Economic savings versus health losses: The cost-effectiveness of generic antiretroviral therapy in the United States

Annals of Internal Medicine

Volumn 158, Issue 2, 2013, Pages 84-92

  Walensky, Rochelle P ^a   Sax, Paul E ^b   Nakamura, Yoriko M ^a   Weinstein, Milton C ^c   Pei, Pamela P ^a   Freedberg, Kenneth A ^a   David Paltiel, A ^d   Schackman, Bruce R ^e  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d YALE UNIVERSITY   (United States)

^e WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATAZANAVIR PLUS RITONAVIR; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LAMIVUDINE PLUS TENOFOVIR DISOPROXIL; ATAZANAVIR; EMTRICITABINE; GENERIC DRUG; LAMIVUDINE; RITONAVIR; TENOFOVIR; TENOFOVIR DISOPROXIL;

ADULT; ARTICLE; CLINICAL EFFECTIVENESS; COMPARATIVE STUDY; CONTROLLED STUDY; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; FEMALE; HEALTH CARE COST; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; QUALITY OF LIFE; SIMULATION; SURVIVAL; UNITED STATES; ANTIVIRAL THERAPY; COHORT ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG SAFETY; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; MEDICATION COMPLIANCE; PRACTICE GUIDELINE; QUALITY ADJUSTED LIFE YEAR; SENSITIVITY ANALYSIS;

EID: 84872577181     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-158-2-201301150-00002     Document Type: Article

References (61)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Washington, DC: U.S. Department of Health and Human Services; 2012. Accessed at www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf on17 April 2012.
2. Sax PE. Generic lamivudine has arrived. HIV and ID Observations. Journal WATCH Blogs Web site. 22 January 2012. Accessed at http://blogs.jwatch. org/hiv-id-observations/index.php/generic-lamivudine-has-arrived/2012/01/22 on 13 September 2012.
3. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Silver Spring, MD: U.S. Food and DrugAdministration; 2012. Accessed at www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=020972&Product_No=003&table1=OB_Rxon 13 September 2012.
4. Bangsberg DR, Ragland K, Monk A, Deeks SG. A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regimens in HIV+ homeless and marginally housed people. AIDS. 2010;24:2835-40.[PMID: 21045636]
5. Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross R, et al. Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel. Ann Intern Med. 2012;156:817-33, W-284-294.[PMID: 22393036]
6. Schinazi RF. Assessment of the relative potency of emtricitabine and lamivudine [Letter]. J Acquir Immune Defic Syndr. 2003;34:243-5.[PMID: 14526216]
7. Svicher V, Alteri C, Artese A, Forbici F, Santoro MM, Schols D, et al. Different evolution of genotypic resistance profiles to emtricitabine versus lamivudine in tenofovir-containing regimens. J Acquir Immune Defic Syndr. 2010; 55:336-44.[PMID: 20739898]
8. Rousseau FS, Wakeford C, Mommeja-Marin H, Sanne I, Moxham C, Harris J, et al; FTC-102 Clinical Trial Group. Prospective randomized trial of emtricitabine versus lamivudine short-term monotherapy in human immunodeficiency virus-infected patients. J Infect Dis. 2003;188:1652-8.[PMID: 14639535]
9. Tang MW, Kanki PJ, Shafer RW. A review of the virological efficacy of the 4 World Health Organization-recommended tenofovir-containing regimens for initial HIV therapy. Clin Infect Dis. 2012;54:862-75.[PMID: 22357809]
10. Freedberg KA, Losina E, Weinstein MC, Paltiel AD, Cohen CJ, Seage GR, et al. The cost effectiveness of combination antiretroviral therapy for HIV disease. N Engl J Med. 2001;344:824-31.[PMID: 11248160]
11. Paltiel AD, Weinstein MC, Kimmel AD, Seage GR 3rd, Losina E, Zhang H, et al. Expanded screening for HIV in the United States-an analysis of cost-effectiveness. N Engl J Med. 2005;352:586-95.[PMID: 15703423]
12. Paltiel AD, Freedberg KA, Scott CA, Schackman BR, Losina E, Wang B, et al. HIV preexposure prophylaxis in the United States: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis. 2009;48: 806-15. [PMID: 19193111]
13. Walensky RP, Paltiel AD, Losina E, Morris BL, Scott CA, Rhode ER, et al; CEPAC Investigators. Test and treat DC: forecasting the impact of a comprehensive HIV strategy in Washington DC. Clin Infect Dis. 2010;51:392-400.[PMID: 20617921]
14. Cost-Effectiveness of Preventing AIDS Complications Web site. Accessed at http://web2.research.partners.org/cepac/mainpage.html on 12 June 2012.
15. Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness in Health and Medicine. New York: Oxford Univ Pr; 1996.
16. Department of Economic and Social Affairs. World Population Prospects: The 2008 Revision. New York: United Nations; 2009. Accessed at www.who.int/pmnch/topics/2008_populationstats/en/index.html on 14 September 2012.
17. Althoff KN, Gange SJ, Klein MB, Brooks JT, Hogg RS, Bosch RJ, et al. Late presentation for human immunodeficiency virus care in the United States and Canada. Clin Infect Dis. 2010;50:1512-20.[PMID: 20415573]
18. Multicenter AIDS Cohort Study (MACS) Public Dataset: Release PO4. Springfield, VA: National Technical Information Service; 1995.
19. N. Red Book. Montvale, NJ: Thomson PDR; 2009.
20. Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, et al; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012;379:2439-48.[PMID: 22748591]
21. Johnson M, Grinsztejn B, Rodriguez C, Coco J, DeJesus E, Lazzarin A, et al. Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures. AIDS. 2005;19:685-94.[PMID: 15821394]
22. Johnson MA, Gathe JC Jr, Podzamczer D, Molina JM, Naylor CT, Chiu YL, et al. A once-daily lopinavir/ritonavir-based regimen provides noninferior antiviral activity compared with a twice-daily regimen. J Acquir Immune Defic Syndr. 2006;43:153-60. [PMID: 16951643]
23. Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, et al; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009; 374:796-806.[PMID: 19647866]
24. Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller MD, et al; 903 Study Group. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 2004;292:191-201.[PMID: 15249568]
25. Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, et al; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007;369:1261-9.[PMID: 17434401]
26. Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, et al; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008;359:1429-41.[PMID: 18832244]
27. Nelson M, Arastéh K, Clotet B, Cooper DA, Henry K, Katlama C, et al. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials. J Acquir Immune Defic Syndr. 2005;40:404-12.[PMID: 16280694]
28. Centers for Disease Control and Prevention. Diagnoses of HIV Infection and AIDS Among Adolescents and Young Adults in the United States and 5 U.S. Dependent Areas, 2006-2009. Atlanta: Centers for Disease Control and Prevention; 2012. Accessed at www.cdc.gov/hiv/topics/surveillance/resources/reports on 29 June 2012.
29. Levinson DR. Medicaid Drug Price Comparisons: Average Manufacturer Price to Published Prices. Washington, DC: U.S. Department of Health and Human Services; 2005.
30. Centers for Disease Control and Prevention. New Hope for Stopping HIV: Testing and Medical Care Save Lives. Atlanta: Centers for Disease Control and Prevention; 2011. Accessed at www.cdc.gov/VitalSigns/HIVTesting on 27 June 2012.
31. McKinnell JA, Willig JH, Westfall AO, Nevin C, Allison JJ, Raper JL, et al. Antiretroviral prescribing patterns in treatment-nai{dotless}̈ve patients in the United States. AIDS Patient Care STDS. 2010;24:79-85. [PMID: 20059309]
32. Cutler DM, Rosen AB, Vijan S. The value of medical spending in the United States, 1960-2000. N Engl J Med. 2006;355:920-7. [PMID: 16943404]
33. Gopalappa C, Farnham PG, Hutchinson AB, Sansom SL. Cost effectiveness of the National HIV/AIDS Strategy goal of increasing linkage to care for HIVinfected persons. J Acquir Immune Defic Syndr. 2012;61:99-105. [PMID: 22580563]
34. Institute of Medicine. Hidden Costs, Value Lost: Uninsurance in America. Washington, DC: National Academies Pr; 2003. Accessed at www.iom.edu/Reports/ 2003/Hidden-Costs-Value-Lost-Uninsurance-in-America.aspx on 14 September 2012.
35. Battling the virus: a huge, strange drug market. New York: The Economist; 2 June 2012. Accessed at www.economist.com/node/21556275 on 14 June 2012.
36. The White House Office of National AIDS Policy. National HIV/AIDS Strategy for the United States. Washington, DC: The White House Office of National AIDS Policy; 2010.
37. Valdiserri R. Proposed National HIV/AIDS Strategy Implementation Fund. Washington, DC: U.S. Department of Health and Human Services; 2011. Accessed at http://blog.aids.gov/2011/06/proposed-national-hiv-aids-strategyimplementation-fund.html on 30 May 2012.
38. The Henry J. Kaiser Family Foundation. U.S. Federal Funding for HIV/ AIDS: The President's FY 2013 Budget Request. Menlo Park, CA: The Henry J. Kaiser Family Foundation; 2012. Accessed at www.kff.org/hivaids/upload/7029-08.pdf on 14 June 2012.
39. Linas BP, Wong AY, Schackman BR, Kim AY, Freedberg KA. Costeffective screening for acute hepatitis C virus infection in HIV-infected men who have sex with men. Clin Infect Dis. 2012;55:279-90. [PMID: 22491339]
40. National Alliance of State & Territorial AIDS Directors. HIV and Viral Hepatitis Co-Infection. Washington, DC: National Alliance of State & Territorial AIDS Directors; 2011. Accessed at www.nastad.org/Docs/031236_HIV%20VH%20CoInfection%20Final.pdf on 14 June 2012.
41. Martin EG, Schackman BR. What does U.S. health reform mean for HIV clinical care? J Acquir Immune Defic Syndr. 2012;60:72-6. [PMID: 22517415]
42. Buscher A, Hartman C, Kallen MA, Giordano TP. Impact of antiretroviral dosing frequency and pill burden on adherence among newly diagnosed, antiretroviral-naive HIV patients. Int J STD AIDS. 2012;23:351-5. [PMID:22648890]
43. Sax PE, Meyers JL, Mugavero M, Davis KL. Adherence to antiretroviral treatment and correlation with risk of hospitalization among commercially insured HIV patients in the United States. PLoS One. 2012;7:e31591. [PMID: 22384040]
44. Cohen C, Davis K, Meyers J. Association between selective adherence to antiretroviral therapy and hospitalization risk in an HIV population. Presented at 52nd Interscience Conference on Antimicrobials and Chemotherapy, San Francisco, California, 9-12 September 2012. Abstract H-211.
45. CDC Diabetes Cost-effectiveness Group. Cost-effectiveness of intensive glycemic control, intensified hypertension control, and serum cholesterol level reduction for type 2 diabetes. JAMA. 2002;287:2542-51. [PMID: 12020335]
46. Berndt ER, Mortimer R, Bhattacharjya A, Parece A, Tuttle E. Authorized generic drugs, price competition, and consumers' welfare. Health Aff (Millwood). 2007;26:790-9. [PMID: 17485758]
47. U.S. Food and Drug Administration. Facts about Generic Drugs. Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm on 27 June 2012.
48. U.S. Food and Drug Administration. Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan. Silver Spring, MD: U.S. Food and Drug Administration; 2012. Accessed at www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ ucm119231.htm on 29 May 2012.
49. Braithwaite RS, Meltzer DO, King JT Jr, Leslie D, Roberts MS. What does the value of modern medicine say about the $50,000 per quality-adjusted life-year decision rule? Med Care. 2008;46:349-56. [PMID: 18362813]
50. Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn't it increase at the rate of inflation? Arch Intern Med. 2003;163: 1637-41. [PMID: 12885677]
51. Gardner EM, McLees MP, Steiner JF, Del Rio C, Burman WJ. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection. Clin Infect Dis. 2011;52:793-800. [PMID: 21367734]
52. Weinstein MC, Toy EL, Sandberg EA, Neumann PJ, Evans JS, Kuntz KM, et al. Modeling for health care and other policy decisions: uses, roles, and validity. Value Health. 2001;4:348-61. [PMID: 11705125]
53. Braithwaite RS. Calibration and validation of a HIV simulation model. Med Decis Making. 2003;23:562.
54. Rydzak CE, Cotich KL, Sax PE, Hsu HE, Wang B, Losina E, et al; CEPAC Investigators. Assessing the performance of a computer-based policy model of HIV and AIDS. PLoS One. 2010;5. [PMID: 20844741]
55. Swiss HIV Cohort Study & Mother and Child HIV Cohort Study. The Swiss HIV Cohort Study (SHCS). Lausanne, Switzerland: Swiss HIV Cohort Study & Mother and Child HIV Cohort Study; 2012. Accessed at www.shcs.ch on 14 September 2012.
56. Centers for Medicare & Medicaid Services. Clinical Laboratory Fee Schedule. Baltimore, MD: Centers for Medicare & Medicaid Services; 2012. Accessed at www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched on 22 May 2012.
57. University HealthSystem Consortium. 2006-2008 Cost Data. Chicago: University HealthSystem Consortium; 2009.
58. Gebo KA, Fleishman JA, Conviser R, Reilly ED, Korthuis PT, Moore RD, et al; HIV Research Network. Racial and gender disparities in receipt of highly active antiretroviral therapy persist in a multistate sample of HIV patients in 2001. J Acquir Immune Defic Syndr. 2005;38:96-103. [PMID: 15608532]
59. Bamezai A, Melnick G, Nawathe A. The cost of an emergency department visit and its relationship to emergency department volume. Ann Emerg Med. 2005;45:483-90. [PMID: 15855942]
60. Seage GR 3rd, Holte SE, Metzger D, Koblin BA, Gross M, Celum C, et al. Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study. Am J Epidemiol. 2001;153: 619-27. [PMID: 11282787]
61. Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, et al; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6:e17502. [PMID: 21826193]