First-line HIV treatment: evaluation of backbone choice and its budget impact
DOI:
https://doi.org/10.7175/fe.v14i2.643Keywords:
HIV, Budget Impact, Antiretroviral therapies, AbacavirAbstract
OBJECTIVE: The gradual increase of persons living with HIV, mainly due to the reduced mortality achieved with effective antiretroviral therapies, calls for increased rationality and awareness in health resources consumption also during the early illness phases. Aim of this work is the estimation of the budget impact related to the variation in backbone prescribing trends in naïve patients.
METHODS: Target population is the number of patients starting antiretroviral therapy each year, according to the Italian HIV surveillance registry, excluding patients receiving non-authorized or non-recommended regimens. We modeled 3-year mortality and durability rates on a dynamic cohort, basing on international literature. A prevalent patients analysis has also been conducted, for which the model is fed by a closed cohort consisting of all the patients without experience of virologic failure. The aim of this collateral analysis is to estimate the difference in current annual expenditures if the past prescription trends for patients starting therapy would have led to the evaluated hypothetical scenarios. Current Italian market shares of triple regimens containing first-choice or alternative backbones (tenofovir/emtricitabine, abacavir/lamivudine, tenofovir/lamivudine and zidovudine/lamivudine) are compared to three hypothetical scenarios (base-case, minimum and maximum) in which increasing shares of patients eligible to abacavir/lamivudine start first line treatment with this backbone. Annual cost for each regimen comprises drugs acquisition under hospital pricing rules, monitoring exams and preventive tests, valued basing on regional reimbursement tariffs.
RESULTS: According to current prescribing trends, in the next three years about 13,000 patients starting HIV therapy will receive tenofovir/emtricitabine (83% of the target population), and minor portions other regimens (9% abacavir/lamivudine, 8% zidovudine/lamivudine). Patients that would be eligible to abacavir/lamivudine are 1.5, 4.5 and 6 thousand more than those presently treated according to the three hypothetical scenarios, leading to a cumulative saving of 850 thousand, 2.4 million and 3.3 million euro, respectively. If in the past the same modification of first line prescription trend was adopted, the annual current cost saving would vary from 922 thousands to 7.3 million euro. Most of this amount is due to reduced acquisition costs and, secondarily, to lower monitoring needs.
CONCLUSION: Where patient features don’t force the choice of the backbone, abacavir/lamivudine prescription may induce substantial savings, allowing the release of resources needed to manage more complicated/advanced cases.
References
LG 2012. Linee Guida Italiane sull’utilizzo dei farmaci antiretrovirali e sulla gestione diagnostico-clinica delle persone con infezione da HIV-1, July 2012, with the approval of the Ministry of Health. Available at: http://www.salute.gov.it/imgs/C_17_pubblicazioni_1793_allegato.pdf
Martínez E, Arranz JA, Podzamczer D, et al. A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in hiv-1-infected patients with virological suppression. J Acquir Immune Defic Syndr 2009; 51: 290-7; http://dx.doi.org/10.1097/QAI.0b013e3181aa12d5
Smith KY, Patel P, Fine D, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinair/ritonavir for initial HIV treatment. AIDS 2009; 23: 1547-56
Sax PE, Tierney C, Collier AC, et al. Abacavir–Lamivudine versus Tenofovir–Emtricitabine for Initial HIV-1 Therapy. N Engl J Med 2009; 361: 2230-40; http://dx.doi.org/10.1056/NEJMoa0906768
Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices - Budget Impact Analysis. Value in health 2007; 5: 33647; http://dx.doi.org/10.1111/j.1524-4733.2007.00187.x
ISS 2011. Notiziario dell’Istituto Superiore di Sanità 2011; 24 Suppl. 1. Last update December 2009
IMFO 2011-2012. Source IMS. Year 2012. ViiV Health Care - data on file
Murray M, Hogg R, Lima V, et al. The effect of injecting drug use history on disease progression and death among HIV-positive individuals initiating combination antiretroviral therapy: collaborative cohort analysis. HIV Med 2011
Colombo GL, Colangeli V, Di Bigagio A, et al. Cost-effectiveness analysis of initial HIV treatment under Italian guidelines. ClinicoEconomics and Outcomes Research 2011: 3; 197-205; http://dx.doi.org/10.2147/CEOR.S24130
Istat 2011. Available at www.demo.istat.it (last accessed April 2012)
Merito M, Bonaccorsi A, Pammolli F, et al. Valutazione economica dei trattamenti anti-HIV: lo studio di coorte I.CO.N.A. Giornale italiano di malattie infettive 2004; 3
Krishnan S, Schouten JT, Atkinson B, et al. Metabolic syndrome before and after initiation of antiretroviral therapy in treatment-naïve HIV-infected individuals. Journal of Acquired Immune Deficiency Syndromes 2012; 61: 381-9;. http://dx.doi.org/10.1097/QAI.0b013e3182690e3c
Buskin SE, Zhang S, Thibault CS. Prevalence of and Viral Outcomes Associated with Primary HIV-1 Drug Resistance. The Open AIDS Journal 2012; 6 (Suppl 1: M17): 181-7
Franzetti M, Violin M, Casazza G, et al. Human immunodeficiency virus-1 B and non-B subtypes with the same drug resistance pattern respond similarly to antiretroviral therapy. Clin Microbiol Infect 2012; 18: E66-E70; http://dx.doi.org/10.1111/j.1469-0691.2011.03740.x
Prosperi MCF, Di Giambenedetto S, Fanti I, et al. A prognostic model for estimating the time to Vvirologic failure in HIV-1 infected patients undergoing a new combination antiretroviral therapy regimen. BMC Medical Informatics and Decision Making 2011; 11: 1-9
Orkin C, Wangb J, Berginc C, et al. An epidemiologic study to determine the prevalence of the HLA-B*5701 allele among HIV-positive patients in Europe. Pharmacogenetics and Genomics 2010; 20: 307-14; http://dx.doi.org/10.1097/FPC.0b013e3283390666
AIDSinfo.nih.gov. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 2008. Available at: www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf (last accessed April 2012)
PDT 2012. Update of “Percorso diagnostico-terapeutico del paziente affetto da malattia HIV-AIDS” D.D.G. 3546 del 23/4/2012. Regione Lombardia
IF 2012- Informatore farmaceutico. May 2012. Available at www.Codifa.it
NomSpec 2009. Agenzia Nazionale per i Servizi Sanitari Regionali. Tariffe delle prestazioni specialistiche ambulatoriali. Updated to 31 December 2009. Available at: www.agenas.it/monitoraggio_costi_tariffe/2009_SPECIALISTICA_ex%20DM%2096per%20sito.pdf (last accessed April 2012)
EACS - European AIDS Clinical Society Guidelines. October, 2011. Available at: http://www.europeanaidsclinicalsociety.org/images/stories/EACS-Pdf/eacsguidelines-v6_english.pdf (last accessed April 2012)
Rizzardini G, Restelli U, Bonfanti P, et al. Cost of human immunodeficiency virus infection in Italy, 2007-2009: effective and expensive, are the new drugs worthwhile? Clinicoecon Outcomes Res 2012; 4: 245-52; http://dx.doi.org/10.2147/CEOR.S35194
Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis 2010; 51: 963-72; http://dx.doi.org/10.1086/656417
McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: aids clinical trials group A5224s, a substudy of ACTG A5202. J Infect Dis 2011; 203: 1791-801; http://dx.doi.org/10.1093/infdis/jir188
Martin A, Bloch M, Amin J, et al. Simplification of antiretroviral therapy with tenofovir-emtricitabine or abacavir-Lamivudine: a randomized, 96-week trial. Clin Infect Dis 2009; 49: 1591-601; http://dx.doi.org/10.1086/644769
Cooper RD, Wiebe N, Smith N, et al. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIVinfected patients. Clin Infect Dis 2010; 51: 496-505; http://dx.doi.org/10.1086/655681
Sabin CA, Worm SW, Weber R, et al. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet 2008, 371: 1417-26; http://dx.doi.org/10.1016/S0140-6736(08)60423-7
Obel N, Farkas DK, Kronborg G, et al. Abacavir and risk of myocardial infarction in HIVinfected patients on highly active antiretroviral therapy: a populationbased nationwide cohort study. HIVMed 2010, 11: 130-6; http://dx.doi.org/10.1111/j.1468-1293.2009.00751.x
Brothers CH, Hernandez JE, Cutrell AG, et al. Risk of myocardial infarction and abacavir therapy: no increased risk across 52 GlaxoSmithKline-sponsored clinical trials in adult subjects. J Acquir Immune Defic Syndr 2009; 51: 20-8; http://dx.doi.org/10.1097/QAI.0b013e31819ff0e6
Ribaudo HJ, Benson CA, Zheng Y, et al. No risk of myocardial infarction associated with initial antiretroviral treatment containing abacavir: short and long-term results from ACTG A5001/ALLRT. Clin Infect Dis 2011; 52: 929-40; http://dx.doi.org/10.1093/cid/ciq244
Bedimo RJ, Westfall AO, Drechsler H, et al. Abacavir use and risk of acute myocardial infarction and cerebrovascular events in the highly active antiretroviral therapy era. Clin Infect Dis 2011, 53: 84-91; http://dx.doi.org/10.1093/cid/cir269
Lang S, Mary-Krause M, Cotte L, et al. Impact of individual antiretroviral drugs on the risk of myocardial infarction in human immunodeficiency virus-infected patients: a case-control study nested within the French Hospital Database on HIV ANRS cohort CO4. Arch Intern Med 2010; 170: 1228-38; http://dx.doi.org/10.1001/archinternmed.2010.197
Ding XA-CE, Cooper C, Miele P, et al. No Association of Myocardial Infarction with Abacavir Use. 18th Conference on Retroviruses and Opportunistic Infections Boston; 2011, Abstract # O-1004
Cruciani M, Zanichelli V, Serpelloni G, et al. Abacavir use and cardiovascular disease events: a meta-analysis of published and unpublished data. AIDS 2011, 25: 1993-2004
Published
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (see The Effect of Open Access).
- Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)