The success of a pharma brand's launch largely depends on its successful market access (MA). The market access strategy and plan must therefore be fully integrated with the product strategy and plan. To achieve that, those responsible for optimizing market access must:
- Leverage key activities that are already planned in clinical development, pricing, marketing etc.; and
- Ensure that market access activities appear in other plans (e.g. global brand plan, clinical development plan ...)
It is thus very important that headquarters put a market access planning process in place for each new brand long before its launch. The process should start prior to phase II with a MA Environment Assessment, and ends with a Final MA Plan prior to registration. Beyond that point, materials need to be handed over to the national marketing organizations. Following is a chronological overview of the different steps:
Market Access Environment Assessment:
Before the commencement of phase II studies, the following information should be gathered:
- Knowledge of healthcare systems in different countries and what their requirements are
- Understanding of disease management and unmet needs
- Understanding of which clinical evidence seems to have had most impact in the past
- Reimbursement status of current treatments, and restrictions
Preliminary Market Access Plan:
Once reactions of payers and physicians to the draft Target Product Profile (TPP) become available, the following information should be compiled to make up the Preliminary MA Plan:
- Disease background
- Clinical/economic impact
- Reimbursement opportunities and strategy
- Planned specific studies
Gap Analysis
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Given the TPP, what evidence do we need to achieve the desired MA position?
- And how are we going to generate this evidence?
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The output from this Gap Analysis should feed into phase III clinical trials and decisions on additional studies required
Final Market Access Plan
Finally, when clinical trial results are available from phase III studies, the MA plan can be finalized along with a timetable for handing over materials to national markets. It is likely that additional pricing research might be required to complete the plan.
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