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.
Highlights
The pediatric antiretroviral (ARV) market is poorly described in the literature, resulting in gaps in understanding treatment access
We present our findings using the World Health Organization (WHO)’s Global Price Reporting Mechanism (GPRM) database which has been tracking international transactions of HIV, tuberculosis and malaria commodities purchased by national programmes in low- and middle-income countries through international procurement organizations since 2004
For each of the 21 ARV single formulations, 7 dual fixed dose combination (FDC), and 5 triple FDCs, we calculated the quantity per year (QTY) and price per year (PTY) using WHO ARV dosing recommendations for a 10 kg child (2004–2005 dosing based on WHO 2002 guidelines, 2006–2009 dosing based on WHO 2006 guidelines, and 2010–2012 dosing based on WHO 2010 guidelines): QTY 1⁄4 ðnumber of units purchasedÞ =1⁄2ðunits used in daily treatmentÞ Â ð365Þ
Summary
The pediatric antiretroviral (ARV) market is poorly described in the literature, resulting in gaps in understanding treatment access. In 2012, 3.4 million children were living with HIV/AIDS, 90 % of whom were in sub-Saharan Africa and only 647,000 were receiving antiretroviral (ARV) therapy [1]. Research and development for pediatric ARVs has been slow. Of the 26 ARVs approved by the United States Food and Drugs Administration (USFDA) and marketed, 7 have no pediatric indication, 8 have no pediatric formulation, and only 11 are approved for use in children below two years of age [3]. In the early years of combined ARV therapy, this lack of appropriate formulations meant that programs in resource limited settings had to resort to breaking adult fixed dose combination (FDC) tablets to treat children [4, 5]. Other milestones include having these formulations listed on the WHO Prequalification Project’s Expression of Interest and subsequently on the Essential Medicines List, enabling developing countries to purchase quality assured generic ARVs, often a requirement from international donors
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