Total Systems EffectivenessEvaluating all trade-offs to inform choice

Total Systems Effectiveness (TSE) Pilot: developing the country use case using rotavirus vaccines as a case study

Birgitte Giersing

Rotavirus Symposium31st August 2018

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TSE working definition

’An approach to identify the value of products and product attributes from a country programme perspective, to guide

investment in research and development, and inform priority setting for national immunisation programmes, global policy

decisions and market shaping’

What does TSE aim to accomplish?

3

R&DSAGE, PQ, procurem

ent

Country uptake

TSE approach: accelerated availability and access to vaccine innovation in LMICs

TSE should create a ‘pull’ for new products that meet LMIC needs

Country needs

Market shaping,

PPC

R&D (TPPs)

TSE promotes a change in the product development paradigm, so that country demand informs product development

Traditional approach

R&DSAGE, PQ, procurem

ent

Country uptake

PQ – pre-qualification; PPC – preferred product characteristics (guidance from WHO for a specific pathogen)TPP – target product profile (produced by product developers for a specific product)

How will TSE inform?

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Preferred product characteristics and public health value

Country barriers assessment

Country Aselection and introduction criteria

Investment & incentives

Novel products with clear use case (market and demand)

Country barriers assessment

Country Cselection and introduction criteria

Country barriers assessment

Country Bselection and introduction criteria

Coun

try

use

case

R&D

use

case

Glo

bal u

se ca

se

TSE partners

Early methodology of TSE

Health & financial impact

Coverage

Safety

Commodity cost

Delivery cost

Impa

ctCo

st

Outputcompare impact and cost trade-offs across products and equity

dimensions

Vaccine attributes (country agnostic)

Country attributes (vaccine agnostic)

• Vaccine efficacy• Factors affecting

potency• Duration of protection

• Disease epidemiology• OOP costs

• Attributes overcoming barriers to coverage

• Target population• Barriers to vaccination

• Factors affecting safety• AEFI incidence

• Wastage • Commodity price• Procurement cost

• Co-financing• Wastage rates

• Method of waste disposal

• Time for administration• etc

• Unit cost (e.g. transport,waste disposal, training)

Original TSE methodology overview

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FINANCIAL RISK PROTECTION Input: OOP cost for vaccination (C)Number doses administered (C2)OOP for RV illness (C)Health impact (H1, H2, H3)

Output:F1: Change in OOP cost per capitaF2: Catastrophic health expenditure cases averted

SAFETYInput:AEFI incidence (P)Attributes affecting vaccine safety (P)Frequency of needlestick injury, contamination, etc(C)Number doses (C3)

Output:S1: Number hospitalisationsS2: Number deaths

HEALTH IMPACT Input: Effectiveness/efficacy (C/P)Duration of protection (P)Attributes affecting vaccine effectiveness (P)Proportion of ineffective vaccine doses administered (e.g. due to heat/freeze exposure) (C)Number fully/partially immunised (C1, C2)Disease epidemiology (number cases, deaths, hospitalisations) (C)

Output:H1: Number cases avertedH2: Number hospitalisations avertedH3: Number deaths averted

COMMODITY COST Input:Number of doses (C3)Number fully immunised (C1)Wastage (P)Commodity price/co-pay (P/C)Procurement cost (P)

Output:CC1: Number of each commodity procuredCC2: Total financial cost (commodities)CC3: Financial cost per FIC

HEALTH SYSTEM CHANGESInput:Social mobilisation/IEC intensity (P)Number of HW (C)Training/supervision intensity (P)Storage volume (P)Storage capacity (C)Quantity of each commodity procured (CC1)

Output:HS1: Additional HW requiredHS2: New storage required

DELIVERY COST Input:Number each commodity (CC1)Waste disposal cost (C)Method of waste disposal (P)Transport cost (C)Change HW at each level(HS1)Change in storage (HS2)Time for administration (P)Cost of administration (C)

Cost of social mobilisation, communication, training (C)Cost of storage (energy etc) (C)

Output:DC1: Total financial cost (delivery)DC2: Financial cost per FIC)

COVERAGEInput:Target population (C)Vx product attributes that relate to coverage (P)Barriers to vaccination (C)

Output:C1: Number fully immunisedC2: Number partially immunisedC3: Number doses administered

KeyP = product attributeC = country attributeC1/S2/etc = output from other TSE component

Purpose and objectives of the TSE pilot project

Purpose: would TSE be useful and of interest to countries?

1) Is TSE applicable for country decisions?

2) Which tools are needed?

3) What are data and capacity constraints?

Rationale for using rotavirus vaccines in the TSE country test case

Products differentiated by:o Priceo No of doseso Wastageo Storageo Cold chain footprinto Relevance & familiarity o Existing data

Pilot country selection

Region Income status Immunisation maturity*

Policy setting**

Status of RV introduction

Indonesia SEARO LMIC (fully self-financing) No data 6 Not introduced

Mali AFRO (W) LIC (initial self-financing) Category 2 3 Introduced (Gavi)

Rwanda AFRO (S&E) LIC (initial self-financing) Category 4 NONE Introduced (Gavi)

Thailand SEARO UMIC No data 6 Introduced

* Defined according to WHO criteria: category 1 (weak) – category 4 (strong)** Measure: # WHO NITAG criteria that are met (max = 6)

• Country interest gauged through official WHO outreach

• Countries with a range of characteristics selected

Country workshops

Participants: EPI, MOH (planning, finance), NITAG, academics, regulatory

Format:

1) Introduction to TSE and objectives

2) Group exercise using TSE tool for decision-making

3) Overview of existing product selection process

4) Discussion: usefulness and applications for TSE

Note: workshop content and agenda was refined throughout the pilot

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Pilot country workshop status

Region Income status Immunisation maturity*

Policy setting**

Status of RV introduction

Indonesia SEARO LMIC (fully self-financing) No data 6 Not introduced

Mali AFRO (W) LIC (initial self-financing) Category 2 3 Introduced (Gavi)

Rwanda AFRO (S&E) LIC (initial self-financing) Category 4 NONE Introduced (Gavi)

(2) Thailand SEARO UMIC No data 6 Introduced

* Defined according to WHO criteria: category 1 (weak) – category 4 (strong)** Measure: # WHO NITAG criteria that are met (max = 6)

At least 2 workshops in each country are scheduled to be completed by end 2018

WHO and independent oversight, and iterative learning for country pilots

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IVIRAC review

Mar 2018

• Indonesia

•Thailand

May 2018

• IPAC, PDVAC

•R&D in SE Asia

Jul 2018

•Thailand review

•Mali

Aug 2018

IVIRAC review

Sep 2018 RwandaOct

2018

Review by TSE steering committee and modelling working group

IVIRAC: Immunization and vaccines related implementation research advisory committeePDVAC: Product Development for Vaccines advisory committeeIPAC: Immunization Practices advisory committee

Indonesia TSE workshop (2nd – 3rd

May 2018)

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Mali TSE workshop (13th-16th Aug 2018)

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R&D meeting in Thailand (1st Aug 2018): outcomes

• There is a lack of clarity regarding preferred products and

characteristics for use in LMICs, but an interest in developing ‘global’

products

• Product developers are interested in understanding what is needed for

products to address programmatic needs and country preferences.

• An understanding of factors affecting in country decision making, and

transparency and consistency of that decision making approach will be

helpful to inform R&D investments

• TSE needs to consider how the R&D environment may change over a 5-

10+ year time horizon. 16

Key lessons learned so far

1) There appears to be an interest from LMICs to use TSE to strengthen

decision-making and to communicate product preferences and needs.

2) TSE should be seen as a process (country level) and system (global level),

with communication mechanisms that incorporate longitudinal and

iterative approaches. A tool-kit to facilitate this is needed.

3) Ensure that TSE remains a bottom-up, country-led approach, with

flexibility to leverage the existing country evidence-base (TSE is an

umbrella).

4) User-friendly tools, technical support and guidance are necessary to

develop and implement TSE.

Limitations of TSE

1) TSE does not (currently) consider the future systems infrastructure of a

country, i.e., what will the delivery system look like for prioritised

products by the time they are taken up?

2) TSE will be most powerful if it could be applied across a portfolio of

vaccines, i.e. which bundles of vaccines would be beneficial, how can we

leverage an innovation across a bundle, or which combinations would be

most beneficial?

3) It will be challenging for TSE to measure impact; how could this be

demonstrated at both a country and a global (R&D and market shaping)

level?

Next steps

1) Working with partners to review pilot experience and align on future

vision of TSE: Sep 2018

2) Develop “TSE toolkit” for country use – initial testing in Mali Q4 2018

3) Developing a proposal for 3 year scope of work starting 2019 take TSE

beyond the pilot phase.

With THANKS!

TSE Modelling Working Group:Rob BaltussenAndrew ClarkFred Debellut

Ben McCormickMartin MeltzerVittal MogasalePraveen Thokala

Noor Tromp

TSE Steering committee:

Jean-Pierre AmorijHeather DeehanRichard Duncan

Deborah KristensenPascale LeroueilMarion Menozzi-

ArnaudMercy MvunduraAnna Osbourne

Sarah PallasJulia Roper

David SarleyNine Steensma

Susan Wang

WHO:Melanie Bertram

Joseph BietVinod Bura

Tessa EdejerNathalie El Omeiri

Raymond HutubessyAnna-Lea KahnTheadora Koller

Patrick LydonJason Mwenda

Marie Rosette NahimanaAlexis Satoulou-MaleyoAnne SchlototheuberAbdoul Karim Sidibe

Baba Tounkara

Indonesia core team:Jarir Atthobari

Santi IkrariSoewarto Koesen

Liza MuniraMardiati NadjibSeptiara Putri

Sri RezekiAuliya SewantikaDidik SetiawanEry Setiawan

Panji Hadi SumartoJulitasari Sundaro

Mali preparatory team:Abdoul Aziz Diakate

Ibrahim DIARRASeydou Kouyate

Alima NacoFanta Niare

Yacouba SangareBoubacar Traore

Souleymane Traore

ASC Academics:Jos LuttjeboerGert Vondeling

Thailand core team:Rachel Archer

Saudamini DabakRajibul Islam

Ritika Kapoor (NUS)Waranya Rattanavipapong

Manushi SharmaYot Teerawattananon

Additional experts:Craig Burgess

Mark JitSamba Sow

CHAI Nigeria

TSE project manager:Siobhan Botwright