Cost-Effectiveness of Long-Acting Injectable HIV Preexposure Prophylaxis in the United States : A Cost-Effectiveness Analysis.
Anne M Neilan, Raphael J Landovitz, Mylinh H Le, Beatriz Grinsztejn, Kenneth A Freedberg, Marybeth McCauley, Nattanicha Wattananimitgul, Myron S Cohen, Andrea L Ciaranello, Meredith E Clement, Krishna P Reddy, Emily P Hyle, A David Paltiel, Rochelle P Walensky
Author Information
Anne M Neilan: Division of General Academic Pediatrics, Division of Infectious Diseases, and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts (A.M.N.). ORCID
Raphael J Landovitz: UCLA Center for Clinical AIDS Research and Education, Los Angeles, and Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California (R.J.L.). ORCID
Mylinh H Le: Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts (M.H.L., N.W.).
Beatriz Grinsztejn: Instituto de Pesquisa Clinica Evandro Chagas, Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil (B.G.). ORCID
Kenneth A Freedberg: Division of Infectious Diseases, Medical Practice Evaluation Center, and Division of General Internal Medicine, Massachusetts General Hospital, Boston, Harvard Medical School, Boston, Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, and Harvard University Center for AIDS Research, Boston, Massachusetts (K.A.F.).
Marybeth McCauley: Science Facilitation, FHI 360, Washington, DC (M.M.).
Nattanicha Wattananimitgul: Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts (M.H.L., N.W.).
Myron S Cohen: Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (M.S.C.).
Andrea L Ciaranello: Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Harvard Medical School, Boston, and Harvard University Center for AIDS Research, Boston, Massachusetts (A.L.C., E.P.H.). ORCID
Meredith E Clement: Division of Infectious Diseases, Louisiana State University Health Sciences Center, New Orleans, Louisiana (M.E.C.). ORCID
Krishna P Reddy: Medical Practice Evaluation Center and Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts (K.P.R.). ORCID
Emily P Hyle: Division of Infectious Diseases and Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Harvard Medical School, Boston, and Harvard University Center for AIDS Research, Boston, Massachusetts (A.L.C., E.P.H.). ORCID
A David Paltiel: Yale School of Public Health, New Haven, Connecticut (A.D.P.). ORCID
Rochelle P Walensky: Division of Infectious Diseases, Medical Practice Evaluation Center, and Division of General Internal Medicine, Massachusetts General Hospital, Boston, and Harvard Medical School, Boston, Massachusetts, and Centers for Disease Control and Prevention, Atlanta, Georgia (R.P.W.).
BACKGROUND: The HIV Prevention Trials Network (HPTN) 083 trial demonstrated the superiority of long-acting injectable cabotegravir (CAB-LA) compared with oral emtricitabine-tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP). OBJECTIVE: To identify the maximum price premium (that is, greatest possible price differential) that society should be willing to accept for the additional benefits of CAB-LA over tenofovir-based PrEP among men who have sex with men and transgender women (MSM/TGW) in the United States. DESIGN: Simulation, cost-effectiveness analysis. DATA SOURCES: Trial and published data, including estimated HIV incidence (5.32, 1.33, and 0.26 per 100 person-years for off PrEP, generic F/TDF and branded emtricitabine-tenofovir alafenamide (F/TAF), and CAB-LA, respectively); 28% 6-year PrEP retention. Annual base-case drug costs: $360 and $16 800 for generic F/TDF and branded F/TAF. Fewer side effects with branded F/TAF versus generic F/TDF were assumed. TARGET POPULATION: 476 700 MSM/TGW at very high risk for HIV (VHR). TIME HORIZON: 10 years. PERSPECTIVE: Health care system. INTERVENTION: CAB-LA versus generic F/TDF or branded F/TAF for HIV PrEP. OUTCOME MEASURES: Primary transmissions, quality-adjusted life-years (QALYs), costs (2020 U.S. dollars), incremental cost-effectiveness ratios (ICERs; U.S. dollars per QALY), maximum price premium for CAB-LA versus tenofovir-based PrEP. RESULTS OF BASE-CASE ANALYSIS: Compared with generic F/TDF (or branded F/TAF), CAB-LA increased life expectancy by 28 000 QALYs (26 000 QALYs) among those at VHR. Branded F/TAF cost more per QALY gained than generic F/TDF compared with no PrEP. At 10 years, CAB-LA could achieve an ICER of at most $100 000 per QALY compared with generic F/TDF at a maximum price premium of $3700 per year over generic F/TDF (CAB-LA price <$4100 per year). RESULTS OF SENSITIVITY ANALYSIS: In a PrEP-eligible population at high risk for HIV, rather than at VHR ( = 1 906 800; off PrEP incidence: 1.54 per 100 person-years), CAB-LA could achieve an ICER of at most $100 000 per QALY versus generic F/TDF at a maximum price premium of $1100 per year over generic F/TDF (CAB-LA price <$1500 per year). LIMITATION: Uncertain clinical and economic benefits of averting future transmissions. CONCLUSION: Effective oral PrEP limits the additional price society should be willing to pay for CAB-LA. PRIMARY FUNDING SOURCE: FHI 360; National Institute of Child Health and Human Development; National Institute of Allergy and Infectious Diseases; National Heart, Lung, and Blood Institute; National Institute on Drug Abuse; the Reich HIV Scholar Award; and the Steve and Deborah Gorlin MGH Research Scholars Award.
References
N Engl J Med. 2014 Aug 28;371(9):796-7
[PMID: 25162885]
