Heartburn Relief is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value Analysis

Abstract

BACKGROUND AND AIMS

Heartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCAB) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment.

METHODS

A decision-analytic model was constructed to compare vonoprazan 20mg daily (an example of a potassium-competitive acid blocker[PCAB]), common over-the-counter or prescription proton pump inhibitor (PPI) regimens, and no treatment over a one-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared to healthy controls. Costs and quality-adjusted life years [QALY] were reported.

RESULTS

Without insurance coverage for appropriate therapy, patients spend $4,443 and insurers spend $3,784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3,000 in annual costs to patients and insurers, could generate QALY gains (+0.06/year), and could be cost-saving to insurers as a covered option at a price up to $8.57/pill, if these drugs are able to demonstrate similar effectiveness to PPIs in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts.

DISCUSSION

We demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.