Australian Managed Entry Scheme (MES)
The Australian Managed Entry Scheme allows new medicines to be temporarily listed on the Pharmaceutical Benefits Scheme when there is uncertainty about their long-term effectiveness. This gives time to collect more evidence while patients can access the medicine at a reduced cost, with agreements in place to monitor outcomes.
At a glance
Use when
There is significant clinical or economic uncertainty that can be resolved through further study; a medicine shows promise but lacks long-term outcomes data; early access is considered beneficial for public health
Avoid when
Evidence gaps are insurmountable or unlikely to be resolved; the medicine poses significant safety risks; no feasible mechanism exists for monitoring outcomes or enforcing agreements
Inputs
Clinical trial data with residual uncertainty, cost-effectiveness analysis, proposed risk-sharing model, evidence generation plan
Outputs
Interim PBS listing decision, deed of agreement, monitoring and reporting requirements, potential full listing or delisting
How it works
A managed-access and risk-sharing mechanism administered by the PBAC and the Australian Department of Health, enabling interim listing of pharmaceuticals on the PBS under formal deeds of agreement. The scheme addresses clinical and economic uncertainty by linking reimbursement to ongoing evidence generation, with pricing adjusted according to cost-effectiveness estimates and real-world performance.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Organisational aspects
- Assumptions
- Sponsors will reliably generate high-quality real-world evidence; health outcomes can be measured and verified; interim pricing reflects value under uncertainty
- Strengths
- Enables earlier patient access to promising therapies; reduces financial risk for the health system; incentivises post-market evidence generation; supports value-based pricing
- Limitations
- Administrative complexity; potential delays in final reimbursement decisions; reliance on sponsor compliance for data collection; limited transparency in deed terms
- Also known as
- MES, Managed Entry Scheme (Australia), PBS Managed Entry Scheme
Questions this answers
- › How can medicines with uncertain clinical benefits be made available to patients while further evidence is gathered?
- › What mechanisms allow interim reimbursement under the PBS when cost-effectiveness is not fully established?
- › How are risk-sharing and evidence generation formalised between sponsors and the Australian government?
- › How is pricing determined for medicines under evidence development conditions?
- › What role does the PBAC play in monitoring medicines under managed access?
- › How are patient access and budget impact balanced in the face of uncertainty?
References & sources
Similar by meaning
- PBAC Guidelines (Guidelines for preparing a submission to the Pharmaceutical Benefits Advisory Committee, Version 5.0)
- Slovak legally-facilitated performance-based Managed Entry Agreements
- Guidelines for preparing assessments for MSAC
- SMC Ultra-Orphan Medicines Pathway
- National framework for reviewing codependent technologies (personalised medicines)
Beta record. Based on the original catalogue summary; primary-source enrichment pending.