Welcome to the TYSABRI ® Australian Prescribing Program (TAPP) training. TYSABRI® (natalizumab) was approved by the Therapeutic Goods Administration (TGA) on 30 October 2006. The conditions for granting marketing approval include the compulsory registration and education of neurologists, pharmacies and infusion centres.

TAPP Education Program

This program is an educational platform for neurologists and other healthcare professionals. TAPP is designed to:

• Ensure that those patients most likely to benefit from treatment receive TYSABRI
• Assist neurologists to appropriately assess the benefit/risk balance for each of their patients.
• Ensure that TYSABRI is discontinued earlier rather than later if symptoms and/or signs appear consistent with PML

TAPP consists of:

• Neurologists - compulsory prescribing program
• Pharmacy and infusion centre staff - compulsory training focusing on dispensing, administration and patient monitoring
• All trained healthcare professionals to be recorded in a dedicated database
  (TAPP database) as per TGA reporting requirements.

TAPP Patient Register

All trained healthcare professionals are to be recorded in a dedicated database (TAPP database) as per TGA reporting requirements. The database now includes a patient register to document the status of all TYSABRI®-treated patients.

The TAPP database has been custom-made for the TYSABRI® Australian Prescribing Program.

The main objective of the database is to facilitate reporting to the TGA and to manage the commitments Biogen Idec has made to the TGA, which are:

• Rollout and tracking of training requirements for healthcare professionals
• Managing 6-monthly follow-ups to neurologists on patient exposure and adverse events
• Biogen Idec must actively solicit and submit to the TGA 6-monthly updates from neurologists registered with the sponsor as potential prescribers of TYSABRI®. These updates must include information recorded in the Patient Register, including:
  • Number of patients treated
  • Dose received by each patient
  • Duration of treatment
  • Current status of each patient
  • Reasons for discontinuation of treatment
  • Presence and nature of adverse drug reactions.

TAPP will focus on clinical monitoring by healthcare professionals as the most appropriate risk management approach for treatment of relapsing remitting multiple sclerosis patients with TYSABRI®.