Introduction Of New Vaccines In The Public Market

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


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




• Translating strategy into measurable and operational objectives - strategic planning

This session will focus on six main themes

operational objectives - strategic planning





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


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


Su

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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

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, effe

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vaccin

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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


• Understanding demand potential -strategic demand forecasting






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


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


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


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


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


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%


New Vaccine with slightly different schedule: Rota, MenA


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%


take 4.5 years to uptake

New Vaccine with no overlap (non-EPI): HPV, Typhoid


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%



0%

20%

40%

60%

80%

100%


0%


0%

20%

40%

60%

80%

100%


0%

20%

40%

60%

80%

100%



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


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








Process to be designed to ensure multiple input and sign-off

SVSbenchmarks

assumption

Assumption owners provide

input

SVS runs

forecast

Feedback

Feedback


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


• 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


Agenda








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

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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

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0%

10%

20%

30%

40%

50%

0

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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

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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

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Mil

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ns

)

Basecase Low High

Strategic Vaccine Supply 236/7/2010 23

Agenda








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

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Fever

Men

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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


Agenda








Feedback loop between strategy & execution activate to ensure alignment and consistency

Project Goal

Execution


Strategydefinition

Planning

Resourcemobilization

THANKS FOR YOUR ATTENTION

[email protected]


Health & Medicine

Introduction Of New Vaccines In The Public Market