cost analysis of hivaids treatment and cost effective analysis of different cd4 baseline in selected provinces, municipalities

1 ACRONYMS AIDS Acquired immunodeficiency syndrome ART Antiretroviral therapy ARV Antiretroviral drug CD4 Cluster of differentiation 4 VC Voluntary care DI Diagnostic imaging DALY Disability adjusted life year DFID LOS Department for International Development Length of Stay PMTCP Prevention of mother-to-child transmission HIV Human immuficiency virus ICER Incremental cost-effectiveness ratio IDU Injecting drug user MSM Men who have sex with men OI Opportunist infection OPC Outpatient clinic PEPFAR President’s Emergency Plan for AIDS Relief QALY Quality adjusted life year GF Global Fund STI Sexually transmitted infection HC Health center UNAIDS Joint United Nations Programme on HIV/AIDS UNICEF United Nations Children's Fund VCT Voluntary counseling and testing WB World Bank WHO World Health Organization 2 INTRODUCTION In the preparation for resources pooling plans for the HIV/AIDS care and treatment program within the National Strategy for HIV/AIDS control by 2020 and vision to 2030, information on HIV/AIDS treatment costs is a vital input for the estimation of financial resources needed to make sure that the care and treatment program is well-designed and viable. In ARV therapy, treatment timing may have massive bearing on the treatment outcomes and access to the program offerings. The World Health Organization recommends early treatment for HIV/AIDS patients, at initiation of CD4<350 cells/mm 3 . Early recognition and treatment however remain a challenge in Vietnam as patients often seek medical help when their condition has progressed to a CD4 cell count of less than 100 cells/mm 3 . In that context, defining the best timing for treatment amid resource constraints remains a question to be answered by managers of the HIV/AIDS therapy program in Vietnam. The “HIV/AIDS therapy costing and cost-effectiveness by CD4 cell count in selected provinces” review aims to cover the following mandates: 1. Situational analysis of HIV/AIDS therapy costs in selected provinces in Vietnam for 2009-2010; 2. Treatment cost-effectiveness analysis by CD4 cell count at different study points. * New inputs of the review - The review provides a comprehensive picture of HIV/AIDS therapy costs in 10 provinces and cities in Vietnam in 2009-2010. The study findings on HIV/AIDS treatment costs are highly representative and may be used for the HIV/AIDS therapy program in Vietnam. The review looks at the changes in HIV/AIDS treatment costs depending on relevant factors and determines the proportions of different cost components by treatment stages. - This is the first work on cost-effectiveness in the field of HIV/AIDS treatment. The study is a combination of a biological review and a health economics review. The study finds the relationship between the costs and effectiveness of HIV/AIDS treatment by different CD4 cell counts, where effectiveness is converted and measured by the added life years at different CD4 levels. * How the report is structured 3 The study has 130 pages and 4 chapters, including Introduction: 2 pages, Chapter 1. Overview: 32 pages, Chapter 2. Subject and methodology: 25 pages, Chapter 3. Findings: 43 pages, Chapter 4. Discussion: 25 pages, Conclusion: 2 pages, Recommendations: 1 page, 39 tables, 39 charts, 7 figures and 150 references, 22 in Vietnamese and 128 in English. Chapter 1. OVERVIEW I.1. HIV/AIDS treatment and HIV/AIDS treatment models in the world and Vietnam I.1.1.The HIV/AIDS treatment context and global ARV therapy needs By the end of 2011, as many as 8 million people in low and middle income countries have had access to antiretroviral drugs, which was a 25 fold increase over 2002. While many HIV-positive people have been admitted to the therapy program, as they often resorted to medical help at a later stage, their CD4 cell counts were often much lower than the level recommended by the World Health Organization for ideal therapy commencement. I.1.2.ARV therapy need in Vietnam As the number of HIV-positive people is increasing, so is the need for HIV/AIDS treatment and care. The need for HIV/AIDS treatment for 2012-2015 is estimated as follows: 2012 – 119,298 people; 2013 – 129,379 people; 2014 – 139,646 people; 2015 – 150,120 people; 2020 projection – 195,380 people. 1.1.3. Existing HIV/AIDS treatment models around the world 1.1.3.1. Centralized treatment at health care facilities 1.1.3.2. Community-based HIV/AIDS treatment 1.1.4. HIV/AIDS treatment models available in Vietnam 1.1.4.1. HIV/AIDS management and treatment within the health system a) At central level hospitals b) At province/district general hospitals c) At province/district health centers 1.1.4.2. HIV/AIDS treatment at institutions outside the health system a) At penitentiaries and 05/06 centers b) Treatment at social welfare facilities c) Piloting models: the treatment initiative 2.0 and commune/ward-based basic therapeutic service delivery. 1.1.5. Cost-effectiveness analysis 4 Cost-effectiveness analyses help estimating costs per incremental effectiveness unit (ICER). These analyses may be used to compare between national or regional interventions. The World Health Organization introduces rules on how to determine cost- effectiveness ratings: - ICER < GDP per capita: very cost-effective intervention - ICER of 1-3 GDP per capita: cost-effective intervention - ICER > 3 GDP per capita: Cost-ineffective intervention. Chapter 2. METHODOLOGY The study has two key components: 1) HIV/AIDS treatment cost breakdown, and 2) cost-effectiveness by CD4 levels. 2.1. Situational analysis of HIV/AIDS therapy costs in selected provinces in Vietnam for 2009-2010 2.1.1. Sites, timing and subjects 2.1.1.1. Sites The study takes place at 17 HIV/AIDS outpatient and inpatient clinics located in 10 provinces and cities in Vietnam, including Hanoi, Ho Chi Minh City, Thai Nguyen, Hai Duong, Ninh Binh, Haiphong, Can Tho, An Giang, Dong Thap and Khanh Hoa. These 17 clinics are purposefully selected from 30 therapeutic facilities participating in the cohort ARV drug resistance follow-up study by the HIV/AIDS Control Administration in 2009. 2.1.1.2. Timing Cost estimating timeline: March 2009 – March 2010. 2.1.1.3. Subjects Adult HIV/AIDS patients (of over 15 years of age) who are known to be HIV-positive and have registered for inpatient and outpatient clinical care, selected for the HIV/AIDS treatment sample, including pre-ART patients, those on first year first line ART, those on first line ART from the second year and those on second-line ART, with periods in treatment meeting the timing requirements for costing. 2.1.2. Methodology 2.1.2.1. Study design This is a cross-sectional study with retrospective data collection and analysis on HIV/AIDS inpatient and outpatient treatment costs. Inpatient treatment costs are calculated based on the cost per patient per episode. Inpatient costs encompass medications, supplies, tests, diagnostic imaging, human resources, overheads, depreciation costs incurred during the patient’s entire hospitalized period. 5 An inpatient episode is the entire amount of time following a patient’s admission to discharge for all patients known to be HIV- positive before or during inpatient treatment. Outpatient costs are estimated based on the cost per patient per year. Outpatient costs include counseling, testing, medication, opportunist infection treatment, human resources, overheads and facility/equipment depreciation divided by the following periods: - Pre-ART treatment (cost/person/year) - First line ART Year 1 (cost/person/year) - First line ART From Year 2 (cost/person/year) - Second line ART (cost/person/year). Outpatient treatment is identified based on the HIV/AIDS treatment protocol using antiretroviral drugs (ARV) issued as part of Decision 3003/2006/QĐ-BYT of June 9, 2009, of the Ministry of Health, providing guidelines on HIV/AIDS diagnostics and treatment. 2.1.2.2. Cost breakdown perspective Costs are considered from a supplier perspective, with public health care facilities involved in HIV/AIDS therapy delivery, including province/city hospitals, HIV/AIDS centers and district health centers. 2.1.2.3. Costing methodology Costing methodology is hybrid of top-down cost analysis (step down) for labor, operating costs, depreciation, and a bottom-up approach, which involves detailed breakdown for medication, supplies, diagnostic imaging and testing. The method allows estimation of average treatment costs by different stages. 2.1.2.4. Sample size 20 adult medical records with different treatment stages are selected. From 16 outpatient clinics, the total number of outpatient non-second-line regimen medical records selected is 960. From 5 second-line regimen clinics, a sample of 150 adult patients on a second-line regimen is selected. For inpatients, 40 adult medical records are collected from every provincial and central level health care facilities. There are no patients of this kind at the district level. From the 8 inpatient clinics in the sample, a total of 320 inpatient medical records are selected. The gross number of medical records collected for costing is 1430. Of these, 1401 inpatient and outpatient HIV/AIDS medical records have been processed. 2.1.3. Study parameters 6 - Participant background indicators in the study include demography, median CD4, percentages of patients by different CD4 counts and distribution of patients by levels of care and types of clinics. - Indicators for HIV/AIDS inpatient and outpatient costs and changes of therapeutic expenses depending on relevant determinants and the proportions of cost components include 27 items. 2.1.4. Toolkit and materials The data collecting toolkit consists of: (i) a form to collect providers’ outputs; (ii) a form to collect staffing cost data; (iii) a form to collect overheads data; (iv) a form to collect depreciation cost data; (v) a form to collect inpatient care cost data; and (v) a form to collect outpatient care cost data. 2.2. Cost-effectiveness analysis by different CD4 basiline 2.2.1. Sites, subjects, locations and timing To estimate effectiveness as gained life years for patients with different CD4 initiation, secondary data review is conducted using clinical and immunological response studies for adult patients on ART in Vietnam to understand the changes in the patients’ survival by different CD4 baseline. Clinical and immunological response studies on adult patients on ART in Vietnam are conducted on 7758 adult HIV/AIDS patients. The studies take place at 30 clinics randomly selected from 120 facilities nationwide having 50 or more patients on ART. These 30 clinics are located in 16 provinces/cities: Hanoi, Hung Yen, Thai Nguyen, Bac Giang, Vinh Phuc, Bac Can, Lang Son, Dien Bien, Quang Ninh, Haiphong, Thanh Hoa, Nghe An, Thai Binh, Binh Duong, Long An and Ho Chi Minh City. The study completed in 2010 was designed as a cohort study, collecting retrospective data from medical records selected at the clinics. 2.2.2. Methodology 2.2.2.1. Study design HIV/AIDS treatment efficacy by CD4 baseline is measured by the ratio of cost to treatment efficacy. Cost parameters are extracted from the results of component 1 and the treatment efficacy is measured by the life years gained by different CD4 baseline calculated based on the patient’s survival chance by CD4 counts. Survival chance by CD4 levels: The Kaplan Meier survival estimator is used to calculate the survival chance of patients in early 7 treatment (CD4 >=100 cells/mm 3 ) and patients in late treatment (CD4 <100 cells/mm 3 ). Mortality risk of participants in the sample: The Cox multiparameter regression model is used to compare mortality-related determinants. The cost-effectiveness of interventions is measured by the incremental cost-effectiveness ratio (ICER) by different CD4 levels. 2.2.3. Study parameters Survival chance of participants by CD4 counts: 6 parameters. Mortality risk of participants in the sample by different determinants: 4 parameters. Added life years by different CD4 levels: 3 parameters. Cost-effectiveness by CD4: one parameter. 2.3. Ethics The study outline was approved by the Ethics Board, National Institute of Hygiene and Epidemiology, and Hanoi School of Public Health. Chapter III. FINDINGS 3.1. Situational analysis of HIV/AIDS therapy costs in selected provinces in Vietnam for 2009-2010 3.1.1. Participant background In total, there are 1401 participants, including inpatients and outpatients. Of these, 319 people are inpatients and 1082 are outpatients (305 pre-ART patients, 332 first year first line ARV patients, 323 first line ARV patients from the second year and 122 second line ARV patients). Male participants account for 64% of the total, with the other 36% being women. Mean ages of participants was 33.6 year (SE + 0.2 year). 3.1.2. HIV/AIDS inpatient costs 3.1.2.1. HIV/AIDS inpatient costs and changes in treatment costs by relevant determinants The HIV/AIDS inpatient cost is VND 4,341,253 per session (SE + VND 299,367). a) HIV/AIDS inpatient cost and average length of stay at clinics The average treatment cost/length of stay in national and municipal level hospitals are higher than those of lower level hospitals (Figure 3.3). 8 Figure 3.3. HIV/AIDS inpatient cost and average LOSat clinics b) Percentage of opportunistic infections and respective treatment costs Respiratory tract infection is the most prevalent opportunistic infection in the sample, followed by tuberculosis, diarrhea, pathogenic fungi and some other symptoms. The most expensive treatment cost is more than VND 10 million for such opportunist infections as toxoplasmosis, though this disease is not as prevalent as the most common conditions of respiratory infections and tuberculosis, which both cost approximately VND 3.7 million for a treatment session. c) Changes in treatment costs by gender and age group Table 3.6 &3.7. HIV/AIDS inpatient cost by gender, age group Description N % Average LOS (days) Mean cost/episode (VND) Mean cost/day (VND) Male 235 74.4 15 4,451,606 296,774 Cost Cost (VND) National Tropical Diseases Hospital HCMC Tropical Diseases Hospital Dong Da Hospital Vietnam- Czech Hospital Ninh Binh General Hospital Hai Duong AIDS Center Dong Thap General Hospital Can Tho General Hospital Frequency to get the disease) C o s t / p a t i e n t / s t a y ( V N D ) Length of stay Fequency Length of stay M e a n C o s t / p a t i e n t ( V N D ) Aver. length of stay (days) Respiratory infections Diherria P Maneifei Unidentifed group Tuberculo sis 9 Female 81 25.6 17 3,936,423 231,554 <=25 24 7.5 11 2,766,480 251,498 26-30 99 31.2 18 4,052,258 225,125 31-35 101 31.8 17 5,596,973 329,234 36-40 46 14.5 13 3,208,808 246,831 41-45 25 7.8 12 4,210,865 350,905 46+ 23 7.2 11 4,227,326 384,302 d) Changes in treatment cost by conditions 42% of the patients in the sample are in serious immunodeficiency conditions with CD4 count of less than 50 cells/mm 3 . The treatment cost for these patients is twice that of patients with improved immunological conditions. Table 3.8. HIV/AIDS inpatient costs by different CD4 levels CD4 levels at admission N % Average LOS (days) Mean cost/episod e (VND) Mean cost/day (VND) <50 56 42.7 19 7,474,717 393,406 51-100 27 20.6 24 5,008,118 208,672 101-200 26 19.8 28 5,466,331 195,226 201+ 22 16.8 15 3,783,965 252,264 The mean cost per day for patients with CD4 < 50 cells/mm 3 is VND 393,406, which is twice that of patients with CD4 count of 50- 101 cells/mm 3 and those with CD4 of 101-200 cells/mm 3 . e) Changes in treatment cost by levels of care Table 3.9. HIV/AIDS inpatient costs by levels of care Patient distribution by N % Average LOS (days) Mean cost/episode (VND) Mean cost/day (VND) National level 80 25.1 12 7,197,176 599,765 Provincial level 195 61.1 11 3,225,616 293,238 Provincial AIDS centers 44 13.8 38 4,092,966 107,710 The mean cost at national level inpatient clinics is 2.5 times higher than that of provincial level clinics. The mean inpatient cost at provincial AIDS centers is higher than that of other provincial level clinics. 10 f) Changes in treatment cost by regions Table 3.10. HIV/AIDS inpatient costs by regions Region N % Average LOS (days) Mean cost/episode (VND) Mean cost/day (VND) North 203 33.5 18 4,576,128 254,229 South 116 66.5 10 3,930,222 393,022 The HIV/AIDS treatment cost in the North is VND 4,576,128/patient/treatment session, which is higher than the VND 3,930,222/patient/session in the South. g) Changes in treatment costs by ART status Table 3.11. HIV/AIDS inpatient costs by ART status ART status N % Average LOS (days) Mean cost/episo de (VND) Mean cost/day (VND) On ART 94 33.5 20 4,778,433 238,922 Not on ART 187 66.5 13 4,349,049 334,542 Only 33.5% of inpatients in the sample are on ART, and the average treatment costs for patients on ART are higher (66.5%). The average treatment cost for patients on ART is higher than that of those not on ART. h) Changes in treatment cost by treatment outcomes Table 3.12. HIV/AIDS inpatient costs by treatment outcomes Treatment outcomes N % Average LOS (days) Mean cost/episod e (VND) Mean cost/day (VND) Cured 28 9.1 14 5,097,543 364,110 Improved 197 64.0 17 4,441,302 261,253 Not improved 57 18.5 6 2,185,549 364,258 More severe 19 6.2 12 6,698,141 558,178 Death 7 2.3 14 9,264,868 661,776 About 9% of the patients in the sample have been cured, with an average treatment cost of VND 5,097,543/patient/session. 64% of the patients achieved improved conditions with an average cost of VND 4,441,302/patient/stay. Mortality cases account for 2.3% of the sample, with an average treatment cost of VND [...]... YEAR GAINED BY DIFFERENT CD4 BASELINE Pre-ART CD4 < 100 Pre-ART CD4 ≥ 100 1st line ART CD4 < 100 1st line ART CD4 ≥ 100 2nd line ART CD4 < 100 2nd line ART CD4 ≥ 100 Figure 3.26 Life years gained by CD4 levels 3.2.2 Cost- effectiveness by different CD4 levels Table 3.30 Cost- effectiveness by different CD4 levels CD4 levels Lifetime cost for living Living years Cost/ living Increased cost/ living 18 (cells/mm... 50 cells/mm 3 and in the clinical stage 4 The treatment cost is twice that of patients with CD4 > 200 cells/mm3, and similarly, the treatment cost for patients in the 4 th clinical stage is often double that of patients in other stages b) HIV/AIDS treatment cost in Vietnam and changes in treatment cost as the patients start their ARV therapy Study findings indicate that the inpatient costs vary between... income and high middle income countries In reference to a PEPFAR review’s findings in Vietnam, the figures in this study are much lower 4.1.3 HIV/AIDS treatment cost in Vietnam, cost components and changes in treatment cost by determinants 4.1.3.1 Treatment cost components a) ARV and opportunist infection drugs take up the largest share in HIV/AIDS treatment cost, followed by subclinical services and. .. largest gap exists in pre-ART settings where only opportunist infection prophylactic medications are often used, and not ARV drugs c) HIV/AIDS treatment cost in Vietnam and changes in treatment cost by types of clinics, levels of care, treatment outcomes and length of treatment Regarding HIV/AIDS inpatient costs, the expenses at the national level of care is twice that of the provincial level This is... level clinics The lower treatment cost is possible since in the clinics in major hospitals, the cost is distributed across large volumes of services delivered, such as tests and diagnostic imaging services, resulting in smaller unit costs compared to clinics having lower volume of services delivered at lower tiers of the system The study provides a convincing evidence of the efficacy of integrating HIV/AIDS... clinics These cost differences may be explained by: (i) differences in the therapeutic models between programs and projects, (ii) differences of the services package offered by programs and projects, and (iii) different organizational and staffing structures between therapeutic models 4.1.3.2 Changes in treatment cost by determinants a) HIV/AIDS treatment cost in Vietnam and changes in treatment cost. .. Paraclinical Dong Thap General Hospital Can Tho General Hospital Medicines and supplies Figure 3.5 Components of HIV/AIDS inpatient cost In the structure of HIV/AIDS inpatient cost, medicines, supplies, subclinical services and labor are the key items that constitute the total cost, accounting for about 70-85% of the grand total The proportions of medicines, supplies and subclinical services in the cost. .. followed by subclinical services, labor, overheads and depreciation Figure 3.16 Percentages of cost items in second-line therapy 3.2 Cost- effectiveness analysis for HIV/AIDS therapy by different CD4 levels 3.2.1 Life years gained by CD4 levels Measurement of ART cost- effectiveness for HIV patients by CD4 < 100 cells/mm3 and CD4 >= 100 cells/mm3 using the TreeAge 2011 software returns the following results... longer length of stay is proof of late treatment in Vietnam as patients often seek medical help when their conditions have progressed 19 Nevertheless, the inpatient cost and length of stay also vary significantly between different clinics The HIV/AIDS inpatient cost at national level health care facilities and those in major cities is higher than that of provincial level clinics The treatment cost for... regimens and percentages of patients adopting the regimens are described in Figure 3.14 below 15 Percentage Other regimens Other mixed regimens Percentate of regimen use Mean cost per regimen (VND) Cost Figure 3.11 HIV/AIDS outpatient costs by second line regimens and number of patients adopting the regimens d) Changes in treatment cost by levels of care and types of clinics The average treatment cost . by different CD4 levels Table 3.30. Cost- effectiveness by different CD4 levels CD4 levels Lifetime cost for living Living years Cost/ living Increased cost/ living LIE YEAR GAINED BY DIFFERENT. HIV/AIDS therapy costs in selected provinces in Vietnam for 2009-2010; 2. Treatment cost- effectiveness analysis by CD4 cell count at different study points. * New inputs of the review - The. background indicators in the study include demography, median CD4, percentages of patients by different CD4 counts and distribution of patients by levels of care and types of clinics. - Indicators