The document outlines the role and evolution of the National Institute for Health and Care Excellence (NICE) in the UK's healthcare system, emphasizing its commitment to evidence-based guidance and equitable access to treatments. It discusses the establishment of the Office for Market Access (OMA) to facilitate engagement with the life sciences sector and streamline the path from product development to adoption. The document highlights the importance of early engagement with NICE to understand its evaluation processes and improve access to innovative therapies.

1. World Pharma Pricing and Market Access Congress, London
Carla Deakin - Associate Director, NICE Office for Market Access
22 February 2017
Why OMA….Why Now?

2. NICE – an evolving organisation
The National Institute for Health and Care Excellence (NICE) is the
independent organisation responsible for providing national guidance
and advice to improve health and social care
The National Institute
for Clinical Excellence
established
Special Health
Authority, to reduce
variation in the
availability and quality
of NHS treatments and
care
1999
Expanded to include
the functions of
Health Development
Agency
Name changed to the
National Institute for
Health and Clinical
Excellence
2005
NICE re-established as
a non departmental
public body
Took on responsibility
for developing
guidance and quality
standards in social
care; name changed to
reflect new
responsibilities
2013
2

3. NICE - aims
Produce evidence-based guidance
Develop quality standards and performance metrics
Provide a range of information services
Speed up NHS uptake of interventions that are both clinically and cost-
effective
Encourage better and more rational use of resources by focussing the
provision of healthcare on the most cost-effective interventions
Encourage more equitable access to healthcare
(reduce post code lottery of care)
Encourage more equitable access to healthcare
(reduce post code lottery of care)

4. Who we are & what we do?
Evidence
Resources
Health and Social
Care Directorate
Health and Social
Care Directorate
PASLU = patient Access Scheme Liaison Unit
* Denotes guidance producing programmes within CHTE for different technologies and value propositions
Technology
Appraisals*
Highly Specialised
Technologies*
Interventional
Procedures*
Science Policy
& Research
PASLU
Medical Technologies
Evaluation Programme (MTEP)*
Diagnostics
Assessment
Programme (DAP)*
Centre for Health
Technology Evaluation
CHTE support for
companies
NICE Office for Market Access
&
NICE Scientific Advice
NICE
Centre for
Guidelines

5. The changing landscape
Exciting times!.......
• Very strong pipelines of products with potential for major patient benefits
• Patients and healthcare systems need access to clinically and cost effective products as quickly
as possible
Challenges:
• High cost of some products
• Timely patient access while the evidence is still emerging
• New initiatives in the landscape
Effective engagement necessary to address challenges:
• The Office for Market Access
• NICE Scientific Advice
PRODUCT
DEVELOPMENT
PRODUCT
DEVELOPMENT
PRODUCT
ADOPTION
PRODUCT
ADOPTIONEMA
Adaptive
Pathways?
PRIME?
(EU)
MHRA
EAMS?
(UK)
?
?
NICE Appraisals
& Highly
Specialised
technologies
NICE
Diagnostics &
Medical
Technologies
EMA/MHRA
(& notified
bodies)
INNOVAT
E UK
NHS
ENGLAND
AHSNs
Accelerated
Access
Review
(UK)
UKTI
Cancer
Drugs
Fund?
(UK)
Life
Sciences
Strategy

6. CHTE = Centre for health Technology Evaluation
* Denotes guidance producing programmes within CHTE for different technologies and value propositions
Evidence
Resources
Health and Social
Care Directorate
Health and Social
Care Directorate
Technology
Appraisals*
Highly Specialised
Technologies*
Interventional
Procedures*
Science Policy
& Research
PASLU
Medical Technologies
Evaluation Programme (MTEP)*
Diagnostics
Assessment
Programme (DAP)*
Centre for Health
Technology Evaluation
CHTE support for
companies
NICE Office for Market Access
NICE
Centre for
Guidelines
& NICE Scientific Advice

7. The Office for Market Access
• Launched in October 2015
• Covers all life sciences products:
Pharmaceuticals and
biopharmaceuticals including:
 Orphan & ultra-orphan
products
 Cell/gene therapies
MedTech including:
 Medical devices
 Diagnostic tests
 Digital (if patient benefit)

8. Engaging with OMA
• Tailored engagement and expert advice to help
companies optimise the journey through NICE
• OMA provides opportunities to engage with NICE at
any stage in the development to adoption pathway
• Our team of experts are available to answer initial
enquiries or refer you to other system partners
where appropriate
 Offered free of charge.
• Every company’s needs are different, so we offer
bespoke services tailored to requirements
 Fees are charged on a not-for-profit basis (varying
in scale to reflect the resources required).
8

9. Office for Market Access (OMA)
Product
Development
Product
Development
Product
Adoption
Product
Adoption
NICE
HTA
NICE OMA - ‘SAFE HARBOUR PRINCIPLE’
From multi stakeholder to focused perspective
Multifaceted opportunity for exploration of key system access questions
Initial discussion & exploration
Fee for service (not for profit)
* Can be reached through OMA or directly
Engagement Meetings
Multi stakeholder
Focussed Input
Portfolio
Reviews
EAMS
Meetings
NICE
Scientific
Advice*

10. OMA engagement meetings under
safe-harbour principles
‘Multi-
stakeholder safe
harbour
engagement
meeting
‘Multi-
stakeholder safe
harbour
engagement
meeting
NICENICE
MHRAMHRA
NHS
England
NHS
England
Patient
Experts
Patient
Experts
Clinical
Experts
Clinical
Experts
COMPANYCOMPANY
• Supported by rules of engagement
to ensure a broad, open and free
flowing discussion within a
confidential framework
• Collaborative event, including
participation from a range of
stakeholders
• Designed to help companies
deliver a market access plan that is
patient & healthcare system
focussed.
10

11. What participants say……….
Multi-
stakeholder
engagement
meetings
NICE EAMS
meetings
Focused
engagements
meetings
•“Very interesting and positive experience, it was unusual and
valuable it is to be included in discussions at this early stage” -
Patient organisation
• “Valuable opportunity to have early discussions which enable
the company to select the most feasible path forward to open
up access to patients as early as possible. There was breadth
and depth of relevant stakeholder input” - Company
•“The session increased our knowledge and understanding”
- Company
•“Useful to gain understanding of the appraisal process
from a NICE perspective” - Company
•“A perfectly organized and held meeting. All input was very
helpful to us. I am very impressed with the friendly, open
and transparent NICE experience you gave us” – Company
•Extremely interesting and really enjoyable… highlight was
that the meeting felt bespoke to us, it was very evident that
you worked hard to understood our needs and the
engagement reflected this… the meeting was conducted in a
very positive and collaborative atmosphere which enabled
us to ask our questions in an open and transparent way.” -
Company

12. CHTE = Centre for health Technology Evaluation
* Denotes guidance producing programmes within CHTE for different technologies and value propositions
Evidence
Resources
Health and Social
Care Directorate
Health and Social
Care Directorate
Technology
Appraisals*
Highly Specialised
Technologies*
Interventional
Procedures*
Science Policy
& Research
PASLU
Medical Technologies
Evaluation Programme (MTEP)*
Diagnostics
Assessment
Programme (DAP)*
Centre for Health
Technology Evaluation
CHTE support for
companies
NICE Scientific Advice
NICE
Centre for
Guidelines
NICE Office for Market Access &

13. NICE Scientific Advice
Fee-for-service programme
Completed over 180 individual projects, advising
25 of the top 30 global pharmaceutical companies
Which products are eligible for scientific advice?
13
Pharmaceuticals and
biopharmaceuticals
including:
 Orphan & ultra-
orphan products
 Cell/gene therapies
 Antibiotics
MedTech including:
 Medical devices
 Diagnostic tests
 Digital (if patient
benefit)

14. What is Scientific Advice?
Why seek Scientific Advice?
•Understand the perspective of decision makers
•Understand pros and cons of different trial /study options
•Maximise relevance of trial programme outputs
•Explore alternative strategies to address data gaps
•Integrate cost effectiveness considerations into early decision
making
•De-risking strategy
14
Advice on
prospective
clinical and
economic
development
plans, which…
Advice on
prospective
clinical and
economic
development
plans, which…
Helps you
generate robust
evidence to
demonstrate
value, which…
Helps you
generate robust
evidence to
demonstrate
value, which…
Can be used for
future
evaluations or
discussions with
payers /
commissioners
Can be used for
future
evaluations or
discussions with
payers /
commissioners

15. Engaging with NICE
PASLU = patient Access Scheme Liaison Unit
* Denotes guidance producing programmes within CHTE for different technologies and value propositions
Evidence
Resources
Health and Social
Care Directorate
Health and Social
Care Directorate
Centre for Health
Technology Evaluation
Technology
Appraisals*
Highly Specialised
Technologies*
Interventional
Procedures*
Science Policy
& Research
PASLU
Medical Technologies
Evaluation Programme (MTEP)*
Diagnostics
Assessment
Programme (DAP)*
CHTE support for
companies
NICE Office for Market Access
&
NICE Scientific Advice
NICE
Centre for
Guidelines
CHTE support for
companies
NICE Office for Market Access
&
NICE Scientific Advice

16. Engaging with NICE; things to consider…
 Build early engagement into your
development plans
 Engage with NICE and key stakeholders to
understand our perspective and needs
 Use the feedback to refine your evidence-
generation and market access strategy

17. What are the benefits of early engagement with NICE?
Healthcare system & patients
Ensuring innovation meets unmet needs, timely access to cost
effective technologies
Healthcare system & patients
Ensuring innovation meets unmet needs, timely access to cost
effective technologies
Innovators
Earlier dialogue helps to maximise the opportunities available,
smooths path to adoption
Innovators
Earlier dialogue helps to maximise the opportunities available,
smooths path to adoption
Investors
Better understanding of factors that NICE consider, how these
factors impact adoption and uptake to reduce financial risk
Investors
Better understanding of factors that NICE consider, how these
factors impact adoption and uptake to reduce financial risk
Life sciences
Stronger industry, growth of the economy, better environment for
market entry
Life sciences
Stronger industry, growth of the economy, better environment for
market entry

18. Get in touch…
Stay up-to-date with the latest from NICE:
Subscribe online to NICE News
https://www.nice.org.uk/news/nice-newsletters-and-alerts
Follow us on Twitter
@NICEcomms
WWW.nice.org.uk/OMA
OMA@nice.org.uk