9.1 Resubmission pathways
There are four different resubmission pathways available to applicants following a ‘not recommended’ PBAC outcome. Resubmission pathways are not available for submissions that receive a positive recommendation from the PBAC (refer Section 5.7 for procedures to request PBAC reconsideration of a recommendation).
Standard Re-entry Pathway
The Standard Re-entry Pathway is the default pathway for resubmissions, including where the PBAC did not nominate a resubmission pathway. The Standard Re-entry Pathway also applies where:
- an applicant chooses not to accept the PBAC nominated resubmission pathway; or
- an Early Re-entry or Early Resolution Pathway has been nominated by the PBAC and an applicant decides to address issues other than those identified by the PBAC (including a subset of issues); or
- an applicant decides to lodge their resubmission later than the allowable timelines for the other pathways.
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an Early Re-entry, Early Resolution or Facilitated Resolution Pathway resubmission receives a ‘not recommended’ outcome.
Early Re-entry Pathway
An Early Re-entry Pathway may be nominated by the PBAC where the PBAC considers that the remaining issues could be easily resolved and the medicine or vaccine does not represent High Added Therapeutic Value (HATV) for the proposed population. This would include circumstances where:
- new clinical study data requiring evaluation is not considered necessary by the PBAC to support new clinical claims to be made in the resubmission; and
- a revised model structure or input variable changes (beyond those specified by the PBAC) are not necessary to support any new economic claims, or to estimate the utilisation and financial impacts to be made in the resubmission.
Applicants who accept this pathway are eligible for PBAC consideration at the immediate next meeting (Refer Section 9.2 and 9.3).
Where an applicant chooses not to accept the PBAC nominated pathway; addresses additional issues; or is unable to meet the lodgement timeframes, the Standard Re-entry Pathway would apply.
Early Resolution Pathway
The PBAC may nominate an Early Resolution Pathway where the PBAC considers that the remaining issues could be easily resolved, including when:
- new clinical study data requiring evaluation is not considered necessary by the PBAC to support new clinical claims to be made in the resubmission; and
- a revised model structure or input variable changes (beyond those specified by the PBAC) are not necessary to support any new economic claims, or to estimate the utilisation and financial impacts to be made in the resubmission.
and where the medicine or vaccine meets the HATV criteria:
- 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.
Applicants who accept this pathway are eligible for PBAC consideration out-of-session (before the main meeting), unless the department, in consultation with the PBAC Chair, identifies an unexpected issue such that the resubmission needs consideration at the next main PBAC meeting.
Where an applicant chooses not to accept the PBAC nominated pathway; or is unable to meet the lodgement timeframes, the Standard Re-entry Pathway would apply.
Facilitated Resolution Pathway
A Facilitated Resolution Pathway may be nominated by the PBAC where the PBAC considers the issues for resolution could be explored through a workshop and where the medicine or vaccine meets the HATV criteria:
- 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.
Applicants who accept this pathway are eligible for a solution-focussed workshop with one or more members of the PBAC (refer Section 9.4 for further details). It is expected that Facilitated Resolution Pathway resubmissions will require evaluation of a new and/or updated model structure and/or input variable changes beyond those specified by the PBAC to support the economic claims or estimate the utilisation and financial impact in the resubmission. This may also include other substantial changes from the previous submission that require re-evaluation.
Applicants will need to request a post-PBAC meeting with the PBAC Chair (see Section 7.1.4) to finalise the workshop agenda, required attendees and to discuss any other matters required to prepare for the workshop.
Where an applicant chooses not to accept the PBAC nominated pathway; addresses additional issues; or is unable to meet the lodgement timeframes, the Standard Re-entry Pathway would apply.
