Managed Entry Agreements (MEAs) enable payers to subsidize access to new medicines while addressing uncertainties. Uncertainties may relate to the criteria for decision-making articulated in decision-making frameworks. The study's aim was to determine if there was any association between the type of MEA and criteria considered during decision-making.
All medicines with MEAs listed on the Australian national subsidy scheme between 2012-2016 were identified. Data were extracted on the types of MEA and information related to the criteria considered in decision-making for each medicine and its associated indication (i.e. a medicine-indication pair [MIP]). The criteria considered in decision-making included the comparator (therapy to which it was compared), type of economic analysis, accepted value, budget impact, financial cost of supply, cost of therapy per patient, access control (such as restrictions or prior authorization), and clinical need. Associations between types of MEA and the criteria were assessed using Chi Squared test.
There were 87 MIPs, of which 56 had only financial MEAs and 31 had performance-based MEAs. Coverage with evidence development MEAs had very high incremental cost-effectiveness ratio (ICER)/quality adjusted life year (QALY) (74 percent > AUD 50,000 [USD 37,822]). Financial MEAs where performance measures were linked to reimbursement had lower ICER/QALY (13 percent > AUD 50,000 [USD 37,822]) but greater budget impact (33% > AUD 80million [USD 60.5million]) compared to simple financial MEAs. A statistically significant association (Cramer's V = 0.5, p < 0.001) was only found between performance-based MEAs and the cost of unsubsidized therapy per patient.
The main influence on the choice of performance based MEA was the provision of access to clinically important medicines with a high treatment cost for patients.