Presentation (CTI)

OBJECTIVES: In-vitro diagnostics (IVD) are tests on human tissue or blood used for diagnosis, monitoring, and precision medicine. In Australia, the Medical Services Advisory Committee (MSAC) assesses IVD funding applications and provides recommendations for reimbursement on the Medicare Benefits Schedule (MBS). There are no standardised timelines for MBS processes, and reasons for delays are unknown. This study analysed timelines and outcomes of IVD submissions to MSAC to identify factors influencing the listing process.
METHODS: An MSAC submission database was developed from public summary documents and the MBS website. IVD applications with ≥1 MSAC meeting between 2016 and 2023 were included. Resubmissions were consolidated with the original application. Variables captured included number of meetings, resubmission reason, economic evaluation type, co-dependency with drug (i.e. companion diagnostics), application date, MSAC outcome, submission and meeting dates, and MBS listing date. The primary outcome was time from the start of MSAC submission to MBS listing. Recommendation and resubmission rates were also analysed.
RESULTS: Eighty consolidated applications met the inclusion criteria. Sixty-two (78%) had a positive recommendation (38 first-time recommendations). All were listed on the MBS. Mean time from submission to listing was 38 months (SD=22; range=93). Mean time to listing increased with the number of MSAC meetings: 1 meeting (n=38), 28 months; 2 meetings (n=19), 51 months; 3+ meetings (n=5), 66 months. Those requiring resubmission due to insufficient clinical evidence (n=5) took on average 70 months to list. Submissions with drug co-dependency (n=20) had an average time of 36 months, compared to 39 months for those not linked to listing a new medicine (n=42).
CONCLUSIONS: Delays and variability in the time to MBS listing are significant. Co-dependent submissions contain a drug component which may lead to quicker IVD reimbursement. The greatest potential to reduce delay is initial shared understanding of evidentiary requirements prior to submission.