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Jennifer Jacobs, Stowaway
Jennifer is a New York based artist
living with Type 1 diabetes.
Clare Hague
Senior Director, Health Economics, Market Access & Reimbursement
Janssen Europe, Middle-East and Africa
July 15, 2021
The Value of Innovation to Patients & Health Systems
2
Cancer remains a public health challenge - the second leading
cause of death in Europe
Cancer accounted for 1 in 4 deaths in Europe2
3.91 million
new cases
1.93 million
deaths
In Europe in 2018, an estimated
Source:
1. Ferlay, J., et al., Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer, 2018. 103: p. 356-387.
2. The Pharmaceutical Industry in Figures, 2017. EFPIA Report based on Eurostat, 2014 data
Cancer remains a health challenge1
Confidential – for Johnson and Johnson internal use only
0
10
20
30
40
50
60
70
80
1975 1980 1985 1990 1995 2000 2005 2010 2015 2020
IMID
3
However, advances in the treatment of multiple myeloma over the
last >20 years have contributed to improvements in overall
survival outcomes1
23
+6 months
overall survival
increase
+3 months
overall survival
increase
+17 months
overall survival
increase
+23
months
Predicted
overall survival
increase
1. Drawid A et al. Impact of Novel Therapies on Multiple Myeloma – Current and Future Outcomes. Poster presented at the 20th Congress of the
European Haematology Association; Vienna, Austria, June 11-14, 2015
29
32
49
72
Median
OS
(months)
Chemotherapy
Auto
SCT
Allo
SCT
Confidential – for Johnson and Johnson internal use only
IMID
PI
Next generation
Despite scientific and therapeutic breakthroughs, once new
medicines are approved by EMA, time to reimbursement has
been slow in certain jurisdictions1-3
Source:
1. EPFL IRGC. The economics of precision medicine: a risk-governance perspective. Available at: https://www.epfl.ch/research/domains/irgc/specific-risk-domains/projects-precision-medicine/page-154106-en-html/ Last accessed March 2020.
2. Morrell L, et al., Will the reformed Cancer Drugs Fund address the most common types of uncertainty? An analysis of NICE cancer drug appraisals. BMC Health Serv Res. 2018;18:393. 3. IQVIA.
3. EFPIA Patients Waiting to Access Innovative Therapies Indicator 2018 survey. 2019. Available at: https://www.efpia.eu/media/412747/efpia-patient-wait-indicator-study-2018-results-030419.pdf Last accessed March 2020.
Accelerated
Regulatory
Approvals
Time to
reimbursement
and adoption in
certain
countries
Confidential – for Johnson and Johnson internal use only
5
Time to patient access for new cancer medicines varies
significantly across Europe
925
726
634 618 612 603
547 539
498 492 486
449 445 428 426 417 402 401 395 385
333
292 291 288 269
220 209
171 146 119
0
100
200
300
400
500
600
700
800
900
1000
Average
delay
(days)
The average time between marketing authorisation and patient access – the number of days
elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA
countries) to the day of completion of post-marketing authorisation administrative process1
In most countries patient access equates to granting of access to the reimbursement list, except for hospital product in DK, FI, NO, SE where some
products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovation products without competitors can be made available prior to market authorisation under the system of Temporary
Authorisations. As these are not taking into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
Source:
1. IQVIA, EFPIA Patients Waiting to Access Innovative Therapies Indicator 2018 survey. 2019. Available from: https://www.efpia.eu/media/412747/efpia-patient-wait-indicator-study-2018-results-
030419.pdf
Confidential – for Johnson and Johnson internal use only
The pace at which innovation in new cancer treatments is
evolving evokes budget impact concerns from payers
Uncertainties in the evidence base can also make timely decision-making difficult
Budget
Impact
Concerns
Evidence
Uncertainty
Decision-
Making
Challenges
Fund
now
Restrict
Reject
Defer
Costs and
Consequences
of waiting for
Certainty
Confidential – for Johnson and Johnson internal use only
Achieving the ‘Desired State’ for patient access is a step-wise
approach
Collaborative
approach to
solutions -
development
Faster time from
EMA approval to
patient access
Value recognition
of innovation
reflected in HTA
methods
Faster adoption of
innovation
Improved patient
outcomes
Every patient
receives the right
treatment at the
right time, in a
sustainable way
Collaboration is needed between multiple stakeholders to
address challenges to patient access across Europe
Evolution of HTA methods is needed to address current access challenges facing innovative cancer
therapies. Changes to the way that innovation is valued and how uncertainty is considered, is essential
in overcoming access challenges and reaping the benefits for patients.
To reduce inter-country
variation in access to
innovation and tackle
disparities in cancer
outcomes between
countries
To improve the
time to achieving
patient access to
innovative
treatments
9
Healthcare
Systems
Reduction in Costs
Better Health
Innovation benefits a range of stakeholders
Society
Healthy & Productive
Society that
Contributes to
Economic Growth
Patients
Longer, Healthier
and more
Productive lives
9
Access & Adoption targets are needed to reach desired
public health outcomes
Adoption of innovative
cancer therapies should
be guided by diagnostic
and/or biomarker testing,
where available
Mechanisms that enable
broader access to
innovation are needed,
such as outcomes-based
payment models
Trusted partnerships
between manufacturers
and payers are needed to
agree managed entry
agreements in a timely
manner
Sustainability of Health Systems is Key but the Right
Investments are needed
To make progress towards achieving our common goal: that every patient receives the right
treatment at the right time and in a sustainable way…..
We need to:
 Find sustainable ways to fund solutions that
achieve health targets and value-based outcomes
 Shift the focus from restricting expenditure
to making long-term investments in earlier
disease detection, prevention and delivery
of effective cancer care
 Support a productive and profitable life sciences
industry to encourage innovation.
Ensuring people can access the treatments they need when they need them, builds a healthy
population and sustainable future - healthy populations are linked to healthy economies.
12
Conclusions
Confidential – for Johnson and Johnson internal use only
Pharmaceutical innovation leads to improved outcomes for patients and
can have broader economic benefits for society.
Important strides have been made in treating a whole range of diseases,
but unmet need for patients remains high.
Pharmaceutical innovation is risky and complex. Healthcare systems need
to incentivise and reward investment in innovation.
Society needs a healthy pharmaceutical sector with the resources and
skills to discover and develop the medicines of tomorrow

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Clare Hague PhD, Pharma & Health Conference 2021

  • 1. Jennifer Jacobs, Stowaway Jennifer is a New York based artist living with Type 1 diabetes. Clare Hague Senior Director, Health Economics, Market Access & Reimbursement Janssen Europe, Middle-East and Africa July 15, 2021 The Value of Innovation to Patients & Health Systems
  • 2. 2 Cancer remains a public health challenge - the second leading cause of death in Europe Cancer accounted for 1 in 4 deaths in Europe2 3.91 million new cases 1.93 million deaths In Europe in 2018, an estimated Source: 1. Ferlay, J., et al., Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer, 2018. 103: p. 356-387. 2. The Pharmaceutical Industry in Figures, 2017. EFPIA Report based on Eurostat, 2014 data Cancer remains a health challenge1 Confidential – for Johnson and Johnson internal use only
  • 3. 0 10 20 30 40 50 60 70 80 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 IMID 3 However, advances in the treatment of multiple myeloma over the last >20 years have contributed to improvements in overall survival outcomes1 23 +6 months overall survival increase +3 months overall survival increase +17 months overall survival increase +23 months Predicted overall survival increase 1. Drawid A et al. Impact of Novel Therapies on Multiple Myeloma – Current and Future Outcomes. Poster presented at the 20th Congress of the European Haematology Association; Vienna, Austria, June 11-14, 2015 29 32 49 72 Median OS (months) Chemotherapy Auto SCT Allo SCT Confidential – for Johnson and Johnson internal use only IMID PI Next generation
  • 4. Despite scientific and therapeutic breakthroughs, once new medicines are approved by EMA, time to reimbursement has been slow in certain jurisdictions1-3 Source: 1. EPFL IRGC. The economics of precision medicine: a risk-governance perspective. Available at: https://www.epfl.ch/research/domains/irgc/specific-risk-domains/projects-precision-medicine/page-154106-en-html/ Last accessed March 2020. 2. Morrell L, et al., Will the reformed Cancer Drugs Fund address the most common types of uncertainty? An analysis of NICE cancer drug appraisals. BMC Health Serv Res. 2018;18:393. 3. IQVIA. 3. EFPIA Patients Waiting to Access Innovative Therapies Indicator 2018 survey. 2019. Available at: https://www.efpia.eu/media/412747/efpia-patient-wait-indicator-study-2018-results-030419.pdf Last accessed March 2020. Accelerated Regulatory Approvals Time to reimbursement and adoption in certain countries Confidential – for Johnson and Johnson internal use only
  • 5. 5 Time to patient access for new cancer medicines varies significantly across Europe 925 726 634 618 612 603 547 539 498 492 486 449 445 428 426 417 402 401 395 385 333 292 291 288 269 220 209 171 146 119 0 100 200 300 400 500 600 700 800 900 1000 Average delay (days) The average time between marketing authorisation and patient access – the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative process1 In most countries patient access equates to granting of access to the reimbursement list, except for hospital product in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average. • In France, some innovation products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taking into account in the analysis, the average for France is higher than in reality. • Average of 29 European countries in the analysis (excludes Macedonia) Source: 1. IQVIA, EFPIA Patients Waiting to Access Innovative Therapies Indicator 2018 survey. 2019. Available from: https://www.efpia.eu/media/412747/efpia-patient-wait-indicator-study-2018-results- 030419.pdf Confidential – for Johnson and Johnson internal use only
  • 6. The pace at which innovation in new cancer treatments is evolving evokes budget impact concerns from payers Uncertainties in the evidence base can also make timely decision-making difficult Budget Impact Concerns Evidence Uncertainty Decision- Making Challenges Fund now Restrict Reject Defer Costs and Consequences of waiting for Certainty Confidential – for Johnson and Johnson internal use only
  • 7. Achieving the ‘Desired State’ for patient access is a step-wise approach Collaborative approach to solutions - development Faster time from EMA approval to patient access Value recognition of innovation reflected in HTA methods Faster adoption of innovation Improved patient outcomes Every patient receives the right treatment at the right time, in a sustainable way
  • 8. Collaboration is needed between multiple stakeholders to address challenges to patient access across Europe Evolution of HTA methods is needed to address current access challenges facing innovative cancer therapies. Changes to the way that innovation is valued and how uncertainty is considered, is essential in overcoming access challenges and reaping the benefits for patients. To reduce inter-country variation in access to innovation and tackle disparities in cancer outcomes between countries To improve the time to achieving patient access to innovative treatments
  • 9. 9 Healthcare Systems Reduction in Costs Better Health Innovation benefits a range of stakeholders Society Healthy & Productive Society that Contributes to Economic Growth Patients Longer, Healthier and more Productive lives 9
  • 10. Access & Adoption targets are needed to reach desired public health outcomes Adoption of innovative cancer therapies should be guided by diagnostic and/or biomarker testing, where available Mechanisms that enable broader access to innovation are needed, such as outcomes-based payment models Trusted partnerships between manufacturers and payers are needed to agree managed entry agreements in a timely manner
  • 11. Sustainability of Health Systems is Key but the Right Investments are needed To make progress towards achieving our common goal: that every patient receives the right treatment at the right time and in a sustainable way….. We need to:  Find sustainable ways to fund solutions that achieve health targets and value-based outcomes  Shift the focus from restricting expenditure to making long-term investments in earlier disease detection, prevention and delivery of effective cancer care  Support a productive and profitable life sciences industry to encourage innovation. Ensuring people can access the treatments they need when they need them, builds a healthy population and sustainable future - healthy populations are linked to healthy economies.
  • 12. 12 Conclusions Confidential – for Johnson and Johnson internal use only Pharmaceutical innovation leads to improved outcomes for patients and can have broader economic benefits for society. Important strides have been made in treating a whole range of diseases, but unmet need for patients remains high. Pharmaceutical innovation is risky and complex. Healthcare systems need to incentivise and reward investment in innovation. Society needs a healthy pharmaceutical sector with the resources and skills to discover and develop the medicines of tomorrow