Antenatal corticosteroids (ACS) are administered to pregnant women at risk of preterm birth, to improve health outcomes for the preterm newborn. To address a lack of evidence for this important intervention in low-resource hospitals, WHO established an international research collaboration to conduct hospital-based, placebo-controlled efficacy trials of ACS (dexamethasone) in Bangladesh, India, Kenya, Nigeria and Pakistan. This collaboration recently completed the WHO ACTION-I Trial, which showed that dexamethasone (a corticosteroid) is safe and effective for this indication.

This follow-up study will establish the additional economic evidence required for the adoption of ACS in health benefits packages. Specifically, we will address the following aims:

1. Cost-effectiveness of ACS: Estimate the cost per disability-adjusted life year (DALY) averted from ACS use in Bangladesh, India, Kenya, Nigeria and Pakistan.
2. Affordability of ACS: Estimate the total additional annual cost of including ACS into the health benefits packages of Bangladesh, India, Kenya, Nigeria and Pakistan.
3. Sensitivity analysis: Identify key cost and epidemiological inputs that have the greatest influence on total cost and cost-effectiveness.
4. ACS in other low- and middle-income countries (LMICs): Use the results of (1) to (3) to model the affordability and cost-effectiveness of ACS in other priority low- and middle-income countries.

We will assemble cost data from hospitals that participated in the ACTION-I Trial, and combine this with effectiveness estimates reported in the trial.

This study will provide important evidence to support implementation of ACS in LMICs, including: updating related WHO recommendations, including ACS in health benefits packages, informing policy-makers about cost-effectiveness and affordability of ACS, and facilitating efficient implementation by identifying key cost drivers.

Timeline

• Ethics approval – February 2021
• Local site approvals – March 2021
• Interviews and data assembly – April-June 2021
• Data analysis – June 2021
• Review model and update analysis – July 2021
• Report results – August 2021