Novartis Access Principles to establish access plans during development
A systematic approach to developing access strategies for each new medicine during development.
To ensure all new medicines are supported by access provisions, starting during early-stages of development.
By putting plans in place early during development, companies can accelerate the rate by which new products become available to people living in low- to middle-income countries.
Novartis has established a systematic approach to develop access strategies for each of its new medicines during development. As it is developing products that target some of the most pressing needs in low- and middle-income countries, establishing access strategies for all new medicines could have a significant impact in these countries. In 2017, senior leaders at Novartis approved the Novartis Access Principles, and it was implemented in 2018.
What are the Access Principles?
Previously, pharmaceutical companies have focused on establishing access plans only for R&D projects developed in partnership. However, stakeholders now expect companies to establish access plans for in-house R&D projects too. The new Novartis Access Principles are designed to streamline this process to increase the success of access strategies and to provide accountability for access. Through this approach, Novartis’ global, regional and country teams establish strategies for access once a clinical candidate enters later stages of clinical development (usually at Phase IIb). These teams then update these strategies as the clinical candidate progresses toward market approval.
Stakeholders expect companies to establish access plans for pipeline projects from at least Phase II of clinical development on. Novartis’ new principles align with this timeline, with its access strategies including plans for registration, pricing and licensing, among others. Novartis will develop strategies for all of its innovative medicines as well as biosimilars developed by Sandoz, its generics division, with separate strategies for its adaptive R&D projects.
What makes this an innovation?
A number of companies have processes enabling them to consider and develop
access plans across pipelines. However, Novartis is the first to commit fully to establishing access strategies across its pipeline regardless of disease type, signalling a unique willingness to consider access for diseases with high and low commercial potential for use in countries in scope.
In putting in place company-wide access strategies, and to ensure these are implemented, Novartis has created accountability with both a structured timeline and through the endorsement of these principles by senior leadership. While it will take time to see the effect of these principles for new medicine launches, Novartis will use key performance indicators to measure impact in expanding access to medicine for the first two years following launch.