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

Eric D Shah; Michael A Curley; Amit Patel; Wai-Kit Lo; Walter W Chan

doi:10.1016/j.cgh.2024.01.049

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

Clin Gastroenterol Hepatol. 2024 Feb 16:S1542-3565(24)00202-7. doi: 10.1016/j.cgh.2024.01.049. Online ahead of print.

Authors

Eric D Shah¹, Michael A Curley², Amit Patel³, Wai-Kit Lo⁴, Walter W Chan⁴

Affiliations

¹ Division of Gastroenterology, Michigan Medicine, Ann Arbor, Michigan. Electronic address: ershah@umich.edu.
² Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
³ Division of Gastroenterology, Duke University School of Medicine, Durham, North Carolina; Division of Gastroenterology, Durham Veterans Affairs Medical Center, Durham, North Carolina.
⁴ Division of Gastroenterology, Durham Veterans Affairs Medical Center, Durham, North Carolina; Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts.

PMID: 38367746
DOI: 10.1016/j.cgh.2024.01.049

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 (PCABs) 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 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-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 with healthy control subjects. Costs and quality-adjusted life years were reported.

Results: Without insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors 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.

Keywords: Gastroesophageal Reflux Disease; Potassium-Competitive Acid Blocker; Proton Pump Inhibitor.