licensing routes & accelerated access to innovative ... · 2 accelerated access –what are we...
TRANSCRIPT
Licensing Routes & Accelerated
Access to Innovative Medicines in an
Evolving Regulatory Landscape
17 September 2019
Head EU/International Regulatory Policy & Intelligence
David King, PhD
Takeda Pharmaceutical Company Limited
1
What is Happening in the Environment?
17/09/19
Increased Innovation
Increased demand for Rare Disease Treatments
Increased Proof of Value for Money
R&D Cost Transparency
Data Transparency
RWEDig Data
Pricing Transparency
2
Accelerated Access – What are we Talking about?
Decreased time to approval
• Procedural pathways to reduce review time
• Increased scientific advice to decrease the number of issues
17/09/19
Increased Availability to the Patient
• Often dependent on Pricing & Re-imbursement
US Accelerated Approval
Priority Review
Fast Track
EU Accelerated Assessment
Conditional Approval
Exceptional Circumstances
Japan Priority Review
Conditional Early Approval
SystemOrphan
3
Decreased Time to Approval
17/09/19
Switzerland Fast Track for Innovative ProductsPrior
Notification
Canada Priority Review
Notice of Compliance with
Conditions (NOC/C)
TGA TGA PriorityTGA Provisional
Approval
4
Decreased Time to Approval
17/09/19
FDA
• Breakthrough Therapy
EMA
• PRIME
• MHRA Early Access to Medicines Scheme (EAMS)
PMDA
• Sakigake
5
Increased Scientific Advice
17/09/19
6
Key Features and Advantages
17/09/19
Source: CIRS R&D Briefing 70 (2019)
7 | Title | DD/MM/YY
Source: CIRS R&D Briefing 70 (2019)
8 17/09/19
Source: CIRS R&D Briefing 70 (2019)
9 17/09/19
Source: CIRS R&D Briefing 70 (2019)
10
Use of Accelerated Assessment by Agency
17/09/19
Source: CIRS R&D Briefing 70 (2019)
11
Patient Access
17/09/19
Lots of pathways to increase the number of treatments quicker
What about Patient Access?!?
12
EU Initiatives
17/09/19
EUnetHA MoCA
Parallel consultations EMA and HTA bodies
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on health technology assessment and amending Directive 2011/24/EU
EAMS
Accelerated Access
Collaborative
??Questions??