Case Study / Evidence & Access

HEOR and access support for a new product in the treatment of mantle cell lymphoma and Waldenstrom’s macroglobulinemia

Created - Monday, May 1, 2023

Challenge

A drug developer from mainland China was entering the US and EU markets for an innovative therapy. OPEN Health partnered with the pharma company to develop HEOR evidence and HTA submission packages for the US, EU5, Canada and Australia.

Approach

Our Strategic Market Access and Modeling & Meta-Analysis teams collaborated closely across independent workstreams to ensure a highly creative and efficient multidisciplinary approach that included Strategic Literature Reviews, Indirect Treatment Comparisons and MAICs. Global Value Dossier, AMCP dossiers, trial data analyses. core model and model adaptations, ad board meetings, HTA submissions and publication support.

Outcome / Impact

We used the results to support regulatory decision-making and inform market access and reimbursement discussions around the product in multiple countries.