Current Trends in Healthcare Drive the Rise of Patient Engagement

Recognition of Patient Importance in Regulatory and Market Access Fields

Recent regulatory and market access changes are a powerful driver behind the rise of patient engagement. Both the European Medicines Agency (EMA) and the Food & Drug Administration (FDA) have provided guidelines on how to include patient engagement during product development and the regulatory process. The implementation of these guidelines fosters and increases the role of patient engagement in regulatory submissions.

The Inflation Reduction Act of 2022 (IRA) is another sign of the increasing importance of patient engagement, pushing companies that want to do business in the United States (US) to embrace a patient-centric approach in pharmaceutical development. Under the IRA, the Centers for Medicaid & Medicare Services (CMS) can now negotiate prices for high expenditure drugs; the CMS provided guidance which includes mandatory patient-focused listening sessions for each selected drug. Patient voices in the process will help the CMS to understand the drugs’ value. This change should signal to companies that you need to pursue a meaningful patient engagement strategy, if you have not already done so.

Real-World Evidence as a Driver for Patient Engagement

In the past, Real-World Evidence (RWE) mainly played a role during the post-launch period, but increasingly, RWE is considered at both the regulatory and market access stages. Greater acceptance of RWE is driving increased patient engagement because companies need to generate relevant patient data throughout the product lifecycle.

This trend is enmeshed with regulatory changes and enhanced by regulatory bodies. For example, the FDA launched the Advancing RWE Program in October 2022, offering select sponsors the chance to meet with FDA staff before developing clinical trial plans to discuss the use of RWE in product development. In 2021, the EMA released a Guideline on registry-based studies to help enable the use of patient registry data to complete evidence in support of regulatory decisions. In terms of regulations affecting market access and commercialization, RWE could be a key factor in price negotiations as seen in the IRA and EMA Regulatory Science to 2025.

Informed and Empowered Patients

The third key trend that we observe is patient empowerment. Patients today have access to more information than ever and due to social media, patients are more connected with others in managing their disease, can share information and experiences, and are even becoming influencers. Digitalization and interconnection are also creating new ways of living with disease for patients. Armed with more knowledge, and the courage to ask questions of healthcare providers, patients are empowered as decision-makers.

Thanks to patient empowerment, patient advocacy groups (PAGs) are playing a more significant role in shading light on the patients’ journey and needs during drug development and approval, particularly in rare diseases with no treatment.

Many companies have started to focus on patient engagement. But most have not yet fully embedded patient engagement into their company DNA. Whether or not you’ve set up a dedicated department, patient engagement must play a strategic role in your company because it’s increasingly critical to success.