An analysis of volumes, prices and pricing trends of the pediatric antiretroviral market in developing countries from 2004 to 2012

Abstract

BackgroundThe pediatric antiretroviral (ARV) market is poorly described in the literature, resulting in gaps in understanding treatment access. We analyzed the pediatric ARV market from 2004 to 2012 and assessed pricing trends and associated factors.MethodsData on donor funded procurements of pediatric ARV formulations reported to the Global Price Reporting Mechanism database from 2004 to 2012 were analyzed.Outcomes of interest were the volume and mean price per patient-year ARV formulation based on WHO ARV dosing recommendations for a 10 kg child. Factors associated with the price of formulations were assessed using linear regression; potential predictors included: country income classification, geographical region, market segment (originator versus generic ARVs), and number of manufacturers per formulation. All analyses were adjusted for type of formulations (single, dual or triple fixed-dose combinations (FDCs))ResultsData from 111 countries from 2004 to 2012 were included, with procurement of 33 formulations at a total value of USD 204 million. Use of dual and triple FDC formulations increased substantially over time, but with limited changes in price. Upon multivariate analysis, prices of originator formulations were found to be on average 72 % higher than generics (p < 0.001). A 10 % increase in procurement volume was associated with a 1 % decrease (p < 0.001) in both originator and generic prices. The entry of one additional manufacturer producing a formulation was associated with a decrease in prices of 2 % (p < 0.001) and 8 % (p < 0.001) for originator and generic formulations, respectively. The mean generic ARV price did not differ by country income level. Prices of originator ARVs were 48 % (p < 0.001) and 14 % (p < 0.001) higher in upper-middle income and lower-middle income countries compared to low income countries respectively, with the exception of South Africa, which had lower prices despite being an upper-middle income country.ConclusionsThe donor funded pediatric ARV market as represented by the GPRM database is small, and lacks price competition. It is dominated by generic drugs due to the lower prices offered and the practicality of FDC formulations. This market requires continued donor support and the current initiatives to protect it are important to ensure market viability, especially if new formulations are to be introduced in the future.

Removal of antiretroviral drugs stavudine and zidovudine in water under UV254 and UV254/H2O2 processes: Quantum yields, kinetics and ecotoxicology assessment

“…ZDV was the first marketed antiretroviral [12] and is still one of the most widely used. STV is also one of the most common ARVs, despite presenting several side effects, because of its relatively low price [13]. Collectively, ARVs increase the life expectancy of HIV-positive patients, however, significant concerns have been raised about their simultaneous release to the environment [4,5,9].…”

Weight-for-age distributions among children with HIV on antiretroviral therapy in the International epidemiology Databases to Evaluate AIDS (IeDEA) multiregional consortium

“…Nevertheless, beyond this purpose, data about weight in children may also be helpful to create a secondary-hand framework for observing changes overtime regarding growth on ART, during childhood and adolescence as this has been done in the past [7,11]. Especially, these data will be useful in refining projections of the number of CHIV who may need specific ARV formulations and doses allowing HIV care and treatment programs to procure sufficient quantities of medications for CHIV, avoiding both medication stock outs and medication wastage, furthering the critical goal of improving access to ART for CHIV globally [1].…”

“…Accurate forecasting of antiretroviral needs is particularly important, because the pediatric antiretroviral market is small. Procurement volume has a large impact on market prices and failure to procure sufficient quantities of antiretroviral medications (ARVs) leads to gaps in treatment access in low-income and middleincome countries [1]. While validated estimates exist of the numbers of children at each age likely to need ART [2], additional information about the weight distribution for CHIV by age are needed to permit accurate forecasts of the medication quantities that will be required.…”

Redefining and revisiting cost estimates of routine ART care in Zambia: an analysis of ten clinics

“…taking vitals and restocking/dispensing drugs), thereby enabling decentralization of treatment initiation and management of ART to peripheral health centres and changes in treatment guidelines . Additionally, with developments of new regimens and increased shifting to generics as well as strong donor support, ART drug prices have greatly decreased over the last decade . With the adoption of the World Health Organization’s (WHO) expanded ART eligibility, the percentage of people receiving ART has increased sharply in high burden countries; for example, Zambia has reported a 25% increase since 2011 .…”