Cost Of Antiretroviral Drugs Research Articles

ФАРМАКОЭКОНОМИЧЕСКИЕ ПОДХОДЫ К АНАЛИЗУ СТОИМОСТИ АНТИРЕТРОВИРУСНЫХ ПРЕПАРАТОВ, ПРИМЕНЯЕМЫЕ В ТЕРАПИИ ВИЧ-ИНФИЦИРОВАННЫХ ПАЦИЕНТОВ

The legislation in force in the Russian Federation guarantees HIV patients protection of their rights in labor, education and other spheres of life, as well as free counseling, diagnosis and treatment of HIV infection. The continued increase in the number of infected people and, more importantly, the emergence of the HIV epidemic from risk groups into the general population highlights the need for additional improvement in the effectiveness of measures taken to counter the spread of infection. In this regard, it is necessary to use the most rational measures, both from the point of view of efficiency and safety, and from the point of view of costs. The most suitable tool for solving these problems is pharmacoeconomical analysis. At the same time, conducting pharmacoeconomical analysis in the field of HIV infection, as well as in any other nosology, involves the need to take into account certain features at the stages of planning and implementation of the study. It is necessary to highlight some key features of the methodology of pharmacoeconomical analysis in the assessment of healthcare technologies in the field of HIV infection, in particular, cost minimization analysis, which involves choosing a medical technology with minimal costs by comparing the monetary value of alternative technologies, provided the same therapeutic effectiveness. The main object of the study was the documented medical histories of HIV-infected patients, statistical and analytical methods of analysis were used and it was established that in the Russian Federation and in Kuzbass there are all drugs for the treatment of patients with HIV infection included in modern lists of treatment standards according to clinical recommendations. The difference in the cost of antiretroviral drugs at the price of government funding has been established, which affects the costs of treating HIV-infected patients.

An optimal combination of antiretroviral treatment and immunotherapy for controlling HIV infection

Antiretroviral (ART) drugs have been used to treat HIV patients over last two decades. But, the daily use of these drugs in order to control HIV load in patients’ body results different side effects and high cost over long period of time. Motivated by these, researchers have been trying to find other treatment strategy whose combination with antiretroviral treatments can control HIV without use of large quantities of drugs. Immunotherapy is one of such treatment which assist natural immune system of patients in order to get control over viral infection. Administration of immunotherapy in combination with antiretroviral drugs has been found safe and effective after different clinical trials on humans and other animals. In this paper, we propose a mathematical model to describe HIV dynamics under antiretroviral treatment and immunotherapy combination. We find that our model is biologically feasible and the findings of the clinical trials support the dynamics of our model. The stability analyses of HIV-free equilibrium point are performed and found the basic reproduction number as a threshold parameter. Also, we calculate a critical efficacy for overall antiretroviral treatment such that when the efficacy of overall treatment exceeds this value HIV will be completely removed. Also, we have found that critical drug efficacy for antiretroviral drugs decreases with increasing immunotherapy, which indicates combination of immunotherapy with antiretroviral treatments minimize the quantity of antiretroviral drugs for HIV eradication, hence minimize the side effects and cost of antiretroviral drugs. Numerical simulations are carried out to substantiate the analytical results and to illustrate different drug administration scenarios. Moreover, an optimal combination of drugs which can control HIV with lower costs and side effects, is obtained by solving an optimal control problem numerically.

Estimating the hospital costs of care for people living with HIV in England using routinely collected data.

Understanding the health care activity and associated hospital costs of caring for people living with HIV is an important component of assessing the cost effectiveness of new technologies and for budget planning. Data collected between 2010 and 2017 from an English HIV treatment centre were combined with national reference costs to estimate the rate of hospital attendances and costs per quarter year, according to demographic and clinical factors. The final dataset included records for 1763 people living with HIV, which was analysed using negative binomial regression models and general estimating equations. People living with HIV experienced an unadjusted average of 0.028 (standard deviation [SD] 0.20) inpatient episodes per quarter, equivalent to one every 9 years, and 1.85 (SD 2.30) outpatient visits per quarter. The unadjusted mean quarterly cost per person with HIV (excluding antiretroviral drug costs) was £439 (SD 604). Outpatient appointments and inpatient episodes accounted for 88% and 6% of total costs, respectively. In adjusted models, low CD4 count was the strongest predictor of inpatient stays and outpatient visits. Low CD4 count and new patient status (having a first visit at the Trust in the last 6 months) were the factors that most increased estimated costs. Associations were weaker or less consistent for demographic factors (age, sex/sexual orientation/ethnicity). Sensitivity analyses suggest that the findings were generally robust to alternative parameter and modelling assumptions. A number of factors predicted hospital activity and costs, but CD4 cell count and new patient status were the strongest. The study results can be incorporated into future economic evaluations and budget impact assessments of HIV-related technologies.

Efficiency of the EmERGE Pathway of Care in Five European HIV Centres.

We aimed to calculate the efficiency of the EmERGE Pathway of Care in five European HIV clinics, developed and implemented for medically stable people living with HIV. Participants were followed up for 1 year before and after implementation of EmERGE, between April 2016 and October 2019. Micro-costing studies were performed in the outpatient services of the clinics. Unit costs for outpatient services were calculated in national currencies and converted to US$ 2018 OECD purchasing parity prices to enable between clinic comparisons in terms of outcomes and costs. Unit costs were linked to the mean use of services formedically stable people living with HIV, before and after implementation of EmERGE. Primary outcome measures were CD4 count and viral load; secondary outcomes were patient activation (PAM13) and quality of life (PROQOL-HIV). Out-of-pocket expenditure data were collected. There were 2251 participants: 87-93% were male, mean age at entry was 41-47 years. Medically stable people living with HIVhad outpatient visits in four sites whichdecreased by 9-31% and costs by 5-33%; visits andcosts increased by 8% in one site, which had to revert back to face-to-face visits. Antiretroviral drugs comprised 83-91% of annual costs: the Portuguese site had the highest antiretroviral drug costs in US$ purchasing parity prices. Primary and secondary outcome measures of participants did not change during the study. EmERGE is acceptable and provided cost savings in different socio-economic settings. Antiretroviral drug costs remain the main cost drivers in medically stable people living with HIV. While antiretroviral drug prices in local currencies did not differ that much between countries, conversion to US$ purchasing parity prices revealed antiretroviral drugs were more expensivein the least wealthy countries. This needs to be taken into consideration when countries negotiate drug prices with pharmaceutical vendors. Greater efficiencies can be anticipated by extending the use of the EmERGE Pathway to people with complex HIV infection or other chronic diseases. Extending such use should be systematically monitored, implementation should be evaluated and funding should be provided to monitor and evaluate future changes in service provision.

Economic impact on direct healthcare costs of missing opportunities for diagnosing HIV within healthcare settings.

The economic consequences of a missed opportunity for HIV testing at an earlier stage of infection within a healthcare setting are poorly described. For all newly diagnosed HIV patients followed at the Southern Alberta HIV/AIDS Clinic (SAC), Calgary, Canada, between 1 April 2011 and 1 April 2016, all clinical encounters occurring <3years prior to diagnosis within the region were obtained. The direct costs of HIV care after diagnosis to 31 March 2019 were determined from a payers' perspective and reported as mean cost per patient per month (PPPM) in 2019 Canadian dollars (CDN$). Patients with no encounters for 3years prior to diagnosis were compared with patients with encounters, with special attention to patients with HIV clinical indicator conditions (HCICs). Of 388 patients, 60% had one or more prior encounter without HIV testing; 14% had been treated for an HCIC. Females, older patients and heterosexuals were more likely to have prior encounters. At diagnosis, patients with previous encounters presented with lower CD4 counts and higher rates of AIDS. The mean PPPM costs for patients with any prior encounter or for an HCIC-based encounter were 16% and 33% higher, respectively, than for patients with no prior encounters. While mean PPPM costs for antiretroviral drugs and outpatient visits were slightly higher, in-patient costs were 10 times higher for people with HIV who had a previous HCIC encounter vs. those with no encounters (CDN$316 vs. $31, respectively). Any healthcare visit, especially for an HCIC, represents relatively easy opportunities for HIV testing. Not testing can result in poorer health and higher costs. Targeted clinical testing and novel interventions to correct overlooked testing opportunities within healthcare settings may be an easy way to implement cost savings.

Complejidad de la transición de los esquemas antirretrovirales en un programa de atención de VIH en Bogotá durante el periodo de 2015-2017

Cuando se decide cambiar una terapia antirretroviral se puede llegar a limitar futuras opciones‚ y es allí donde las conductas del personal tratante deben ser las más acertadas. Se realizó un estudio transversal-descriptivo‚ revisando las principales causas de cambios de esquema en los pacientes VIH de la IPS CEPAIN de Bogotá (Colombia) durante el periodo 2015-2017. Los cambios de tratamiento se estimaron en 8,1%; 8,8% y 5,8% durante los 3 años, el principal motivo de cambio fueron las reacciones adversas con 53,1%; 46%, y 49,6% respectivamente‚ seguidos de simplificación con 17,5; 25,1 y 26,5% y fracaso terapéutico en 19,8; 20,9 y 14,8% para cada año. Durante el primer año de tratamiento existió la necesidad de cambiar los esquemas en 12,9; 18,5, y 7,6% de los pacientes que iniciaron tratamiento en esos respectivos años. Las decisiones en los cambios de tratamiento antirretroviral involucran la introducción de nuevos antirretrovirales, la necesidad de reducir el número de tabletas o medicamentos, distintos perfiles de eficacia, tolerancia, efectos secundarios, toxicidad, barrera genética e interacciones. Otros factores a tener en cuenta son: el costo creciente de los medicamentos antirretrovirales, la dinámica en la transición y aplicación de los nuevos esquemas para garantizar un enfoque clínico, y económico sustentable.

Cost-Effectiveness of Dolutegravir as a First-Line Treatment Option in the HIV-1–Infected Treatment-Naive Patients in Russia

To evaluate the cost effectiveness of dolutegravir + abacavir/lamivudine (DTG + ABC/3TC) compared with raltegravir + abacavir/lamivudine (RAL + ABC/3TC) and ritonavir-boosted darunavir + abacavir/lamivudine (DRV/r + ABC/3TC) in HIV-1-infected treatment-naive patients in Russia. A dynamic Markov model was developed with five response states and six CD4+-based health states. Efficacy estimated as probability of viral suppression (HIV RNA <50 copies/ml) at 48 weeks was obtained from a published network meta-analysis. Baseline cohort characteristics and health state utilities were informed using DTG phase 3 clinical trials. Health care resource use was obtained from literature and costed using published unit costs. Costs (presented in Russian rubles) included antiretroviral drug costs; HIV management costs such as routine care; costs of treating cardiovascular conditions, opportunistic infections, and drug-related adverse effects; and mortality costs. A patient lifetime analysis was conducted using the societal perspective. Outcomes were quality-adjusted life-years (QALYs), life-years, incremental cost per QALY ratio, and incremental cost per responder. The viral suppression rate among patients receiving DTG + ABC/3TC was 71.7% compared with 65.2% for RAL + ABC/3TC and 59.6% for DRV/r + ABC/3TC. The mean duration of response per patient was 116.6 months for DTG + ABC/3TC, 108.6 months for RAL + ABC/3TC, and 98.9 months for DRV/r + ABC/3TC. Total discounted costs for treatment over patient lifetime were RUB 2.89, 5.32, and 4.38 million for DTG + ABC/3TC, RAL + ABC/3TC, and DRV/r + ABC/3TC, respectively. Lifetime discounted QALYs were 12.73 for patients on DTG + ABC/3TC and 12.72 each for patients on RAL + ABC/3TC and DRV/r + ABC/3TC. DTG + ABC/3TC thus dominated the other two alternatives. With lower costs, higher response rates, and comparable QALYs, DTG + ABC/3TC can be considered as a cost-effective alternative.

Short-term cost and efficiency analysis of raltegravir versus atazanavir/ritonavir or darunavir/ritonavir for treatment-naive adults with HIV-1 infection in Spain

Introduction: The AIDS Clinical Trial Group (ACTG) 5257 clinical trial showed that raltegravir (RAL) was superior to atazanavir/ritonavir (ATV/r) and darunavir/ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir DF (FTC/TDF), in a 96-week composite endpoint combining virologic efficacy and tolerability for treatment-naive adults with HIV-1 infection. This study aimed to estimate the efficiency associated with these three regimens in Spain.Methods: An economic model was developed to estimate costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating first-line therapy. Antiretroviral drug costs were based on hospital costs with mandatory discounts applied. Adverse event management costs and HIV care costs were obtained from published sources and inflated to 2015 euros. Head-to-head efficacy and safety data (discontinuation rates, mean CD4 cell-count changes, adverse event incidence) up to 96 weeks for each regimen were obtained from the clinical trial. The efficiency of each regimen, as measured by the cost per successfully treated patient (i.e. on first-line therapy for 96 weeks), was estimated and examined in sensitivity analyses. All cost outcomes were discounted at 3.0% annually.Results: Total costs per successfully treated patient were €22,377 for RAL, €26,629 for ATV/r, and €23,928 for DRV/r. These results were found to be robust in sensitivity analyses.Discussion: RAL has the lowest cost per successfully treated patient when compared with DRV/r and ATV/r, each used in combination with FTC/TDF, for treatment-naive adults with HIV-1 infection in Spain. This economic evidence complements the clinical benefits of RAL reported in the ACTG 5257 clinical trial.

Economic evaluation of HIV pre-exposure prophylaxis among men-who-have-sex-with-men in England in 2016.

Clinical effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV acquisition in men who have sex with men (MSM) at high HIV risk is established. A static decision analytical model was constructed to inform policy prioritisation in England around cost-effectiveness and budgetary impact of a PrEP programme covering 5,000 MSM during an initial high-risk period. National genitourinary medicine clinic surveillance data informed key HIV risk assumptions. Pragmatic large-scale implementation scenarios were explored. At 86% effectiveness, PrEP given to 5,000 MSM at 3.3 per 100 person-years annual HIV incidence, assuming risk compensation (20% HIV incidence increase), averted 118 HIV infections over remaining lifetimes and was cost saving. Lower effectiveness (64%) gave an incremental cost-effectiveness ratio of + GBP 23,500 (EUR 32,000) per quality-adjusted life year (QALY) gained. Investment of GBP 26.9 million (EUR 36.6 million) in year-1 breaks even anywhere from year-23 (86% effectiveness) to year-33 (64% effectiveness). PrEP cost-effectiveness was highly sensitive to year-1 HIV incidence, PrEP adherence/effectiveness, and antiretroviral drug costs. There is much uncertainty around HIV incidence in those given PrEP and adherence/effectiveness, especially under programme scale-up. Substantially reduced PrEP drug costs are needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size.

Cost-effectiveness of pre-exposure prophylaxis for HIV prevention in men who have sex with men in the UK: a modelling study and health economic evaluation

In the UK, HIV incidence among men who have sex with men (MSM) has remained high for several years, despite widespread use of antiretroviral therapy and high rates of virological suppression. Pre-exposure prophylaxis (PrEP) has been shown to be highly effective in preventing further infections in MSM, but its cost-effectiveness is uncertain. In this modelling study and economic evaluation, we calibrated a dynamic, individual-based stochastic model, the HIV Synthesis Model, to multiple data sources (surveillance data provided by Public Health England and data from a large, nationally representative survey, Natsal-3) on HIV among MSM in the UK. We did a probabilistic sensitivity analysis (sampling 22 key parameters) along with a range of univariate sensitivity analyses to evaluate the introduction of a PrEP programme with sexual event-based use of emtricitabine and tenofovir for MSM who had condomless anal sexual intercourse in the previous 3 months, a negative HIV test at baseline, and a negative HIV test in the preceding year. The main model outcomes were the number of HIV infections, quality-adjusted life-years (QALYs), and costs. Introduction of such a PrEP programme, with around 4000 MSM initiated on PrEP by the end of the first year and almost 40 000 by the end of the 15th year, would result in a total cost saving (£1·0 billion discounted), avert 25% of HIV infections (42% of which would be directly because of PrEP), and lead to a gain of 40 000 discounted QALYs over an 80-year time horizon. This result was particularly sensitive to the time horizon chosen, the cost of antiretroviral drugs (for treatment and PrEP), and the underlying trend in condomless sex. This analysis suggests that the introduction of a PrEP programme for MSM in the UK is cost-effective and possibly cost-saving in the long term. A reduction in the cost of antiretroviral drugs (including the drugs used for PrEP) would substantially shorten the time for cost savings to be realised. National Institute for Health Research.

Willingness to pay for antiretroviral drugs among HIV and AIDS clients in south-east Nigeria.

BackgroundThe current trend of withdrawal of donor support for HIV/AIDS treatment in Nigeria may require that the cost of antiretroviral drugs be borne in part by infected people and their families.ObjectiveThis study was conducted to determine the economic value for free antiretroviral drugs (ARVs) expressed by clients receiving treatment for HIV/AIDS in a tertiary hospital.Study methodThe contingent valuation method was used to elicit the values attached to free ARVs from people living with HIV/AIDS that were receiving care in a public tertiary hospital in south‐east Nigeria. Exit poll using a pre‐tested questionnaire was undertaken with adult clients on treatment. The bidding game technique was used to elicit their willingness to pay (WTP) for ARVs for themselves and members of their households. Ordinary least squares (OLS) multiple regression analysis was used to test the construct validity of elicited WTP amounts.ResultsAbout a third of the respondents were willing to pay for a monthly supply of ARVs for themselves and household members. The mean WTP for monthly supply of ARVs for self was US$15.32 and for household member was US$15.26 (1US$=₦160). OLS regression analysis showed that employment status and higher socio‐economic status were positively associated with higher WTP. OLS showed that age and transport cost per clinic visit were negatively related to WTP. Knowing the risks of not adhering to treatment protocol was positively related to WTP.ConclusionThe respondents positively valued the free ARVs. This calls for greater financial support for the sustainable provision of the treatment service. However, holistic financing mechanisms should be explored to ensure sustained funding in the event of complete withdrawal of donor support.

Kazakhstan can achieve ambitious HIV targets despite expected donor withdrawal by combining improved ART procurement mechanisms with allocative and implementation efficiencies

BackgroundDespite a non-decreasing HIV epidemic, international donors are soon expected to withdraw funding from Kazakhstan. Here we analyze how allocative, implementation, and technical efficiencies could strengthen the national HIV response under assumptions of future budget levels.MethodologyWe used the Optima model to project future scenarios of the HIV epidemic in Kazakhstan that varied in future antiretroviral treatment unit costs and management expenditure—two areas identified for potential cost-reductions. We determined optimal allocations across HIV programs to satisfy either national targets or ambitious targets. For each scenario, we considered two cases of future HIV financing: the 2014 national budget maintained into the future and the 2014 budget without current international investment.FindingsKazakhstan can achieve its national HIV targets with the current budget by (1) optimally re-allocating resources across programs and (2) either securing a 35% [30%–39%] reduction in antiretroviral treatment drug costs or reducing management costs by 44% [36%–58%] of 2014 levels. Alternatively, a combination of antiretroviral treatment and management cost-reductions could be sufficient. Furthermore, Kazakhstan can achieve ambitious targets of halving new infections and AIDS-related deaths by 2020 compared to 2014 levels by attaining a 67% reduction in antiretroviral treatment costs, a 19% [14%–27%] reduction in management costs, and allocating resources optimally.SignificanceWith Kazakhstan facing impending donor withdrawal, it is important for the HIV response to achieve more with available resources. This analysis can help to guide HIV response planners in directing available funding to achieve the greatest yield from investments. The key changes recommended were considered realistic by Kazakhstan country representatives.

Antiretroviral Drugs: Analysis of Ukrainian pharmaceutical market and Intellectual Property

The aim of this study was to analyze Ukrainian pharmaceutical market and patent protection of antiretroviral drugs in Ukraine and abroad. It has established that in Ukraine most of medicines are foreign antiretroviral drugs under patent protection. Take into account the prevalence of HIV in Ukraine the introduction into clinical practice domestic generic antiretroviral drugs which included in clinical guidelines for the management of HIV and AIDS in adults and adoloscents and have obvious economic benefits is prospect and economically reasonable. It has found out that the most negative risks of commercialization antiretroviral drugs which influence on their access for patients with HIV are next risks: high cost of foreign antiretroviral drugs; lack of original domestic antiretroviral drugs; sharp rise in antiretroviral drug prices as a result of switch to second- and third line therapy; patent protection and monopolization of antiretroviral drugs; exclusivity data of clinical trials. It has proved that the use of the flexible mechanisms of the TRIPS Agreement in Ukraine, namely involving the grant of compulsory licenses, the implementation of parallel imports, the tightening of the criteria for patentability is necessary for increase of antiretroviral drugs access for patients with HIV infection.

Analysis of antiretroviral therapy modification in routine clinical practice in the management of HIV infection

ObjectivesThe main goal was to assess the reasons for antiretroviral therapy (ART) change in patients with HIV in a hospital setting in routine clinical practice. The economic impact of ART...

Validation of Computational Approaches for Antiretroviral Dose Optimization.

Strategies for reducing antiretroviral doses and drug costs can support global access, and numerous options are being investigated. Efavirenz pharmacokinetic simulation data generated with a bottom-up physiologically based model were successfully compared with data obtained from the ENCORE I clinical trial (efavirenz at 400 mg once per day versus 600 mg once per day). These findings represent a pivotal paradigm for the prediction of pharmacokinetics resulting from dose reductions. Validated computational models constitute a valuable resource for optimizing therapeutic options and predicting complex clinical scenarios.

Cost-effectiveness analysis of tenofovir/emtricitabine and abacavir/lamivudine in combination with efavirenz or atazanavir/ritonavir for treatment-naïve adults with HIV-1 infection in the UK, based on the AIDS Clinical Trials Group 5202 clinical trial.

The aim of the study was to assess the cost-effectiveness of the four regimens studied in the AIDS Clinical Trials Group (ACTG) 5202 clinical trial, tenofovir/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC) in combination with efavirenz (EFV) or atazanavir/ritonavir (ATV/r), for treatment-naïve adults with HIV-1 infection in the UK. A Markov model with six health states based on CD4 cell count ranges was developed to predict long-term costs and health outcomes for individuals on first-line therapy. Head-to-head efficacy data comparing TDF/FTC+EFV, TDF/FTC+ATV/r, ABC/3TC+EFV, and ABC/3TC+ATV/r were obtained from ACTG 5202 for up to 192weeks. Antiretroviral drug costs were based on current list prices. Other medical costs (2013 UK pounds sterling), utility values, and mortality rates were obtained from published sources. Base-case, sensitivity, and subgroup analyses (by baseline viral load) were conducted. Individuals using TDF/FTC-based regimens were predicted to remain on first-line therapy longer and accrue more quality-adjusted life-years (QALYs) than individuals using ABC/3TC-based regimens. At a willingness-to-pay threshold of £30000 per QALY gained, TDF/FTC-based regimens were predicted to be cost-effective compared with ABC/3TC-based regimens, with incremental cost-effectiveness ratios of £23355 for TDF/FTC+EFV vs. ABC/3TC+EFV and £23785 for TDF/FTC+ATV/r vs. ABC/3TC+ATV/r. Results were generally robust in subgroup, sensitivity, and scenario analyses. In an analysis of the regimens studied in ACTG 5202 for treatment-naïve adults with HIV-1 infection in the UK, TDF/FTC-based regimens yielded more favourable health outcomes and were generally predicted to be cost-effective compared with ABC/3TC-based regimens. These results confirm that TDF/FTC-based regimens are not only clinically effective but also cost-effective.

Cost analysis of antiretroviral agents available in India

Background: AIDS is one of the most prevalent causes of death due to infectious origin which requires a lifelong therapy. There is variation in prices of antiretroviral drugs available in Indian market. Thus, a study was planned to find out variation in prices of antiretroviral drugs either as a single drug or in combination and to evaluate the difference in cost of various brands of the same antiretroviral drugs by calculating percentage variation in cost in Indian rupees. Methods: Cost of antiretroviral drugs manufactured by different pharmaceutical companies, in the same strength and dosage forms was obtained from “Current Index of Medical Specialties” July-October 2014 and “Indian Drug Review” Vol. XXI, Issue No. 4, 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in cost was calculated. Results: Percentage variation in cost for antiretroviral drugs marketed in India was found to be zidovudine (100 mg) - 436%, lamivudine (100 mg) - 268%, tenofovir (300 mg) - 149.5%, didanosine (250 mg) - 73.75%, indinavir (400 mg) - 35.26%. Among the combination therapy, price variation was lamivudine + zidovudine (150 + 300 mg) - 314%, lamivudine + stavudine (150 + 40 mg) - 105%, lopinavir + ritonavir (133.3 + 33 mg) - 25%. Conclusion: There is wide variation in the prices of antiretroviral agents available in the market. Regulatory authorities, pharma companies, physicians should maximize their efforts to reduce the cost of drugs.

Cost effectiveness of darunavir/ritonavir combination antiretroviral therapy for treatment-naive adults with HIV-1 infection in Canada.

The AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects (ARTEMIS) clinical trial examined the efficacy and safety of two ritonavir-boosted protease inhibitors (PI/r), darunavir/r 800/100 mg once daily (QD) and lopinavir/r 800/200 mg daily, both used in combination with tenofovir disoproxil fumarate/emtricitabine. This study aimed to assess the cost effectiveness of the darunavir/r regimen compared with the lopinavir/r regimen in treatment-naive adults with HIV-1 infection in Canada. A Markov model with a 3-month cycle time and six CD4 cell-count-based health states (>500, 351-500, 201-500, 101-200, 51-100, and 0-50 cells/mm(3)) followed a cohort of treatment-naive adults with HIV-1 infection through initial darunavir/r or lopinavir/r combination therapy and a common set of subsequent regimens over the course of their remaining lifetimes. Population characteristics and transition probabilities were estimated from the ARTEMIS clinical trial and other trials. Costs (in 2014 Canadian dollars), utilities, and mortality were estimated from Canadian sources and published literature. Costs and health outcomes were discounted at 5% per year. One-way and probabilistic sensitivity analyses were performed, including a simple indirect comparison of the darunavir/r initial regimen with an atazanavir/r-based regimen. In the base-case lifetime analysis, individuals receiving initial therapy with the darunavir/r regimen experienced 0.25 more quality-adjusted life-years (QALYs) with lower antiretroviral drug costs (-$14,246) and total costs (-$18,402) than individuals receiving the lopinavir/r regimen, indicating that darunavir/r dominated lopinavir/r. In an indirect comparison with an atazanavir/r-based regimen, the darunavir/r regimen remained the dominant choice, but with lower cost savings (-$2,303) and QALY gains (0.02). Results were robust to a wide range of other changes in input parameter values, population characteristics, and modeling assumptions. The probabilistic sensitivity analysis demonstrated that the darunavir/r regimen was cost effective compared with the lopinavir/r regimen in over 86% of simulations for willingness-to-pay thresholds between $0 and $100,000 per QALY gained. Darunavir/r 800/100 mg QD may be a cost-effective PI/r component of initial antiretroviral therapy for treatment-naive adults with HIV-1 infection in Canada.

Estimating age-based antiretroviral therapy costs for HIV-infected children in resource-limited settings based on World Health Organization weight-based dosing recommendations.

BackgroundPediatric antiretroviral therapy (ART) has been shown to substantially reduce morbidity and mortality in HIV-infected infants and children. To accurately project program costs, analysts need accurate estimations of antiretroviral drug (ARV) costs for children. However, the costing of pediatric antiretroviral therapy is complicated by weight-based dosing recommendations which change as children grow.MethodsWe developed a step-by-step methodology for estimating the cost of pediatric ARV regimens for children ages 0–13 years old. The costing approach incorporates weight-based dosing recommendations to provide estimated ARV doses throughout childhood development. Published unit drug costs are then used to calculate average monthly drug costs. We compared our derived monthly ARV costs to published estimates to assess the accuracy of our methodology.ResultsThe estimates of monthly ARV costs are provided for six commonly used first-line pediatric ARV regimens, considering three possible care scenarios. The costs derived in our analysis for children were fairly comparable to or slightly higher than available published ARV drug or regimen estimates.ConclusionsThe methodology described here can be used to provide an accurate estimation of pediatric ARV regimen costs for cost-effectiveness analysts to project the optimum packages of care for HIV-infected children, as well as for program administrators and budget analysts who wish to assess the feasibility of increasing pediatric ART availability in constrained budget environments.

Antiretroviral drug costs and prescription patterns in British Columbia, Canada: 1996-2011.

Treatment options and therapeutic guidelines have evolved substantially since highly active antiretroviral treatment (HAART) became the standard of HIV care in 1996. We conducted the present population-based analysis to characterize the determinants of direct costs of HAART over time in British Columbia, Canada. We considered individuals ever receiving HAART in British Columbia from 1996 to 2011. Linear mixed-effects regression models were constructed to determine the effects of demographic indicators, clinical stage, and treatment characteristics on quarterly costs of HAART (in 2010$CDN) among individuals initiating in different temporal periods. The least-square mean values were estimated by CD4 category and over time for each temporal cohort. Longitudinal data on HAART recipients (N = 9601, 17.6% female, mean age at initiation = 40.5) were analyzed. Multiple regression analyses identified demographics, treatment adherence, and pharmacological class to be independently associated with quarterly HAART costs. Higher CD4 cell counts were associated with modestly lower costs among pre-HAART initiators [least-square means (95% confidence interval), CD4 > 500: 4674 (4632-4716); CD4: 350-499: 4765 (4721-4809) CD4: 200-349: 4826 (4780-4871); CD4 <200: 4809 (4759-4859)]; however these differences were not significant among post-2003 HAART initiators. Population-level mean costs increased through 2006 and stabilized post-2003 HAART initiators incurred quarterly costs up to 23% lower than pre-2000 HAART initiators in 2010. Our results highlight the magnitude of the temporal changes in HAART costs, and disparities between recent and pre-HAART initiators. This methodology can improve the precision of economic modeling efforts by using detailed cost functions for annual, population-level medication costs according to the distribution of clients by clinical stage and era of treatment initiation.