MAPGuideⓇ
Equitable Access Toolkit
Agreements in the Context of End-to-End Access
The end-to-end perspective
Starting with the end goal in mind, an end-to-end approach to access ensures that “access is not an afterthought.” It starts by establishing patient and healthcare provider needs for a product or product class, and identifying the optimal pathway to meeting those needs.
Tools such as “access roadmaps” can be used as part of an end-to-end planning approach to assess potential barriers to achieving the optimal access pathway and identify the interventions needed to address those barriers. These approaches support engagement and alignment between stakeholders on roles and responsibilities for different interventions, as well as determining hand-off points between different organizations across the access value chain.
In addition to directly supporting or undertaking product R&D and commercialization activities, considerations forming part of an access roadmap may include, amongst others:
Development of access-oriented target product profiles (TPPs)
Community engagement activities
Establishment of regional clinical trial capacity
Development of procurement pathways
Regional manufacturing capacity assessment and development
Product demand forecasting
Market shaping interventions such as pricing and volume guarantees
Supporting regulatory harmonization and development of regulatory pathways
Establishment of cost-effective product distribution networks
Development of product adoption models and pilot programs
Evidence generation and implementation research
Impact monitoring, evaluation and learning frameworks
Connecting agreements with access roadmaps
Access roadmaps can help to contextualize the role that individual R&D and commercialization agreements should play in facilitating equitable access to an end product. Agreement parties can then apply their understanding of the end-to-end access pathway to ensure that agreement access commitments and access plans are aligned with the needs, expectations, roles and responsibilities of other key stakeholders, for example by:
Undertaking R&D to meet a TPP that has been developed with patient and healthcare provider input;
Developing manufacturing capacity plans and supply volume commitments with demand forecasts;
Utilizing regional manufacturing capacity assessments to support identification of licensing and technology transfer opportunities; and/or
Incorporating information on likely procurement mechanisms and into commercialization and launch plans.
How will the access provisions in an individual agreement be aligned with end-to-end access planning?
How will the access plan attached to an individual agreement take into account inputs from an access roadmap?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.