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contact:
phone:
email:
date:
office:
web:
Dr Suki Kandola
+44 1628 486048
skandola@curo.co.uk
May 12th 2016
Chilterns House, Dean St, Marlow, SL7 3AA
www.curo.co.uk
From Evidence
to Access:
How GVDs
Need to Evolve
Overview
What you will learn:
 How to avoid the common pitfalls experienced when developing GVDs
 An effective approach to developing GVDs
 Some simple mechanics for insight generation and more effective management of the
value creation process
 How global engagement and sharing of the GVD through an interactive user-friendly
cloud-based Platform ensures an integrated and consistent approach to
reimbursement across multiple jurisdictions
 iGVD analytics to track usage by affiliates and to help inform future evidence
generation strategy
The GVD
A key market access
strategy document
summarising the
Value and supporting
evidence (including
clinical, economic,
quality of life studies)
for a new product to
clearly communicate
the value proposition
story to all relevant
stakeholders.
The Challenge
Very often the GVD remains unused
for several reasons:
 Lack of a systematic review of the literature – building a differentiating and
payer-relevant value strategy requires a comprehensive understanding of the
SoC landscape.
 Sometimes they are developed as a data dump rather than a value story
presenting document – the goal is to include everything!
 They do not present the TOTAL value proposition – economic, humanistic,
clinical, safety and market access value story - GVD should not fail to target the
messaging to the product-relevant Payer stakeholders
 Often the needs of the local affiliates e.g. local treatment guidelines may have
not been assessed and captured
 The GVD is developed as a long difficult-to-navigate document
 GVD feedback is difficult to capture to inform future GVD and evidence
generation strategy
The Challenge
Very often the GVD remains unused
for several reasons:
 Lack of a systematic review of the literature – building a differentiating and
payer-relevant value strategy requires a comprehensive understanding of the
SoC landscape.

 They do not present the TOTAL value proposition – economic, humanistic,
clinical, safety and market access value story - GVD should not fail to target the
messaging to the product-relevant Payer stakeholders

 The GVD is developed as a long difficult-to-navigate document

Buildingwebbasedsolutions
The Challenge
3 ways to get more from your GVD:
1. Lack of a systematic review of the literature
 It is critical that the value messaging is aligned with unmet need. Burden of
disease analysis is required to substantiate and evolve current messaging
around unmet need. Performance of a given new product vs. these unmet
needs will be a core driver of Access
2. They do not present the TOTAL value proposition
 Creating a GVD means planning to ensure that you are building a multi-
faceted value proposition, before you start writing. Evidence standards are
rising so a Value strategy needs to evolve over time based on new,
validated data and changing comparators i.e. it must be iterative.
3. The GVD is developed as a long difficult-to-navigate
document – how to drive and monitor usage
 We know GVD use is instrumental to ensure a consistent approach to
Access. Having an effective means for communicating the Value Story and
evidence base to affiliates, allowing them to customise the GVD to a local
dossier readily, and capture feedback to inform evidence generation
strategy, is really the only way to measure your return on investment.
An Effective Approach to GVDs
Conduct
systematic
reviews to
optimise the
TPP
Assess the
current
landscape,
burden of
disease data
and unmet
need
Engage
with the local
affiliates to
assess need
Plan and
create a
multi-faceted
Value
Proposition
Local
Value
Proposition
testing
Create the
GVD
Create iGVD
platform to
share, update,
disseminate to
affiliates and
track usage
Building web based solutions
Evidence Review
1. Systematic Literature Review process
Defining
appropriate
research
question
Eligibility
criteria
Identifying
relevant
studies
Study
selection
Data
extraction
Critical
appraisal
of
included
studies
Data
synthesis
Report
writing
LENS (Literature & Evidence Navigation System)
LENS (Literature & Evidence Navigation System)
Creating the Value Proposition
2. Value Proposition Development
Value: The benefit of the product beyond price, to the customer or
decision maker in quantitative terms
1
CORE
VALUE
MESSAGE
1.1
SUPPORTING
MESSAGE
1.2
SUPPORTING
MESSAGE
2
CORE
VALUE
MESSAGE
2.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
3
CORE
VALUE
MESSAGE
3.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
4
CORE
VALUE
MESSAGE
4.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
SUPPORTING
DATA
SUPPORTING
DATA
Value Proposition
Creating the Value Proposition
2. Value Proposition Development
Value: The benefit of the product beyond price, to the customer or
decision maker in quantitative terms
1
CORE
VALUE
MESSAGE
1.1
SUPPORTING
MESSAGE
1.2
SUPPORTING
MESSAGE
2
CORE
VALUE
MESSAGE
2.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
3
CORE
VALUE
MESSAGE
3.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
4
CORE
VALUE
MESSAGE
4.1
SUPPORTING
MESSAGE
SUPPORTING
DATA
SUPPORTING
DATA
Value Proposition
Creating the Value Proposition
Planning and building a multi-faceted
Value Proposition
Creating the Value Proposition
VET:
Value Evidence
Tracker - how
the Value
Messages are
supported and
the likelihood of
success
VET: Value Evidence Tracker
VET:
Track
comparative
performance vs
value messages
to understand
level of
differentiation
The iGVD Platform
3. How to drive and monitor usage of your GVD
Users of the GVD, need to find the information they need easily and as
quickly as possible - from the value story, to differentiation compared to their
local SoC, the supporting body text, to the source reference.
A GVD can never fully encompass the needs of every jurisdiction but we can
ensure that the information and the Tools to adapt and customise the GVD
are readily available to the affiliates
Contrary to a traditional GVDs, an iGVD allows users to
interact with, consume and localize GVD content more easily.
Definitions of interactive:
 Hyperlinked document to allowing the user to find
information more easily
 Platform based interactive Tool which allows the user
to edit / add / remove / content online and change
the GVD structure
The iGVD Platform
iGVD:
find what you
want from
anywhere within
the GVD
with simple
parameter
based search
iGVD Analytics
 Content changes
across countries
 Tracking usage of the
GVD for Product X
iGVD:
Identify changes
and usage
across affiliates
Summary
 Comprehensive understanding of the current landscape to ensure
that value messaging aligns to unmet need. Involve affiliates early
to capture relevant local data (BoI, treatment guidelines,
comparators, etc), or through a LENS built for your SLR.
 Sharing the GVD through an interactive user-friendly cloud-
based Platform to facilitate use, make it more readily localisable
and ensure a consistent approach to reimbursement across
multiple jurisdictions. iGVD analytics track usage and help
inform future evidence generation strategy.
 Simple mechanics to support building a Value Proposition
across the organisation , assessing the relative strength of the
evidence that supports the CVMs, identify data gaps and align
on designing evidence to close the gap
An effective approach to developing your GVD
and maximising usage:
About the Author
Suki Kandola, PhD MBA
Director – Health Economics & Market Access
With over 15 years’ pharmaceutical experience, working within both
pharma R&D and a variety of customer facing roles, Suki brings her
considerable industry knowledge to the table at Curo.
Combined with a PhD in Research Chemistry and an MBA, Suki
works closely with our customers to create bespoke solutions for
their Market Access needs, helping to implement an innovative and
collaborative approach between our customers and healthcare
funding bodies.
skandola@curo.co.uk
Curo is a global Market Access consultancy and communications agency. We work
with the pharmaceutical industry and healthcare funding bodies (Payers) to enable an
innovative and collaborative approach to Market Access for new therapies.
Curo can enable you to formulate a solid Market Access strategy by offering honest
perspectives on evidence and value. Working with your HEOR data, our analysts can
help you to understand the real-world impact of your therapy in a given disease area.
Curo helps you to create a narrative that means much more than just numbers on a
spreadsheet – we breathe life into your data.

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How GVDs Need to Evolve

  • 1. contact: phone: email: date: office: web: Dr Suki Kandola +44 1628 486048 skandola@curo.co.uk May 12th 2016 Chilterns House, Dean St, Marlow, SL7 3AA www.curo.co.uk From Evidence to Access: How GVDs Need to Evolve
  • 2. Overview What you will learn:  How to avoid the common pitfalls experienced when developing GVDs  An effective approach to developing GVDs  Some simple mechanics for insight generation and more effective management of the value creation process  How global engagement and sharing of the GVD through an interactive user-friendly cloud-based Platform ensures an integrated and consistent approach to reimbursement across multiple jurisdictions  iGVD analytics to track usage by affiliates and to help inform future evidence generation strategy
  • 3. The GVD A key market access strategy document summarising the Value and supporting evidence (including clinical, economic, quality of life studies) for a new product to clearly communicate the value proposition story to all relevant stakeholders.
  • 4. The Challenge Very often the GVD remains unused for several reasons:  Lack of a systematic review of the literature – building a differentiating and payer-relevant value strategy requires a comprehensive understanding of the SoC landscape.  Sometimes they are developed as a data dump rather than a value story presenting document – the goal is to include everything!  They do not present the TOTAL value proposition – economic, humanistic, clinical, safety and market access value story - GVD should not fail to target the messaging to the product-relevant Payer stakeholders  Often the needs of the local affiliates e.g. local treatment guidelines may have not been assessed and captured  The GVD is developed as a long difficult-to-navigate document  GVD feedback is difficult to capture to inform future GVD and evidence generation strategy
  • 5. The Challenge Very often the GVD remains unused for several reasons:  Lack of a systematic review of the literature – building a differentiating and payer-relevant value strategy requires a comprehensive understanding of the SoC landscape.   They do not present the TOTAL value proposition – economic, humanistic, clinical, safety and market access value story - GVD should not fail to target the messaging to the product-relevant Payer stakeholders   The GVD is developed as a long difficult-to-navigate document  Buildingwebbasedsolutions
  • 6. The Challenge 3 ways to get more from your GVD: 1. Lack of a systematic review of the literature  It is critical that the value messaging is aligned with unmet need. Burden of disease analysis is required to substantiate and evolve current messaging around unmet need. Performance of a given new product vs. these unmet needs will be a core driver of Access 2. They do not present the TOTAL value proposition  Creating a GVD means planning to ensure that you are building a multi- faceted value proposition, before you start writing. Evidence standards are rising so a Value strategy needs to evolve over time based on new, validated data and changing comparators i.e. it must be iterative. 3. The GVD is developed as a long difficult-to-navigate document – how to drive and monitor usage  We know GVD use is instrumental to ensure a consistent approach to Access. Having an effective means for communicating the Value Story and evidence base to affiliates, allowing them to customise the GVD to a local dossier readily, and capture feedback to inform evidence generation strategy, is really the only way to measure your return on investment.
  • 7. An Effective Approach to GVDs Conduct systematic reviews to optimise the TPP Assess the current landscape, burden of disease data and unmet need Engage with the local affiliates to assess need Plan and create a multi-faceted Value Proposition Local Value Proposition testing Create the GVD Create iGVD platform to share, update, disseminate to affiliates and track usage Building web based solutions
  • 8. Evidence Review 1. Systematic Literature Review process Defining appropriate research question Eligibility criteria Identifying relevant studies Study selection Data extraction Critical appraisal of included studies Data synthesis Report writing
  • 9. LENS (Literature & Evidence Navigation System)
  • 10. LENS (Literature & Evidence Navigation System)
  • 11. Creating the Value Proposition 2. Value Proposition Development Value: The benefit of the product beyond price, to the customer or decision maker in quantitative terms 1 CORE VALUE MESSAGE 1.1 SUPPORTING MESSAGE 1.2 SUPPORTING MESSAGE 2 CORE VALUE MESSAGE 2.1 SUPPORTING MESSAGE SUPPORTING DATA 3 CORE VALUE MESSAGE 3.1 SUPPORTING MESSAGE SUPPORTING DATA 4 CORE VALUE MESSAGE 4.1 SUPPORTING MESSAGE SUPPORTING DATA SUPPORTING DATA SUPPORTING DATA Value Proposition
  • 12. Creating the Value Proposition 2. Value Proposition Development Value: The benefit of the product beyond price, to the customer or decision maker in quantitative terms 1 CORE VALUE MESSAGE 1.1 SUPPORTING MESSAGE 1.2 SUPPORTING MESSAGE 2 CORE VALUE MESSAGE 2.1 SUPPORTING MESSAGE SUPPORTING DATA 3 CORE VALUE MESSAGE 3.1 SUPPORTING MESSAGE SUPPORTING DATA 4 CORE VALUE MESSAGE 4.1 SUPPORTING MESSAGE SUPPORTING DATA SUPPORTING DATA Value Proposition
  • 13. Creating the Value Proposition Planning and building a multi-faceted Value Proposition
  • 14. Creating the Value Proposition VET: Value Evidence Tracker - how the Value Messages are supported and the likelihood of success
  • 15. VET: Value Evidence Tracker VET: Track comparative performance vs value messages to understand level of differentiation
  • 16. The iGVD Platform 3. How to drive and monitor usage of your GVD Users of the GVD, need to find the information they need easily and as quickly as possible - from the value story, to differentiation compared to their local SoC, the supporting body text, to the source reference. A GVD can never fully encompass the needs of every jurisdiction but we can ensure that the information and the Tools to adapt and customise the GVD are readily available to the affiliates Contrary to a traditional GVDs, an iGVD allows users to interact with, consume and localize GVD content more easily. Definitions of interactive:  Hyperlinked document to allowing the user to find information more easily  Platform based interactive Tool which allows the user to edit / add / remove / content online and change the GVD structure
  • 17. The iGVD Platform iGVD: find what you want from anywhere within the GVD with simple parameter based search
  • 18. iGVD Analytics  Content changes across countries  Tracking usage of the GVD for Product X iGVD: Identify changes and usage across affiliates
  • 19. Summary  Comprehensive understanding of the current landscape to ensure that value messaging aligns to unmet need. Involve affiliates early to capture relevant local data (BoI, treatment guidelines, comparators, etc), or through a LENS built for your SLR.  Sharing the GVD through an interactive user-friendly cloud- based Platform to facilitate use, make it more readily localisable and ensure a consistent approach to reimbursement across multiple jurisdictions. iGVD analytics track usage and help inform future evidence generation strategy.  Simple mechanics to support building a Value Proposition across the organisation , assessing the relative strength of the evidence that supports the CVMs, identify data gaps and align on designing evidence to close the gap An effective approach to developing your GVD and maximising usage:
  • 20. About the Author Suki Kandola, PhD MBA Director – Health Economics & Market Access With over 15 years’ pharmaceutical experience, working within both pharma R&D and a variety of customer facing roles, Suki brings her considerable industry knowledge to the table at Curo. Combined with a PhD in Research Chemistry and an MBA, Suki works closely with our customers to create bespoke solutions for their Market Access needs, helping to implement an innovative and collaborative approach between our customers and healthcare funding bodies.
  • 21. skandola@curo.co.uk Curo is a global Market Access consultancy and communications agency. We work with the pharmaceutical industry and healthcare funding bodies (Payers) to enable an innovative and collaborative approach to Market Access for new therapies. Curo can enable you to formulate a solid Market Access strategy by offering honest perspectives on evidence and value. Working with your HEOR data, our analysts can help you to understand the real-world impact of your therapy in a given disease area. Curo helps you to create a narrative that means much more than just numbers on a spreadsheet – we breathe life into your data.

Hinweis der Redaktion

  1. 2) Multi-faceted VP
  2. GVD creation is about planning and reiterative building… Planning – is about analysing your evidence, doing the gap analysis, assessing your evidence against the VM and ensuring you have a multifaceted VP Very often we see people start dropping text into a template and populating a GVD template with BOD, unmet need etc. without doing any gap analysis So we urge you to plan plan plan before you start writing to ensure that you have capture evidence to: - not only support a clinical VS which will give you a 1 dimensional Value Prop - but also all the relevant components such as policy, economic and even PROs And that’s when you start writing and building your GVD… Remembering that the Value Story needs to be iterative as new evidence comes to light - on an ongoing basis