Implications of Recent US Policy Changes on Evidence Generation Requirements for Enabling Access to Medicines and Vaccines in Low- and Middle-Income Countries
Author(s)
Anna Tarrant1, Anna Krivelyova, MS2, Xuan Wang, MD3.
1Icon Clinical Research, LLC, Blue Bell, PA, USA, 2ICON plc, London, United Kingdom, 3ICON plc, Taby, Sweden.
1Icon Clinical Research, LLC, Blue Bell, PA, USA, 2ICON plc, London, United Kingdom, 3ICON plc, Taby, Sweden.
OBJECTIVES: Many low- and middle-income countries (LMICs) rely partially or completely on donor funding to pay for health commodities such as vaccines and medicines. The United States (U.S.) is historically one of the largest of these donors. The authors sought to understand the impact of recent policy changes in the U.S. enacted by the Trump administration on health funding in LMICs. We explore the implications of these policies on evidence generation requirements for enabling access to vaccines and medicines in LMICs over the next ten years.
METHODS: The authors conducted a landscape review of published peer-reviewed articles (Pubmed, Embase, etc.), news articles, and grey literature. We conducted interviews with key opinion leaders to explore our findings in further detail.
RESULTS: Two main themes emerged from our landscape review. (1) LMICs will face enormous health funding gaps over the next several years as a result of U.S. funding and support being withdrawn. Most countries will not be able to replace this funding and will have to make tradeoffs and significant cuts to expenditures for health commodities. (2) Potential changes to U.S. domestic policies (including to the Advisory Committee on Immunization Practices (ACIP)) are likely to lead to spillover effects in LMICs, particularly related to access to vaccines.
CONCLUSIONS: As a result of anticipated funding gaps brought on by changes to U.S. policies and funding priorities, manufacturers of vaccines and medicines targeted at LMICs may need to generate stronger evidence that their product will help achieve broad population-wide long-term health outcomes at a low cost in order for uptake to occur. They may also need to demonstrate the value of their product to new and different payers and funders who may assess value in diverse ways.
METHODS: The authors conducted a landscape review of published peer-reviewed articles (Pubmed, Embase, etc.), news articles, and grey literature. We conducted interviews with key opinion leaders to explore our findings in further detail.
RESULTS: Two main themes emerged from our landscape review. (1) LMICs will face enormous health funding gaps over the next several years as a result of U.S. funding and support being withdrawn. Most countries will not be able to replace this funding and will have to make tradeoffs and significant cuts to expenditures for health commodities. (2) Potential changes to U.S. domestic policies (including to the Advisory Committee on Immunization Practices (ACIP)) are likely to lead to spillover effects in LMICs, particularly related to access to vaccines.
CONCLUSIONS: As a result of anticipated funding gaps brought on by changes to U.S. policies and funding priorities, manufacturers of vaccines and medicines targeted at LMICs may need to generate stronger evidence that their product will help achieve broad population-wide long-term health outcomes at a low cost in order for uptake to occur. They may also need to demonstrate the value of their product to new and different payers and funders who may assess value in diverse ways.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR120
Topic
Epidemiology & Public Health, Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
Infectious Disease (non-vaccine), Vaccines