Health Care Resource Utilization and Costs Associated with US Medicaid Sobriety Restrictions on Direct-Acting Antivirals for Hepatitis C Virus: A Retrospective Claims Database Analysis.

Background and aims: Many state Medicaid programs implemented sobriety restrictions that delay timely initiation of direct-acting antivirals (DAAs) for patients with hepatitis C virus (HCV) infections. This claims database study examined the economic impact of sobriety restrictions on DAAs among Medicaid-insured patients with HCV.

Methods: A retrospective database analysis of the Anlitiks All Payor Claims data (APCD) during the period January 1, 2020 to June 30, 2022 was conducted. Continuously enrolled adult (aged 18-64 years) Medicaid-insured patients with HCV who initiated DAAs (i.e., index date) during the period January 1, 2021 to December 31, 2021 with ≥ 12 months pre-index and ≥ 6 months post-index follow-up were categorized into two cohorts (states with sobriety restriction [SR] and states with no sobriety restriction [NSR]) based on the sobriety restriction status in the state of residence on the index date. Measures analyzed were the proportion of patients with one or more all-cause medical health care resource utilization (HCRU) (inpatient hospitalization [IP], emergency department [ED], outpatient [OP], professional office [PV], and other [OV] visits) and mean per-patient medical, pharmacy, and overall costs. HCRU and cost differences were compared using adjusted multivariable logistic and gamma-log link regression models, respectively.

Results: Patients in the SR (n = 2,295) versus NSR (n = 4,623) cohort had a higher mean age (45 ± 12.02 vs. 43 ± 11.51 years), fewer males (50.28% vs. 58.1%), and they had lower substance use rates (44.10% vs. 59.68%), all significant at p < 0.05. The SR vs. NSR cohort had higher rates of patients with all-cause HCRU by type (IP 22.0% vs.18.1%; ED 42.3% vs. 37.4; OP 62.5% vs. 55.4%; PV 76.4% vs. 69.1%; other visits 47.4% vs. 46.5%). The SR vs. NSR cohort had a significantly higher adjusted odds ratio (95% confidence interval) for IP (2.09; 1.59-2.73) and OP (1.52; 1.28-1.82). Similarly, the SR versus NSR cohort had a significantly higher all-cause adjusted least squares mean cost per patient for IP ($42,616 vs. $15,063), ED ($982 vs. $420), OP ($715 vs. $349), PV ($840 vs. $621), medical ($11,845 vs. $3,850), pharmacy ($53,453 vs. $38,298), and overall ($63,935 vs. $41,524).

Conclusion: Patients who initiated DAAs with SR versus NSR had 2 times and 1.5 times greater likelihood of IP and OP visits, respectively. Similarly, the SR versus NSR cohort had 3 times greater medical costs. Restricting DAA access among patients with HCV increases HCRU and cost burden, potentially impeding World Health Organization (WHO) 2030 HCV global elimination goals.