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Clinical Risk and Outpatient Therapy Utilization for COVID-19 in the Medicare Population

Wilcock et al., JAMA Health Forum, doi:10.1001/jamahealthforum.2023.5044
Jan 2024  
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Analysis of Medicare beneficiaries in 2022 showing that outpatient COVID-19 treatments like antivirals and monoclonal antibodies were disproportionately used by patients at lower risk of severe infection and outcomes.
Retrospective studies of treatment effectiveness may overestimate efficacy if they do not fully adjust for this difference. Full adjustment may not be possible because potentially related factors are typically not available in the data. For example, patients with greater knowledge of effective treatments may be more likely to access prescription treatments but result in confounding because they are also more likely to use known beneficial non-prescription treatments.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid Hoertel. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid" FDA.
Wilcock et al., 26 Jan 2024, retrospective, peer-reviewed, 8 authors, study period January 2020 - December 2022.
This PaperPaxlovidAll
Clinical Risk and Outpatient Therapy Utilization for COVID-19 in the Medicare Population
PhD; Andrew D Wilcock, PhD Stephen Kissler, MD Ateev Mehrotra, PT Brian E Mcgarry, PhD Benjamin D Sommers, PhD David C Grabowski, PhD Yonatan H Grad, MD Michael L Barnett
JAMA Health Forum, doi:10.1001/jamahealthforum.2023.5044
IMPORTANCE Multiple therapies are available for outpatient treatment of COVID-19 that are highly effective at preventing hospitalization and mortality. Although racial and socioeconomic disparities in use of these therapies have been documented, limited evidence exists on what factors explain differences in use and the potential public health relevance of these differences. OBJECTIVE To assess COVID-19 outpatient treatment utilization in the Medicare population and simulate the potential outcome of allocating treatment according to patient risk for severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study included patients enrolled in Medicare in 2022 across the US, identified with 100% Medicare fee-for-service claims. MAIN OUTCOMES AND MEASURES The primary outcome was any COVID-19 outpatient therapy utilization. Secondary outcomes included COVID-19 testing, ambulatory visits, and hospitalization. Differences in outcomes were estimated based on patient demographics, treatment contraindications, and a composite risk score for mortality after COVID-19 based on demographics and comorbidities. A simulation of reallocating COVID-19 treatment, particularly with nirmatrelvir, to those at high risk of severe disease was performed, and the potential COVID-19 hospitalizations and mortality outcomes were assessed. RESULTS In 2022, 6.0% of 20 026 910 beneficiaries received outpatient COVID-19 treatment, 40.5% of which had no associated COVID-19 diagnosis within 10 days. Patients with higher risk for severe disease received less outpatient treatment, such as 6.4% of those aged 65 to 69 years compared with 4.9% of those 90 years and older (adjusted odds ratio [aOR], 0.64 [95% CI, 0.62-0.65]) and 6.4% of White patients compared with 3.0% of Black patients (aOR, 0.56 [95% CI, 0.54-0.58]). In the highest COVID-19 severity risk quintile, 2.6% were hospitalized for COVID-19 and 4.9% received outpatient treatment, compared with 0.2% and 7.5% in the lowest quintile. These patterns were similar among patients with a documented COVID-19 diagnosis, those with no claims for vaccination, and patients who are insured with Medicare Advantage. Differences were not explained by variable COVID-19 testing, ambulatory visits, or treatment contraindications. Reallocation of 2022 outpatient COVID-19 treatment, particularly with nirmatrelvir, based on risk for severe COVID-19 would have averted 16 503 COVID-19 deaths (16.3%) in the sample. CONCLUSION In this cross-sectional study, outpatient COVID-19 treatment was disproportionately accessed by beneficiaries at lower risk for severe infection, undermining its potential public health benefit. Undertreatment was not driven by lack of clinical access or treatment contraindications.
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