introduction of new vaccines in the public market
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Introduction of new vaccines in the Introduction of new vaccines in the public market of developing countries, strategy definition and planning
Stefano Malvolti
Director Strategic Vaccine Supply, PATH
First of all, let me introduce myself …
• Strategic Vaccine Supply Director @ PATH in
charge of strategic demand and supply
forecasting for GAVI vaccines portfolio
• 2005-2008 Global Head of Forecasting @
Novartis PharmaNovartis Pharma
• 2000-2005 Head Global Sales & Operation planning / Strategic Planning @ Baxter
Healthcare
• MSc in Business Administration @ Bocconi
University in Milan – dissertation on “Strategy,
mental models and organizational learning”
6/7/2010 2Strategic Vaccine Supply
… and let me share the objectives of this session
• Share best practices in public sector vaccine demand forecasting
• Stimulate discussion on role of strategic forecasting as cornerstone of strategy formulation and implementationformulation and implementation
• Showcase the potential of private-public partnerships in vaccine introduction
6/7/2010 3Strategic Vaccine Supply
This session will focus on six main themes
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 4Strategic Vaccine Supply
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planning
This session will focus on six main themes
operational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 5Strategic Vaccine Supply
PATH a catalyst for global health
An international nonprofit organization that creates
sustainable, culturally relevant solutions, enabling
communities worldwide to break longstanding cycles
of poor health through collaboration with diverse
public- and private-sector partners.public- and private-sector partners.
PATH: Arvind Chengi
• Health technologies
• Maternal and child health
• Reproductive health
• Vaccines and immunization
• Emerging and epidemic
diseases
6/7/2010 6Strategic Vaccine Supply
VAD: the partner for vaccine access in the public health space
Reduce morbidity and mortality from vaccine preventable diseases by improving access to appropriate traditional, underutilized, and new vaccines.
Shape Health Attack Syndromic Advocate for Priority Shape Health Policy
Attack SyndromicDiseases
Advocate for Priority
Advocacy
Communication
Demand & Supply Forecasting
Evidence Generation
Immunization Systems
Policy Development
Project Management
6/7/2010 7Strategic Vaccine Supply
Su
fficie
nt q
uan
tity o
f safe
, effe
ctiv
e a
pp
rop
riate
vaccin
e to
meet d
em
an
d
SVS: the partner for execution of vaccine introduction in developing countries
• DEMOGRAPHY &
EPIDEMIOLOGY
• PRODUCT PROFILE
• PREFERENCES
• PRICING
• COST OF GOOD
SUPPLY- DEMAND MATCHING
STRATEGICDEMAND FORECASTING
6/7/2010 8
qu
an
tity o
f safe
, effe
ctiv
e a
pp
rop
riate
vaccin
e to
meet d
em
an
d
FORECASTING PROCESSES & POLICIES
FORECAST MODEL
INFORMATION SHARING PLATFORM
Infra
stru
ctu
re
• COST OF GOOD
• LOGISTIC REQS
• PIPELINE
STRATEGIC SUPPLY FORECASTING
Strategic Vaccine Supply
Agenda
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential -strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 9Strategic Vaccine Supply
Demand ForecastDosage
Targetpopulation
Intro Date
Demography& Epidemiology
Simple modeling allow focusing discussion on key strategic variables
WHO & Concomit-ant intro
6/7/2010 10
CoverageTarget
Coverage
IntroductionAnalogue
CoverageAnalogue
Uptake
Wastage
Buffer Stocks
Required Supply (SDF)
Co financing & Pricing
Cost to GAVI
Independent variables
Dependent variables
Product Share
Conjoint
Supply Availability
Supply Forecast
Cost to Country
Strategic Vaccine Supply
Demographic, coverage &size of private market determines target population
Total Population
Crude Birth Rate
CurrentBirth Cohort
Infant Mortality Rate
Surviving Routine
Past Birth Cohorts
Catch-Up Surviving
Surviving Infants
Vaccinated via public support
Vaccinated in EPI
Routine Immunization
Coverage
Catch-Up Coverage
Vaccinated in Catch-Up
campaigns
Total Vaccinated
Surviving population at
age x
Private market
6/7/2010 11Strategic Vaccine Supply
Decision making process mirrored into estimate of introduction dates
Interest & Intention to
Pre-Intro Activities
IRC Review &
Board Application Submission
Application Preparation
ProjectedIntro
Success Ratio based on historical data
Standard time+ potential additional
delay
Min. 6 months Min. 3 months Min. 12 months1-2 years
6/7/2010 12
Intention to Apply
ActivitiesBoard
Approval(twice p.a)
Submission (twice p.a)
PreparationIntroDate
WHO regional offices & HQUNICEF regional offices & HQ
via NUVI quarterly calls & meetings
WHOGAVI Program Delivery
CCL & Large Country Input
Concomitant
Introduction
Strategic Vaccine Supply
Standardized approach for coverage projections allow focusing on exceptions
1. If historical coverage increases steadily, continue up to 90%
2. If decreasing, flat, or variable, increase 1% per annum (p.a.) up to 90%
3. If previously above 90% return to that level at 1% p.a.
4. If steady above 90%, remain at that level
Example 1 :
Niger has a steady
Niger Coverage Trend vs. Rules
60%
70%
80%
90%
100%
Covera
ge
6/7/2010Strategic Vaccine Supply 13
Niger has a steady
trend (rule 1), which
is continued up to
90%
Example 2 :
Mozambique has a
flat trend (rule 2),
which is projected to
increase at 1% p.a.
Mozambique Coverage Trend vs. Rules
60%
65%
70%
75%
80%
85%
90%
95%
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Covera
ge
Manually Chosen Historical Data
0%
10%
20%
30%
40%
50%
60%
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Covera
ge
Manually Chosen Historical Data
Time to peak estimate dependent on country size
• Small countries (birth cohort < 1m SI) take 2 years to uptake
• Med/Large countries (birth cohort between 1m and 3.5m SI) take 3 years to uptake
• Very Large (birth cohort >3.5m SI): take 4 years to uptake**
• Different uptake is used for catch-up campaigns
6/7/2010 14
Year 1 Year 2 Year 3 Year 4
Small 50% 100% 100% 100%
Med/Large 45% 75% 100% 100%
Very Large 35% 65% 85% 100%
First 4 years of Penta coverage
40%
60%
80%
100%
120%
Small Large All
Small 68% 91% 108%
Large 62% 85% 81%
All 64% 88% 95%
Year 1 Year 2 Year 3
Strategic Vaccine Supply
Uptake speed dependent on vaccine type
• New Vaccine replacing analogue: Penta, Rubella
• New Vaccine with analogue schedule: Pneumo, YF, JE
• New Vaccine with slightly different schedule (partial analogue overlap): Rota, MenA
• New Vaccine with no overlap (non-EPI): HPV, TyphoidVaccine replacing analogue: Penta, Rubella
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 1.75 years to uptake Samll: 0% 60% 100%
Large countries take 2.5 years to uptake Large: 0% 50% 90% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 40% 70% 90% 100% 20%
40%
60%
80%
100%
6/7/2010 15
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 40% 70% 90% 100%
take 4 years to uptake
New Vaccine with analogue schedule: Pneumo, YF, JE
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 2 years to uptake Samll: 0% 50% 100%
Large countries take 3 years to uptake Large: 0% 45% 75% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 35% 65% 85% 100%
take 4 years to uptake
New Vaccine with slightly different schedule: Rota, MenA
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 2.5 years to uptake Samll: 0% 50% 90% 100%
Large countries take 3.5 years to uptake Large: 0% 40% 70% 90% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 30% 55% 75% 90% 100%
take 4.5 years to uptake
New Vaccine with no overlap (non-EPI): HPV, Typhoid
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 3 years to uptake Samll: 0% 40% 75% 100%
Large countries take 4 years to uptake Large: 0% 25% 50% 75% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 20% 40% 60% 80% 100%
take 5 years to uptake
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Strategic Vaccine Supply
Scarce information available make validation process even more crucial
Assumption Ptrimary Source Benchmarks and alternative inputs
Introduction date WHO (NUVI) UNICEF - Local sources
Cross vaccines validation
Uptake (time to match target coverage)
AVI WHO / Analogues / Intelligence from
other sources
Target Coverage (historical data)
WHO-UNICEF
estimate
cMYP – Specific studies
Target Coverage GAVI-WHO GAVI / Benchmarks
6/7/2010Strategic Vaccine Supply 16
Target Coverage (projections)
GAVI-WHO
standard rule (draft)
GAVI / Benchmarks
Target population UNPD Country applications
Dosage Vaccine specific
Wastage/Buffer stocks WHO GAVI / Specific Studies
Vaccination Schedule WHO
Product Share Market Research
Supply availability SVS Intelligence from other sources
Pricing / Co-financing GAVI
Agenda
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 17Strategic Vaccine Supply
Process to be designed to ensure multiple input and sign-off
SVSbenchmarks
assumption
Assumption owners provide
input
SVS runs
forecast
Feedback
Feedback
6/7/2010Strategic Vaccine Supply 18
SVSconsolidates all
countries (with and w/o India)
SVS Sub teamreviews and
approves draft
SVS Directorpresents to PLT
for approval
AVI AMT / GAVI reviews and
approves
Version Locked
Feedback
SVS Director distributes
Assumptions clearly spelled out define conditions for the forecast to be true
Finance & support
• No global financial and supply constraints included into the demand forecast
• GAVI support based on revised eligibility approved by November 2009 board (prev. slide)
• One round of applications in September 2010, 2 rounds p.a. from 2011
• NVS support at country level (no separate state support)
• Once approved, GAVI commitment to countries ensures 5 years protection from graduation
• Financing available for product purchase & introduction costs (AMC / GAVI / local gov’nt) confirmed after prioritization work
• Sustainable co-financing prices (also after 2010 policy revision)
• PAHO single price clause not impacting negatively intention to introduce from manufacturers
6/7/2010Strategic Vaccine Supply 19
• PAHO single price clause not impacting negatively intention to introduce from manufacturers
Target Population
• Surviving Infants based on 2008 UN population prospect, medium variant for population, birth & infant mortality rates (Cameroon & Congo based on more updated country census)
Products • All products WHO pre-qualified, meet or exceed AMC profile and have suitable presentation
• Mix of international and developing countries suppliers ensures no capacity constraint; first dev’ countries products to become available in 2015
• India preference for introduction with local manufacturer can be derogated in the first years
• Schedule = 6, 10 and 14 weeks of age with DTP or Pentavalent / No Booster – some countries as India may have different schedule
• Presentation = 1-dose and 2-dose liquid vials
Close feedback loop activated between workplan and forecasts
6/7/2010 20Strategic Vaccine Supply
Agenda
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 21Strategic Vaccine Supply
Achievable impact of the selected strategy to be clearly measured
0
0
0
01 6
1015
20 21 21 21 22 23 24 26 26
32
37
45
4951
53 54 54 54 53 53 53 53 53 53 53 53
50%
60%
70%
80%
90%
100%
30
40
50
60
Imm
un
ized
In
fan
ts (
Mil
lio
ns)
Pneumococcal immunized infants and average coverage over time
0 2
8
16
23
32
37
4448 50
4743
3833 33 32 32 31 30 28 27 27
00
0
0
0
0
02
8
16
23
0%
10%
20%
30%
40%
50%
0
10
20
30
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Imm
un
ized
In
fan
ts (
Mil
lio
ns)
Routine Immunized Infants (With graduation) Routine Immunized Infants (No Graduation)
72 country routine coverage (With graduation) 72 country routine coverage (No Graduation)
Introduced country routine coverage (No Graduation)
Strategic Vaccine Supply 226/7/2010
Forecasts delivered in multiple scenarios to better assess cone of uncertainty
159167
157159
221228
237245
252 254 253 251
227
205
177200
250
300
Do
se
s (
Mil
lio
ns
)
SDF required supply v1.1 (scenario comparison)
112
36
57
77
114124
154159
167157
143
126
110 109 107 106102 97 94 90 89
110
23
40
56
7178
89100
114
84 85 87 83 82 8271 71 70 70 69 68
1
17
53
84
132
159150 146 143 144 144
0
50
100
150
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
Do
se
s (
Mil
lio
ns
)
Basecase Low High
Strategic Vaccine Supply 236/7/2010 23
Agenda
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 24Strategic Vaccine Supply
Adequate governance key success factor specially in multi-organisation setup
Steering Committee (SC)
Strategy oversight, Conflict Resolution
& Institutional Buy-in
GAVI, WHO, UNICEG, AVI-TAC
Management team (AMT)Management team (AMT)
Strategy implementation &
Operational coordination
ASC representative, departmental
heads, area directors
Functional Sub-teams (FST)
Operations management Functional representatives
11/15/2010 25
Monitoring of introduction progress critical for project success
Action Responsible Deadline Status Comments
�Availability of Financial Resources ☺ � � ? N/A
GAVI finances cover country’s introduction GAVI ☺ � � ? N/A
Vaccine co-pay terms met GAVI ☺ � � ? N/A
Country’s local financial needs budgeted GAVI/WHO ☺ � � ? N/A
� Supply Considerations ☺ � � ? N/A
Vaccine and injection supplies confirmed UNICEF SD ☺ � � ? N/A
Pen
taP
neu
mo
Ru
bell
aR
ota
JE
Country 6Country 1 Country 3Country 2 Country 4 Country 5 Country 6 Country 7 Country 8
Approval or registration requirements met UNICEF SD ☺ � � ? N/A
�Country Preparedness ☺ � � ? N/A
�Logistics WHO/UNICEF ☺ � � ? N/A
Cold chain infrastructure has sufficient
capacity at central, regional and district
levels
WHO/UNICEF ☺ � � ? N/A
Transport WHO/UNICEF ☺ � � ? N/A
Sufficient Waste Management capacity WHO/UNICEF ☺ � � ? N/A
�Training & Mobilization WHO ☺ � � ? N/A
�Advocacy and communication WHO ☺ � � ? N/A
�Monitoring & Evaluation Capacity ☺ � � ? N/A
Surveillance (AEFI and sentinel) WHO ☺ � � ? N/A
Programmatic monitoring UNICEF ☺ � � ? N/A
Ru
bell
aY
ell
ow
Fever
Men
ing
itis
AT
yp
ho
idH
PV
6/7/2010 26Strategic Vaccine Supply
Resources monitoring & corrective plans in place to deal with alternative scenarios
• Resources for critical work plan areas closely monitored by introduction team and appropriate risk-mitigation plans prepared in case of resources at risk
• Areas lagging behind in implementation • Areas lagging behind in implementation carefully assessed by introduction team and appropriate plans developed / resources identified
6/7/2010 27Strategic Vaccine Supply
Agenda
• Partnering for introduction - PATH a catalyst for global health
• Understanding demand potential - strategic demand forecasting
• Translating strategy into measurable and operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case and managing expectations
• Executing the strategy - introduction planning and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback loop
6/7/2010 28Strategic Vaccine Supply
Feedback loop between strategy & execution activate to ensure alignment and consistency
Project Goal
Execution
6/7/2010Strategic Vaccine Supply 29
Strategydefinition
Planning
Resourcemobilization