Development and Proof-of-Concept Study of a Life-Cycle Prioritization Framework for Oncology Product Innovation

OBJECTIVES: The translational pathway for emerging oncology products is time-consuming. Oncology trials last 13.1 years from Phase I to Phase III, with only 3.4% of trialed products receiving regulatory authorization. Considered alongside rising the costs of cancer care, value-based mechanisms can accelerate translation of safe, effective, and cost-effective oncology products. We developed a life-cycle prioritization framework to address translational inefficiencies. This proof-of-concept study of targeted radiopharmaceutical development implements our framework to prioritize innovation focusing on metastatic castration-resistant prostate cancer (mCRPC).

METHODS: Through literature review and multi-disciplinary expert consultations, we developed a life-cycle framework for prioritizing candidate oncology products. We engaged patient partners, clinicians, decision-makers, industry, and health researchers to co-develop and refine framework components. We are piloting the framework for a radiopharmeutical treating patients with mCRPC. Drawing on multi-criteria decision analysis with our stakeholder committee, we use Keeney-Raiffa derivation of swing weights to score competing value elements and determine relative importance.

RESULTS: We engaged n=15 pan-Canadian stakeholders to inform our prioritization framework. The framework includes three gated stages throughout the entire product life-cycle, with sequentially planned evaluative methods that iteratively guide decision-making. Key components for each stage include: (i) needs assessment for prioritizing product innovation areas; (ii) early value assessment for go/no-go decision-making on continued development and further evidence generation; and (iii) life-cycle health technology assessment to support regulatory and reimbursement pathways. In mCRPC, we are identifying which value elements stakeholders, including patients, prioritize most highly for radiopharmaceutical product prioritization.

CONCLUSIONS: Our framework enables value-based innovation for candidate oncology products, from very early stages of development to evaluation and implementation. Weighted prioritization scores measured in our proof-of-concept study can be contrasted across indications to inform future research and development investment. Application of our framework throughout the oncology product life-cycle will ensure translational medicine achieves timely patient benefit and value-for-money in healthcare.