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Ronan Mahon

Lecturer in Economics

I attended a (really enjoyable) industry conference recently and have been reflecting on a couple of themes that emerged during the presentations & discussions. ? 'Real World Evidence' (RWE) is often claimed to be something that is not readily accepted by decision-makers in a cost-effectiveness analysis (CEA). This sentiment baffles me somewhat as RWE (i.e. observational evidence) is used extensively in almost every CEA (e.g. to inform resource utilisation rates, general population mortality, long-term OS and PFS and so on). I suspect some commentators may mean, specifically, that RWE is not so readily accepted as an evidence source for relative effectiveness. Such hesitance among decision-makers seems the height of reasonableness to me. An RCT is undoubtedly a more reliable basis for relative effectiveness estimates compared to RWE (e.g. as an external control arm) and it is important that decision-makers highlight this. In my experience, decision-makers do generally accept the realities of an evidence base even if relative effectiveness is ultimately based partially on RWE, but they quite rightly need to account for the (often significant) resultant uncertainty when making resource-allocation decisions. Relatedly, it is sometimes claimed that there is a reluctance among decision-makers to consider alternative pricing/payment models (IPMs) and that they just want to 'keep it simple' with price discounts. There may be truth in this, I can imagine for administrative reasons if nothing else. But the key point in my view is that whatever the mechanism for payment (and some of these IPMs indeed may help to address issues of uncertainty and upfront affordability), we still must, first and foremost, calculate an average cost per QALY gained and if this is not below a suitable threshold, then adopting the treatment would do more harm than good. There's nothing more simple than that.??

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