10.1 Drug Utilisation Sub-Committee review
DUSC has a role in reviewing PBS-listed medicines (see Section 6.1.3)
10.1.1 Drug Utilisation Sub-Committee review process and timeframes
DUSC regularly reviews the PBS Schedule for medicines that have been listed for 24 months. DUSC selects individual medicines or groups of medicines to be reviewed. DUSC may also undertake ‘ad hoc’ reviews as requested by the PBAC or the Minister. The applicant is informed of the review after the meeting.
Planned reviews are listed in the outcomes of the DUSC meeting, which are published on the PBS website. Applicants are notified at least ten weeks before a DUSC meeting if a report on the use of a medicine they applicant will be considered.
Applicants are provided with the DUSC reports on the utilisation of medicines four weeks before the DUSC meeting (PBAC week 8). Each applicant has two weeks to provide a written response to the department (DUSC Secretariat) if they choose. Responses must be provided to the department by close of business on the Wednesday of week 10 of the PBAC cycle. Refer to Appendix A for contact details.
DUSC considers the report in conjunction with any responses received from applicants and other relevant stakeholders at the DUSC meeting.
Each applicant is provided with a copy of the DUSC Minutes prepared following DUSC consideration.
Advice to the PBAC
The report, stakeholder responses and DUSC Minutes are referred by DUSC to the PBAC for noting or consideration. DUSC may provide specific advice for PBAC to consider.
A list of DUSC reports on the utilisation of PBS medicines to be considered by the PBAC are published on the PBS website 10 weeks before the date of the PBAC meeting. Consumers are invited to make comments that are submitted directly to the department (see Section 6.7.1).
The PBAC meeting occurs five weeks after the DUSC meeting. The PBAC can make a number of different recommendations to the Minister after it considers the DUSC reports, including, but not limited to:
- revising the restriction wording
- revising the category of the listing or type of approved prescriber
- requesting DUSC to revise the utilisation report, as specified by the PBAC
- requesting further consultation
- advising the Minister for Health that a post-market review is warranted (refer to Section 10.2)
Each applicant receives a copy of the PBAC Minutes following the PBAC consideration of DUSC advice and reports for their medicine.
10.1.2 Publication of DUSC reports
The DUSC public release documents provide public access to DUSC utilisation analysis reports.
Applicants are given the opportunity to provide a short comment for publication with the report. Applicants may also request information they consider commercially sensitive to be redacted.
The DUSC public release document is sent to each relevant applicant 15 weeks after the DUSC meeting. Applicants have two-and-a-half weeks to review the public release document and provide comments to the DUSC Secretariat. Within the next three weeks, there may be further negotiation on wording between the Secretariat and the applicant depending on the nature of the proposed comments and redactions. The Secretariat provides the finalised public release document to the applicant at the end of the three weeks. The DUSC report is published on the PBS website two weeks later.
