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Heartburn Relief Is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value
Eric D Shah1, Michael A Curley2, Amit Patel3
1Division of Gastroenterology, Michigan Medicine, Ann Arbor, Michigan.
New potassium-competitive acid blockers (PCABs) for gastroesophageal reflux disease (GERD) could save patients and insurers over $3000 annually. These novel GERD therapies may also improve quality of life and be cost-effective for insurers.
Area of Science:
- Gastroenterology
- Pharmacoeconomics
- Health Services Research
Background:
- Heartburn symptoms are a primary driver for healthcare utilization in gastroesophageal reflux disease (GERD).
- Current GERD management is often constrained by insurance restrictions, impacting treatment choices.
- Potassium-competitive acid blockers (PCABs) represent a new therapeutic class under development for GERD.
Purpose of the Study:
- To conduct economic analyses of novel GERD therapies within a value-based healthcare environment.
- To evaluate the cost-effectiveness of PCABs compared to existing treatments and no treatment.
- To align drug development incentives for industry, insurers, patients, and clinicians.
Main Methods:
- A decision-analytic model was developed to compare vonoprazan (a PCAB) at 20 mg daily with standard proton pump inhibitor (PPI) regimens and no treatment over a one-year period.
- Clinical efficacy was assessed based on heartburn-free days from a phase 3 trial.
- Healthcare utilization data for GERD were obtained from national observational studies.
Main Results:
- Inadequately treated GERD costs patients an average of $4443 and insurers $3784 annually.
- PCABs have the potential to save at least $3000 annually in costs for both patients and insurers.
- PCABs could offer quality-adjusted life year gains of +0.06 per year and be cost-saving for insurers if priced up to $8.57 per pill, assuming comparable efficacy to PPIs.
Conclusions:
- Drug development for GERD should prioritize heartburn relief to create aligned cost-effective incentives.
- PCABs show promise as a cost-effective treatment option for GERD, potentially benefiting all stakeholders.
- Economic evaluations are crucial for guiding the development and adoption of new GERD therapies.
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