9 Procedures for submissions not recommended
All applicants with a ‘not recommended’ PBAC outcome are able to lodge a resubmission via the Standard Re-entry Pathway.
Based on the PBAC’s independent assessment of the level of additional information required and issues to be addressed before further PBAC consideration, the PBAC many nominate an Early Resolution, Early Re-entry or Facilitated Resolution Pathway. Should the applicant not accept the PBAC nominated resubmission pathway, but still wish for further PBAC consideration, the Standard Re-entry Pathway applies.
The PBAC will nominate a resubmission pathway based on the PBAC’s independent assessment of:
- the issues for resolution; and
- whether the medicine or vaccine represented High Added Therapeutic Value (HATV) for the proposed population:
- the medicine or vaccine addresses a high and urgent unmet clinical need; and
- the medicine or vaccine is expected to provide a substantial and clinically relevant improvement in efficacy, or reduction of toxicity, over any alternative therapies.
Once an applicant is advised of a PBAC decision not to recommend and has received the PBAC Minutes, an applicant lodging a resubmission is required to:
- Lodge an Intent to Apply Form (Refer Section 9.2).
- Lodge the Resubmission (Refer Section 9.3).