Articles by TACS Healthcare

Understanding the broader healthcare environment into which a product will be launched is critical, especially in HTA markets where fiscally constrained Governments are the main payer.

Market Access Feasibility & Assessment

Every product is unique and usually the success of market access will depend upon one or two key issues. Unfortunately, these 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 commenced to determine the pricing implications of reimbursement submission sequence.

Identified data gaps also 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 utilisation evidence can increasingly be sourced. Although 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 should also be applied to products under consideration for in-licensing during the due diligence phase.

Case Study

Clinical Development Program Input

Situation:

Phase II results for a first-in-class medicine in a new therapeutic area were generating interest from Australian clinicians.

Involvement:

Organised a Focus Group meeting with the Global product lead in attendance. Extensive input from Australia and New Zealand opinion leaders was forthcoming on treatment algorithms, study design, competitive advantage and reimbursement strategies.

Outcome:

The data generated by the Phase III studies was pivotal in obtaining a first submission positive PBAC recommendation. Although new to the clinical space, the company was well-regarded by key local clinicians.

Case Study

In-Licensing Due Diligence

Situation:

Two published Phase IV studies were referenced in marketing materials as support for the superior efficacy of a product being considered for in-license.  On-line access to all company clinical data (voluminous) was also made available during negotiations.

Involvement:

As a member of the review team,  I independently under took a systematic review and collation of all clinical trials and real-world evidence studies cross-checking against FDA evaluations and the NIH clinical trial registry.

Outcome:

Exposed unpublished efficacy data that led to a no-go decision.  The 2 Phase III studies versus placebo, as required by the FDA, showed no difference in efficacy to placebo whereas the published studies were versus a different comparator.

TACS Healthcare in-licensing due diligence