A framework to support new product introduction in national health systems
Product Adoption & Decision-Making
Supporting a Ministry of Health's decision to incorporate products into national guidelines
To guide the adoption of and decisions around new products, programs should work collaboratively with the Ministry of Health, implementing partners, and community groups.
Product Adoption & Decision-Making Checklist
Evaluate the benefits and considerations of new products using the five lenses approach (outlined in the Product Adoption and Decision-Making chapter)
Gather key information on the new product to build a case for its adoption and introduction (examples and samples included in the resources section below)
Build consensus on product adoption by engaging key stakeholders and decision makers utilizing existing forums such as technical working groups
Conduct a guidelines analysis and costing evaluation
Update national treatment guidelines based on new product decisions
Product Adoption & Decision-Making Tools and Resources
In preparing for national discussions on product adoption, sufficient information on the new product should be compiled. This section outlines critical resources and tools that should be assembled and developed for sharing with key stakeholders during the technical engagement processes.
Pediatric DRV/r (pDRV/r) Resources
Pediatric darunavir/ritonavir 120/20mg (pDRV/r) is a new fixed-dose combination of darunavir (DRV) with ritonavir for children living with HIV (CLHIV) who are at least 3 years old and weigh at least 10kg. Laurus Labs, with CHAI and Unitaid, is currently developing this product with the goal of tentative US FDA approval in the second half of 2024. These resources will support country programs to evaluate adopting pDRV/r within their own contexts.
CHAI Cost of Optimizing Second-Line Treatment (COST) Tool
The CHAI COST Tool is a model that helps to estimate the financial impact of switching existing second-line (2L) patients to optimized, clinically superior regimens, such as DTG and DRV/r. The proactive switching of existing 2L patients to more optimal regimens, such as DTG and DRV/r, can improve clinical outcomes and lead to significant commodity cost savings for national programs. Further transition planning and national quantifications can help to lead to a more granular cost-savings analysis. Please reach out to Jessica Fox (jfox@clintonhealthaccess.org) with any questions about this tool.
HIV Market Intelligence
CHAI's HIV market intelligence reports provide information on the latest developments in the HIV treatment marketplace and product pipeline. These reports can be used to help stakeholders stay informed of the latest market developments and make informed decisions about national treatment options based on the global or regional outlook.
Implementation and Normative Guidance
These resources include consolidated international recommendations and guidance on new ARVs, overviews of clinical and programmatic benefits, and considerations for product adoption, summaries of clinical evidence and trials, market information, phase-in strategies, and FAQs for new products.
Diagnostic Resources
CHAI’s diagnostic resources, produced in conjunction with the African Society for Laboratory Medicine, can be used across all steps of new product introduction to guide countries as they introduce point-of-care HIV technologies, HIV self-testing technologies, and HIV viral load technologies into existing national diagnostic systems.
