Integrated Global HEOR & Market Access Support

Aim

A long-standing client sought our support in the development of a suite of global HEOR and value materials, to facilitate market access for their infectious disease product.

Approach

The project began with structured interviews with affiliates from 9 key markets (EU5, US, Canada, Japan and China), to inform the development of the HEOR materials and value narrative for this product. Alongside our technical expertise and direction from our global client, these affiliate insights fed into all of the materials produced in this project: clinical and economic SLRs, cost-effectiveness and budget impact models (including clinical validation), a feasibility assessment and ITCs, publications, and global value materials.

Our specialist in-house technical and medical writing teams worked on the different project components, to ensure each component benefitted from relevant expertise and strategic input. At the same time, we provided seamless, holistic project management and integration between our specialist teams, with one overarching project manager, close communication across internal workstreams, and regular touchpoints with the client, covering all project components.

Given our intricate knowledge of the global HEOR and market access materials, we were asked to support the client’s US affiliate with the development of a US-specific BIM and creation of the corresponding AMCP dossier chapter. We were able to do this efficiently and in line with the high standard of the global work, thus supporting access in the US directly.

De novo research from the project was also disseminated externally, to support affiliates in their local access and reimbursement activities. Both the ITC and cost-effectiveness model were published at conferences, and as manuscripts in the client’s first-choice scientific journals, with only minor comments from peer-reviewers in each instance.

Challenges

The target population for the product was a relatively small proportion of patients with the infectious disease, and there was limited directly relevant literature available. Additionally, the pivotal trial included a small number of patients. We therefore needed to take a broad approach to the SLRs to identify all suitable evidence, and novel statistical methods to perform the ITCs. Additionally, the burden of disease and clinical evidence required careful communication, to pull together a compelling overall payer value story.

Impact

• Our technical expertise and strategic input supported the development of technically- and scientifically-robust HEOR and market access materials, which facilitated successful access and reimbursement across the client’s priority markets and beyond.
• Efficient and holistic project management, integrated across all deliverables, ensured our client could focus on the strategic direction and technicalities of the project, rather than day-to-day practicalities or coordinating between vendors.