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Lower-middle income countries: study results on adoption and financing of new vaccines SAGE November 2010 Geneva Marty Makinen, Principal and Managing Director

Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

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Page 1: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Lower-middle income countries: study results on adoption and financing of new vaccines

SAGE November 2010 Geneva

Marty  Makinen,  Principal  and  Managing  Director  

Page 2: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Organization of presentation

  Background   Why LMIC new vaccine adoption?   Study TORs   Methods: country case studies, key informant

interviews, quantitative analyses   Limitations   Findings from country cases, industry interviews, and

quantitative work   Summary of what is new

Page 3: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Background

•  Overseen by Bill and Melinda Gates Foundation and WHO •  Advisory Group provided guidance and support •  Study implemented by Results for Development Institute (R4D),

Washington, DC •  Began in November 2009, nearing completion

WHO/Gates  LMIC  New  Vaccine  Adop9on  Study  

Page 4: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Study  Advisory  Group    

•  Gian  Gandhi,  GAVI  Secretariat  

•  Rana  Hajjeh,  US  CDC  

•  Jan  Hendriks,  Netherlands  Vaccine  InsDtute  

•  Akira  Homma,  DCVMN  •  Miloud  Kaddar,  WHO  

•  Steve  Landry,  BMGF  

•  Rob  MaMhews,  UNICEF  SD  

•  Violaine  Mitchell,  BMGF  

•  Ezzedine  Mohsni,  EMRO  •  Jaco  Smit,  IFPMA  

•  Gina  Tambini,  PAHO  

Page 5: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LMICs 2008 LMIC, GAVI ineligible

2008 LMIC, graduating from GAVI in 2011

2008 LMIC, will remain GAVI eligible

•  World Bank definition: 2008 GNI/capita $976 - $3,855 •  Population 3.8 billion (1.4 billion excluding China and India) •  Birth cohort 76 million (33 million excluding China and India) •  Unlike LICs, most do not receive GAVI funding

Page 6: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LMIC Hib adoption

2008 LMIC, Adopted Hib

2008 LMIC, Yet to adopt Hib

Adopted  Hib   Yet  to  adopt  Hib  

No.  of  countries   42  (78%)   12  (22%)  

Birth  cohort  (millions)   22  (29%)   54  (71%)  

Source: WHO Immunization surveillance, assessment and monitoring. Reported immunization schedules by vaccine [Internet]. Geneva: WHO; [updated 2010 Oct 11; cited 2010 Nov 8]. Available from http://apps.who.int/immunization_monitoring/en/globalsummary/scheduleselect.cfm

Page 7: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LIC Hib adoption

2008 LIC, Adopted Hib

2008 LIC, Yet to adopt Hib

Adopted  Hib   Yet  to  adopt  Hib  

No.  of  countries   34  (89%)   4  (11%)  

Birth  cohort  (millions)   29  (81%)   7  (19%)  

Source: WHO Immunization surveillance, assessment and monitoring. Reported immunization schedules by vaccine [Internet]. Geneva: WHO; [updated 2010 Oct 11; cited 2010 Nov 8]. Available from http://apps.who.int/immunization_monitoring/en/globalsummary/scheduleselect.cfm

Page 8: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Hib adoption: comparing LICs and LMICs

Adopted  Hib   Yet  to  adopt  Hib  

No.  of  countries  

Birth  cohort  

(millions)  

No.  of  countries  

Birth  cohort  

(millions)  

LICs   34  (89%)   29  (81%)   4  (11%)   7  (19%)  

LMICs   42  (78%)   22  (29%)   12  (22%)   54  (71%)  

Page 9: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

NIP performance in LMICs

Coverage  generally  high  

27  

12  9  

7  0  

5  

10  

15  

20  

25  

30  

≥90%   80-­‐89%   70-­‐79%   <70%  

DTP3  coverage  by  class  among  LMICs  

Num

ber  of    cou

ntries  

Page 10: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Terms  of  Reference  

Purpose:      •  Determine  constraints  to  adopDon  of  new  vaccines  in  LMICs  and  

opDons  for  addressing  constraints  

ObjecDves:  •  IdenDfy  and  analyze  constraints    •  Formulate  soluDons  •  PrioriDze  strategic  intervenDons  •  Analyze  impact  of  increased  LMIC  demand  

Focuses:      •  LMICs  not  eligible  for  GAVI  support  or  graduaDng  from  GAVI  support  •  Vaccines:    Hib,  Pneumo,  Rota,  and  HPV  

Page 11: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

RaDonale  for  country  case  selecDon  

•  Regional  balance  •  Lessons  from  selected  UMICs  •  Mix  of  adopters/non-­‐adopters  of  Hib  •  Include  some  GAVI  graduaDng  countries  

•  Select  AMR  countries  not  included  in  a  PAHO  study  •  India  on  iniDal  list,  replaced  by  Indonesia  

Page 12: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Data collection

Country  Studies  

China

Egypt

Turkey

Philippines

South Africa

Morocco

Ecuador

Panama Thailand

Indonesia

Cape Verde

Tunisia

Syria

Armenia

Albania

Remote LMIC Country Study

In-Depth LMIC Country Study

In-Depth UMIC Country Study

Remote UMIC Country Study

Page 13: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Country  case  studies  

•  Interviews  with  5-­‐10  key  informants  •  Vaccine  adopDon  decision  making  

•  Regulatory  system  

•  Financial  allocaDons  •  External  support  •  Vaccine  suppliers  •  Lessons,  suggesDons  

Page 14: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Data collection

•  Immunization program experts (20) •  Vaccine manufacturers (10 total: 5 IFPMA, 5 DCVMN) •  Regional Working Group members •  Procurement agencies (UNICEF, PAHO)

Expert  Consulta9ons  

Page 15: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Data  analysis  

•  Kaplan-­‐Meier  survival  funcDons  –   PloZng  countries  adopDng  from  Dme  of  availability  –  Samples:    UMICs,  LMICs,  and  LICs  

•  Cox  survival  model  regressions  –  Dependent  variables:    Dme  from  availability  of  pre-­‐qualified  Hib  and  Hep  B  vaccine  to  adopDon  

–  Independent  variables:    measurable  factors  hypothesized  to  affect  decisions  

–  Samples:    LICs+MICs;  MICs  only  

Page 16: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LimitaDons  

•  Much  of  informaDon  collected  and  analyzed  is  observaDonal  

•  SelecDon  of  countries  non-­‐random,  rather  it  was  deliberate  

•  Many  factors  hypothesized  to  affect  adopDon  decisions  not  measurable  

•  Access  limited  to  some  sensiDve  data  

Page 17: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Status of study

•  All country case studies, manufacturer interviews, and global vaccine expert interviews

•  Third draft report on country and global expert interviews following AG input

•  Draft section on findings from manufacturers •  Draft quantitative analysis •  Session on preliminary results at NUVI in June

Complete  components  

Page 18: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Status of study

•  Report to SAGE (November 11, 2010) •  Integration of manufacturer interview results and

quantitative analysis with country and global expert information

•  Analysis of impact of projected faster adoption on vaccine markets

Components  to  be  completed  

Page 19: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary  of  findings  from  countries  Broadly  important  factors   Factors  important  in  

mul9ple  countries  Other  factors  

Country   Epidem

iology  

Cost-­‐related  Concerns  

WHO    

Recommen

da9on  

Engagemen

t  by  Glob./

Reg.  Orgs  

UNICEF  or  PA

HO  

procurem

ent  

Neighbo

rs’  experience  

NIP  stren

gth  

Local  produ

c9on  

Local  events  

Percep

9on

 of  vaccine

 Safety  

Cham

pion

s  

Private  market  

MDG  4  Progress  

Cost-­‐effec9vene

ss  

Budget  fo

r    

vaccines  

Price  

Albania   X   X   X   X   X   X   X  Armenia   X   X   X   X   X   X   X   X   X  Cape  Verde   X   X   X   X   X   X   X  

X  X   X  

China   X   X   X   X   X   X   X   X   X  Ecuador   X   X   X   X   X  Egypt   X   X   X   X   X  Indonesia   X   X   X   X   X  Morocco   X   X   X   X   X   X  Panama   X   X   X   X   X   X  Philippines   X   X   X   X   X   X  South  Africa   X   X   X   X   X   X   X   X   X   X  

Syria   X   X   X   X   X   X   X  Thailand   X   X   X   X  Tunisia   X   X   X  Turkey   X   X   X   X   X   X   X  Total    X’s   15   11   11   9   14   5   6   7   3   3   3   3   4   2   3  

Matrix  used  to  analyze  findings  across  countries  –  to  be  shown  in  detail  in  

following  slides  

Page 20: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

Grouping of factors in country decision making: •  Factors important in the majority of countries •  Factors important in multiple countries •  Other factors mentioned by countries •  Hypothesized factors of small importance

LMIC  vaccine  decision-­‐making  is  deliberate  and  ra9onal  

Page 21: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary findings

Factors  important  in  the  majority  of  countries  (max.  15)  

0   2   4   6   8   10   12   14  

Price  

Cost-­‐effec9veness  

Budget  for  vaccines  

WHO  recommenda9on  

Local  epi  evidence  

Page 22: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary findings

Factors  important  in  the  majority  of  countries  (max.  15)  

0   2   4   6   8   10   12   14  

Price  

Cost-­‐effec9veness  

Budget  for  vaccines  

WHO  recommenda9on  

Local  epi  evidence  

These  three  items  are  interconnected  in  

terms  of  costs,  prices,  value,  and  financing  

Page 23: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

0   2   4   6   8   10   12   14  

Engagement  by  Reg/Glob  Orgs  

Use  of  pooled  procurement  

Neighbors'  experience  

Summary of findings

Factors  important  to  mul9ple  countries  (max.  15)  

Page 24: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

Other  factors  men9oned  by  countries  (max.  15)  

0   2   4   6   8   10   12   14  

Private  markets  

NIP  Strength  

Local  produc9on  

Local  events  

Vaccine  safety  

MDGs  

Champions  

Page 25: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

•  Vaccine characteristics •  Media

Hypothesized  factors  of  small  importance  to  countries  

Page 26: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

•  LMICs important—but LMICs not seen as a single market •  No capacity constraint to meeting demand from LMICs

outside India and China (latter are special cases) •  IFPMA members appreciate UNICEF SD for forecasting,

multi-year contracts, standard requirements •  DCVMN members want more tech transfers •  Wish to preserve ability to pursue company pricing

strategies (for IFPMA members “tiered pricing”)

Industry  perspec9ve  

Page 27: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

•  Pools provide advantages to industry – simplify marketing, standardize products, allow large volumes

•  DCVMN members feel disadvantaged by some LMIC regulatory practices and lack of presence

•  DCVMN members mainly focused on domestic markets, but working to enter MIC and HIC markets

•  Believe budget availability, political commitment, and program performance more important than price in country adoption decisions – worry about GAVI grads

Industry  perspec9ve  

Page 28: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

Kaplan-Meier survival functions

•  Hep B •  UMICs and LMICs adopted at statistically similar rates,

significantly faster than LICs •  LICs began to catch up following start of GAVI

•  Hib •  UMICs adopted faster than LMICs and LICs that adopted at

statistically similar rates

Quan9ta9ve  analysis  results  

Page 29: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

Cox survival model regression analysis of years to adoption of Hep B and Hib vaccines

•  Measurable independent variables: •  Income, NIP strength, region, govt health spending, govt

immunization spending, line-item, BOD evidence, Hep B and meningitis BOD, neighbors’ adoption

•  Analyses conducted for: (1) MICs and (2) LICs and MICs together

Quan9ta9ve  analysis  

Page 30: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Summary of findings

Significant positive associations with vaccine adoption in multiple analyses:

•  Adoption by neighbors (HepB across income groups) •  Strength of NIP (LMICs/LICs across vaccines) •  AMR countries (Hib across income groups)

Significant positive associations in only one analysis: •  Income level •  Line-item for immunizations •  WPR countries •  EMR countries

Quan9ta9ve  analysis  results  

Page 31: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

So  what  is  new?  

1.  Cost  and  price-­‐related  issues  (CEA,  prices/budgets)  important  to  LMICs  –  they  assume  they  have  to  pay  and  are  concerned  about  value  for  money  and  sustainability  

2.  LMICs  take  epidemiological  evidence  seriously,  yet  don’t  invest  much  in  gathering  high-­‐quality  data.    There  is  liMle  to  no  inter-­‐country  cooperaDon  or  collaboraDon  

3.  There  is  awareness  of  neighbors  adopDon  decisions  and  an  element  of  compeDDon  

4.  No  readily  available  and  complete  informaDon  source,  especially  concerning  prices,  vaccine  availability,  procurement  opDons,  and  market  dynamics  

Page 32: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

So  what  is  new?  

4.  Decisions  are  made  at  high  levels  of  MOHs  (and  beyond)  and  focused  on  disease  reducDon  with  an  integrated  prevenDon  and  treatment  approach  –  not  a  simple  adopt/do  not  adopt  vaccine  decision  taken  at  NIP  Director  level  

5.  NITAGs  growing  in  importance,  have  even  greater  potenDal  to  influence  decisions  

6.  GAVI  graduates  uncertain  about  whether  they  can  sustain  financing,  even  though  other  peer  LMICs  are  doing  so  

7.  No  one-­‐size-­‐fits-­‐all  approach  possible  for  this  diverse  set  of  countries  

Page 33: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Thank  you.    

QuesDons?  

Page 34: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LMIC GAVI eligibility in 2011

2008 LMIC, GAVI ineligible

2008 LMIC, GAVI eligible

Page 35: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

LIC + LMIC Hib adoption

2008 LIC, Adopted Hib

2008 LIC, Yet to adopt Hib

2008 LMIC, Adopted Hib

2008 LMIC, Yet to adopt Hib

Adopted  Hib   Yet  to  adopt  Hib   Total  

LMIC   42  (78%)   12  (22%)   54  

LIC   34  (89%)   4  (11%)   38  

Source: WHO Immunization surveillance, assessment and monitoring. Reported immunization schedules by vaccine [Internet]. Geneva: WHO; [updated 2010 Oct 11; cited 2010 Nov 8]. Available from http://apps.who.int/immunization_monitoring/en/globalsummary/scheduleselect.cfm

Page 36: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Advisory Group involvement

•  Advice on methods •  Input into selection of countries •  Identification of key informants •  Providing documents, data, and introductions •  Tracking progress (monthly phone calls, NUVI face-

to-face) •  Assisting with decision making along the way •  Review and comment on draft reports •  Assistance with prioritizing recommendations

Page 37: Lower-middle income countries: study results on adoption ...€¦ · • Report to SAGE (November 11, 2010) • Integration of manufacturer interview results and quantitative analysis

Background

November 2008 SAGE: “WHO conduct further situation analysis of financial challenges for low and middle-income countries and consultation with countries concerned & partners to distil issues to more actionable activities”.

2008 WHA requested the DG: “To collaborate with international partners, donors as well as vaccine producers to mobilize necessary resources to support low income and middle income countries with the aim of increasing supply of affordable vaccines of assured quality”.

Relevance  to  SAGE