Integrated care experiences and out-of-pocket expenditures: a cross-sectional survey of adults receiving treatment for HIV and hypertension in Malawi.

OBJECTIVES: As HIV-positive individuals' life expectancy extends, there is an urgent need to manage other chronic conditions during HIV care. We assessed the care-seeking experiences and costs of adults receiving treatment for both HIV and hypertension in Malawi. DESIGN, SETTING AND PARTICIPANTS: A cross-sectional survey was conducted with HIV-positive adults with hypertension at a health facility in Lilongwe that offers free HIV care and free hypertension screening, with antihypertensives available for purchase (n=199). Questions included locations and costs of all medication refills and preferences for these refill locations. Respondents were classified as using 'integrated care' if they refilled HIV and antihypertensive medications simultaneously. Data were collected between June and December 2017. RESULTS: Only half of respondents reported using the integrated care offered at the study site. Among individuals using different locations for antihypertensive medication refills, the most frequent locations were drug stores and public sector health facilities which were commonly selected due to greater convenience and lower medication costs. Although the number of antihypertensive medications was equivalent between the integrated and non-integrated care groups, the annual total cost of care differed substantially (approximately US$21 in integrated care vs US$90 for non-integrated care)-mainly attributable to differences in other visit costs for non-integrated care (transportation, lost wages, childcare). One-third of those in the non-integrated care group reported no expenditure for antihypertensive medication, and six people in each group reported no annual hypertension care-seeking costs at all. CONCLUSIONS: Individuals using integrated care saw efficiencies because, although they were more likely to pay for antihypertensive medications, they did not incur additional costs. These results suggest that preferences and experiences must be better understood to design effective policies and programmes for integrated care among adults on antiretroviral therapy.

Cost-effectiveness of initial antiretroviral treatment administered as single vs. multiple tablet regimens with the same or different components / Coste-efectividad del tratamiento inicial antirretroviral de comprimido único vs. tratamiento con regímenes de múltiples comprimidos con los mismos o diferentes componentes

Objective: To evaluate the efficiency of single-tablet regimens (STR) and multiple-tablet regimens (MTR) with exactly the same or different components. Methods: A study was conducted on HIV-1-infected antiretroviral-naïve patients from 6 Spanish or French centers, who were started on treatment with STR-Atripla®, or the same components separately (MTR-SC), or a different MTR (MTR-Other). Effectiveness was measured as percentage of HIV-RNA <50copies/mL at 48 weeks (ITT). Efficiency was the ratio between costs (direct cost of antiretrovirals plus outpatient visits, hospital admissions, and resistance tests) and effectiveness. Results: The study included a total of 2773 patients (759 STR-Atripla®, 483 MTR-SC, and 1531 MTR-Other). Median age was 37 years, 15% were HCV co-infected, 27% had a CD4+ count <200cells/μL, and 30% had viral load ≥100.000copies/mL. The duration of the assigned treatment was longer for STR-Atripla® (P<.0001). Response rates (adjusted for CD4+ count, viral load, and clustered on hospitals) at 48 weeks were 76%, 74%, and 62%, respectively (P<.0001). Virological failure was more common in MTR patients (P=.0025), and interruptions due to intolerance with MTR-Other (P<.0001). Cost per responder at 48 weeks (efficiency) was euros12,406 with STR-Atripla®, euros11,034 with MTR-SC (0.89 [0.82, 0.99] times lower), and euros18,353 (1.48 [1.38, 1.61] times higher) with MTR-Other. Conclusions: STR-Atripla® and MTR-SC regimens showed similar effectiveness, but virological failure rate was lower with STR-Atripla. MTR-SC, considered less convenient, had a marginally better efficiency, mainly due to lower direct costs. MTR-Other regimens had both a worse effectiveness and efficiency. Similar efficiency analyses adjusting for baseline characteristics should be recommended for new STRs (AU)

Objetivo: Evaluar la eficiencia de un régimen antirretroviral de comprimido único diario (STR) y de regímenes de múltiples comprimidos (MTR) con exactamente los mismos (MTR-SC) o distintos componentes (MTR-Other). Métodos: Se incluyeron pacientes con infección por VIH-1 no tratados de 6 centros españoles o franceses que iniciaron tratamiento con STR-Atripla®, MTR-SC, o MTR-Other. La eficacia se midió como el porcentaje de VIH-ARN <50copias/ml (48 semanas, ITT). La eficiencia fue el cociente entre los costes (costes directos de los antirretrovirales, visitas ambulatorias, ingresos y estudios de resistencia) y la eficacia. Resultados: Fueron incluidos 2.773 pacientes (759 STR-Atripla®, 483 MTR-SC, 1.531 MTR-Other) con una edad media de 37 años, el 15% coinfectados por VHC, el 27% con CD4+ <200células/μl y el 30% con carga viral ≥100.000copias/ml. La duración del tratamiento asignado fue mayor para STR-Atripla® (p<0,0001). La respuesta (ajustada para CD4+, carga viral y centro hospitalario) a 48 semanas fue del 76, 74 y 62%, respectivamente (p<0,0001). El fracaso virológico fue más frecuente con ambos MTR (p=0,0025), y las interrupciones por intolerancia lo fueron con MTR-Other (p<0,0001). El coste por respondedor a 48 semanas (eficiencia) fue 12.406euros con STR-Atripla®, 11.034euros con MTR-SC (0,89 [0,82-0,99] veces menor), y 18.353euros (1,48 [1,38-1,61] veces mayor) con MTR-Other. Conclusiones: STR-Atripla® y MTR-SC mostraron una eficacia similar, pero con menor fracaso virológico con STR-Atripla. MTR-SC, considerado menos conveniente, tuvo una eficiencia marginalmente mayor, principalmente debido a menores costes directos. MTR-Other tuvo una eficacia y eficiencia peores. Deberían recomendarse estudios similares con otros nuevos STR ajustados a las características basales de los pacientes (AU)

Funding antiretroviral treatment for HIV-positive temporary residents in Australia prevents transmission and is inexpensive.

Background The aim of this study is to estimate the reduction in new HIV infections and resultant cost outcomes of providing antiretroviral treatment (ART) through Australia's 'universal access' health scheme to all temporary residents with HIV infection living legally in Australia, but currently deemed ineligible to access subsidised ART via this scheme. METHODS: A mathematical model to estimate the number of new HIV infections averted and the associated lifetime costs over 5 years if all HIV-positive temporary residents in Australia had access to ART and subsidised medical care was developed. Input data came from a cohort of 180 HIV-positive temporary residents living in Australia who are receiving free ART donated by pharmaceutical companies for up to 4 years. RESULTS: Expanding ART access to an estimated total 450 HIV+ temporary residents in Australia for 5 years could avert 80 new infections. The model estimated the total median discounted (5%) cost for ART and associated care to be A$36million, while the total savings in lifetime-discounted costs for the new infections averted was A$22million. CONCLUSIONS: It is estimated that expanded access to ART for all HIV-positive temporary residents in Australia will substantially reduce HIV transmission to their sexual partners at little additional cost. In the context of Australia's National HIV strategy and Australia's endorsement of global goals to provide universal access to ART for all people with HIV, this is an important measure to remove inequities in the provision of HIV-related treatment and care.

New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy).

BACKGROUND: In the healthcare sector, it is crucial to identify sustainable strategies in order to allow the introduction and use of innovative technologies. Now, and over the next few years, the expiry of patents for different antiretroviral drugs offers an opportunity to increase the efficiency of resources allocation. The aim of the present study was to assess the impact, on the budget of the Italian National Healthcare Service, of generic antiretroviral drugs and of new antiretroviral drugs entering the market from 2015 to 2019. METHODS: A budget impact model was developed in order to forecast the rate of use of ARTs, based on trends observed within the Lombardy Region (Italy), on clinical experts' opinion, and the consequent impact on the Italian NHS budget in a five year time horizon. Different scenarios were developed, considering the sole introduction of generic drugs, of new drugs, and their cumulative effects. A multivariate sensitivity analysis was also performed. RESULTS: The cumulative use of generic drugs and new drugs would lead to annual savings of 4.6 million € (-0.6 %) in 2015; 16.9 million € (-2.1 %) in 2016; 19.4 million € (-2.4 %) in 2017; 51.1 million € (-6.1 %) in 2018 and -110.3 million € (-12.8 %) in 2019. The impact of new drugs in percentage terms is +2.0 % in 2015, +3.4 % in 2016, +3.9 % in 2017, +5.7 % in 2018 and +7.7 % in 2019. The impact of generic drugs would lead to savings of 4.9 million € in 2015, 18.6 million € in 2016, 22.8 million € in 2017, 76.5 million € in 2018 and 187.4 million € in 2019. The sensitivity analysis showed annual mean savings for the Italian NHS ranging from 12.6 million €, -1.5 % compared to the base case scenario (decreasing all the rates of transition used in the simulation, and increasing the cost of generic drugs) to 76.0 million €, -9.1 % (increasing all the rates of transition used in the simulation, and decreasing the cost of generic and new drugs). CONCLUSIONS: The use of antiretroviral generic drugs may lead to savings that would compensate the expenditure increase due to new, innovative drugs available on the market.

Opportunities for improving the efficiency of paediatric HIV treatment programmes.

OBJECTIVES: To conduct two economic analyses addressing whether to: routinely monitor HIV-infected children on antiretroviral therapy (ART) clinically or with laboratory tests; continue or stop cotrimoxazole prophylaxis when children become stabilized on ART. DESIGN AND METHODS: The ARROW randomized trial investigated alternative strategies to deliver paediatric ART and cotrimoxazole prophylaxis in 1206 Ugandan/Zimbabwean children. Incremental cost-effectiveness and value of implementation analyses were undertaken. Scenario analyses investigated whether laboratory monitoring (CD4 tests for efficacy monitoring; haematology/biochemistry for toxicity) could be tailored and targeted to be delivered cost-effectively. Cotrimoxazole use was examined in malaria-endemic and non-endemic settings. RESULTS: Using all trial data, clinical monitoring delivered similar health outcomes to routine laboratory monitoring, but at a reduced cost, so was cost-effective. Continuing cotrimoxazole improved health outcomes at reduced costs. Restricting routine CD4 monitoring to after 52 weeks following ART initiation and removing toxicity testing was associated with an incremental cost-effectiveness ratio of $6084 per quality-adjusted life-year (QALY) across all age groups, but was much lower for older children (12+ years at initiation; incremental cost-effectiveness ratio = $769/QALY). Committing resources to improve cotrimoxazole implementation appears cost-effective. A healthcare system that could pay $600/QALY should be willing to spend up to $12.0 per patient-year to ensure continued provision of cotrimoxazole. CONCLUSION: Clinically driven monitoring of ART is cost-effective in most circumstances. Routine laboratory monitoring is generally not cost-effective at current prices, except possibly CD4 testing amongst adolescents initiating ART. Committing resources to ensure continued provision of cotrimoxazole in health facilities is more likely to represent an efficient use of resources.

An economic case for providing free access to antiretroviral therapy for HIV-positive people in South Australia.

BACKGROUND: As financial constraints can be a barrier to accessing HIV antiretroviral therapy (ART), we argue for the removal of copayment requirements from HIV medications in South Australia. METHODS: Using a simple mathematical model informed by available behavioural and biological data and reflecting the HIV epidemiology in South Australia, we calculated the expected number of new HIV transmissions caused by persons who are not currently on ART compared with transmissions for people on ART. The extra financial investment required to cover the copayments to prevent an HIV infection was compared with the treatment costs saved due to averting HIV infections. RESULTS: It was estimated that one HIV infection is prevented per year for every 31.4 persons (median, 24.0-42.7 interquartile range (IQR)) who receive treatment. By considering the incremental change in costs and outcomes of a change in program from the current status quo, it would cost the health sector $17860 per infection averted (median, $13651-24287 IQR) if ART is provided as a three-dose, three-drug combination without requirements for user-pay copayments. CONCLUSIONS: The costs of removing copayment fees for ART are less than the costs of treating extra HIV infections that would result under current conditions. Removing the copayment requirement for HIV medication would be cost-effective from a governmental perspective.

Costing human rights and community support interventions as a part of universal access to HIV treatment and care in a Southern African setting.

Expanding access to antiretroviral therapy (ART) has both individual health benefits and potential to decrease HIV incidence. Ensuring access to HIV services is a significant human rights issue and successful programmes require adequate human rights protections and community support. However, the cost of specific human rights and community support interventions for equitable, sustainable and non-discriminatory access to ART are not well described. Human rights and community support interventions were identified using the literature and through consultations with experts. Specific costs were then determined for these health sector interventions. Population and epidemic data were provided through the Statistics South Africa 2009 national mid-year estimates. Costs of scale up of HIV prevention and treatment were taken from recently published estimates. Interventions addressed access to services, minimising stigma and discrimination against people living with HIV, confidentiality, informed consent and counselling quality. Integrated HIV programme interventions included training for counsellors, 'Know Your Rights' information desks, outreach campaigns for most at risk populations, and adherence support. Complementary measures included post-service interviews, human rights abuse monitoring, transportation costs, legal assistance, and funding for human rights and community support organisations. Other essential non-health sector interventions were identified but not included in the costing framework. The annual costs for the human rights and community support interventions are United States (US) $63.8 million (US $1.22 per capita), representing 1.5% of total health sector HIV programme costs. Respect for human rights and community engagement can be understood both as an obligation of expanded ART programmes and as a critically important factor in their success. Basic rights-based and community support interventions constitute only a small percentage of overall programmes costs. ART programs should consider measuring the cost and impact of human rights and community support interventions as key aspects of successful programme expansion.

Integrated tuberculosis and HIV care in a resource-limited setting: experience from the Martin Preuss centre, Malawi.

OBJECTIVES: To describe the development and operation of integrated tuberculosis (TB) and HIV care at the Martin Preuss Centre, a multipartner organization bringing together governmental and non-governmental providers of HIV and TB services in Lilongwe, Malawi. METHODS: We used a case study approach to describe the integrated TB/HIV service and to illustrate successes and challenges faced by service providers. We quantified effective TB and HIV integration using indicators defined by the World Health Organization. RESULTS: The custom-designed building facilitates patient flow and infection control, and other important elements include coordinated leadership; joint staff training and meetings; and data systems prompting coordinated care. Some integrated services have worked well from the outset, such as promoting HIV testing among patients with TB (96% of patients with TB had documented HIV status in 2009). Other aspects of integrated care have been more challenging, for example achieving high uptake of antiretroviral therapy among HIV-positive TB patients and combining data from paper and electronic systems. Good TB treatment outcomes (>85% cure or completion) have been achieved among both HIV-positive and HIV-negative individuals. CONCLUSIONS: High-quality integrated services for TB and HIV care can be provided in a resource-limited setting. Lessons learned may be valuable for service providers in other settings of high HIV and TB prevalence.

Cost of using a patient tracer to reduce loss to follow-up and ascertain patient status in a large antiretroviral therapy program in Johannesburg, South Africa.

OBJECTIVE: To evaluate a pilot intervention to engage a patient tracer to follow up lost patients at a large public clinic in South Africa. METHODS: A social worker spent 4 months contacting by telephone a random sample of patients who had initiated antiretroviral therapy (ART) at least 6 months earlier and were >or=1 month late for a scheduled visit. The tracer was authorized to assist patients to return to care if needed. Cost was calculated from the perspective of the clinic. RESULTS: The tracer was able to determine the final status of 260 of a sample of 493 lost patients. Of the 260, 55 (21%) had died, 56 (21%) were still on ART at the same site, 79 (30%) reported transferring to another site and 70 (27%) had discontinued treatment. Among those discontinuing, commonly cited reasons were relocation (n = 18, 26%), traditional medicine or religious beliefs (n = 11, 16%), fear of disclosure or other family barriers (n = 9, 13%), and employment obstacles (n = 7, 10%). Twenty patients returned to care at the original site as a result of the intervention, at an average cost of $432 per patient returned. CONCLUSIONS: A patient tracer was an effective way to determine the final status of lost patients and succeeded in returning some to care, but the cost per patient returned was high. Better information systems allowing sites to track deaths and transfers would greatly improve the efficiency of loss to follow-up interventions.

Nutritional status of HIV-positive individuals on free HAART treatment in a developing nation.

INTRODUCTION: HIV positive individuals are prone to malnutrition due to inadequate dietary intake. Additionally, in low-income countries, including Nigeria, stigmatization and discrimination result in a lack of support for HIV-positive individuals ultimately contributing to even further reduced food availability and inadequate dietary intake. This study aimed to determine the nutrirional status of HIV-positive individuals on free, highly active antiretroviral therapy (HAART) in Abakaliki, southeast Nigeria. METHODOLOGY: Subjective global assessment (SGA) technique was used to survey the nutritional status of 120 HIV-positive individuals and a control group over a one-year period. RESULTS: All the HIV-positive individuals and their control group were physically active, with a third of them belonging to the lower socioeconomic status. There were significantly more malnourished individuals among the HIV-positive group than in the control group (P < 0.05). CONCLUSION: Malnutrition is common among HIV-positive patients in southeast Nigeria.  

The Brazilian experiment: HIV drugs for all.

The World Health Organization Joint Report of 2007 (WHO/UNAIDS/UNICEF) estimated that in developing world economies, 2 million people with HIV/AIDS were being treated with antiretroviral drugs (ARVs) out of the 7 million needing treatment. The ongoing political and humanistic movement in Brazil highly relates to health care provision, especially to treatment of the HIV/AIDS epidemic. "Compulsory licensing" (patent breaking) was used by Brazil to manufacture and import HIV/AIDS drugs. The Brazilian government provided top-of-the-line antiretroviral drugs in the form of HAART (highly active antiretroviral therapy) to all needing treatment for HIV/AIDS. Subsequently, the international community found Brazil as an eager "poster child" in the universal access movement for HIV/AIDS drugs. However, can this program of justice and humanity in Brazil be feasible when applied to the HIV/AIDS epidemic in other developing world countries? It is worth exploring.

Overcoming policy and financing barriers to integrated buprenorphine and HIV primary care.

Treatment for substance abuse and human immunodeficiency virus (HIV) infection historically have come from different providers, often in separate locations, and have been reimbursed through separate funding streams. We describe policy and financing challenges faced by health care providers seeking to integrate buprenorphine, a new treatment for opioid dependence, into HIV primary care. Regulatory challenges include licensing and training restrictions imposed by the Drug Addiction Treatment Act of 2000 and confidentiality regulations for alcohol and drug treatment records. Potential responses include the development of local training programs and electronic medical records. Addressing the complexity of funding sources for integrated care will require administrative support, up-front investments, and federal and state leadership. A policy and financing research agenda should address evidence gaps in the rationales for regulatory restrictions and should include cost-effectiveness studies that quantify the "value for money" of investments in integrated care to improve health outcomes for HIV-infected patients with opioid dependence.

Economic evaluation of HIV treatments: the I.CO.N.A. cohort study.

OBJECTIVE: To describe the changes in costs of care for HIV-positive patients in Italy after the spread of antiretroviral combination therapies (HAART). METHODS: Five thousand four hundred and twenty-two patients from the I.CO.N.A. (Italian Cohort Naive Antiretrovirals) study were followed between 1997 and 2002. Costs included antiretroviral therapies (ART), hospital admissions, prophylaxis, and main laboratory examinations. The perspective was that of the National Health Service. RESULTS: Admission costs per person-year decreased from 2148 euro in 1997 to 256 in 2002, while the average annual costs of ART increased from 2145 to 3149 euro (1997 prices). From 1997 to 1999, ART costs increased from 42.3 to 85.9% of the total, while admission costs decreased from 42.3 to 7.0% and prophylaxis from 7.3 to 1.7%. The breakdown of ART costs shows how dual therapies decreased over time in favor of HAART, falling from 26.8% in 1997 to 5.9% in 2002. Patients with fewer than five treatment switches had the lowest costs distributions over the entire observation period. CONCLUSIONS: From 1997 to 2002 inpatient costs progressively decreased in favor of antiretroviral therapy. Annual average costs per patient decreased, while total direct costs increased over time: health resources, initially concentrated on hospitalized patients were then distributed over a growing number of subjects.

HIV and AIDS in the People's Republic of China: a collaborative review.

The number of individuals diagnosed with HIV in China has risen dramatically in the last two years coincident with increased awareness and an attitude change within government. UNAIDS has suggested that China could have 10 million HIV infected people by 2010. However, antiretroviral treatments and HIV testing are not yet widely available and infected individuals often live in remote areas. It is unlikely that cheaper, locally produced, generic antiretroviral formulations will be available in China in the near future. Consequently, alternative strategies to manage HIV infection are being considered including the use of hydroxyurea, chloroquine and traditional Chinese herbal medicines. It is recognized in China that prevention and educational strategies will need to be at the forefront of approaches to control this epidemic.

The ART of rationing--the need for a new approach to rationing health interventions.

A key element in dealing with HIV/AIDS in South Africa depends on the resolution of the antiretroviral therapy (ART) paradox: while a universal First-World-style ART programme is unaffordable, a rationed treatment programme that includes ART is not only affordable but also vital for basic human rights reasons, to enhance prevention efforts and to keep the fabric of society together. Our recent paper on ART demonstrated how such a rationed programme would be both affordable and highly cost-effective. Traditional rationing mechanisms are unable to provide sufficient guidance as to how to go about this novel form of rationing. An alternative rationing mechanism is therefore proposed which seeks to balance ART in terms of three primary dimensions: total resource allocation to treatment, design of the treatment intervention, and setting targets on numbers to treat. Two secondary dimensions, related to total HIV and social spending, deserve equal attention. The current global context that precipitates and exacerbates the parallel contouring of disease burden and poverty should be constantly challenged.