Incidence and cost of treatment-emergent comorbid events in insured patients with chronic hepatitis C virus infection: a retrospective cohort study

BMC Health Services Research

Gilbert L’Italien³  Michael S Broder²  Eunice Chang²  Sandhya Sapra¹ 

[1] Bristol-Myers Squibb, 1146 Lawrenceville Road, Lawrenceville, NJ, USA;Partnership for Health Analytic Research, LLC, 280 S. Beverly Drive, Suite 404, Beverly Hills, CA, USA;Yale University School of Medicine, 333 Cedar Street, New Haven, CT, USA

关键词: Ribavirin;    Pegylated interferon alpha;    Retrospective study;    Insurance claims;   

Others  :  1126169
DOI  :  10.1186/1472-6963-14-429

 received in 2014-03-14, accepted in 2014-09-11,  发布年份 2014

【 摘 要 】

Background

Treatment-emergent comorbid events (TECs) are common In patients initiating treatment with pegylated interferon alpha (PEG-IFN-alfa) and ribavirin for chronic hepatitis C virus (HCV) infection. The purpose of this study was to estimate the incidence and incremental cost of these events.

Methods

In a retrospective cohort analysis of healthcare claims, we studied patients with HCV who were newly treated with PEG-IFN-alfa/ribavirin between 2006 and 2008. TECs were defined by new medical/pharmacy claims for predefined conditions in the 12 months after treatment initiation. The net incremental cost of the TECs was the difference between baseline and follow-up costs for these comorbidities and their treatment, excluding PEG-IFN-alfa/ribavirin costs.

Results

Of 3,795 newly treated patients, 1,269 (mean age 50.2, 36.2% female) met the selection criteria. New TECs were common, with 61.6% of patients having ≥1 event. Anemia was identified in 29.2% of patients, fatigue in 16.4%, depression in 11.5%, and neutropenia in 11.0%. The mean incremental cost for the predefined TEC in the postindex period was $6,377 ($2,782 for medical and $3,595 for pharmacy claims).

Conclusions

In an insured US cohort with chronic HCV infection, TECs with PEG-IFN-alfa/ribavirin were common and increased costs by approximately $6,000 per treated patient. This estimate may be conservative because it excludes indirect costs. Costs might increase with new regimens that include a protease inhibitor because additional TECs may be expected. Better-tolerated therapies that reduce the financial burden on the healthcare system and improve patient experience are needed.

【 授权许可】

   
2014 Sapra et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Lavanchy D: The global burden of hepatitis C. Liver Int 2009, 29(Suppl 1):74-81.
• [2]Spiegel BM, Younossi ZM, Hays RD, Revicki D, Robbins S, Kanwal F: Impact of hepatitis C on health related quality of life: a systematic review and quantitative assessment. Hepatology 2005, 41:790-800.
• [3]Clark PJ, Muir AJ: Overcoming barriers to care for hepatitis C. N Engl J Med 2012, 366:2436-2438.
• [4]Volk ML, Tocco R, Saini S, Lok AS: Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology 2009, 50:1750-1755.
• [5]Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ: The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006, 144:705-714.
• [6]Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J: Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002, 347:975-982.
• [7]Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK: Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001, 358:958-965.
• [8]Swain MG, Lai MY, Shiffman ML, Cooksley WG, Zeuzem S, Dieterich DT, Abergel A, Pessôa MG, Lin A, Tietz A, Connell EV, Diago M: A sustained virologic response is durable in patients with chronic hepatitis C treated with peginterferon alfa-2a and ribavirin. Gastroenterology 2010, 139:1593-1601.
• [9]Veldt BJ, Heathcote EJ, Wedemeyer H, Reichen J, Hofmann WP, Zeuzem S, Manns MP, Hansen BE, Schalm SW, Janssen HL: Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Ann Intern Med 2007, 147:677-684.
• [10]Fried MW: Side effects of therapy of hepatitis C and their management. Hepatology 2002, 36:S237-S244.
• [11]McHutchison JG, Manns M, Patel K, Poynard T, Lindsay KL, Trepo C, Dienstag J, Lee WM, Mak C, Garaud JJ, Albrecht JK: Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology 2002, 123:1061-1069.
• [12]O’Brien TR: Interferon-alfa, interferon-lambda and hepatitis C. Nat Genet 2009, 41:1048-1050.
• [13]Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP, SPRINT-2 Investigators: Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011, 364:1195-1206.
• [14]Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S, ADVANCE Study Team: Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011, 364:2405-2416.
• [15]Beste LA, Ioannou GN, Larson MS, Chapko M, Dominitz JA: Predictors of early treatment discontinuation among patients with genotype 1 hepatitis C and implications for viral eradication. Clin Gastroenterol Hepatol 2010, 8:972-978.
• [16]Butt AA, McGinnis KA, Skanderson M, Justice AC: Hepatitis C treatment completion rates in routine clinical care. Liver Int 2010, 30:240-250.
• [17]Average Wholesale Price: PriceRx Pro [electronic database]. Wolters Kluwer Health. 2013. https://pricerx.medispan.com webcite. Accessed 9/27/2013
• [18]Salomon JA, Weinstein MC, Hammitt JK, Goldie SJ: Cost-effectiveness of treatment for chronic hepatitis C infection in an evolving patient population. JAMA 2003, 290:228-237.
• [19]Mitra D, Davis KL, Beam C, Medjedovic J, Rustgi V: Treatment patterns and adherence among patients with chronic hepatitis C virus in a US managed care population. Value Health 2010, 13:479-486.
• [20]Zeuzem S: Interferon-based therapy for chronic hepatitis C: current and future perspectives. Nat Clin Pract Gastroenterol Hepatol 2008, 5:610-622.
• [21]PegIntron (peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2011.
• [22]PEGASYS (peginterferon alfa-2a) Injection for Subcutaneous Use [package insert]. Package Insert. South San Francisco, CA: Genentech, Inc; 2011.
• [23]COPEGUS® (ribavirin) tablets [package insert]. South San Francisco, CA: Genentech, Inc; 2011.
• [24]Ribasphere® (ribavirin, USP) tablets [package insert]. New York, NY: Kadmon Pharmaceuticals; 2012.
• [25]Hwang W, Weller W, Ireys H, Anderson G: Out-of-pocket medical spending for care of chronic conditions. Health Aff (Millwood) 2001, 20:267-278.
• [26]Papatheofanis F, Bookhart BK, Muser E, Piech CT: An examination of productivity and resource utilization associated with epoetin alfa treatment in employees with predialysis chronic kidney disease. J Occup Environ Med 2008, 50:584-589.
• [27]Kimel M, Leidy NK, Mannix S, Dixon J: Does epoetin alfa improve health-related quality of life in chronically ill patients with anemia? Summary of trials of cancer, HIV/AIDS, and chronic kidney disease. Value Health 2008, 11:57-75.
• [28]Druss BG, Rosenheck RA, Sledge WH: Health and disability costs of depressive illness in a major U.S. corporation. Am J Psychiatry 2000, 157:1274-1278.
• [29]Ozminkowski RJ, Wang S, Walsh JK: The direct and indirect costs of untreated insomnia in adults in the United States. Sleep 2007, 30:263-273.
• [30]Iqbal SU, Cunningham F, Lee A, Miller DR, Li NC, Cheung R, Kazis L: Persistence with hepatitis C therapy in the Department of Veterans Affairs. J Clin Pharm Ther 2008, 33:251-261.
• [31]Zein NN, Rakela J, Krawitt EL, Reddy KR, Tominaga T, Persing DH: Hepatitis C virus genotypes in the United States: epidemiology, pathogenicity, and response to interferon therapy. Collaborative Study Group. Ann Intern Med 1996, 125:634-639.
• [32]Hyams KC, Riddle J, Rubertone M, Trump D, Alter MJ, Cruess DF, Han X, Nainam OV, Seeff LB, Mazzuchi JF, Bailey S: Prevalence and incidence of hepatitis C virus infection in the US military: a seroepidemiologic survey of 21,000 troops. Am J Epidemiol 2001, 153:764-770.
• [33]Strader DB, Wright T, Thomas DL, Seeff LB, American Association for the Study of Liver Diseases: Diagnosis, management, and treatment of hepatitis C. Hepatology 2004, 39:1147-1171.
• [34]Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S: Telaprevir for retreatment of HCV infection. N Engl J Med 2011, 364:2417-2428.