Keiko Tone, VP market access, Shionogi Limited Pharma Pricing & Market Access Congress 2017 22 February 2017 London

1. Structural market access challenges
in anti-infectives
Keiko Tone, VP Market Access
Shionogi Limited
Pharma Pricing and Market Access Congress 2017
Feb, 2017

2. 2Antimicrobial resistance (AMR) is a major
global threat to humanity
If resistance not addressed:
• 10m deaths in 2050
• Largest cause of death,
greater than cancer
GDP impact due to increased
premature deaths estimated to
be $100 Trillion
Source: https://amr-review.org/infographics.html, http://www.bbc.co.uk/guides/z8kccdm (Accessed on 16th Feb 17)

3. 3
• Establish a Global Innovation Fund for early-stage
and non-commercial research
• Better incentives to promote investment for new
drugs and improving existing ones
Global leaders agree that the need for
incentivising investment for new drugs
AMR was one of the top topics for 2016 across major
global forums
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Firstly, the specific steps to reduce demand
Secondly, we must increase the number of effective
antimicrobial drugs to defeat infections that have become
resistant to existing medicines
Extract from AMR Review Final Report Executive Summary
G7
UN Gen.
Assembly
Source: http://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf
G20

4. 4What makes the anti-infectives business
model challenging
 “Save the best to the last”
 Very heterogeneous local epidemiology.
Uncertain evolution of future resistance/epi
 Data package “Less than comprehensive”
Less than what typically payers would like to
see
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5. 5
“Save the best to the last”
Source: https://amr-review.org/sites/default/files/ENPV-1_0.png
• New drugs should be used appropriately
• Volume initially limited even if (or esp when) the new
product is considered to be good
• Many companies left anti-infectives, hence limited new
launches -> Often drugs used today are old and cheap
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6. 6Epidemiology is uncertain and
heterogeneous
Carbapenem-resistant Acinetobacter spp.
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• How will resistance pattern be in 3, 5,
10 years?
• What resistance mechanisms will be
the future concern?
Source: ECDC

7. 7
Data package “Less than comprehensive”
Source: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1146_16_ceftolozane_tazobactam_Zerbaxa
Data package “Less than comprehensive”
• Non-inferiority and descriptive study designs
• For multidrug resistance (MDR), what is the right
comparator? (as other drugs are already resistant). Often
limited data from resistant infection available
• Challenges in defining “Infection caused” mortality and
resource use
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8. 8
 Heterogeneous
and uncertain
epidemiology
 Data package
“Less than
comprehensive”
What could pharma companies do?
 “Save the best to
the last”
• Understand who are the patients
for your new drug
• Reflect that in your strategy and
economics
• Start early on collecting such
data. Make data as locally
relevant as possible
• Tailor the offers
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3 • Establish SoC and epidemiology
• What other data beyond clinical
studies are meaningful?
• Engage local medical
community early

9. 9Will there be measures to address the
broken model?
• AMR continues to be one of the priority topics at
global forums, e.g., 2017 G20 in Germany
• Decoupling the volume and price is the main theme
discussed in different forums, e.g., AMR Review
report
• What level (e.g., global, country, regions, or hospital
level) would the change likely to happen?
• How long will it take for a global alignment?
• Unlikely that 1 country starts additional funding or
new economic model to stimulate R&D -> the
discussion has to be addressing the local needs

10. 10
Final personal remarks
• Global mobility – issues elsewhere could be your local
issue in the near future
• “Life or death”, no treatment options
• Short term answers and long term answers are both
needed

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Confidential Information
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