Abstract

Price and value forecasting is challenging for developmental products where only early efficacy data is available, with products often reaching pivotal clinical development stages without an estimate of likely price potential and, effectively, returns. This may result in missing the opportunity to optimise the asset’s evidence generation plan, price and launch sequence. To define the value and forecast the price potential of assets in development, we have selected a variety of different value attributes that drive decision-making within oncology to arrive at a value framework. A Multiple Criteria Decision Analysis (MCDA) framework was developed using 21 weighted criteria validated by previously published research on MCDA and value framework methodologies from ICER (Institute for Clinical and Economic Review) and ASCO for the evaluation of medicines. The MCDA was based on a scoring system on a scale of 0 to 5 depending on each criterion. The MCDA framework included two groups: the first (core) group includes attributes that measure clinical benefit, economic value and disease characteristics; the second (extended) group covers additional broader considerations such as public health interests and non-health benefits. A linear regression analysis was performed using monthly cost of treatment as the dependent variable and aggregate MCDA score as the independent variable for immune-oncology products launched in US. For 6 immuno-oncology products, a strong correlation between the MCDA scores and the average monthly cost of treatment was observed [R of 0.89 for core group and 0.93 for the extended group]. The correlation that statistically measures how close the data are to the fitted regression line (R2) was over 0.8 for both groups suggesting a high explanatory power of the developed value framework. The study provides a robust framework for estimating the value and price of assets within immuno-oncology indications to inform Pricing and Market Access strategy.

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