Blockchains, Formulary Evaluations and Health Technology Assessment.

Blockchains have the potential, if appropriately implemented and managed, of contributing to a fundamental change in the application of techniques of health technology assessment in formulary decision making. Rather than continuing to rely on claims made by manufacturers that are non-evaluable, the introduction of blockchains as adjunct to the electronic medical record, meet an unmet medical need in enabling a platform for the real time assessment of claims. Rather than focusing the case for their product on lifetime cost-per-QALY models, which have no chance of ever being validated, the blockchain platform offers a low cost opportunity for claims evaluation. Manufacturers would be required to abandon the construction of imaginary cost-per-QALY worlds to support claims for pricing and formulary trier position, in favor of claims that can be evaluated and reported back to formulary committees in a short yet meaningful time horizon. Manufacturers would present a claims assessment protocol as part of the formulary submission package. If agreed with the formulary committee, the protocol would be implemented and managed through the patient blockchain membership. Claims would be monitored and evaluated in real time with a final report to the formulary committee in a matter of months. Lifetime imaginary claims for cost-per-QALY, set alongside willingness-to-pay thresholds, would be a thing of the past. Pricing decisions and formulary placement would reflect a robust evidence base and not just extrapolations from pivotal clinical trials.