or (2) inquire about how to become certified.
13. 13.Provide the Pharmacy Guide, REMS Program Overview, and Inpatient Pharmacy Enrollment Form or Outpatient Pharmacy Enrollment Form, as appropriate, to pharmacies that (1) attempt to dispense FINTEPLA and are not yet certified or (2) inquire about how to become certified.
14. 14.Notify prescribers, patients, and pharmacies within 2 business days after they become enrolled and/or certified in the REMS.
15. 15.Provide certified prescribers access to the database of certified pharmacies and enrolled patients.
16. 16.Provide certified pharmacies access to the database of certified prescribers and enrolled patients.
17. 17.Provide authorized wholesalers-distributors access to the database of certified pharmacies.
18. 18.Establish and maintain a registry for all patients that includes a reporting and collection system for all patients to provide information on patient outcomes and the incidence of valvular heart disease and pulmonary arterial hypertension.
19. 19.Ensure that, once a report suggestive of valvular heart disease or pulmonary arterial hypertension is received, UCB, Inc. follows up with the healthcare provider(s) to complete a Cardiovascular Adverse Event Reporting Form, to obtain all required data related to the adverse event for the registry.

To ensure REMS participants’ compliance with the REMS, UCB, Inc. must:

1. 20.Ensure the Patient Status Form is received for each patient on the following schedule: For treatment initiation, the patient is not authorized to receive the drug until the form is received. For subsequent dispensing, if the Patient Status Form is not received within 180 calendar days of the date of receipt of the last Patient Status Form, UCB, Inc. must contact the prescriber to obtain the form. If the form is not received within 270 calendar days, the patient is not authorized to receive the drug until the form is received.
2. 21.Verify annually that the authorized representative’s name and contact information corresponds to those of the current designated authorized representative for the pharmacy. If different, the pharmacy must be required to re-certify with a new authorized representative.
3. 22.Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to, records of FINTEPLA distribution and dispensing; certification of prescribers and pharmacies; enrollment and status of patients; documentation of completed Patient Status Forms and Cardiovascular Adverse Event Reporting Form; and audits of REMS participants. These records must be readily available for Food and Drug Administration (FDA) inspections.
4. 23.Establish a plan for addressing noncompliance with REMS requirements.
5. 24.Monitor prescribers, pharmacies, and wholesalers-distributors on an ongoing basis to ensure the REMS requirements are being met. Take corrective action if noncompliance is identified, including decertification.
6. 25.Audit pharmacies and wholesalers-distributors no later than 90 calendar days after they become certified and have received at least one shipment, and annually thereafter, to ensure that REMS processes and procedures are in place, functioning, and support the REMS requirements.
7. 26.Take reasonable steps to improve operations of and compliance with the REMS requirements based on monitoring and evaluation of the FINTEPLA REMS.