Plans ahead for largest proportion of pipeline
GSK is a leader in planning ahead to make future products accessible. Compared to other companies, it has covered the largest proportion of late-stage projects with access plans, including some of the most comprehensive ones.
To ensure new products are accessible and available as rapidly as possible in low- and middle-income countries.
Companies can plan for access during development. Such plans are referred to by the Index as ‘access provisions’, and can comprise license agreements, supply commitments or equitable pricing strategies.
Several companies have committed to improving access by integrating dedicated access plans into their R&D projects. These include registration in countries in scope, to ensure the product is approved for use in these countries; WHO prequalification, which verifies the quality and safety of a product; equitable pricing strategies, which price products based on a population’s ability to pay; and voluntary licensing agreements, which can facilitate generic entry and market competition, leading to more affordable pricing and increased supply. Out of all the companies that have made commitments to improving access, GSK has risen to become the industry leader by transforming commitment into action.
What makes this a best practice?
Stakeholders such as product development partnerships look to pharmaceutical companies to establish access plans for any drugs in Phase II (late-stage) onwards. GSK has the largest proportion of late-stage R&D projects with access plans in place (32/47); it also has some of the most comprehensive access plans of all companies evaluated. Together, these will help to ensure that critical products are available and affordable in countries in scope.
Most companies apply access plans to late-stage projects through registration commitments or plans to apply for WHO prequalification. These steps are crucial in providing access to new products, but they are not sufficient to ensure products will be both available and affordable. Access plans also need to integrate key provisions such as equitable pricing strategies and licensing and supply agreements. Of GSK’s 32 late-stage projects with access plans in place, 27 have more than one unique component, such as a commitment or strategy, and some have as many as four different types.
How is GSK planning for access during development?
One example is cabotegravir. GSK is developing this Phase III HIV integrase inhibitor as a long-acting injectable drug for pre-exposure prophylaxis (PrEP) of HIV; it is also collaborating with Johnson & Johnson to develop a combination
long-acting injectable of cabotegravir with rilpivirine as treatment and PrEP. For the two projects associated with this clinical trial candidate, GSK has put in place a range of access components, including equitable pricing strategies, a commitment to register in countries in scope, and plans to apply for WHO pre-qualification and to establish non-exclusive voluntary licensing.
One Phase III study (Antiretroviral Therapy as Long-Acting Suppressor, or ATLAS) achieved its primary endpoint for non-inferiority of the dual injectable therapy in maintaining viral suppression in HIV-1-infected adults, given once-monthly, when compared to a three-drug, daily oral regimen.14 By offering an injection that is only required once a month, GSK aims to address key adherence issues, including missed doses, that are associated with current HIV/AIDS therapies and PrEP.