Original article
Pancreas, biliary tract, and liver
Disparities in Absolute Denial of Modern Hepatitis C Therapy by Type of Insurance

https://doi.org/10.1016/j.cgh.2016.03.040Get rights and content

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.

Section snippets

Study Design and Data Source

We conducted a prospective cohort study using data from Burman’s Specialty Pharmacy, which provides HCV pharmacy services to community and academic medical practices across Delaware, Maryland, New Jersey, and Pennsylvania. DAAs often are dispensed by specialty pharmacies because of their high costs and requirements for special handling and delivery.17 Burman’s Specialty Pharmacy obtains medical information from clinicians to complete the prior authorization request and submits the prescription

Study Patients

Between November 1, 2014 and April 30, 2015, Burman’s Specialty Pharmacy received DAA prescriptions for 3791 patients. After exclusions (Figure 1), 2342 patients remained. Among these, 21 (0.9%) patients had an incomplete prior authorization after 60 days and were excluded, leaving 2321 patients (503 with Medicaid [492 (97.8%) with Medicaid managed care and 11 (2.2%) with Medicaid fee-for-service], 795 with Medicare, and 1023 with commercial insurance). Medicaid patients were younger, more

Discussion

In this study of chronic HCV-infected patients prescribed DAA-based HCV therapy across Delaware, Maryland, New Jersey, and Pennsylvania between November 2014 and April 2015, 16% were absolutely denied treatment by their insurance carrier. Notably, 46% of Medicaid beneficiaries from these states did not have their prescription approved for fill, and this was substantially higher than patients with Medicare or commercial insurance. The disparity was even more evident among patients with

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    Conflicts of interest These authors disclose the following: Vincent Lo Re has received investigator-initiated research grant support (to the University of Pennsylvania) from AstraZeneca; Jody Gilmore has served on the advisory boards of AbbVie, Bristol-Myers Squibb, and Gilead Sciences; Jalpa Doshi has served on the advisory boards of Alkermes, Boehringer Ingelheim, Forest, Ironwood Pharmaceuticals, Merck, and Shire, has received research grant support (to the University of Pennsylvania) from Amgen, Merck, Pfizer, PhRMA, and the National Pharmaceutical Council, and has a spouse who holds stock in Merck and Pfizer; Peter Reese has received investigator-initiated research grant support from Merck; K. Rajender Reddy has served on the advisory boards of Merck, AbbVie, Bristol-Myers Squibb, Gilead Sciences, and Janssen, and has received research grant support (to the University of Pennsylvania) from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck; Jay Kostman has served on the advisory board of Gilead Sciences; and Paul Urick, Joshua Halladay, Kathryn Battista, and Cassandra Peleckis are employees of Burman’s Specialty Pharmacy. The remaining authors disclose no conflicts.

    Funding This research was supported by grant funding from the Penn Center for AIDS Research, a National Institutes of Health–funded program (P30 AI 045008). The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

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