Case Study | Market Access

Pharma Company Succeeds in Adding Medicine to World Health Organization Essential Medicines List

Background
A pharmaceutical company with a treatment related to blood disorders needed support to submit a value dossier to the World Health Organization (WHO), seeking to add a medicine to the Essential Medicines List (EML).
Client Challenge

A pharmaceutical company sought to include their medicine in the WHO’s EML. The pharma company needed to gather information from various internal sources, identify the information gaps, find a way to close those gaps using external sources, and build an acceptable value dossier that would meet the WHO’s requirements. They only had five weeks to meet the WHO’s submission deadline.

The client chose Alira Health because they had experience working with the WHO on several projects, including the successful inclusion of a drug in the EML. Alira Health’s team was confident they could achieve the same result again.

Our Approach

To meet the imminent WHO deadline, Alira Health proposed a detailed, structured schedule with day-to-day tasks assigned to specific members of the execution team. Regular touch points were held with the client and close collaboration was vital to success.

Strategically, Alira Health recommended to the client that they meet with the WHO as soon as possible. In this meeting, they clarified the submission and evaluation procedure and timelines for the approval process and aligned the plan for the value dossier with the WHO’s requirements.

When it came to building the dossier, the Alira Health team analyzed the clinical and economic information that the client had, some of which dated back a decade. After this gap analysis, the Alira Health team conducted targeted literature reviews to close the gaps with the most current, relevant evidence. The goal was to build a well-balanced and compelling story. 

Outcomes

With Alira Health’s help, the client met the deadline for submission to the WHO. Their value dossier passed multiple stages of the review process, which lasted about six months. Ultimately the medicine was added to the EML.

Key Success Factors

Clear, frequent communication with the client proved invaluable, along with outstanding project management including prioritization and detailed scheduling over the five-week timeline. The agile, flexible Alira Health team brought previous experience interacting with the WHO and other decision-makers; that knowledge helped them create a dossier that proved this medicine’s value.

Business Impact

Clear communication and outstanding project management by the Alira Health team enabled the client to meet the deadline for submission to the WHO, leading to the medicine’s addition to the EML.

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