Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study.

BACKGROUND: Despite the availability of new direct-acting antiviral (DAA) regimens, changes in DAA reimbursement criteria, and a public health focus on hepatitis C virus (HCV) elimination, it remains unclear if public and private insurers have increased access to these therapies over time. We evaluated changes in the incidence of absolute denial of DAA therapy over time and by insurance type. METHODS: We conducted a prospective cohort study among patients who had a DAA prescription submitted from January 2016 to April 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services across the United States. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. We calculated the incidence of absolute denial, overall and by insurance type (Medicaid, Medicare, commercial), for the 16-month study period and each quarter. RESULTS: Among 9025 patients from 45 states prescribed a DAA regimen (4702 covered by Medicaid, 1821 Medicare, 2502 commercial insurance), 3200 (35.5%; 95% confidence interval, 34.5%-36.5%) were absolutely denied treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than Medicaid (34.5%, P < .001) or Medicare (14.7%, P < .001). The incidence of absolute denial increased across each quarter of the study period, overall (27.7% in first quarter to 43.8% in last quarter; test for trend, P < .001) and for each insurance type (test for trend, P < .001 for each type). CONCLUSIONS: Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.

Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance.

BACKGROUND & AIMS: The high costs of direct-acting antiviral (DAA) agents to treat chronic hepatitis C virus (HCV) infection have resulted in denials of treatment, but it is not clear whether patients' access to these therapies differs with their type of insurance. METHODS: We conducted a prospective cohort study among all patients who had a DAA prescription submitted between November 1, 2014 and April 30, 2015 to Burman's Specialty Pharmacy, which provides HCV pharmacy services to patients in Delaware, Maryland, New Jersey, and Pennsylvania. We determined the incidence of absolute denial of DAA prescription, defined as a lack of approval of a prescription fill by the insurer, according to type of insurance (US Medicaid, US Medicare, or commercial insurance). Multivariable Poisson regression was used to estimate adjusted relative risks of absolute denial associated with patient characteristics. RESULTS: Among 2321 patients prescribed a DAA regimen (503 covered by Medicaid, 795 covered by Medicare, and 1023 covered by commercial insurance), 377 (16.2%) received an absolute denial. The most common reasons for absolute denial were insufficient information to assess medical need (134 [35.5%]) and lack of medical necessity (132 [35.0%]). A higher proportion of patients covered by Medicaid received an absolute denial (233 [46.3%]) than those covered by Medicare (40 [5.0%]; P < .001) or commercial insurance (104 [10.2%]; P < .001). Medicaid insurance (adjusted relative risk, 4.14; 95% confidence interval, 3.38-5.08) and absence of cirrhosis (adjusted relative risk, 1.96; 95% confidence interval, 1.53-2.50) were associated with absolute denial. CONCLUSIONS: There are significant disparities in access to DAA-based treatments for HCV infection among patients with different types of insurance. Nearly half of Medicaid beneficiaries in Delaware, Maryland, New Jersey, and Pennsylvania were denied access to these drugs for chronic HCV infection.

Implementing community-based standards of care.

OBJECTIVE: To briefly review steps that should be followed in the progression from considering therapeutic options on the basis of evidence-based medicine (EBM) to implementing formulary decisions and clinical guidelines. SUMMARY: Results from EBM should guide selection of therapy for routine clinical practice. Pharmacists must spend considerable time carefully reviewing the designs and results of clinical trials and postmarketing information to develop accurate safety and efficacy profiles. The Pharmacy & Therapeutics (P&T) committee also requires pharmacoeconomic data for its deliberations, and that should include information about the economic, clinical, and humanistic value of new therapies. The P&T committee ultimately determines the business value of the new therapy based on the efficacy and safety profile derived from EBM, comparison with treatment alternatives, cost, provider needs, and system orientation. CONCLUSION: Proper accomplishment of all of these steps should result in adoption of efficacious, safe, and cost-effective therapies.