OBJECTIVES: New co-development approaches in personalised medicine challenge current decisional frameworks of health-technology access and reimbursement procedures. We aim to conceptualize an efficient typology-based decisional framework which takes into account the development and market access synchronism between therapeutic (Tx) and diagnostic (Dx) components of personalized medicines.

METHODS: Following systematic literature review, a focus group discussion study was conducted with Belgian personalised medicine industry stakeholders; BeMedTech (Dx-component), Pharma.be (Tx-component), and the Belgian health payer (INAMI). The discussions resulted in Tx-Dx cases to be used to support the personalized medicine access and reimbursement decision-making.

RESULTS: A Tx-Dx typology-based decision support framework was derived and agreed upon by the stakeholders for implementation in the Belgian healthcare system. Within the personalised medicine industry, different strategic development approaches were unfolded for either in vitro diagnostics and therapeutics. The proposed Tx-Dx co-development and market access typology takes into account the synchronism of the strategic development approaches and translates them into access and reimbursement pathways to be used by assessment committees. In the framework, we distinguish different access and reimbursement pathways based on personalized medicine development strategies; (1) The co-development of an innovative therapeutic and companion diagnostic combination (e.g. Vemurafenib and BRAF-case), (2) the novel therapeutic development on a targeted patient population characterized by an already marketed diagnostic (e.g. Olaparib and BRCA-case). (3) The novel diagnostic development on a patient subpopulation within an already marketed therapeutic treatment (e.g. Cetuximab and KRAS/NRAS-case) and (4) the development of an innovative improved diagnostic on an already marketed diagnostic stratification technology [e.g. Immunohistochemistry products and Fluorescence in situ hybridization products-case].

CONCLUSIONS: The proposed typology-based decisional framework might allow for a more efficient and effective assessment and budget impact analysis of personalised medicine products. Accepted for guiding decisions in the Belgian healthcare system, the framework can function as a conceptual basis for other agencies outside Belgium.