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
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.
Our pharmacy claims–based analysis found that 41.1% (n = 180) of patients initiating sofosbuvir or simeprevir were taking concomitant pegylated interferon and ribavirin. A greater proportion of patients (57.1%, n = 250) initiated an interferon-free sofosbuvir regimen. Most health plans covered by our PBM elected to use prior authorization guidelines to determine appropriate use for medication coverage that is consistent with approved indications and evidence-based standard of care. As the proportion of genotype 1 among the chronic HCV population in the United States is at least 70%, it is expected that a similar proportion of sofosbuvir initiators would be on the FDA-approved regimen for genotype 1 (sofosbuvir, pegylated interferon and ribavirin). It may be that a greater proportion of genotype 2 or 3 patients have initiated therapy in this early time period or that a large proportion of genotype 1 patients initiating therapy have been deemed interferon-ineligible. The cost implications of the latter scenario are significant, as treating genotype 1 patients with an interferon-free regimen costs between $58,426 and $80,491 more per patient, and with decreased efficacy. An SVR of 72% was realized in a total of 211 treatment-naïve genotype 1 patients using sofosbuvir and ribavirin in various clinical trials.32 The AASLD/IDSA guidelines recommend that the all-oral combination of sofosbuvir with ribavirin for 24 weeks should be considered only for genotype-1 patients who require immediate treatment, because regimens with improved safety and efficacy will likely be available by 2015.32
The higher costs of more efficacious treatment may be justified as the costs of treatment failure are significant. One analysis found a 10-fold difference in the costs between managing patients who achieved SVR versus those who did not achieve SVR over a 5-year period, with a retreatment rate of 19% among SVR nonachievers.35
The outstanding question is whether these new standard-of-care therapies are cost-effective. A Markov model analysis, published months before sofosbuvir was approved, determined that $112,653 was the maximum drug cost for an all-oral regimen achieving 90% SVR to remain cost-effective using a $100,000 per quality adjusted life-year willingness-to-pay threshold.36 For most patients, the current all-oral sofosbuvir-based regimens do not meet the 90% SVR standard of efficacy and are much more expensive.
The standard of care for the treatment of chronic HCV infection continues to evolve. Several novel drugs are being studied in which preliminary data demonstrate close to 100% SVR (Figure 1).37-39 The future standard of care will be oral regimens that are more effective and presumably more tolerable. Present interferon-free regimens have less evidence of efficacy and a substantial cost (between $180,881 and $202,497 per treatment) for the majority of patients who will receive these treatments. It is yet unknown if the current trend of increasing costs for chronic HCV treatment will continue, or at what point it will no longer be sustainable.
Author Affiliations: Health Outcomes Research (SCE, WQ, CRM-P, SMW, BVP).
Source of Funding: None reported.
Author Disclosures: The authors (SCE, WQ, CRM-P, SMW, BVP) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article. The content is solely the responsibility of the authors and does not necessarily represent the official views of MedImpact Healthcare Systems, Inc.
Authorship Information: Concept and design (SCE, SMW, BVP); acquisition of data (WQ); analysis and interpretation of data (SCE, WQ, CRM-P, SMW); drafting of the manuscript (SCE); critical revision of the manuscript for important intellectual content (CRM- P, SMW); statistical analysis (WQ); administrative, technical, or logistic support (CRM-P, BVP); supervision (BVP).
Address correspondence to: Sara C. Erickson, PharmD, Health Outcomes Researcher, 10181 Scripps Gateway Ct, San Diego, CA 92131. E-mail: email@example.com.
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