Recent Trends in the Treatment of Chronic Hepatitis C | Page 2
Published Online: April 16, 2014
Sara C. Erickson, PharmD; Wenyi Qiu, MS; Crystal R. Maas-Patel, PharmD; Sharon M. Wang, PharmD, MS; and Bimal V. Patel, PharmD, MS
The most recent DAA addition is sofosbuvir, the first NS5B polymerase inhibitor approved to treat chronic HCV and the first approved medication for use in an all-oral HCV treatment regimen. Sofosbuvir provides the additional advantages of once-daily dosing, improved SVR rates, efficacy for all genotypes, no cytochrome P450 3A4 drug interactions, and shorter therapy duration (12 weeks total) for certain patients. Among genotype-1 treatmentnaïve patients, SVR was achieved for 89% with sofosbuvir, pegylated interferon and ribavirin for 12 weeks.31 Limited results are available for sofosbuvir use in patients with genotype 1 who had failed prior therapy with pegylated interferon, and ribavirin; however, the US Food and Drug Administration (FDA) allowed approval of sofosbuvir in this population based on extrapolated results from other difficult-to-treat patient populations. The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) have released treatment guidelines that recommend sofosbuvir regimens, including the unapproved sofosbuvir and simeprevir combination regimen, as standard-of-care treatments (Table).32
Chronic HCV infection has been costly to treat, with average wholesale prices (AWPs) of pegylated interferon products ranging from $20,309 to $44,424 per treatment as of February 2014. The treatment of genotype-1 HCV significantly increased with the addition of NS3/4A protease inhibitors. Current AWPs for NS3/4A protease inhibitors range from $43,808 to $79,632 per treatment. Sofosbuvir has been launched with AWP of $1200 per day. Based on AWP pricing, 12 to 24 weeks of sofosbuvir costs $100,800 to $201,600. The high cost of treatment has raised concerns among patient advocacy groups and payers.33,34 As the treatment costs vary widely across the new standardof- care regimens, this analysis quantifies the proportion of patients initiating sofosbuvir and simeprevir, including interferon-free regimens. An understanding of prescribing patterns with these new drugs will help payers manage appropriate utilization and project drug spend.
A retrospective, cross-sectional analysis was performed using de-identified data from a sample of participating clients in the research database of MedImpact Healthcare Systems, Inc, a national pharmacy benefi ts manager (PBM). Patients initiating sofosbuvir or simeprevir from November 22, 2013 (the FDA approval date for simeprevir; the FDA approval date for sofosbuvir was December 6, 2013), through February 28, 2014, were identified. The first fill date for sofosbuvir was considered the index date. If no fill for sofosbuvir was identified, the first fill date of simeprevir was defi ned as the index date. Each identifi ed patient’s HCV treatment regimen was determined by looking for fill dates of other HCVindicated medications during the concomitant therapy period, which extended from 30 days prior to the index date through 30 days after the index date. The number of patients taking each of the following FDA-approved or ASLD/IDSA-recommended regimens was identifi ed: (1) sofosbuvir, pegylated interferon and ribavirin; (2) sofosbuvir and ribavirin (no interferon products, no protease inhibitors); (3) simeprevir, pegylated interferon, and ribavirin; (4) simeprevir and sofosbuvir with ribavirin (no interferon products); (5) simeprevir and sofosbuvir (no interferon or ribavirin products). Treatment costs were quantified using February 2014 AWP for branded products and maximum acquisition cost (MAC) for generic products (ie, ribavirin products).
In the first few months of market availability of simeprevir and sofosbuvir, nearly 8 times as many patients have initiated sofosbuvir (n = 435) as initiated simeprevir (n = 57) (Figures 2 and 3). These groups are not mutually exclusive. In fact, 95% of simeprevir initiators are taking unapproved, ASLD/IDSA-recommended, interferon-free, sofosbuvir-based regimens. Only 5% of simeprevir initiators began the FDA-approved regimen with pegylated interferon and ribavirin.
Of sofosbuvir initiators, only 41% are taking concomitant pegylated interferon and ribavirin and more than half (57%) are taking interferon-free regimens indicated for genotypes 2 and 3 and interferon-ineligible genotype 1. Two percent of sofosbuvir users did not have claims for recommended concomitant therapy during the 30 days prior to and 30 days after sofosbuvir initiation.
The AWP cost per treatment for 48 weeks of pegylated interferon and ribavirin (standard of care for genotype-1 patients from 2001-2011) is $42,411 to $46,218 (Figure 4). The HCV protease inhibitor–based regimens (boceprevir, telaprevir, or simeprevir with pegylated interferon and ribavirin) are signifi cantly more expensive at AWP costs of $70,768 to $126,432. The AWP cost of a sofosbuvir- based regimen for genotype-1 treatment-naïve or relapser, interferon-eligible patients is between $122,006 and $123,909. The cost of interferon-free sofosbuvir regimens, recommended for interferon-ineligible genotype-1 patients, ranges from $180,432 (sofosbuvir, simeprevir for 12 weeks) to $202,497 (sofosbuvir, ribavirin for 24 weeks). The latter AWP treatment cost is 66% more expensive than the 12-week interferon-based sofosbuvir regimen and approximately twice as much as the protease inhibitor based–regimens that were standard of care between 2011 and 2013.
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