ViiV Healthcare and Medicine Patent Pool statement on voluntary licences in enabling access to fostemsavir

ViiV Healthcare and Medicines Patent Pool assess the suitability of voluntary licences in enabling access to fostemsavir in low- and middle-income countries

Voluntary licences have been successful in enabling broader access to high volume, low-cost, oral, solid dose, generic antiretroviral (ARV) tablet formulations in developing countries for many years by being able to reduce prices, improve supplies and adding manufacturing capacity. This success has partly been driven by generic manufacturers’ ability to incorporate the products into multi-purpose, multi-drug manufacturing facilities which enables economies of scale.

Together, ViiV Healthcare and the Medicines Patent Pool (MPP) have reviewed the potential role of voluntary licences in enabling access to fostemsavir, a first-in-class attachment inhibitor for the treatment of HIV-1 infection, in developing countries. Fostemsavir has been developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current regimen due to resistance, intolerance or safety considerations.

In reviewing the feasibility of voluntary licences for fostemsavir, ViiV Healthcare and the MPP took into consideration the following key elements: the clinical need and priority of fostemsavir as a HIV treatment option in low- and middle-income countries (LMICs) as evaluated by the WHO-led Combined ARV Drug Optimization (CADO) working group, the treatment indication of the medicine, the complexity of fostemsavir’s manufacturing process, and an understanding of availability of third line treatment and beyond in national HIV programmes across LMICs. The conclusion of this evaluation is that, ViiV Healthcare and the MPP do not believe that voluntary licences will be a viable approach to enable access to fostemsavir in these settings at this time.

In general, fostemsavir is anticipated to be needed by a small number of PLHIV in low-income countries, least developed countries, lower-middle income countries and Sub-Saharan African countries, due to its anticipated place in the treatment pathway. The high cost of production for an uncertain and hard to define number of heavily treatment-experienced PLHIV, the requirement for a separate and independent manufacturing facility specific to this product only, alongside the low global health interest in this medicine as indicated by the lack of inclusion as a current or future priority product in any line of therapy in the World Health Organization-led Combined ARV Drug Optimisation (CADO) working group recommendations1 mean that it is unlikely to be a commercially viable option for generic manufacturers.

ViiV Healthcare is working with several partners to determine alternative mechanisms to enable access to fostemsavir in developing countries based on clinical need, as ViiV Healthcare understands that some PLHIV will need, and can benefit from treatment with fostemsavir.

Reference

1. Third Conference on Antiretroviral Drug Optimization (CADO 3) Summary Meeting Report. Available from: https://apps.who.int/iris/bitstream/handle/10665/272291/WHO-CDS-HIV-18.6-eng.pdf Last Accessed: 19 November 2019