HIV New Product Introduction Guide: A Framework for Supporting New Product Introduction in National Health Systems

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Over the past two decades, the landscape of medications used to treat HIV has evolved rapidly. Treatment options have improved dramatically with the development and availability of more efficacious, safer, and more tolerable antiretrovirals (ARVs). These options allow national treatment programs to better serve the needs of their patients, support significant treatment scale-up, reduce costs, and achieve public health goals. Use of the most optimal regimens and products offers many benefits to national HIV programs and people living with HIV (PLHIV), including:

  • Improving quality of patient care and effectiveness of national treatment programs through improved clinical outcomes, reduced side effects, and improved patient convenience, tolerability and adherence;
  • Enabling the continued scale-up of treatment despite funding constraints through less costly products, and ultimately;
  • Enhancing the sustainability of overall public health programs by providing more efficacious and affordable regimens.

Accelerating the availability of new, optimal ARVs and expanding treatment coverage are major priorities for patients and governments in low- and middle-income countries (LMICs). Facilitating rapid access to these products will reduce patient morbidity and mortality while at the same time enhancing the long-term viability of public health programs in reaching the 90-90-90 targets set by the Joint United Nations Programme on HIV/AIDS (UNAIDS). The process of adopting new ARV products requires significant strategic planning and coordination across national and international stakeholders.

The HIV New Product Introduction Guide outlines key considerations for introducing new ARV products. This guide provides a framework for ministries of health (MoHs) and partners to guide the product adoption, phase-in planning, and implementation process. The framework is not intended to be a “one size fits all” approach, but should provide approaches and tools that can be tailored to meet local needs and context. While this framework focuses on ARVs, it can also be applied to other health commodities.

With the World Health Organization’s (WHO) recent inclusion of dolutegravir (DTG) and lower-dose efavirenz (TLE400) as alternate first-line regimens, and availability of tenofovir disoproxil fumurate/lamivudine/dolutegravir (TLD) as a fixed-dose combination (FDC), countries are moving towards large scale shifts in first-line products. Further, several optimal pediatric products are being rolled out across LMICs, with additional new products in the development pipeline for a small treatment population. Development, implementation and monitoring of detailed, systematic product introduction strategies is critical to ensuring smooth product transitions. The approaches and tools in this guide and the accompanying HIV New Product Introduction Toolkit are designed to help MoHs to direct and manage the transition process.