Pharma Company Adopts a Patient-Centric Value Proposition for Regulatory and Payer Dossier

Client Challenge

The client hoped that creating this continuity in patient engagement would allow them to strategically showcase the patient perspective in front of authorities, accelerating regulatory approval and market access for their drug. Without in-house resources, they sought a partner who could manage this effort and take their patient engagement strategy to the next level.

Alira Health was chosen for this project due to its disruptive approach: to strategically embed the patient perspective in the regulatory dossier and the market access dossier, not merely as corollary information but as a key narrative and evidence piece, changing the way the client approached health authorities.

Our Approach

The Alira Health Patient Engagement team customized a tailored approach to meet the client’s goals, with the following strategic milestones:

• Analyzed the client’s existing data. Once the team understood what they had, that became a knowledge base to set up patient engagement activities to generate complementary data that would complete the picture.
• Organized a set of patient advisory boards (PABs). The Alira Health team ran informative meetings with boards in several countries, and in parallel, conducted individual meetings with each patients to enrich the information collected during PABs.
• Leveraged the PABs to understand what symptoms and consequences of the target disease impact patient quality of life (QoL) the most, using a validated and sound methodology to be accepted by health authorities. Alira Health team also tested the blind target product profile of the product with the patients to infer on which QoL aspects the new treatment could have a bigger impact.
• Finally, created a new patient-centric value proposition for the product and socialized it with the client and stakeholders involved in the development and commercialization of the product.

These milestones became the foundation of the product value story and patient objection handler for the dossier for regulatory bodies and the value dossier for payers.

The strategic decision to put the patient perspective at the center of the product’s value was truly disruptive. Instead of offering the results of one-time interaction with patients, the Alira Health team sought to change the authorities’ point of view. Instead of talking about clinical results and the impact the product would have on the healthcare system, the client presented clinical results and long-term benefits for the healthcare system from the patient perspective.

Outcomes

Alira Health’s strategic approach to patient engagement not only cross-functionally supported the clinical, regulatory, and market access phases of the product, but also embedded the patient perspective in the client’s goals, which will continue to support the product through post-launch and commercialization.

The Alira Health Patient Engagement experts worked closely in partnership with the client’s patient engagement team. This project had significant relevance internally because of the disruptive and cross-functional approach applied. The client is currently moving forward with their presentation of the product dossier, including the patient-centric value proposition, to health authorities.

Key Success Factors

The client was willing to fully embrace this new patient-centric strategy that truly challenged the status quo. The Alira Health Patient Engagement team was able to deep-dive into the patient perspective and convert it into valuable strategic insights. In analyzing existing data and gathering new data from patients, then merging it into a powerful patient-centric value proposition and value story, Alira Health’s experienced Patient Engagement team, assisted by the Clinical team, proactively managed the bumps that naturally occur in a long and complex project.

Learn more about developing a patient-centric product strategy.