4.5 Integrated codependent submissions
Health technologies are codependent if their use needs to be combined (either sequentially or simultaneously) to achieve or improve the intended clinical effect of either technology. For example, a medicine–test combination, where a new medicine seeking listing on the PBS may have a related pathology test that helps to determine the population group for that medicine.
The PBAC Guidelines (Product Type 4) provide information about when codependent submissions may be required, so that MSAC and PBAC can consider the submission. The department has developed a coordinated approach to managing these submissions.
Applicants who may need to prepare a codependent submission should contact the HTAAP early to facilitate the submission process, including scheduling meetings with the relevant departmental officers from MBD and TAAD if required. Further details are available on the department’s HTA webpage. Contact details for the HTAAP are in Appendix A.
Where an applicant is making an integrated codependent submission, the Intent to Apply form is required four weeks prior to the MSAC submission due day. As the MSAC submission date is typically four weeks earlier than the corresponding PBAC submission due day (the MSAC submission due day corresponds with the date of the previous meeting of the Evaluation Sub-Committee of MSAC). As a result, the Intent to Apply form for an integrated codependent submission is required eight weeks before the usual PBAC submission due day and the integrated codependent submission due day is four weeks before the usual PBAC submission due day. Dates are available on the MSAC calendar.
Where a PBAC submission involves a streamlined codependent submission to MSAC the normal PBAC timelines apply.