Presentation (CTI)

OBJECTIVES: Demonstrating a benefit in overall survival (OS) has long been considered the ‘gold standard’ for oncology therapies to receive positive Health Technology Assessment (HTA) ratings in Germany and France. This study looks at the impact of immature vs. mature OS data and hazard ratio (HR) on HTA outcomes across France and Germany.
METHODS: NAVLIN was used to explore HTA ratings in France and Germany for all oncology products assessed within the last 5 years. The products were filtered by HTA ratings (with a focus on ASMR III / IV in France and Minor / Considerable Added Benefit in Germany), OS data maturity, and OS HR. Within France, N=28 oncology products with mature and N=24 with immature OS data were analyzed. Within Germany, N=22 oncology products with mature and N=28 with immature OS data were analyzed.
RESULTS: Surprisingly, products with mature OS data did not have significantly better HTA outcomes than those with immature OS, implying other benefit domains (such as safety, QOL, morbidity) are impactful in driving positive HTA assessments. HR plays a significant role in garnering positive HTA outcomes in France and Germany. For products that had HR >0.7, most products received an ASMR IV (vs. III) in France and a Minor Added Benefit rating (vs. Considerable) in Germany. However, N=4 products in France and N=2 products in Germany received ASMR III / Considerable Added Benefit ratings with both immature OS data and HR >0.7.
CONCLUSIONS: While there is no specific threshold for OS HR to receive ASMR III / Considerable Added Benefit, payers are interested in a product’s ability to show significant survival benefit, i.e., ‘curative’ effect, particularly in early lines of therapy. Similarly, if an oncology therapy has favorable data in other domains (e.g., morbidity outcomes), then launching with immature OS data will likely not hinder its benefit rating potential.