OBJECTIVES: There are >300 approved oncology products, with dozens in the pipeline with multiple indications. In addition, combination therapies are increasing, necessitating new methods to assess and allocate value to them. Currently, value based agreements (VBAs) have simple structures and measure one therapy’s impact in isolation or for a single indication. This study explores the current state of oncology VBAs and assesses upcoming near-term combination permutations, identifying new methodologies and technical platforms to support VBA evolution in this increasingly complex area.

METHODS: Publicly available information describing all oncology-related VBAs in the US and EU was collected. Oncology pipelines and marketed product details were collected and reviewed. Analysis of marketed or pipeline combination products and of indication expansions was conducted to quantify complexities and understand effects on VBAs. Current VBA terms were analysed to consider outcome measures, duration, data collection methods, and applicability to combination products or indication expansions.

RESULTS: ~1,200 trials are underway for combination oncology therapies, with 22 indication expansions in 2018. The US has 69 total VBAs, with 7 in oncology, while the EU has 149 VBAs, 77 in oncology. Majority reimburse number of treatment cycles based on responsiveness, while others focus on negative outcomes (e.g. bone breaks). The simple deal parameters for single drugs are not transferable to combination products without adaptation. For indication expansion, current structures may be leveraged to develop RWE for broader value assessment. New tools are needed to assess value allocation for combination therapies with different prices and as treatment become more chronic.

CONCLUSIONS: Oncology VBA methodology adaptations are needed to address the looming complexity of combination products and indication expansion. Additionally, technology platforms for data sharing, analysis of each drug’s value contribution, and adaptive contracting will further efforts. Multi-stakeholder collaboration to develop the new VBA standards will accelerate adoption.