Evolving Access Pathways for Long-Acting HIV Prevention Products - PowerPoint Presentation

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Evolving Access Pathways for Long-Acting HIV Prevention Products

Shelly Malhotra,Senior Director, Global Access, IAVI

No conflicts of interest are declared

Co-authorsS. Malhotra, M. Keane, A. Kurzman, N. Sender, M. Price, IAVI, New York, United States

Evolving Access Pathways for Long-Acting HIV Prevention Products

Goal: To help accelerate access to future HIV biomedical prevention products in LICs &

LMICs by:

highlighting stakeholder perspectives on the evolving landscape, challenges, & opportunities to accelerate broad access.

identifying evidence needed for product adoption; and,

exploring pathways for regulatory approval, policy guidance, financing, procurement, & effective health systems delivery

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Insights gathered from diverse global actors

Policy guidance

WHO, HIV/AIDS

Programme

WHO, Immunizations, Vaccines & Biologicals (IVB)

UNAIDS

PDVAC

Supply & procurement

Access to Medicines Foundation

Global Fund

Medicines Patent Pool

UNICEF

Financing

Bill and Melinda Gates Foundation (BMGF)

Gavi

Global Fund

Unitaid

PEPFAR

USAID

Regulatory

European Medicines Agency (EMA)

U.S Food and Drug Administration (FDA)

WHO, Essential Medicines & Health Products

(EMP)

Health systems delivery

AVAC

CHAI

Treatment Action Group

FHI360ICAP Global Health

57 individuals from 22 organizations interviewed

Several long-acting HIV prevention products approaching market or in the pipelineProducts transcend:

Product types (ARV-based, antibodies, MPTs)Delivery modalities (vaginal rings, long-acting injections, implants, daily or monthly pills)

Robust HIV prevention pipeline across product types

Source: https://www.avac.org/sites/default/files/infographics/BiomedicalHIVpreventTrials_Nov2020.png

Key Findings:

Pathways to registration

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Lack of broad registration can contribute to lags in access to priority products due to:

Delays in filing

Inconsistent requirements

Lack of mutual recognition

Capacity constraints

Collaborative registration & joint reviews represent can accelerate timelines–

if expanded

Recommendation: Efforts needed to expand use of joint review and collaborative registration pathways, and support regulatory capacity building. Apply learnings from COVID-19 to inform regulatory pathways for a broader range of countries &

priority diseases.

Key Findings:

Pathways to

policy guidance

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Integration into WHO policy guidance an important catalyst for broad adoption but potential for delays:

Gaps in programmatic evidence can lead to conditional recommendations or need for additional demonstration studies, delaying impact

Unlike long-acting ARVs, a

ntibodies

for HIV prevention straddle policy-making pathways, introducing complexity and ambiguous ownership

Recommendation:

Early engagement & coordination critical. Gathering clinical &

programmatic evidence concurrently important for broad & timely

policy guidance.

Key Findings:

Pathways for

f

inancing &

procurement

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Platforms for financing & pooled procurement have been critical to access, however gaps in coverage:

Funding gaps for HIV prevention efforts

At-risk for countries transitioning from donor support

Specific hurdles for antibody-based products:

Not integrated into current financing & procurement mechanismsNot historically affordable

Recommendation

:

Affordability is critical. Innovative partnership models & adequate

investment needed to ensure affordability and sustainable procurement for

future HIV prevention products.

Key Findings:

Delivery & implementation

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Social, cultural, and programmatic barriers can hinder uptake:

Stigma, product-related issues, and delivery hurdles can limit demand & uptake of HIV prevention services

Antibodies & other long-acting technologies may carry unique considerations, including administration & storage requirements, that must be addressed

Recommendation:

Engaging with communities to understand potential acceptability

& delivery barriers early in development -- & ensuring they are

factored in product & program design -- critical

Conclusions & Recommendations

Begin early

Early cross-sector and country-based dialogue critical to ensure products designed with user needs in mind & to integrate into plans of key financing & procurement platforms.

Strengthen coordination

Coordination mechanisms with an end-to-end perspective limited. Coordination efforts – working from early development through product introduction- needed.

Build innovative partnerships:

New strategies needed to ensure

affordability & broad availability. Innovative

multisector partnership models can

catalyze R&D, mobilize co-investment, &

support low-cost manufacturing & affordability

Streamline regulatory pathways

Efforts needed to harness learnings from

COVID-19 experience and expand use

of reliance-based & harmonized regulatory

pathways, while building regulatory capacity

Gaps in evidence can delay widespread

scale-up. Ensuring robust evidence on

cost-effectiveness, programmatic suitability,

and epidemiological impact critical.

Gather clinical & programmatic

evidence concurrently

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Conclusions & Recommendations

Sustainable platforms are needed to pool procurement & support global distribution, not only for countries benefiting from donor support, but across a broader range of countries.

Invest in future products

Political will and financial commitment needed to meet HIV prevention targets. Demonstrating relative value proposition, cost-effectiveness, and impact will be vital.

Reimagine product design & delivery

Understanding acceptability & implementation barriers & factoring them into

product design &

delivery

strategies essential. Early demand creation and health systems preparedness critical.

Pool procurement, sustainably

iavi.org/news-resources/fact-sheets-publications

To read the full report, please visit:

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Acknowledgements

This report was funded in part through an independent public policy grant from Merck, Sharp & Dohme Corp., a subsidiary of Merck and Co., Inc.

IAVI thanks the representatives from global health organizations who generously gave their time to participate in consultations and those who contributed to reviewing and providing their feedback on the report, including:

Rachel

Baggaley

Richard Isbrucker

Devin Sok

Ana Cespedes

Hester Kuipers

Markus Steiner

Olayinka Fagbayi

Gayle Patenaude

Kristine Torjeson

Mark Feinberg

Gabriella Quintard

Johan

Vekemans

Lisa Gieber

Cherise Scott

Mitchell Warren

Lusine Ghazaryan

Ayesha Sitlani

Karie Youngdahl

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