Innovative technologies for reverse total shoulder arthroplasty in Australia: Market access challenges and implications for patients, decision-makers, and manufacturers.

Purpose: The success of reverse total shoulder arthroplasty (RTSA) has expanded its use for a broader range of shoulder indications worldwide. Evidence regarding the relative efficacy and long-term safety of medical technologies used in RTSA is subjected to rigorous assessment. Nonetheless, substantial challenges impede market access for innovative shoulder implant technologies for RTSA in Australia, resulting in delayed patient access. Approach: This paper addresses the key challenges associated with generating evidence for the health technology assessments of innovative medical technologies for RTSA that are required for access to the Australian market. The transition to value-based care requires establishing a benchmarking reference that incorporates patient-reported outcome measures (PROMs) and combines revision outcomes with additional clinical outcomes to increase patient cohort sizes. Establishing the benchmark would require agreement on the outcome measures to be collected for each indication, and investment in reporting patient-reported outcomes for RTSA to the national orthopaedic registry. Implications for practice: The need for increased flexibility in developing evidence for health technology assessment of RTSA medical technologies is required. Optimised approaches for benchmarking RTSA require extensive stakeholder discussions, including the agreement on evidence requirements and follow-up periods, selection of clinical outcomes, as well as pre-operative and post-operative PROMs as a value assessment.

Factors associated with Pharmaceutical Benefits Advisory Committee decisions for listing medicines for diabetes and its associated complications.

Objective To retrospectively analyse the key factors associated with listing decisions by the Pharmaceutical Benefits Advisory Committee (PBAC) for medicines for diabetes and its complications on the Pharmaceutical Benefits Scheme. Methods The clinical and economic evidence were retrieved from public summary documents (PSD) of all major submissions between July 2005 and March 2020. A multivariate binary logit regression analysis was conducted to assess the relationship between the categorical explanatory variables and PBAC recommendations. Results We identified a total of 211 PSD of which 118 (56%) were recommended for listing. Clinical and economic uncertainty were significantly and inversely associated with the PBAC recommendation. Submissions with high clinical and economic uncertainty were less likely to be recommended. Conclusion Our findings will enhance the understanding of medical professionals, pharmaceutical companies, and other stakeholders about the rationale of PBAC reimbursement decisions for these medicines and assist prospective applicant sponsor companies in preparing their submissions.