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Deriving more value from Real world
evidence (RWE) to ensure timely access
of medicines by patients
Dr. Sarah Wamala Andersson
Consultant, Real World Evidence and Value-based medicines
EVIDENCE CONFERENCE February 22, 2017, LONDON
Deriving more value from RWE to ensure timely
access of medicines by patients
1. Why RWE now?
2. Enhancing value-based medicines through RWE
3. RWE as a means to develop strategic partnerships and
alliances
4. Challenges of realising the real value of RWE
Why increasing
interest for RWE?
Potential cost-savings with RWE
Development Launch In-market
Clinical development
(100-200m USD)
- Pricing, market access
(100m USD)
- Planning & tracking
reimbursement process
(150m USD)
- Safety & value
demonstration (200-
600m USD)
- Effectiveness
commercialization (200-
300m USD)
(RWE) Productivity & cost saving (100-200m USD)
Ref. Hughes, Kessler, 2013
Deriving more value from RWE to ensure timely
access of medicines by patients
1. Why RWE now?
2. Enhancing value-based medicines through RWE
3. RWE as a means to develop strategic partnerships and
alliances
4. Challenges of realising the real value of RWE
RCTs and RWE studies
1. Demonstrates effectiveness in the
real world of clinical practice
2. Generalizable study finding on facts
about patient journeys and
outcomes
3. Broader & more representative of
the patient population over a longer
time frame
4. Real world setting (Busy practices,
uncontrolled patients)
5. Demonstrates value for patients
and benefits within health systems
1. Demonstrates clinical efficacy and
safety
2. Randomization as an effective tool to
minimize bias and confounding
3. Limited segment of the population is
eligible for inclusion - questionable
external validity & generalizability
4. Ideal, controlled setting (”Good”
patient adherence and compliance)
5. Limited ability to investigate costs and
value within health systems
Refs. SVM Pharma
PWC 2013
i
Population in the RCTs,
Do they represent the
real world?
Utilizationinreallife
Population studied
Phases I-III Post-approval research
Variances in populations
using therapies in the real
world Vs that studied
• Age-groups
• Socio-demography
• Comorbidities
• Lifestyle
• Severity of disease
• Level of compliance
Ref. Czirakym & Pollock, Applied Clinical
Trials, 2015
RCTs
Mind the efficacy - effectiveness gap?
Deriving more value from RWE to ensure timely
access of medicines by patients
1. Why RWE now?
2. Enhancing value-based medicines through RWE
3. RWE as a means to develop strategic partnerships and
alliances
4. Challenges of realising the real value of RWE
Framework for Developing RWE
Encourages cross-functional working & external partnerships
Design
Research
questions/
Hypothesis
Identify
RWD
sources
Conduct
Statistical
Analyses
RWE
SOLUTIONS
Identify
Gaps
Cross-functional RWE teams
External partnerships
Trends towards adaptive licensing
-A push for more RWE and strategic partnerships
and alliances?
Clinical Pharmacology & TherapeuticsVolume 91, Issue 3, Version of Record online: 15 FEB 2012
Current situation Future?
Patients in RWE studies
Pharmaceuticals Licensing and Reimbursement in the European Union,
United States, and Japan
PAST FUTURE
Clinical Pharmacology & Therapeutics
Volume 100, Issue 6, pages 626-632, 17 OCT 2016 DOI: 10.1002/cpt.505
http://onlinelibrary.wiley.com/doi/10.1002/cpt.505/full#cpt505-fig-0001
Introduction of new medicines in Sweden
(collaborations between county councils, governmental agencies and the pharmaceutical industry)
Deriving more value from RWE to ensure timely
access of medicines by patients
1. Why RWE now?
2. Enhancing value-based medicines through RWE
3. RWE as a means to develop strategic partnerships and
alliances
4. Challenges of realising the real value of RWE
Challenges of RWE
1. The enthusiasm level of RWE not matched with how to actually put it
into practice
2. Poor reputation of RWE studies due to lower hierarchy of scientific
evidence
3. Lack of capabilities
4. DATA
• Size & complexity of data
• Fragmented data
• Transparency & quality of data
• Industry access to data
• Limited skills to evaluate big data with sophisticated methodology
5. Traditional design of research
• Scientists with little understanding of the real world environment
• Epidemiologic research methods
• Limited engagement of patients and relevant stake-holders in
research design Ref. PWC 2013
Concluding Remarks
1. RWE provides a huge potential to contribute to value-
based medicines.
2. RWE enables access of medicines to patients effectively,
timely and safely.
3. RWE encourages cross-functional working within
companies and external strategic partnerships and
alliances.
4. The real value of RWE will be realised by increasing
capabilities and building the scientific reputation of RWE.
RWE is here to stay! Start with RWE now!
To ensure timely access of medicines by patients
THANK YOU!

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Deriving more value from real world evidence to ensure timely access of medicines by Patients

  • 1. Deriving more value from Real world evidence (RWE) to ensure timely access of medicines by patients Dr. Sarah Wamala Andersson Consultant, Real World Evidence and Value-based medicines EVIDENCE CONFERENCE February 22, 2017, LONDON
  • 2. Deriving more value from RWE to ensure timely access of medicines by patients 1. Why RWE now? 2. Enhancing value-based medicines through RWE 3. RWE as a means to develop strategic partnerships and alliances 4. Challenges of realising the real value of RWE
  • 4. Potential cost-savings with RWE Development Launch In-market Clinical development (100-200m USD) - Pricing, market access (100m USD) - Planning & tracking reimbursement process (150m USD) - Safety & value demonstration (200- 600m USD) - Effectiveness commercialization (200- 300m USD) (RWE) Productivity & cost saving (100-200m USD) Ref. Hughes, Kessler, 2013
  • 5. Deriving more value from RWE to ensure timely access of medicines by patients 1. Why RWE now? 2. Enhancing value-based medicines through RWE 3. RWE as a means to develop strategic partnerships and alliances 4. Challenges of realising the real value of RWE
  • 6. RCTs and RWE studies 1. Demonstrates effectiveness in the real world of clinical practice 2. Generalizable study finding on facts about patient journeys and outcomes 3. Broader & more representative of the patient population over a longer time frame 4. Real world setting (Busy practices, uncontrolled patients) 5. Demonstrates value for patients and benefits within health systems 1. Demonstrates clinical efficacy and safety 2. Randomization as an effective tool to minimize bias and confounding 3. Limited segment of the population is eligible for inclusion - questionable external validity & generalizability 4. Ideal, controlled setting (”Good” patient adherence and compliance) 5. Limited ability to investigate costs and value within health systems Refs. SVM Pharma PWC 2013 i
  • 7. Population in the RCTs, Do they represent the real world? Utilizationinreallife Population studied Phases I-III Post-approval research Variances in populations using therapies in the real world Vs that studied • Age-groups • Socio-demography • Comorbidities • Lifestyle • Severity of disease • Level of compliance Ref. Czirakym & Pollock, Applied Clinical Trials, 2015 RCTs
  • 8. Mind the efficacy - effectiveness gap?
  • 9. Deriving more value from RWE to ensure timely access of medicines by patients 1. Why RWE now? 2. Enhancing value-based medicines through RWE 3. RWE as a means to develop strategic partnerships and alliances 4. Challenges of realising the real value of RWE
  • 10. Framework for Developing RWE Encourages cross-functional working & external partnerships Design Research questions/ Hypothesis Identify RWD sources Conduct Statistical Analyses RWE SOLUTIONS Identify Gaps Cross-functional RWE teams External partnerships
  • 11. Trends towards adaptive licensing -A push for more RWE and strategic partnerships and alliances?
  • 12. Clinical Pharmacology & TherapeuticsVolume 91, Issue 3, Version of Record online: 15 FEB 2012 Current situation Future? Patients in RWE studies
  • 13. Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan PAST FUTURE Clinical Pharmacology & Therapeutics Volume 100, Issue 6, pages 626-632, 17 OCT 2016 DOI: 10.1002/cpt.505 http://onlinelibrary.wiley.com/doi/10.1002/cpt.505/full#cpt505-fig-0001
  • 14. Introduction of new medicines in Sweden (collaborations between county councils, governmental agencies and the pharmaceutical industry)
  • 15. Deriving more value from RWE to ensure timely access of medicines by patients 1. Why RWE now? 2. Enhancing value-based medicines through RWE 3. RWE as a means to develop strategic partnerships and alliances 4. Challenges of realising the real value of RWE
  • 16. Challenges of RWE 1. The enthusiasm level of RWE not matched with how to actually put it into practice 2. Poor reputation of RWE studies due to lower hierarchy of scientific evidence 3. Lack of capabilities 4. DATA • Size & complexity of data • Fragmented data • Transparency & quality of data • Industry access to data • Limited skills to evaluate big data with sophisticated methodology 5. Traditional design of research • Scientists with little understanding of the real world environment • Epidemiologic research methods • Limited engagement of patients and relevant stake-holders in research design Ref. PWC 2013
  • 17. Concluding Remarks 1. RWE provides a huge potential to contribute to value- based medicines. 2. RWE enables access of medicines to patients effectively, timely and safely. 3. RWE encourages cross-functional working within companies and external strategic partnerships and alliances. 4. The real value of RWE will be realised by increasing capabilities and building the scientific reputation of RWE.
  • 18. RWE is here to stay! Start with RWE now! To ensure timely access of medicines by patients