US Cost Effectiveness of Darunavir/Ritonavir 600/100mg bid in Treatment-Experienced, HIV-Infected Adults with Evidence of Protease Inhibitor Resistance Included in the TITAN Trial

Abstract

From a US societal perspective and based on an analysis of the patients with primary IAS-USA PI RAMs enrolled in the darunavir phase III TITAN trial, a highly active antiretroviral therapy (HAART) regimen containing DRV/r 600/100 mg bid is estimated to be a cost-effective therapy when compared with a HAART regimen containing LPV/r, for the management of treatment-experienced, PI-resistant, HIV-infected adults with a broad range of previous PI use/failure.

Do Value Thresholds for Oncology Drugs Differ from Nononcology Drugs?

“…Standard care 190,000 (low risk with uterus) 100,000 72,000 (low risk without uterus) 57,000 (high risk with uterus) 37,000 (high risk without uterus) Breast cancer 20 Adjuvant trastuzumab Standard care 39,000 N/A Breast cancer 21 Anastrozole Tamoxifen 26 OnabotulinumtoxinA Best supportive care 24,000 N/A Knee osteoarthritis 27 Disease-modifying osteoarthritis drugs Standard care 57,000 N/A Chronic low back pain 28 Duloxetine Naproxen 59,473 N/A Human immunodeficiency virus 29 Generic-based antiretroviral therapy No antiretroviral therapy 21,000 100,000 Branded antiretroviral therapy Generic-based antiretroviral therapy 114,000 Type 2 diabetes 30 Exenatide Insulin glargine 15,000 N/A ADHD 31 Guanfacine XR + stimulant Stimulant monotherapy 31,000 50,000 Anticoagulation in cancer patients 32 Low molecular-weight heparin No prophylaxis 90,893 N/A Stroke prevention in atrial fibrillation 33 Rivaroxaban Warfarin 27,000 100,000 Multiple sclerosis 34 Fingolimod IFN beta-1a 73,000 100,000 S. aureus vaccine in hemodialysis patients 35 Vaccine (1% colonization rate) No vaccine 25,217 N/A Schizophrenia 36 Olanzapine ODT SOT 19,000 N/A Olanzapine ODT Risperidone SOT 39,000 End-stage renal disease 37 Erythropoietin stimulating agents Routine blood transfusions 873 N/A Hyperlipidemia 38 Atorvastatin Simvastatin 45,000 N/A Acute coronary syndrome 39 Ticagrelor Genotype-driven treatment 10,000 50,000 Human immunodeficiency virus 40 Atazanavir -ritonavir Lopinavir -ritonavir 26,000 50,000 Type 2 diabetes 41 Liraglutide Exenatide 40,000 N/A Human immunodeficiency virus 42 Darunavir -ritonavir Lopinavir -ritonavir 23,000 N/A Macular degeneration 43 Bevacizumab Ranibizumab -54,000 N/A Cardiovascular disease 44 Rosuvastatin (20-year horizon) Placebo 10,000 N/A Rosuvastatin (10-year horizon) 44 …”

A Review of Economic Evaluations of Darunavir Boosted by Low-Dose Ritonavir in Treatment-Experienced Persons Living with HIV Infection

“…Table II presents the results of the economic analyses of DRV/r plus an OBR compared to LPV/r plus an OBR using efficacy data from the subset of participants in the TITAN trial who had at least one International AIDS Society USA primary PI RAM at baseline in the same countries. [13,26] With the exception of the efficacy-related inputs, which were directly derived from this subpopulation of TITAN study participants, most input parameter values and model assumptions used in the POWER-based models were kept the same in this adaptation. Switching to the tipranavir boosted with ritonavir-based follow-up regimen was, however, assumed to occur sooner in PLHIV with a less than 1 log 10 decrease in the HIV-RNA level from baseline at 24 weeks and before the CD4 cell count begins to decline for all virological response groups.…”

“…Reflecting this, the PSAs generally estimated somewhat lower probabilities (75.4% for the USA and at least 67% for the European countries) of having a cost-utility ratio below US$50 000 or h30 000, respectively. [13,26] It should be noted that, in comparison with the PLHIV included in the POWER trials, the TITAN subpopulation modelled in this analysis had less advanced HIV disease and a more limited degree of previous treatment experience (only 60% of them were three-class experienced in contrast to the POWER participants, who were all three-class experienced at baseline). [19,21] More importantly, whereas all POWER participants had received (and failed) at least two PIcontaining HAART regimens before enrolment, more than 40% of the PI-resistant TITAN subgroup modelled in this analysis had only received up to one PI before enrolment in TITAN.…”

“…[5][6][7][8][9][10][11][12][13] The outputs of these models are frequently presented from the societal perspective as the ratio of the incremental lifetime total healthcare costs and incremental lifetime QALYs when comparing the new treatment regimen with the standard regimen. Alternatively, cost-effectiveness ratios can be presented with shorter time horizons, with the denominator in natural units and from the decision-maker perspective rather than the societal perspective.…”

“…[12,13,[25][26][27] All the studies use as the basis for their costs and benefits estimates the efficacy results of the DRV/r clinical trials in treatmentexperienced individuals. Each study, however, estimates a different aspect of the economics of DRV/r including:…”