Every product is unique and usually the success of market access will depend upon one or two critical issues. Unfortunately, these issues are often not apparent until considerable reimbursement submission writing has been undertaken.

For this reason, it is critical that sponsors commence market access feasibility and data assessment work as early as possible in the life cycle of each product. For example, many new medicines, such as immunotherapies, are being trialed in different combinations across multiple indications and considerable upfront work should be undertaken to determine the pricing implications of reimbursement submission sequence.

Identified data gaps require time to address. This does not always necessitate a clinical study. Digitisation of records, well-advanced in pockets of Australia, mean that real-world, retrospective clinical and utilization evidence can increasingly be sourced. Note that Ethics Committee approval will be required in the majority of circumstances.

The market access strategy developed must be considerate of the broader healthcare, political and economic context which a reimbursement submission will be required to navigate. Proactive, and reactive, engagement with Government, research institutes, clinicians, patient support groups, private providers and the media should be deliberated. The approach to price negotiations, potential Managed Access Programs, and resubmissions must be part of any action plan.

This approach is also applicable to products under consideration for in-licensing during the due diligence phase.