Cost-effectiveness analysis of Option B+ for HIV prevention and treatment of mothers and children in Malawi.

BACKGROUND: The Ministry of Health in Malawi is implementing a pragmatic and innovative approach for the management of all HIV-infected pregnant women, termed Option B+, which consists of providing life-long antiretroviral treatment, regardless of their CD4 count or clinical stage. Our objective was to determine if Option B+ represents a cost-effective option. METHODS: A decision model simulates the disease progression of a cohort of HIV-infected pregnant women receiving prophylaxis and antiretroviral therapy, and estimates the number of paediatric infections averted and maternal life years gained over a ten-year time horizon. We assess the cost-effectiveness from the Ministry of Health perspective while taking into account the practical realities of implementing ART services in Malawi. RESULTS: If implemented as recommended by the World Health Organization, options A, B and B+ are equivalent in preventing new infant infections, yielding cost effectiveness ratios between US$ 37 and US$ 69 per disability adjusted life year averted in children. However, when the three options are compared to the current practice, the provision of antiretroviral therapy to all mothers (Option B+) not only prevents infant infections, but also improves the ten-year survival in mothers more than four-fold. This translates into saving more than 250,000 maternal life years, as compared to mothers receiving only Option A or B, with savings of 153,000 and 172,000 life years respectively. Option B+ also yields favourable incremental cost effectiveness ratios (ICER) of US$ 455 per life year gained over the current practice. CONCLUSION: In Malawi, Option B+ represents a favorable policy option from a cost-effectiveness perspective to prevent future infant infections, save mothers' lives and reduce orphanhood. Although Option B+ would require more financial resources initially, it would save societal resources in the long-term and represents a strategic option to simplify and integrate HIV services into maternal, newborn and child health programmes.

Antiretrovirals for low income countries: an analysis of the commercial viability of a highly competitive market.

BACKGROUND: The price of antiretroviral drugs (ARVs) in low income countries declined steadily in recent years. This raises concerns about the commercial viability of the market of ARVs in low income countries. METHODS: Using 2 costing scenarios, we modeled the production cost of the most commonly used ARVs in low income countries in 2010 and 2012, and assessed whether, at the median price paid by low income countries, their manufacturers would still make profits. By interviews we consulted 11 generic manufacturers on the current state of the ARV market, and on what would be required to ensure their continued commitment to supply ARVs to low income countries. RESULTS: Using the lowest prices for active pharmaceutical ingredients (API) quoted to WHO, and applying published assumptions about the production cost of ARVs, our baseline estimate was that Indian generic manufacturers would have made profits on only 1 out of 13 formulations of ARVs in both 2010 and 2012, and publicly owned manufacturers would have made profits on 5 and 3 out of 13 formulations in 2010 and 2012, respectively. We needed to assume a 20% and a 40% lower API cost for our model to predict that publicly owned and Indian manufacturers, respectively, would make profits on the sale of the majority of their ARVs. Between 2010 and 2012, we estimate that--across the ARV portfolio--the gross profit on sales of ARVs to low income countries decreased with between 6% and 7% of their sales price. Generic manufacturers consider that current prices are unsustainable. They suggested amendments to the tender procedures, simplified regulatory procedures, improved forecasting, and simplification of the ARV guidelines as critical improvements to maintain a viable ARV market. CONCLUSIONS: While recent price decreases indicate that there is still space for price reduction, our estimate that gross profit margin on sales decreased by 6 to 7% between 2010 and 2012 lends credibility to assertions by generic manufacturers that the ARV market in low income countries is under considerable price pressure. This might create problems for the quality and/or the continued supply of ARVs to low income countries.

The global strategy to eliminate HIV infection in infants and young children: a seven-country assessment of costs and feasibility.

OBJECTIVE: Model the feasibility and affordability of the 2001 UN General Assembly Special Session on AIDS goals to reduce mother-to-child transmission of HIV (MTCT) by 50% by 2010 and achieve 80% coverage of interventions to reduce it among women presenting for antenatal care. METHODS: The cost and human resource needs of prevention of MTCT (PMTCT) and paediatric treatment were modelled for 2007-2015 and compared with the AIDS budgets and available health workforce in Burkina Faso, Cameroon, Cote d'Ivoire, Malawi, Rwanda, United Republic of Tanzania, and Zambia. Interventions used were promotion of family planning to people living with HIV, HIV testing and counselling, antiretroviral treatment to prevent MTCT and for HIV-infected children, and cotrimoxazole prophylaxis for mothers with advanced HIV infection and HIV-exposed children. RESULTS: The cumulative cost from 2007 to 2015 of the intervention in the seven countries combined amounted to US$587 688 291, 86% for PMTCT and 14% for paediatric treatment. Three out of the seven countries - Rwanda, Zambia, and Burkina Faso (almost) - were predicted to have sufficient AIDS funding, but only one - Zambia - was predicted to have also sufficient human resources to scale up the interventions by 2010 and sustain them up to 2015. The cost-effectiveness would be less than US$1150 per infection prevented in fully scaled-up programmes. CONCLUSION: Scaling up PMTCT will require more funds than currently available in many countries, but human resources appear to be a greater bottleneck than funding. We suggest that human resource capacity be assessed when increased funds for PMTCT are requested.