PDP Access Steering Committee

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Steering Committee Meetings

2013/New York

ECONOMIC APPRAISALS FOR PRODUCT DEVELOPMENT PARTNERSHIPS

January 23-24, 2013     Population Council, New York, New York

Executive Summary

Background

The robust PDP pipelines of health technologies provide potential to improve global health. However it has become increasingly clear over the last few years that it is essential for PDPs to have an in-depth understanding of the activities and processes needed for adoption and uptake of products in developing countries. The issue of economic and financial appraisal was identified by the PDPs as an area that needs to be better understood and discussed.

This fourth technical meeting of the PDP Access group, hosted by the Population Council in New York, involved participants of 13 Product Development Partnerships (PDPs), the WHO, PAHO and USAID, health economists and financing experts from partner organizations and academia. The meeting included presentations from leading economists, as well as case studies of how PDPs have commissioned, executed and applied economic and financing studies in their work.

Aims and objectives of the meeting:

  • To identify the types of economic valuations needed to support product development and global and country policy decision-makers
  • To identify the key factors that drive health and economic impact of interventions and to pinpoint where better information or research would fill critical knowledge gaps to better inform decision makers

The objectives for the PDP Access Group were:

  • Understanding the key concepts, methodologies and tools available for economic appraisal
    • Examining questions of how stakeholders apply various economic valuations, including cost- effectiveness, cost-benefit and cost-utility analyses, along with considerations of affordability, acceptance, compliance, and logistics
    • Exploring how PDPs can design and develop the most useful cost-effectiveness studies to assist with decision-making that will lead to access.

The meeting sessions

1. Key concepts and methodologies 

Session 1 gave a comprehensive overview of the concepts, techniques, and methods for economic appraisal, with some specific examples to help inform the PDP participants how to select the most appropriate methodologies.

Discussion topics included:

  • How to illustrate spin–offs from, and the broader impact of, a health intervention on the health system,  an issue that many of the PDPs, WHO and donors are interested in
  • How PDPs should be supporting country level decision-makers, especially regarding analysis of benefits of combinations/sequencing of interventions the challenges of application of economic analysis in low-resource setting.

2: What to do when

In session 2, determining which type of economic analysis to use at what phase of the product development cycle and cost-effectiveness analysis for different product categories was reviewed and discussed. Specific examples were discussed as well as what role the PDPs should play in commissioning or carrying out economic analysis.

The importance of cost-effectiveness analysis data to policy makers was highlighted, but also the fact that cost–effectiveness data is not a key influencer in product adoption decisions.  The common dilemma for PDPs of how to address the need for CEA when a product is still 10 years or so away from licensure was also raised.

3: Use of economic analysis: Case studies and stakeholder perspectives

Economic study conducted as part of advocacy for MenA vaccine: A microeconomic perspective of the cost of meningitis to the population in Burkina Faso, in the context of establishing the investment case for introduction of the MenAfric® vaccine was presented. The context, study design and rationale, the results and conclusions, and how these have been used for both advocacy and improved surveillance and response systems were discussed.

Cost-effectiveness of Insecticide-Treated Wall Nets: This study estimated the cost effectiveness of Insecticide-Treated Wall Liner (ITWL) plus Insecticide Treated Net (ITN) vs. ITN alone and identified key policy questions for research and scale up.

Malaria prevention and ITN distribution systems: Role of economic evaluation in determining how the product will reach consumers: This presentation looked at the various models proposed and used for delivery of ITNs, and discussed the questions arising from the different approaches and economic appraisal studies.

Stakeholder perspectives

There is a need to start thinking about access strategies early on in the product development phase and to gather existing data for scale-up. The onus is on donors to push for relevant economic analyses data earlier and more often, to facilitate planning for introduction and access. CE can help set parameters for the TPP and in costing and price negotiations for procurement later on.

Country–level perspectives from PATH: it was emphasized that although developing countries are increasingly becoming aware of the importance of economic analyses, most evaluations are driven by other institutions, rather than the country itself. The Importance of PDPs in providing country-level capacity building support to help use/understand these tools was emphasized in the discussion.

PAHO regional perspectives: The growing interest in Health Technology Assessment (HTA) and economic evaluation (EE) for decision-making and processes and legislation in the Americas region was comprehensively presented. The PAHO agreement and resolution on HTA and the decision-making process in which countries agreed on 6 essential elements for the region was presented. The challenge now is the implementation of the resolution.

WHO initiative on research on immunization, vaccines and biologicals: This presentation highlighted: which tools are relevant and when to use them; going beyond traditional CEA to look at the broader value of vaccines; WHO’s normative role to increase transparency and country ownership of economic analysis; and WHO’s role in building technical capacity in LMICs.

Approaches to look at the broader value of vaccines were discussed and illustrated with a WHO framework that has been developed.

4: Evaluating and translating results of economic evaluations in resource-constrained settings

This session started with a summary of discussions from recent GAVI consultations on ‘the value of vaccines in health and economic development’ at the GAVI Alliance Partners Forum (December 2012) and a workshop on the value of vaccines.

Although there is increased interest in this approach, it was acknowledged that that looking at the broader impact is not a substitute for traditional economic analysis but an adjunct.

Challenges in translating results of economic evaluations: This presentation considered the challenges of translating results of economic evaluation, from the perspectives of the various stakeholders. It was illustrated with the example of the population health impact and cost- effectiveness of TB diagnosis with Xpert MTB/RIF[1] and explored translation of economic evaluation results into appropriate decision-making.

Vaccine economic in low and middle income settings: Recent major growth in economic evaluations in low and middle-income countries was discussed and the fact that specific types of evaluations have experienced more growth than others (e.g. cost-utility analysis) was highlighted. Overall, it was concluded that more attention should be paid to measuring societal benefits of vaccines and more information on costs, treatment savings, and benefits and outcomes is needed.

 5: Case studies from PDPs

1.  Population council: a case study from family planning. Product development timelines are somewhat different for contraceptives, as developing countries want to know if the product will be feasible/acceptable in their countries before it is even approved – there is often pre-approval (by the FDA) for demonstration products. Product introduction needs to demonstrate capacity, affordability, acceptability, access, use, and longer-term outcomes, as well as how it fits into the overall method mix in a given country.

2.TB Alliance: Cost-effectiveness analysis of REMox regimen: The TB Alliance is working with a consortium of LSHTM, AIGHD and JHSPH to look at the cost-effectiveness of REMox, which would shorten treatment from six to four months.

The study will measure provider and patient costs in four countries and use a two-stage methodology: 1) model a cohort of TB patient through to cure, recovery, or death and 2) a transmission model of indirect impact. The study was initiated at the end of 2012 and results should be available in Q3-Q4 2013.

3. IAVI: HIV Vaccines: Exploring the potential cost-benefit: IAVI is working with the Futures Institute on impact modeling of an HIV vaccine, which will help IAVI in making the case for investment. The model estimates the impact of an HIV vaccine under three scenarios depending on assumed efficacy and population coverage. Impact modeling indicates that an HIV vaccine could avert between 5.2 million and 10.7 million HIV infections. This effectiveness assessment was helpful but IAVI looked at cost-effectiveness as well in two scenarios.  Targeting the general population and assuming a vaccine efficacy of 70% – a vaccine costing as much as $189/person vaccinated would be cost saving. A vaccine of $332 would be highly cost-effective by WHO standards.

4. Aeras: Economics of TB vaccines : TB is not as well funded as HIV or malaria and needs increased donor investment in R&D, so the economic analysis is important for the case for investment, moreover, it is clear there is a need to move away from looking at preventive vaccines in a silo. Vaccines will not prevent the need for drugs and treatments, so immunization must work in tandem with other interventions.

5. MVI Case Study: Cost of illness projects: The objectives of this study were to estimate costs of both uncomplicated and severe malaria disease borne by health systems and households in Burkina Faso, Nigeria, Ghana, and Uganda. The importance of collecting prospective data that captures key changes in the health system in developing country settings was highlighted. As new interventions are introduced, it is also important to understand the potential impact on treatment costs.

Key messages for PDPs  

Understand what type of analysis a particular audience want, know your audience and use the tools available

Country-level:

  • There is a clear a need to help build capacity in country to assess CEA; PDPs have a role in providing country-level capacity building assistance to help use/understand economic analysis tools. PDPs can also play a role in supporting countries in assessing  their own CE criteria and/or the limitations needed in using WHO criteria.

CEA & modeling: Sharing of methodologies and analyses among PDPs is important

  • Transparency is crucial in model development and people need to understand the model that is proposed to them. Modeling  needs to take into account weakness of data for particular countries  and there is a great need for improved techniques for measuring denominator savings.
  • The cost per DALY is not meaningful to most decision-makers, so need to consider population impact, cost-effectiveness, and affordability relative to other available options.
  • Few evaluations explicitly incorporate changes in economics over time. Impact is projected over many years but assumes that costs remain relatively stable – which is not the case
  •  More attention should be paid to measuring societal benefits of vaccines and more information on costs, treatment savings, and benefits and outcomes is needed. It is important  to collect prospective data that captures key changes in the health systems (e.g. national insurance schemes, AMFm etc.) in developing country settings
  • Modeling combined interventions is a major gap right now and a priority for future work .We need to move away from looking at preventive vaccines in a silo, vaccines will not do away with the need for drugs so we must work in tandem;  packages of interventions  including diagnostics, drugs, vaccines, insecticides etc.

[1] Menzies et al 20102 PLOS medicine 9 (11) e10001347


Download Presentations from the Meeting

Aylward – AIDS Vaccines / exploring the potential cost/benefit

Brady Pop – A case study from family planning

Colombini – Economic study conducting as part of advocacy for Meningitis A vaccine

Constenla – Vaccine economics in low and middle income settings

Dowdy – Challenges in Translating Results of Economic Evaluations

Gardiner – Cost effectiveness analysis of REMoxTB regimens

Hutubessy – WHO Perspective on the Use of Economic Analysis for Vaccines and Immunization Programs

Hutubessy – Update from recent meetings on Broader Impact of Vaccines and Economic Analysis

Kelly – Introduction to the PDP Access Group

Lemgruber – HTA, economic evaluation and decision making in the Region of the Americas

Muhib – MVI Case study: Cost of illness projects

Shepard – Economic Appraisals: Overview of Key Concepts for Product Development Partnerships

Shepard – Cost-effectiveness of insecticide treated wall liner for malaria prevention in rural western Kenya

Wilson – The uses of economic evaluation by PDPs: When to do what

Yukich – Malaria prevention and ITN distribution systems: the role of economic evaluation in determining how the product will reach consumers