For many years, the route to market access has been focused around completing clinical trials and meeting the safety and efficacy data needs of the regulators. This data is then used to persuade payers that the therapeutic is safe and works, and is therefore worth paying the price demanded. However, as budget cuts bite, competition increases and development costs rise, and as the demands for evidence change, this development model is having to change. These changes are driving a root and branch change throughout the whole development lifecycle in order to meet the very different evidence needs of all the individual stakeholders.

Mapping the stakeholders
Understanding the stakeholder’s needs starts with mapping the stakeholders in the markets of interest, and then prioritising and segmenting them according to their importance and influence in the market access process. The final step is distilling this list down to those who have a key role in making market access decisions. Payers are one of the key players in this process.

Changing the perspective on payers
Payers are often seen as the adversaries that are blocking market access, rather than as customers, and as the gatekeepers to better patient outcomes. With this changed perspective in mind, pharma need to develop an understanding of the needs of national and regional payers through engagement at an early stage. Along with this, the needs of providers, guideline bodies, purchasing organisations and policy makers are also important.

These insights can be used throughout the drug development cycle by:

• Playing a part in the landscape assessment that helps companies to decide which projects should enter the R&D pipeline
• Supporting decisions in the clinical trial development pipeline, including choice of patients and endpoints, to ensure that the trials will produce the kind of evidence that the payers need
• Identifying the most important claims
• Highlighting gaps in the data sets
• Collecting data to support the value messages
• Helping pharma understand the nuances of different markets
• Ascertaining where payer education might be needed
• Learning more about willingness to pay
• Shedding light on reimbursement issues relevant to different product types and therapy areas
• Getting advance warning of anticipated changes in market-specific healthcare reimbursement processes

Develop payer-centric value messages that avoid uncertainty
Market access strategies need to tie the clinical development process to the needs in each country, at both regional and local level. By using the feedback and insights from early payer engagement and by understanding what the stakeholders need in each market of interest, pharma can tailor the value messages and dossier to specific stakeholder requirements. To reduce the risk of refusal of reimbursement, the draft messages should be pressure tested through payer interviews and/or advisory boards. This kind of gap analysis can help to refine and validate the target product profile and help companies to present the value story in the way payers want to see.

This approach can also identify what additional arguments or evidence are needed to mitigate any uncertainty or concerns, which can be used to inform the development of solid negotiation strategies and tool kits, such as objection handlers in addition to pricing strategy.

To find out how we at Valid Insight can help optimise your market access and pricing strategy, contact us at discover@validinsight.com.