Cost-effectiveness and budget impact of adding tranexamic acid for management of post-partum hemorrhage in the Indian public health system.

BACKGROUND: Postpartum hemorrhage (PPH) is the global leading cause of maternal mortality, affecting nearly 3 to 6 percent of all women giving birth in India. The World Health Organization (WHO) has updated its guidelines to recommend the early use of intravenous (IV) tranexamic acid (TXA) in addition to standard care for all diagnosed PPH cases. This study aimed to assess the cost-effectiveness of introducing TXA for PPH management in the Indian public health system. METHODS: A decision analytic model was built using a decision tree to determine the cost-effectiveness of administering IV TXA to women experiencing PPH within 3 h of birth to existing management with uterotonics and supportive care. Using a disaggregated societal perspective, the costs and consequences for a hypothetical cohort of women experiencing PPH in public health facilities was estimated. The model was populated using probabilities, clinical parameters, and utilities from published literature, while cost parameters were largely derived from a primary economic costing study. The primary outcome of interest was the incremental cost-utility ratio (ICUR). Associated clinical events and net benefits were estimated. One-way and probabilistic sensitivity analysis (PSA) was undertaken. The budget impact was estimated for a national-level introduction. RESULTS: For an estimated annual cohort of 510,915 PPH cases in India, the addition of IV TXA would result in a per-patient disaggregated societal cost of INR 6607 (USD 95.15) with a discounted gain of 20.25 QALYs, as compared to a cost of INR 6486 (USD 93.41) with a discounted gain of 20.17 QALYs with standard care PPH management. At an ICUR value of INR 1470 per QALY gained (USD 21), the addition of IV TXA is cost-effective in Indian public health settings. The intervention is likely to prevent 389 maternal deaths, 177 surgeries, and 128 ICU admissions per 100,000 PPH cases. The findings are robust under uncertainty, with 94.5% of PSA simulations remaining cost-effective. A cumulative increase of 2.3% financial allocation for PPH management over five years will be incurred for TXA introduction. CONCLUSIONS: Addition of tranexamic acid for primary PPH management, as recommended by WHO, is cost-effective in Indian public health settings. Policy guidelines, training manuals, and facility checklists should be updated to reflect this recommendation.

Health facility-based interventions and the uptake of contraception among people living with HIV: A systematic review & meta-analysis.

BACKGROUND OBJECTIVES: The prong 2 of 4 prong strategy introduced by the World Health Organization aims at averting unintended pregnancies among people living with HIV (PLHIV). This systematic review aimed to generate evidence on the effectuality of facility-based interventions in improving uptake of modern and dual contraception, for reducing unmet family planning (FP) needs and unintended pregnancies among PLHIV. METHODS: Articles evaluating facility-based interventions to integrate human immunodeficiency virus (HIV) and FP published in English language were included. Eligible studies were identified from electronic and lateral search from three databases (PubMed, Cochrane Library and Web of Science) and grey literature. HIV care with no/minimal focus on FP was considered a comparator. Quality was assessed using design-appropriate tools. Descriptive analysis was presented in tables. Uptake of dual methods, unmet FP needs and unintended pregnancies were included in the meta-analysis to estimate pooled odds ratio (OR) with random effect model, P and I2 values. RESULTS: The search yielded 2112 results. After excluding duplicates and unfit articles, 17 were found eligible for review and nine for meta-analysis. The pooled OR for uptake of dual contraception was 1.69 (1.14, 2.5) ( P =0.008; I2 =90%), for unmet FP needs was 0.58 (0487, 0.69) ( P <0.00001; I2 =0%) and for unintended pregnancies was 0.6 (0.32, 1.1) ( P =0.1, I2 =38%). INTERPRETATION CONCLUSIONS: The results of this meta-analysis suggest that health facility-based interventions to integrate HIV and FP services do result in improved uptake of dual methods and reduce unmet need for contraception along with a protective trend on incidence of unintended pregnancies. Such facility-based integration would ensure universal access to effective contraception and facilitate in achieving Sustainable Development Goals that aim at ending epidemics like HIV.

Health system cost for providing antiretroviral therapy, family planning, and pregnancy-related services to women living with HIV in public health settings, Mumbai, India.

Background: Integration of HIV care into family planning (FP) services would help in reducing unintended pregnancies among women living with HIV. Objectives: This study focuses on determining the health system cost for providing the linked HIV-FP services per beneficiary for the year 2019-2020. Materials and Methods: Using mixed micro-costing approach costs were collected from two tertiary hospitals in Maharashtra, India. The economic costs collected from gynaecology department and anti-retroviral treatment center were combined and added with package, program, and intervention costs to obtain health-system costs. We conducted probabilistic sensitivity analysis. Results: The unit cost and annual per-capita cost for providing HIV care (without considering cost of drugs and investigations) per beneficiary were INR 1033.8 (USD 13.6) and INR 9304.2 (USD 122.7), respectively. The unit cost was least for the outpatient services INR 197.5 (USD 2.6), followed by inpatient services INR 2735.92 (USD 36.21) and operation theater INR 4410 (USD 58.2). Cost was highest for dual-permanent (INR 13866.8 [USD 182.9]) followed by dual-reversible user (INR 2104.8 [USD 24.8]). It was the least for a person who only used condoms at INR 1674.1 (USD 22.1). In pregnancy-related services, cost for ante-natal services was least (INR 2043.6 [USD 27.96]), followed by vaginal delivery (INR 7120.5 [USD 93.93]), abortion (INR 11530.5 [USD 152.097]), and C-section (INR 18703.8 [USD 246.7]). Conclusion: We found no staggeringly additional costs for providing FP and pregnancy-related services to HIV-affected population, in comparison to general population. The findings could improve programs and insurance with a focus on this vulnerable population.

Assessment of Health-Related Quality of Life Using EQ-5D-5L Tool With Indian Tariffs Among Reproductive Age Group Women Living With HIV in India.

OBJECTIVE: India is witnessing declining HIV prevalence because of dedicated efforts by the government. The highly active antiretroviral therapy has improved life span of people living with HIV but bearing many side effects. Women living with HIV (WLHIV) in reproductive age group have additional burden of pregnancy-related issues. This study aimed to estimate the health utility score among WLHIV in India, particularly in context of their contraceptive use, during pregnancy and postpartum period. METHODS: A primary cross-sectional study was conducted among 195 WLHIV availing antiretroviral treatment services at public health facilities of Mumbai. The EQ-5D-5L interview-based questionnaire in local language and Indian value set was used to estimate health-related quality of life (QOL) reported as mean (± SD) utility and visual analog scale (VAS) scores. The relationship between utility values and VAS scores was assessed. RESULTS: The WLHIV with mean age of 31.6 (6.4) years were on antiretroviral medication for nearly 7 years, and 63% had CD4+ cell count > 500 cells/mm3. Response of "11111," that is, in full health state, was reported by 66.7%. The mean utility and VAS scores were 0.976 (± 0.0519) and 82.21 (± 15.77). Reduced health-related QOL scores were associated with pain and discomfort dimension. Utility scores among contraceptive users (0.986 [± 0.029]) was higher than nonusers (0.976 [± 0.028]). Currently pregnant WLHIV had least utility score (0.959 [± 0.088]). CONCLUSIONS: WLHIV had better QOL while using contraceptives more so when they were sterilized. Pregnancy reduces the QOL. This emphasizes the need to promote effective contraceptive methods among WLHIV and prevent unintended pregnancies.

Identifying populations with chronic pain in primary care: developing an algorithm and logic rules applied to coded primary care diagnostic and medication data.

BACKGROUND: Estimates of chronic pain prevalence using coded primary care data are likely to be substantially lower than estimates derived from community surveys. Most primary care studies have estimated chronic pain prevalence using data searches confined to analgesic medication prescriptions. Increasingly, following recent NICE guideline recommendations, patients and doctors opt for non-drug treatment of chronic pain thus excluding these patients from prevalence estimates based on medication codes. We aimed to develop and test an algorithm combining medication codes with selected diagnostic codes to estimate chronic pain prevalence using coded primary care data. METHODS: Following a scoping review 4 criteria were developed to identify cohorts of people with chronic pain. These were (1) people with one of 12 ('tier 1') conditions that almost always results in the individual having chronic pain (2) people with one of 20 ('tier 2') conditions included when there are also 3 or more prescription-only analgesics issued in the last 12 months (3) chronic neuropathic pain, or (4) 4 or more prescription-only analgesics issued in the last 12 months. These were translated into 8 logic rules which included 1,932 SNOMED CT codes. RESULTS: The algorithm was run on primary care data from 41 GP Practices in Lambeth. The total population consisted of 386,238 GP registered adults ≥ 18 years as of the 31st March 2021. 64,135 (16.6%) were identified as people with chronic pain. This definition demonstrated notably high rates in Black ethnicity females, and higher rates in the most deprived, and older population. CONCLUSIONS: Estimates of chronic pain prevalence using structured healthcare data have previously shown lower prevalence estimates for chronic pain than reported in community surveys. This has limited the ability of researchers and clinicians to fully understand and address the complex multifactorial nature of chronic pain. Our study demonstrates that it may be possible to establish more representative prevalence estimates using structured data than previously possible. Use of logic rules offers the potential to move systematic identification and population-based management of chronic pain into mainstream clinical practice at scale and support improved management of symptom burden for people experiencing chronic pain.

Cost of managing atonic postpartum haemorrhage with uterine balloon tamponade devices in public health settings of Maharashtra, India: an economic microcosting study.

OBJECTIVE: Postpartum haemorrhage (PPH) is the worldwide leading cause of preventable maternal mortality. India offers free treatment for pregnancy and related complications in its public health facilities. Management with uterine balloon tamponade (UBT) is recommended for refractory atonic PPH cases. As part of health technology assessment to determine the most cost-effective UBT device, this study estimated costs of atonic PPH management with condom-UBT, Every Second Matters (ESM) UBT and Bakri balloon UBT in public health system of Maharashtra, India. DESIGN: Health system cost was estimated using primary economic microcosting, data from Health Management Information System and published literature for event probabilities. SETTINGS: Four public health facilities from the state of Maharashtra, India representing primary, secondary and tertiary level care were chosen for primary costing. OUTCOME MEASURES: Unit, package and annual cost of atonic PPH management with three UBT devices were measured. This included cost of medical treatment, UBT intervention and PPH related surgeries undertaken in public health system of Maharashtra for year 2017-2018. RESULTS: Medical management of atonic PPH cost the health system US$37 (95% CI 29 to 45) per case, increasing to US$44 (95% CI 36 to 53) with condom-UBT and surgical interventions for uncontrolled cases. Similar cost was estimated for ESM-UBT. Bakri-UBT reported a higher cost of US$59 (95% CI 46 to 73) per case. Overall annual cost of managing 27 915 atonic PPH cases with condom-UBT intervention in Maharashtra was US$1 226 610 (95% CI 870 250 to 1 581 596). CONCLUSIONS: Atonic PPH management in public health facilities of Maharashtra with condom-UBT, ESM-UBT or Bakri-UBT accounts to 3.8%, 3.8% or 5.2% of the state's annual spending on reproductive and child health services. These findings can guide policy-makers to include PPH complication management in publicly financed health schemes. Economic evaluation studies can use this evidence to determine cost effectiveness of UBT in Indian settings.

Cost-effectiveness of uterine balloon tamponade devices in managing atonic post-partum hemorrhage at public health facilities in India.

OBJECTIVE: Post-partum hemorrhage (PPH) is the leading direct cause of maternal mortality in India. Uterine balloon tamponade (UBT) is recommended for atonic PPH cases not responding to uterotonics. This study assessed cost-effectiveness of three UBT devices used in Indian public health settings. METHODS: A decision tree model was built to assess cost-effectiveness of Bakri-UBT and low-cost ESM-UBT alternatives as compared to the recommended standard of care i.e. condom-UBT intervention. A hypothetical annual cohort of women eligible for UBT intervention after experiencing atonic PPH in Indian public health facilities were evaluated for associated costs and outcomes over life-time horizon using a disaggregated societal perspective. Costs by undertaking primary costing and clinical parameters from published literature were used. Incremental cost per Disability Adjusted Life Years (DALY) averted, number of surgeries and maternal deaths with the interventions were estimated. An India specific willingness to pay threshold of INR 24,211 (USD 375) was used to evaluate cost-effectiveness. Detailed sensitivity analysis and expected value of information analysis was undertaken. RESULTS: ESM-UBT at base-case Incremental Cost-Effectiveness Ratio (ICER) of INR -2,412 (USD 37) per DALY averted is a cost-saving intervention i.e. is less expensive and more effective as compared to condom-UBT. Probabilistic sensitivity analysis however shows an error probability of 0.36, indicating a degree of uncertainty around model results. Bakri-UBT at an ICER value of INR -126,219 (USD -1,957) per DALY averted incurs higher incremental societal costs and is less effective as compared to condom-UBT. Hence, Bakri-UBT is not cost-effective. CONCLUSION: For atonic PPH management in India, condom-UBT offers better value as compared to Bakri-UBT. Given the limited clinical effectiveness evidence and uncertainty in sensitivity analysis, cost-saving result for ESM-UBT must be considered with caution. Future research may focus on generating high quality comparative clinical evidence for UBT devices to facilitate policy decision making.

Improving public health service delivery response to address contraceptive needs of socio-economically disadvantaged HIV positive people in Maharashtra, India.

BACKGROUND: People living with HIV (PLHIV) receive free antiretroviral treatment (ART) in public health facilities of India. With improved life expectancy, unmet sexual and reproductive health needs of PLHIV have to be addressed through a converged programmatic response strategy. Evidence shows that socioeconomically disadvantaged women are most vulnerable to high reproductive morbidities, especially HIV positive women with an unmet need of contraception. METHODS: Programmatic convergence by linking ART and family planning services were strengthened at two public health facilities (district hospitals) generally accessed by disadvantaged socio-economic sections of the society. Barriers to linking services including stigma and discrimination were addressed through analysis of existing linkage situation, sensitization and training of healthcare providers and system-level interventions. This facilitated provider-initiated assessment of contraceptive needs of PLHIV, counseling about dual contraception using a couple approach, linkage to family planning centers and maintaining data about these indicators. Six hundred eligible PLHIV seeking care at ART centers were enrolled and followed up for a duration of 6 months. Acceptance of family planning services as a result of the intervention, use of dual contraception methods and their determinants were assessed. RESULTS: Eighty-seven percent HIV couples reached FP centers and 44.6% accepted dual methods at the end of the study period. Dual methods such as oral contraceptive pills (56.2%), IUCDs (19.4%), female sterilization (11.6%), injectable contraception (9.9%) and vasectomy (2.9%) in addition to condoms were the most commonly accepted methods. Condom use remained regular and consistently high throughout. The study witnessed seven unintended pregnancies, all among exclusive condom users. These women availed medical abortion services and accepted dual methods after counseling. Female index participants, concordant couples, counseling by doctors and women with CD4 count above 741 had higher odds of accepting dual contraception methods. Standard operating procedures (SOP) were developed in consultation with key stakeholders to address operational linkage of HIV and family programs. CONCLUSION: The study saw significant improvement in acceptance of dual contraception by PLHIV couples as a result of the intervention. Implementation of SOPs with supportive supervision can ensure efficient linkage of programs and provide holistic sexual and reproductive healthcare for PLHIV in India.