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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?
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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