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Market Access: the Final Pharmaceutical Frontier?

Now firmly embedded as the "fifth hurdle”, market access is the prevailing debate in the healthcare industry and, given that clearing this barrier can make the difference between success or market failure for a new technology, it is rapidly emerging as a huge growth area for research.

Obtaining licensing approval (e.g. by the FDA, EMEA) is no longer sufficient for Pharma to access the market and have their new brands prescribed widely. Approval and reimbursement by national health systems is also imperative, otherwise physicians will not have prescribing freedom and the market is effectively unavailable.

In their decision making processes, national gatekeepers, such as NICE in the UK, IQWIG in Germany and LFN in Sweden, all appear to be driven by cost-containment (in all probability due to political pressure) and therefore seek either cost-effectiveness evidence or the lowest possible price application before endorsement.

In order to arrive at the critical point of market access armed with the type of evidence gatekeepers require, it is important for Pharma to engage in an early dialogue with Payers and Decision-Makers to determine their needs.  Only then is it possible to formulate an effective strategy for the brand that will guarantee successful market entry and wide penetration.

Pharma needs to embrace the model that market access possesses a timeline that follows the clinical development of their products and that failure to acknowledge this concept carries the real risk of expensive extension of clinical development.  Specific clinical trials should be designed keeping in mind the evidence and end-points required by national gatekeepers who review cost-effectiveness information after the brand has received licensing approval.  Thus, market access begins in Phase II.

National gatekeepers are not the only obstacles to market access.  In any country there is a huge burden of Regulators and Regional Payers to consider and the importance of identifying and mapping stakeholder influence is an essential and complex component of access strategy development.

The needs of Stakeholders, Payers and Decision-Makers require careful study by independent research, in order to help develop a robust market access strategy carrying the required cost-effectiveness message.  Given the challenge presented by market access and the reliable, politically inspired changes to the environment, placing the "access strategy” at the core of Pharma’s marketing plans would appear to provide the best opportunities for brand development and optimal market success.

GfK Healthcare Market Access Centre can support Pharma in this quest.