2022
2022

Understanding manufacturing and cost for HIV prevention game changer: generic CAB-LA COGS analysis and FAQ brief

As part of a growing portfolio of biomedical HIV prevention options, long-acting injectable cabotegravir (CAB-LA) was approved by the US FDA in December 2021. Evidence from two clinical trials, HPTN 083 and HPTN 084, which enrolled nearly 8,000 participants across 13 countries (including 7 countries in sub-Saharan Africa), demonstrated that CAB-LA is safe and highly effective at preventing HIV. With 1.5 million new infections globally in 2021 progress reducing new HIV infections has stalled, and new, highly effective options for HIV prevention are urgently needed.

While oral pre-exposure prophylaxis (PrEP), which was US FDA approved in 2012, is also safe and highly effective for HIV prevention, many people struggle with adherence due to pill burden, stigma, and low risk perception. As a 23-year-old woman from Kenya recently explained in a qualitative study, “Taking PrEP [pills daily], in fact is a burden, it is not easy. I prefer you inject me instead of giving me pills.” Moreover, progress scaling up oral PrEP has been slow. With an estimated 1.6 million people using oral PrEP in 2021 according to the latest UNAIDS report, we are not on track to reach the UNAIDS target of 10 million PrEP users by 2025. There is significant unmet need for PrEP and millions lack access to safe, effective, and acceptable options for protection.

As a bimonthly injection, CAB-LA offers a much-needed discreet, long-acting, user-controlled PrEP option. Numerous preferences studies, including discrete choice experiments (Minnis et al, 2019), qualitative research among trial participants (Tolley et al, 2019), and surveys among various groups at elevated risk of HIV infection (Ogunbajo et al, 2022) have demonstrated that long-acting injections for PrEP are highly acceptable and many of those at risk of HIV prefer long-acting injections to daily pills and other product forms. Due to its alignment with user preferences and the opportunity to address many of the challenges seen with daily oral PrEP, CAB-LA has the potential to transform HIV prevention and contribute to a dramatic reduction in new infections.

With a license granted in July 2022 and generic CAB-LA availability several years away, there are still pending questions about whether CAB-LA will be affordable enough to support delivery at scale among the millions with unmet need for HIV prevention. While generic companies supply the vast majority of HIV drugs in low- and middle-income countries, some stakeholders have expressed uncertainty about whether these generic companies would be able to affordably manufacture quality-assured CAB-LA.

To inform stakeholder discussions and introduction planning, CHAI leveraged its Cost of Goods Sold (COGS) analysis for CAB-LA to estimate the production costs of manufacturing generic CAB-LA. As a companion resource, CHAI developed a brief addressing frequently asked questions about COGS analyses in general and the findings of CHAI’s generic CAB-LA COGS analysis. This brief, jointly released by CHAI and AVAC, covers key topics such as the differences between originator and generic drugs, how injectables can be inexpensive to manufacture, and how long-acting injectable production costs may compare to daily oral formulations. The brief aims to inform interpretation and use of COGS analyses in introduction planning.

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Updated as of October 14, 2022 with additional key takeaway.