Ignorance is not Bliss: The Value of Diagnostics in the Absence of Optimal Therapies
If there’s nothing you can do about it, would you really want to know? For individuals, there would likely be a mix of responses. From the perspective of experts, the answer is clearer. Despite being saddled with an ISPOR graveyard slot (10am before congress close at 12pm), session 316 was among the most interesting and thought-provoking discussions.1
Richard E Rothman, Vice Chair of Research in Emergency Medicine at Johns Hopkins University, presented the clinical and public health perspective through an emergency room (ER) lens, often the front line of new and emerging diseases. HIV/AIDS served as a powerful case study amid the backdrop of public fear coupled with a lack of understanding and effective treatment in the early 1990s. Incidental testing in the ER, despite the dearth of interventions, aided epidemiological understanding, boosted awareness, and also helped drive down transmission. More generally, molecular diagnostics aid in the identification of unmet need. The ER offers an obvious opportunity to catch diseases whilst they are still indolent, potentially improving long-term outcomes, especially if effective treatments do emerge.
The health economic perspective presented by the eminent Lou Garrison stated the “value of knowing”, as well as “knowing the value”. Diagnostic tests reduce uncertainty, an undervalued commodity that isn’t reflected in quality-adjusted life years (QALYs) and incremental benefits. Far-reaching indirect, or societal, benefits, also play a valuable role in demonstrating the outsized value that diagnostics can have. Nonetheless, it was lamented that payers mostly look at cost, and not at the potential for value generation. Value-based, flexible pricing for both diagnostics and treatments could help address this, and may provide a stronger incentive for companies (and payers) to innovate in their development and deployment of diagnostics.
A nice idea, but impractical from a payer perspective, offered by Lon Castle of eviCore healthcare. Three essential criteria were laid out when it comes to diagnostics (Figure 1): analytical validity (does it detect X?); clinical validity (does detecting X predict Y?); and clinical utility (does predicting Y change anything?). The recurring theme? If it doesn’t have clinical utility, forget it. This means that even the most novel, innovative or rapid diagnostics that emerge may struggle to get a look-in if the link to pushing the dial on clinical endpoints can’t be convincingly demonstrated. An example might be if a test improves the time to diagnosis, but in doing so it can’t be shown to improve a meaningful metric, such as patient response or survival. And whilst some healthcare plans may be willing to take a chance on a diagnostic, others will drag their heels, content that they will be the last to offer it, as is their prerogative in a healthcare landscape driven by free-market economics.
Figure 1. Basic US payer pathway in evaluating diagnostics for reimbursement
The patient perspective was summarised by the moderator, indicating that simply receiving a correct diagnosis can boost patients’ quality of life, both in terms of assurance and eventual receipt of effective treatment. Though it could be argued that this might not be true of all cases, coupled with the associated public health and economic benefits, there is a strong case for knowing, provided someone’s willing to pay for it.
