Stefan Holmstrom - eyeforpharmasocial.eyeforpharma.com/sites/default/files/stefan_holmstrom.pdf ·...
Transcript of Stefan Holmstrom - eyeforpharmasocial.eyeforpharma.com/sites/default/files/stefan_holmstrom.pdf ·...
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Build a deeper appreciation and understanding of HTA needs into
your wider organization
Stefan HolmstromExecutive Director HEOR
Medical Affairs, Global
Astellas Pharma
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Outline of presentation
1. Changing environment of Pharma
2. The Challenge
• External
• Internal
3. Integrating HTA needs into organization and internal alignment
4. Conclusion
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Changes in the healthcare environment
A number of factors are having increasing influence on
healthcare decision making, resulting in pressure and
focus on healthcare budgets.
Pressure on
healthcare
budgets
Ageing
population
& resulting
increase in
chronic illness
Advances in
medical
technology
Slower
economic
growthCost
containment
measures
by payers
Increasing
number &
types of
healthcare
professionals
Increase
in public
expectation
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Defining the challenges
External challenges
The HTA and Payers
Internal challenges
The internal stakeholders and focus
points
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We all have different focus
ExternalHTA and Payer is focusing on optimizing the use of limited resources/budgets
InternalDevelopment organization is focusing on getting NDA and MAA approvals
Pricing department is focusing on getting the “best possible price” = highest possible price?
Commercial is focusing on getting the biggest market share
Health Economics is focusing on getting an acceptable ICER
Market Access is focusing on getting payer acceptance
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Regulators versus HTA bodies
“Having an approved NDA/MAA,
qualifies you to talk to me”
Dr. Andrew Walker,
Sr. Economic Reviewer, SMC
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Payer Need Payer performance measures
R&D delivery
Performance Reduction in symptoms RCT – show efficacy improvements (x-y%)
Effective Usage Clear stop/start rules Identify responders/diagnostics
Value for Money Benefit vs. costs is acceptable Economic Modeling
Human Impact Acceptable QoL for patients Demonstrate effect on QoL and family
Stakeholders Level of pressure from key influencers
Build Constituent need in trial design
Real-world Proof (based on data) that it will deliver real world results
Phase IV open label, Observational, Chart review
HTA & Payer relevant endpoints
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Our challenges
Safety & Efficacy
Quality
Payers/ HTA
Cost Effective
Budget Impact
Physician and
Patient
acceptance
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Dialog with regulators, payers & HTA bodies on endpoints and design
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Defining the challenges
External challenges
The HTA and Payers
Internal challenges
The internal stakeholders and focus
points
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Stakeholder views on the role of a GVD
4
1
2
5
EU5 (n=6) Non EU5 (n=6)
EU5 vs. non EU5 LAF
Yes No
HQ:
“Without the GVD you may have submissions
prepared by people that don’t understand your
strategy behind the positioning of the drug..”
UK-LAF:
“No, it purely depends on the data and
if the data is relevant to the market.”
Can a GVD influence submission outcome?
5
6
7
1
0% 50% 100%
LAF (n=12)
HQ (n=7)
HQ and LAF responses
Yes
No
N/A
With permission of Quintiles Advisory Services, Pim Kooreman, 2015
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• HQ: All sections presented in the GVD are equally important (n=7/7; 100%)
• LAF: Some sections are more important than others (n=11/12; 92%)
» Clinical data (n=8)
» Positioning statements (n=5)
» Economical data (n=3)
Stakeholder views on the content of a GVD
DE-LAF:
“Not really missing but not
as in depth as I need it from
a country perspective.”
HQ:
“They are all equally
important, the GVD is
telling a story. “
Are there any sections in the GVD more important than others?
Is there information missing from the GVD?
7 5
5 1
0% 20% 40% 60% 80% 100%
LAF (n=12)
HQ (n=6)
HQ and LAF responses
Yes
No
Ambiguous
With permission of Quintiles Advisory Services, Pim Kooreman, 2015
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Outline of presentation
1. Changing environment of Pharma
2. The Challenge
• External
• Internal
3. Integrating HTA needs into organization and internal alignment
4. Conclusion
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HEOR Key activities to maximize product value
10% 20% 30% 40%
Drug discovery today 02/2012; 17(11-12):615-22
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Pyramid of refinementFinding the balance with your intrinsic data & results and the HTA/Payer needs
Blue Sky
Testing your message hypothesis, endpoints,
PRO’s and models
Delivering final Value Propositions and
HE model
RWE and
refined Value
POC
Launch
LCM
ph2
ph3
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The Global Value Alignment model
(Phase II) Phase IIIARegulatorysubmission
HTA/ Reimbursement
submissions, Phase IIIb/IV
To LCM
Value Arguments
Early Evidence Generation
Value dossier Country dossiersEarly Value Dossier
(POC)
Late Phase Evidence Generation/Value Dissemination
Data examples Data examples
Global Value Team
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Global Value Team
Chair
Region
Region
Region
Global
Strategic
Alignment
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Integrated focus for optimal Market Access
HTA strategy
Reimbursement
strategy
Brand support
LCM and
Regional supportGuidance
Competitors and
RWE
R&D Focus
Development focus
R&D Commercial
Regions/
Affiliates
Strategic
support
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2020
Integrated focus for optimal Market Access
HTA strategy
Reimbursement
strategy
Brand support
LCM and
Regional support
Guidance
Competitors and
RWE
R&D Focus
Development
focus
Multidisciplinary approach
Market Access
Governmental
Affairs/PolicyClinical
Medical
HEOR
CommercialRegulatory
Statistics
R&D Commercial
Regions/
Affiliates
Strategic
support
KAM
Pre Clinical
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Global Value Team
Chair
Region
Region
Region
Global
Strategic
Alignment
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What does good look like?
• GVD Structural optimization
• Regional and Affiliate input
• Focus on Medical Affairs Core Medical Team
• Endpoint selection
• Guidance
• Focus on development structure Core Team
• Methodology excellence
• HTA Expert networks
• Early Scientific Advice
• PRO and QoL guidance
• Instrument control
• PRO Expert network
PRO’s HTA
Global VDEarly
Development
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Value chain, working by stage
Launch readiness Post approval supportLocal level
engagement
Strategic
and
tactical
activities
• HEOR input into
Development studies
(Phase 2 / 3 studies)
• Preparation of Global
Value Dossier
• PRO assessment and
input
• Landscape assessment
(e.g. unmet need, disease
burden, competitor
analysis)
• Engagement with
customers (e.g. product
presentations)
• Adjust Global Value
Dossier to country needs
• HEOR projects:
− disease registries
− External database
analyses
− Post hoc analyses
− Big data analyses
• Adjust Global Value
Dossier to region and
country needs
• Alignment and governance
of HEOR activities
ApprovalEarly decision
Involve-
ment
Global,
(with region input)
Region,
with Global coordination
Country execution
(with region support)
Global Value team coordination
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Key recommendations
• Tailor global market access strategy based on product qualities
• Breakthrough/first in class vs. me too vs. follower
• Be pro-active and understand setting-specific requirements and payer mindset
• engage with key stakeholders early on (regulators, HTAs, patients); not always easy, but necessary
• Ensure global alignment with development team members (statistics, project lead, medical, regulatory, HEOR, commercial, etc.) as well as continuous regional and policy input
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Key recommendations
• Ensure Value Dossier is available at NDA/MAA approval
• Enhance skills and capacity internally to understand client needs:
• Health systems
• Pricing, Health economics and outcomes
• Patient advocacy
• Regulatory
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CONCLUSION
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Conclusion
● Planning for evidence generation should begin in early phase and be regarded as a “living” process that can be updated to account for new internal data and new external pressures throughout the product lifecycle
• Identify unmet information needs
• Align evidence with product value
proposition
• Build implementation plan
• Health Care Professionals
• Patients & Caregivers
• Regulators/Health Authorities
• Payers
P r o d u c t L i f e C y c l e
Integrated,
Holistic
Evidence
Generation
Develop credible evidence…
…when it is needed
…for appropriate audiences…
Phase II Phase III Phase IV Loss of Exclusivity (LOE)
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To accomplish great things,
we must not only act,
but also dream;
not only plan,
but also believe
- Anatole France