- Phase II reimbursement success
- Early negotiation with PBAC & MSAC
- Pricing research
- Project management of quality co dependent applications
- Ensure patient advocacy alignment
- Stakeholder management & government liaison
- Establish early access programs & associated digital platforms
Reimbursement in Australia is essential for market success
The Australian Government assists Australians in accessing many health services and technologies by providing cost subsidies through the Pharmaceutical Benefits Scheme (PBS), the Medicare Benefits Schedule (MBS) and through private health insurance.
A Health Technology Assessment (HTA) involves a range of processes and mechanisms that use scientific evidence to assess the quality, safety, efficacy, effectiveness and cost effectiveness of health services. It is useful to understand these requirements when designing your clinical trial to ensure adequate evidence is available for your HTA submission.
The impact on the Commonwealth budget for approvals is extensive and because of this, government liaison, particularly with the Health Minister and patient advocacy groups, is critical. The Minister has broad discretion in relation to product pricing and the Senate holds the final decision to approve a budget increase for new treatments. A well-planned, patient focused pricing strategy must consider both the clinical needs of patients and the Commonwealth’s financial pressures, particularly if the application utilizes a cost effective model.
The path to reimbursement in Australia can be complex, time consuming and expensive, especially when a co-dependent submission is required (pharmaceutical and associated diagnostic). We have experience in expediting and successfully reimbursing pharmaceutical products, with or without diagnostics, for chemotherapy, targeted therapies, small molecules and immune oncology products.