Knowing ARV Projections
Generic competition has historically been key to reducing prices and increasing access to medicines. Generic drug development processes, from active pharmaceutical ingredient (API) production to finished drug registration, typically takes at least four years with most companies beginning development work once there is certainty of demand. Without market demand security, generic manufacturers may not be willing to invest in development of promising pipeline antitretrovirals (ARVs) and new chemical entitities, even if voluntary licences are in place.
Projecting the use of ARVs is key to providing generic manufacturers with guidance and motivation for timely generic development of pipeline ARVs for use in developing countries.
Timely generic development of new drugs may help in the prompt adoption of appropriate drugs in treatment recommendations. Moreover, projections guide our industry partners on access strategies, prioritization and building capacity, thereby ensuring industry readiness for timely availability of adequate amounts of recommended drugs to help achieve international treatment targets. They also provide broad support to the HIV community and support financing agencies in identifying drugs that may optimise spend on treatment. Policymakers, procurement agencies, regulatory agencies and other public health bodies also rely on these analyses to plan their policies and place new drugs on the market.
For the Medicines Patent Pool, projections are needed to engage originator companies into licensing their pipeline ARVs, and facilitate decision-making by generic manufacturers for seeking licences and investing in development, production and regulatory approval of needed ARV formulations.
MPP-WHO Collaboration on Projections
The MPP and the World Health Organization (WHO) prepare joint projections on the use of antiretroviral medicines in developing countries. We work together to pool respective information and insights from our partners. We review epidemiology data from UNAIDS and model the use and uptake of drugs based on, among other factors:
- Past trends
- WHO guidelines
- Clinical data, including safety and efficacy of drugs
- Expected date of generic availability
- Degree of generic competition
- Availability of FDCs
- Extent of generic distribution
- Expected price of drugs over the years
- Expert opinion.
Experts who have worked with us on these projections are associated with World Health Organization, UNAIDS, Avenir Health and University of British Colombia.
MPP-WHO’s projection methodology is available for all to review, with methods and results shown both here (see below) and on the WHO website. Notably, the projections have been published in the peer-reviewed journal PLOS ONE which is openly accessible. Our projections have been presented at multiple international meetings, including IAS and the Joint WHO/UNAIDS annual consultations with manufacturers and partners.
We update our projections annually and publish them on our website. Read our published studies and presentations on our methodology and findings below: