Feasibility of de-linking reimbursement of antimicrobials from sales: the Australian perspective as a qualitative case study

BACKGROUND: There is a disparity in the economic return achievable for antimicrobials compared with other drugs because of the need for stewardship. This has led to a decline in pharmaceutical companies’ willingness to invest in the development of these drugs and a consequent global interest in funding models where reimbursement is de-linked from sales. OBJECTIVES: To explore the perspective of stakeholders regarding the feasibility of de-linked reimbursement of antimicrobials in Australia. METHODS: Semi-structured interviews were conducted with 18 participants sourced from the pharmaceutical industry and individuals representing public-sector payers or regulators. Interviews were transcribed verbatim, coded and thematically analysed using the framework method. RESULTS: Five key themes were identified in the interviews: funding silos are a barrier to de-linking reimbursement; varying levels of supporting evidence are (currently) required for funding depending upon setting; funding status or cost is used as a stewardship tool; a de-linked model may cost more; and concerns regarding governance and access to antimicrobials exist in the private sector. CONCLUSIONS: Australia’s current multi-tiered funding of medicines across different levels of government was perceived as a barrier to de-linked reimbursement. Participants felt that the responsibility for antimicrobial funding and stewardship should be integrated and centralized. Implementing a nationally funded de-linked reimbursement model for new antimicrobials would require a review of funding decision-making criteria, given that most MDR infections are off-label indications and could not then be funded through the Australian Pharmaceutical Benefits Scheme. Findings from this study could be applicable to other countries with reimbursement frameworks similar to Australia.