Cost-Effectiveness of Vonoprazan- and Rifabutin-Based Regimens.

Abstract

The publication “Effectiveness of Vonoprazan- and Rifabutin-Based vs Other Regimens as First-Line Treatment of Helicobacter pylori Infection in the United States” by Yunusa and Love (1) addresses the important question of cost-effectiveness of various therapies for H. pylori in the United States. This study relied on network meta-analysis eradication rates, when available, to inform their model. Regrettably, some key eradication rates used in the model were incorrectly selected; therefore, certain conclusions regarding vonoprazan triple therapy are not applicable to the United States. Thus, these results are likely to be misleading to readers and could negatively affect patient care and access. In an apparent oversight, the authors did not take into consideration the substantial difference in eradication rates between US and Asian populations; they used Asian trial data for a key analysis of vonoprazan triple therapy when a more relevant US trial was available (2). Treatment paradigms are widely variable between the United States and Asia, and Graham et al (3) recently noted that meta-analysis is often used incorrectly to assess H. pylori therapy outcomes. The aim of this publication was to evaluate the efficacy and pricing in the United States, thus, the most appropriate cohorts with which to compare various treatments are the all-patient populations (i.e., intention-to-treat or ITT) from US studies. Although the authors used a US ITT population for the vonoprazan dual therapy analysis (2), they used an inconsistent approach for vonoprazan triple therapy; they exclusively used Asian study data (4) instead of the more recent and relevant US Phase 3 data (2) and US prescribing information. The contemporary US eradication rates available from the US vonoprazan triple therapy Phase 3 pivotal trial showed an efficacy rate of 80.8% for the US ITT population. However, the authors used an inflated eradication rate of 91.4% for vonoprazan triple therapy, calculated exclusively from Asian studies (4). The eradication rate of 91.4% for vonoprazan triple therapy is not reflective of US outcomes. In fact, the publication reporting on the US vonoprazan Phase 3 trial outcomes noted that US efficacy rates did not reach the level seen in Japanese trials (2). Given the efficacy difference of over 10% for US versus Asian populations, outcomes of this comparative analysis would probably be less favorable for vonoprazan triple therapy had its relevant US eradication rate been used (i.e., US ITT population: 80.8%). Assessing cost-effectiveness of H. pylori eradication regimes by geography is an important endeavor, and Drs. Yunusa and Love are commended for initiating this work. However, without appreciation of the very real differences in eradication rates between US and Asian populations, the conclusions provided by the authors are inaccurate. To ensure a cost-effectiveness analysis that adequately reflects the US population, a reanalysis that uses vonoprazan US-specific ITT data is strongly encouraged. CONFLICTS OF INTEREST Guarantor of the article: June Almenoff, MD, PhD. Specific author contributions: Full authorship. Financial support: RedHill Biopharma, which is the manufacturer of Talicia. Potential competing interests: Employee of RedHill Biopharma.