A goal of this toolkit is to stimulate conversations between government, partners, and communities on new product introduction. Please feel free to share any thoughts, questions, or additional resources for consideration by contacting us via email at any time: HIVToolkit@clintonhealthaccess.org.

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National-Level Planning and Budgeting

Transition and budgeting strategies for effective implementation and rollout of new products

Thorough national-level planning that includes consideration of phase-in strategies, existing stocks and procurement plans, national and donor budgetary cycles, and rollout implementation and monitoring requirements is key to building consensus and providing a roadmap for product introduction.

National-Level Planning Checklist

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)

Budgeting Checklist

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 (COP) for Global Fund PSM Plan)


Earmark funding for key programmatic activities such as training and mentorship

Review reference pricing (e.g. CHAI reference price list, Global Fund Pooled Procurement Mechanism) which can provide inputs for the budgeting process 

Use the links below to download the entire HIV New Product Introduction Guide or the National-Level Planning and Budgeting chapter only

National-Level Planning and Budgeting Tools

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 transition. The below section outlines key tools and resources that can be leveraged in national level planning and budgeting processes. 

Featured Tool: CHAI ARV Phase-In/Phase-Out Tool (APIPO)

As national programs introduce new, generic ARVs, like TLD, there is a need for planning of 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). This tool is designed to help national programs simulate scenarios for product phase-in and evaluate different options to decide the rollout plan.  The output of this tool can also help define scale up targets at national, regional or facility level:

 

New Product Transition Planning Resources

 

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New Product Transition Planning Resources

 

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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.  Reference prices lists can be accessed here:

New Product Transition Planning Resources

 

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Donor Engagement

 

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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, MOHs will conduct quantification and forecasting, and develop a supply plan which should be shared with relevant donor representatives at 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 Plans (COP):