A framework to support new product introduction in national health systems
National-Level Planning & Budgeting
Transition and budgeting strategies for effective implementation and rollout of new products
National-level planning, including phase-in strategies, stock and procurement plans, national and donor budgetary cycles, rollout implementation, and monitoring requirements, is key to building consensus and providing a roadmap for product introduction.
Develop a detailed rollout strategy, including identification of target patient populations, regions, or facilities
Consider available financial and human resources when developing a rollout strategy (i.e. nationwide versus targeted)
If resources are limited, consider a phased rollout strategy until there are sufficient resources to facilitate national scale-up (e.g. required trainings, mentorships etc.)
Inventory existing products to be phased out
Develop phase-out strategy for existing products that will be switched out (e.g. CHAI ARV Phase-In/Phase-Out Tool)
Consider budget cycles for the funding source to align procurement with funding availability
Include new products within national budgets and donor budget plans (e.g. PEPFAR Country Operational Plan or Global Fund PSM Plan)
Earmark funding for key programmatic activities such as training and mentorship
Review reference pricing (e.g. CHAI benchmark comparison price list, Global Fund Pooled Procurement Mechanism) which can provide inputs for the budgeting process
Planning & Budgeting Resources
Countries should develop comprehensive product introduction strategies that will guide phase-in and leverage the skills, expertise, and resources of all key stakeholders to ensure a highly coordinated and effective transition. Programmatic plans should be aligned with budgetary processes to ensure timely availability of funds and resources required for the transition. The below section outlines key tools and resources that can be leveraged in national-level planning and budgeting processes.
CHAI ARV Phase-In/Phase-Out Tool
As national programs introduce new, generic ARVs, they must plan how and when the new product will be phased-in to ensure smooth and sustained adoption of optimal formulations. Ministries of Health must decide 1) which patient groups will be eligible to initiate on the new product, 2) when each patient group will start, and 3) how the new product will be rolled out geographically (national, regional, facility, or pilot). The ARV Phase-In Phase-Out Tool is designed to help national programs simulate scenarios for product phase-in and evaluate rollout plan options. The output of this tool can also help define scale up targets at the national, regional, or facility-level.
To access this tool, reach out to HIVToolkit@clintonhealthaccess.org.
New Product Transition Planning
Countries should develop comprehensive product introduction plans depending on their priorities and resources available. Planning tools, guides, and presentations to build the case for introducing and transitioning a new product in-country can be found in this section.
Countries should ensure sufficient funds are allocated for new products within national and donor budgetary processes. Timely budget planning can help ensure that approval and release of funds will not disrupt the timing or implementation of the rollout plan. The forecast quantities of new products required to implement the phase-in plan, plus an estimate of product cost derived from using reference price list is required for budgeting purposes.
Given their role in funding and procuring commodities, it is important to align product introduction plans with donor budgetary processes and keep donors informed of national transition plans. Specifically, after deciding to adopt a new product in country, Ministries of Health will conduct quantification and forecasting and develop a supply plan, which should be shared with relevant donor representatives at the country-level to discuss procurement plans for that product and support for implementation of product transition. Activities required to effectively implement product transition, such as trainings and printing of clinical reference materials, should also be incorporated into budgets. Donor engagement will be critical to ensuring that the budget and product rollout timelines are aligned, thereby contributing to a smooth product transition.
The primary mechanisms for funding through the two largest donors for ARV procurement are the Global Fund Concept Note process and the PEPFAR Country Operational Plan (COP).