Quantification and Budgeting for Rapid and Sustainable Access to New Pediatric Antiretroviral Therapies

Overview

EGPAF/Unitaid, October 2020

New, child-friendly formulations of dolutegravir (DTG) and lopinavir ritonavir (LPV/r) are expected to be approved for use by the end of 2020. These formulations are less expensive, easier to administer, and allow for the full implementation of WHO treatment guidelines. To ensure rapid introduction and scale of new pediatric therapies, national ministries of health and partners should begin quantification, budgeting and supply planning as soon as possible. This technical brief outlines key steps for quantifying the full portfolio of optimal pediatric ARV products needed for different treatment regimens and weight bands, estimating the cost, and developing a supply plan. It also includes useful tables on recommended dosing, current product pricing, cost per patient per year, and other core data required for timely and accurate pediatric ARV quantification and budgeting.

To improve health and save lives, children living with HIV must have access to timely diagnosis and effective, child-friendly, antiretroviral (ARV) treatment and care. EGPAF, with funding and support from Unitaid, has been assisting national ministries of health in five African countries to rapidly introduce and scale up access to new, WHO-recommended pediatric ARV formulations. In just one year, the proportion of children 0-14 years old on first-line ARV treatment prescribed optimal formulations of lopinavir ritonavir (LPV/r) and dolutegravir (DTG) 50mg tablets increased from 16% to 55% in the five EGPAF focus countries. With the US Food and Drug Administration (US FDA) approval of DTG 10mg dispersible tablets and LPV/r 4-in-1 granules for children weighing less than 20kg, it is at last possible to implement fully the WHO 2019 treatment guidelines ^(1). Both new formulations are less expensive than existing options. For example, the DTG 10mg –based regimen costs an estimated $115 per patient per year compared to the LPV/r pellet-based regimen of $439.20 per patient per year. In addition, the DTG 10mg dispersible is easier to administer and requires only one dose per day, compared to two doses per day for LPV/r regimens. Early and accurate quantification and budgeting are critical first steps towards ensuring rapid and sustainable access to new optimal pediatric ARVs.

⁽¹⁾ Update of recommendations on first- and second-line antiretroviral regimens. Geneva, Switzerland: World Health Organization; 2019 (WHO/CDS/HIV/19.15) (https://www.who.int/hiv/pub/arv/arv-update-2019-policy/en/)