Accelerated Development and Introduction Plan ADIP evaluation and recommendations

1
Accelerated Development and Introduction Plan
(ADIP) evaluation and recommendations

• Report of a study for GAVI
• GAVI Board
• 11 May, 2007

2
Terms of Reference of study

• Assess evolution of environment for new vaccine
  development and introduction over past four
  years,
• Evaluate progress and lessons learnt through
  ADIPs approach, the Hib initiative and other
  related GAVI supported activities, and
• Recommend to the GAVI Board on structure and
  finance of continued support.

3
Methodology as outlined in TORs

• Review documents, including financial documents,
  available from GAVI or from structures
  themselves,
• Interviews with key stakeholders (list provided
  by Steering Committee and ADIPs and HI)
• Information on other PPPs with similar remit
• Study limited by the RFP as to methodology, time,
  and funding. For example, not intended to
  document country impact by field visits

4
Available finance
Market incentives
Predictable (and lower) price
Disease burden
Predictable (and growing) demand
Predictable(and growing) capacity
Supply strategy
Advocacy
Demand estimates
VIRTUOUS CYCLE
5
Findings Main achievements

• Pneumo ADIP developed a solid basis for
  introduction of pneumococcal conjugate vaccine
  more than 5 years before historical precedents
  through
• Developing international consensus on key
  technical issues
• Communicating key messages to core stakeholders
• Developing sound disease burden data
• Planning a pilot introduction project with
  vaccine proposed for WHO prequalification
• Obtaining commitment from suppliers for tiered
  pricing
• Achieving commitment for G8 funding to finance an
  AMC for 1.5 B

6
Findings Main achievements

• Rota ADIP set the stage for rotavirus vaccine
  introduction in 2007, 1 year after international
  marketing approval, by
• Disseminating information on its
  cost-effectiveness and impact on known disease
  burden
• Collaboration with Sabin Foundation and PAHO for
  introduction into Latin America
• Advocating its use through disseminating
  information about expanded clinical trial safety
  results
• Ensuring adequate supply through competitive
  market among rotavirus vaccine producers, both
  multinational and emerging suppliers
• Obtaining a commitment from both multinational
  manufacturers to offer the product at tiered
  prices to the GAVI market

7
Findings Main achievements

• Hib Initiative accelerating introduction of Hib
  vaccine in GAVI-eligible countries by
• Contributing to the revision of the WHO Position
  Paper that now clearly recommends use of the Hib
  vaccine
• Providing a stronger evidence base by focusing on
  surveillance and impact determinations
• Assembling cost-effectiveness data
• Focusing advocacy strategy to support country
  decision making
• Exceeding its 2007 introduction targets, as 24/49
  countries in regions with well documented disease
  burden have introduced or approved the
  introduction of Hib

8
Main constraints

• Delays in the product development process
• Lack of clarity in original RFPs and in adhering
  to them
• Limited GAVI Board engagement
• For the Hib Initiative, lack of a supply strategy
• Complex management structures for Hib Initiative
  and initially for Rota ADIP
• Especially for Hib Initiative, lack of country
  representation on Management Committee

9
The Counterfactual the Hib Story

• While it is difficult to assess the absolute
  impact the ADIPs have had in the absence of a
  counterfactual, we can compare the status of
  rotavirus and pneumococcal conjugate vaccines
  today, poised to enter the GAVI market, with the
  status of Hib at the same stage in its life cycle
  
• The ADIPs have thus contributed to the
  programme-readiness of their respective products

10
Lessons learned

• Importance of early involvement of GAVI gt
  signalling
• Importance of a supply strategy
• Importance of firm demand forecasts
• Needs at country level
• Disease burden
• Method of measuring impact
• Financing
• Assurance of sustainability
• Attention to introduction issues

11
Three phases where GAVI could be involved

• Surveying the research pipeline
• Preparing the pathway via virtuous cycle and
• Establish Value
• Communicate Value
• Deliver Value
• Introduction

12
Possible approaches

• Surveying the vaccine pipeline
• Do nothing let the market work
• Commission a study on pipeline products most
  relevant to GAVI and convene a meeting to select
  products for interventions
• Develop pre-ADIP study groups for a number of new
  vaccines

13
Possible approaches

• Preparing the pathway
• Phase out ADIP process and existing ADIPs
• Continue time-limited ADIP process
• Change the ADIP process to have all products
  handled by a single mega-ADIP
• Continue an ADIP process for a limited number of
  vaccines that will also oversee country
  introduction

14
Possible approaches

• Implementation country introduction
• Do nothing rely on existing structures
• Add implementation to the charge of the mega-ADIP
• Add a new structure to facilitate country
  introduction for all new vaccines

15
Additional Recommendations

• GAVI should review its mission and working
  procedures to determine how best to manage and
  promote new vaccine introduction
• For both Vaccine-Specific and Implementation
  ADIPs, oversight should involve GAVI Board,
  through appropriate Management Committee(s), and
  GAVI Secretariat, through project teams with
  relevant skill sets

16
Additional Recommendations for GAVI management of
ADIP structures

• ADIPs should have a single strong manager in a
  single supportive organization.
• Vaccine-Specific ADIPs should regularly
  re-evaluate the relevance of their product(s).
• ADIPs should carefully define interactions with
  GAVI Partners at country level.
• RFPs, mandate, and governance structures must be
  clear and appropriate.