Direct‐Acting Antiviral Treatment Use Remains Low Among Florida Medicaid Beneficiaries With Chronic Hepatitis C

Abstract

Medicaid prior authorization (PA) policies for treatment of hepatitis C virus (HCV) with direct‐acting antiviral (DAA) therapy are changing. We aimed to evaluate effects of changes in PA requirements on treatment uptake and to determine the factors associated with DAA treatment among Florida Medicaid beneficiaries with HCV. This is a retrospective cohort analysis of Florida’s Medicaid administrative claims and electronic medical records (2013‐2018). A total of 14,063 newly diagnosed patients with HCV were grouped based on human immunodeficiency virus (HIV) co‐infection and/or a substance use disorder (SUD) (7,735 HCV mono‐infected with a SUD, 5,180 HCV mono‐infected without a SUD, 564 HCV/HIV co‐infected with a SUD, and 584 HCV/HIV co‐infected without a SUD). Although the treatment rate increased three‐fold after June 1, 2016, when a fibrosis‐stage restriction was eliminated, only 8% received DAAs. Compared to HCV mono‐infected without a SUD, HCV mono‐infected with a SUD and HCV/HIV co‐infected with a SUD were 47% (adjusted hazard ratio, 0.53; 95% confidence interval, 0.47‐0.60) and 59% (adjusted hazard ratio, 0.41; 95% confidence interval, 0.28‐0.61) less likely to initiate DAAs. Those with HCV/HIV/SUD did not experience a DAA initiation increase after a fibrosis‐stage restriction was eliminated. Compared with Whites, Blacks were less likely to receive DAAs but were more likely to complete treatment. Use of medication‐assisted therapy was low, despite those on medication‐assisted therapy being 60% more likely to initiate DAA therapy and no more likely to discontinue therapy. Conclusion: Despite changes in Florida’s Medicaid PA requirements for DAA treatment, only 8% received treatment. Disparities in treatment access were found among patients with HIV and a SUD, and who were Black.

The use of all-oral direct-acting antivirals in hepatitis C virus-infected patients with substance use disorders

“…9,10,12,24,25 Patient-level barriers include poor knowledge of HCV, stigma associated with having HCV, mental health issues, and general challenges with accessing the health care system. 23,26 On the other The low treatment initiation in the SUD population may be due to factors such as patients' refusal, physicians' concerns, and payer's rejection/rigid eligibility criteria which appears to be most relevant to those who was similar to other recent studies which also showed that among those with SUDs those that started treatment were highly likely to complete treatment and to obtain a cure. 25,33,34 We found that those whose treatment regimens included RBV were almost four times as likely to discontinue therapy regardless of their SUD status as those who did not have RBV as part of their therapy.…”

“…Patients were considered to have discontinued early if the observed treatment duration (summing the number of days from the filling of the first prescription to the end date of the last prescription claim fill date plus days' supply) was shorter than the expected treatment duration (a 30-day gap was allowed as discussed in prior studies). [21][22][23] The expected treatment duration was based on the 2017 AASLD/IDSA HCV treatment guidelines accounting for baseline cirrhosis diagnosis. 21 For example, we used 8 weeks for sofosbuvir/ < 0.001).…”

Health care utilization and costs associated with direct-acting antivirals for patients with substance use disorders and chronic hepatitis C

“…51 Second, given the current reimbursement requirements, it is possible that our population might have had to abstain from alcohol or injectable drug use for a certain period of time to be able to obtain the insurance approvals necessary to cover the costs of DAA treatment. 29,65 Thus, our DAA group may have been more likely to be former substance users, but our non-DAA group may have been more likely to be current substance users. We attempted to mitigate this limitation by controlling for SUD-related ED or inpatient visits at baseline.…”

“…24,25 Despite these recommendations, access to DAAs for patients with SUD and chronic HCV has still been limited. [26][27][28][29] This divergence from the AASLD/IDSA clinical guidelines for patients with SUD and chronic HCV may reflect concerns of payers and providers. [29][30][31] Concerns regarding high prescription DAA costs have led private and public payers to restrict access to these medications, requiring that patients meet specific prior authorization approvals.…”

“…[26][27][28][29] This divergence from the AASLD/IDSA clinical guidelines for patients with SUD and chronic HCV may reflect concerns of payers and providers. [29][30][31] Concerns regarding high prescription DAA costs have led private and public payers to restrict access to these medications, requiring that patients meet specific prior authorization approvals. [32][33][34] Although some restriction criteria (eg, patient liver disease stage) have been eased, current illicit substance and/or alcohol use still pose as restrictions to accessing DAA.…”