developing a country-level launch plan for global health...

Developing a Country-level Launch Plan for Global Health InnovationsMini-U | September 14,2017

USAID/CII: what we do

IDEA to IMPACT Series

Overview of workshop

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Promote and reinforce innovative, business-minded approaches to address key bottlenecks in development, introduction and scale up

Role

Approach

What we do

Accelerate the development, introduction and scale up of priority global health interventions

Catalyze Innovation

Scale for Impact

Identify Cutting-Edge Practices

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Source: Bill & Melinda Gates Foundation, Dalberg Global Development Advisors, Boston Consulting Group

Critical global health interventions historically seen late introduction, slow uptake, and low coverage

Gaps in coverage fall disproportionately on the poor and amplify inequity

FIGURE 1: YEARS TO SCALE-UP FIGURE 2: BENEFITS OF ACCELERATED UPTAKE

Accelerating scale-up by one year can result in an increased reach of 10% of the target population

CII’s IDEA to IMPACT Series looks to accelerate impact by helping practitioners plan for launch

The IDEA to IMPACT series shares guidance for scaling global health innovations to help practitioners accelerate impact through better coordination and earlier planning.

IDEA to IMPACT• Priority delivery-related

activities through the product development process

• Project management oversight

READY, SET, LAUNCH • Geographic

prioritization• Strategy development• Implementation

planning and costing

PATHWAYS to SCALE • Business-model design• Partnership evaluation


IDEA to IMPACT SeriesPathways to ScaleReady, Set, Launch


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Pathways to Scale supports business-model design and partnership evaluation

Pathways to Scale:

Guide

Toolkit

Download at www.usaid.gov/cii

• Introduces most commonly found models for scaling up global health innovations

• Features case studies that highlight pathways innovators have taken to scale up

• Contains exercises, structured questions, and key considerations to identify suitable scaling model(s)

Pathways to Scale: Scope and definitions

Innovations in scope

▪ Medical device▪ Medical diagnostic▪ Delivery mechanism for vaccines, drugs, and nutrition▪ Information and communication technology (ICT) for health

“Scale”▪ Maximizing level of usage among targeted end-user segments in target countries in

order to significantly improve health outcomes

Pathways to scale▪ A series of choices regarding business model and partnership approach to access

the appropriate resources and capabilities needed to achieve scale

Scaling models

▪ Broad categories of pathways to scale, including:1. Organic growth with selective out-sourcing2. Multi-stakeholder partnership3. Licensing out 4. Open licensing5. Getting acquired


IDEA to IMPACT SeriesPathways to ScaleReady, Set, Launch


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Ready, Set, Launch is designed to support targeted country selection and launch planning

Ready, Set, Launch: Guide

Supplemental Toolkit

• Ready, Set, Launch Framework• Key Questions and Outputs• Illustrative Exercises• Real-World Vignettes and Case

Studies

• Editable Tools and Templates (Illustrative and Blank)

• Country Launch Canvas

Download at www.usaid.gov/cii

Ready, Set, Launch is organized across a three-step framework

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Ready? Select a Geography

Prioritizes an appropriate country (or set of countries) for scale-up, based on the vision for the product and market realities at hand

Set… Build a Strategy

Assess the chosen market in depth in an effort to identify barriers to scale and address those barriers with thoughtfully designed interventions

Launch! Plan for Scale-Up

Develop a detailed operational launch plan to guide day-to-day activities, set realistic uptake targets, and create a plan to monitor progress

The Supplemental Toolkit contains tools to structure, inspire, and guide the process

SUPPLEMENTAL TOOLKIT: • Spans all steps and provides editable versions of

the tools and templates highlighted in the Guide • Growing set of tools, including

1. Country Prioritization Matrix Tool

2. Country Prioritization Table Tool

3. Go/No-Go Checklist Tool

4. Stakeholder Mapping Tool

5. Market Assessment Tool

6. Barrier Assessment Tool

7. Market Segmentation Analysis Tool

8. Comparable Product Analysis Tool

9. Intervention Design Tool10. Operational Launch Plan

Tool11. Cost Estimate Tool12. Monitoring and

Evaluation Tool13. Goals and Targets Tool14. Country Dashboard Tool15. M&E Framework

Dictionary Tool(Other additions welcome!)

COUNTRY LAUNCH CANVAS:• Provides a composite of all key elements of a

scaling strategy in one place− Living document to collect notes and

learnings− Can be continually revisited and updated to

ensure all pieces of the plan align− Not intended to replace more detailed

launch planning documents or tools




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Your turn! Apply the tools to your innovation (or one you’re familiar with)

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Fill out the tools – analyze how you would complete for your innovation (20 minutes total)

Pair up – find another team member or two

Discuss in pairs: what introduction planning aspects are highlighted by each tool, what questions does it raise, what might be next steps to consider? (20 minutes total)

Country prioritization tool Market assessment tool

4 Share a few reflections with the largest group (10 minutes total)

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Ready? Select a Geography | Ready, Set, Launch STEP 1 2 3

STEP 1.1 EXERCISE 1Country Prioritization Matrix Tool

Short List of Countries

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Evaluation of country need based on neonatal mortality rate (NMR) and home births across USAID’s 24 priority countries

Larger market size countries:

PakistanEthiopiaYemenNigeriaIndia

Demonstration effect countries:

HaitiNepalKenyaZambia

Analysis is limited to a select number of countries based on priorities

Short list of countries is split according to qualitative preferences

NMRAnalysis examines two quantifiable data points that are most relevant to the product

Illustrative

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India2

Nigeria

Pakistan

Ethiopia

Bangladesh

NepalKenya

Liberia

Madagascar

Malawi

Senegal

Mozambique

DRC

Indonesia Rwanda

MaliGhana

Yemen

Haiti

ZambiaTanzania

Uganda

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Larger market size countries:

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Demonstration effect countries:

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Data on x-axis

Evaluation of country need based on _ and _ across _ priority countries

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STEP 1.1 EXERCISE 1Country Prioritization Matrix Tool

Short List of Countries

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STEP 1.2 EXERCISE 1Country Prioritization Table Tool

Market Size Feasibility1 (Measures of feasibility blend qualitative and quantitative information)

Country Burden Addressable market size

Bangladesh 3m 1m

Uganda 10m 2m

In-country relationships

Align with national priorities

Product on EML or related list

Product registered

Existing substitutes

Uptake of similar products

Overall feasibility2,3

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Overall feasibility = (distribution mechanism) + (2 * payers) –(other products) + (.5 * substitutes)…Overall feasibility formula will use simple math and favorably weight inputs that are more credible or that are better indicators of success

Note: (1) Use Harvey Balls to track feasibility variables with the exception of ‘overall feasibility.’ Other variables can be used as identified; (2) Roll up individual countries‘ feasibility variables to score overall on a scale of 1 (lowest feasibility) to 10 (highest feasibility); (3) Create bubble chart based on these two metrics.

Harvey Balls are visually easier to absorb but each rating can map back to a specific number

Market size will apply a limiting factor to the total population impacted by the disease/health issue to estimate the addressable market

Track feasibility vs. market size in a scorecard to populate underlying data for bubble chart

Measures of feasibility blend qualitative and quantitative information

Illustrative

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STEP 1.2 EXERCISE 1Country Prioritization Table Tool

Note: (1) Use Harvey Balls to track feasibility variables with the exception of ‘overall feasibility.’ Other variables can be used as identified; (2) Roll up individual countries‘ feasibility variables to score overall on a scale of 1 (lowest feasibility) to 10 (highest feasibility); (3) Create bubble chart based on these two metrics.

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Overall feasibility = (distribution mechanism) + (2 * payers) –(other products) + (.5 * substitutes)…

Market Size Feasibility1 (Measures of feasibility blend qualitative and quantitative information)

Country Burden Addressable market size

In-country relationships

Align with national priorities

Product on EML or related list

Product registered

Existing substitutes

Uptake of similar products

Overall feasibility2,3

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Set…Build a Strategy | Ready, Set, Launch STEP 1 2 3

STEP 2.1 EXERCISE 2Market Assessment Tool

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• Who is the target user?• Who influences the target user?• What is the point of care/point of access that is most relevant?• What competing products exist?

Key questions to ask a part of a market assessment

• Will the product be supplied via local and/or global manufacturing?• What are the target delivery channels to reach target users (e.g., public, private)?• Are production economics in line with ability and willingness to pay?

• What additional clinical evidence is needed?• What does the regulatory approval process require? How long does the process take?

• Who is the target payer? What is their ability to pay? Willingness to pay?• What organizations have been involved in or provided resources for scale-up activities for similar activities in the past?• How much have scale-up interventions in the past cost?• What is the process for including the product in appropriate protocols/lists (e.g., essential medicines list, national (protocol)?

• Who are ideal candidates to lead the launch and scale-up and/or serve the uptake coordinator role?• What entities have owned/managed interventions in the past? How long did these efforts take to carry out?

Core Component

MARKET AND USER

MANUFACTURING AND DISTRIBUTION

CLINICAL EVIDENCE AND REGULATORY

POLICY, ADVOCACY, AND FINANCING

COORDINATION

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