© NICE 2019. All rights reserved. Subject to notice of rights.

NICE perspective: working in coordination with regulatory authorities and stakeholders to facilitate access to innovative medicines

David Thomson,

Associate Director, Commercial Liaison

(PASLU), NICE

Overview

• NICE Commercial and Managed Access (CMA) as a case study for working with stakeholders to facilitate access

• Development of NICE Commercial and Managed Access (CMA)

• Structure and function of NICE CMA

• Office for Market Access (OMA)

• Managed Access (MA)

• Commercial Liaison (PASLU) (CL(PASLU))

2

NICE & the evolving life sciences landscape……

NICE is involved throughout the product development to adoption

pathway

CONFIRMING TECHNOLOGY VALUE

TECHNOLOGY APPRAISALS

HIGHLY SPECIALISED TECHNOLOGIES

DIAGNOSTICS ASSESSMENT

MEDICAL TECHOLOGY EVALUATION

COMMERCIAL & MANAGED ACCESS

ACTIVITIES (includes Cancer Drugs

Fund)

EARLY /PROACTIVE ENGAGEMENT TO

INFORM DEVELOPING TECHNOLOGY

‘VALUE PROPOSITIONS’

NICE OFFICE FOR MARKET ACCESS

(OMA)

NICE SCIENTIFIC ADVICE( NSA)

UK PHARMASCAN

HEALTHTECH CONNECT

FACILITATING &

ENHANCING UPTAKE

ADOPTION &

MEASURING IMPACT

BUDGET IMPACT

TEST

P r o d u c t D e v e l o p m e n t NICE EVALUATION

PRODUCT ADOPTION

& UPTAKE

Accelerated Access Collaborative (AAC) Partner

‘Travelling the development to adoption pathway’

4

Technology Development TECHNLOGY

ADOPTION

TECHNOLOGY

EVALUATION

THE IDEAL………..

COMPANIES NICE NHSE COMPANIES

NICE NHSE COMPANIES NHSE COMPANIES ‘ THE SYSTEM’ NICE

Technology Development TECHNOLOGY

EVALUATIONTECHNLOGY

ADOPTION

NICE

.i.e. OMA & NSANHSE

COMPANIES NICE NHSE

HOW IT CAN FEEL….

NICE Centre for Health Technology Evaluation – evolving with the landscape

2017 2018 2019 2020

Single

Technology

Appraisal

(STA)• ‘One size fits all

approach ‘

• Frequent

• guidance

delays after 1st

Committee

meeting

Fast Track

Appraisals

(FTA) • Faster patient

access, less

resource intensive

process for low

risk appraisals

• Increased

opportunity for

proactive

discussions with

companies

Technical

Engagement

Step • Faster patient

access, less

resource intensive

process for many

appraisals

• Early Opportunity

for proactive

discussions with

companies ahead

of 1st Committee

Meeting

Methods &

Processes Review • Meet the needs of a

changing health

and care

environment

Where change is:

• clearly needed

• supported by the

evidence (if

available)

• Agreed with all our

key partners

Commercia

l Liaison

Cancer

Drugs

Fund Team

2016

6

Increased

commercial

liaison between

NICE & NHSE&I

Providing a systematic interface between NICE guidance production and

NHSE&I to support timely patient access and value for money

2019

NICE Commercial &

Managed Access

Function

NICE Commercial & Managed Access –a further evolution

Programme Director

- TA, HST, CSP, CDF,

PASLU

Programme Director

- TA,& HST

Programme Director

Commercial &

Managed Access

Committees

A

B

C

D

E

F

Commercial

Liaison

(PASLU)

Managed

Access (ODU)

NICE OMA &

AACS

Supporting,

facilitating

(‘wrapping around’)

guidance production

Core CHTE guidance

production

(ex MTEP & DAP)Early 2018

2019 onwards

NICE Commercial & Managed Access –a further evolution

8

Commercial & Managed Access Programme

Carla Deakin – programme director

NICE Office for Market Access

NICE AAC

Secretariat Fay McCracken

associate director

Managed Access* ODU

Brad Groves associate director

Commercial Liaison

PASLU

David Thomson associate director

* Includes all Managed Access e.g. CDF & HST

Centre for Health Technology Evaluation

Meindert Boysen - Director

NICE Commercial & Managed Access

The ‘development to adoption pathway’ …moving towards the ideal

9

Facilitating interaction & early engagement Single

Committee

Meeting

COMMERCIAL

LIAISON (PASLU )

Systematise & optimise

NICE/NHSE ‘in guidance

production’ interactions

NICE OFFICE FOR MARKET ACCESS

(OMA) Systematise & optimise

Early Engagement processes - move

value proposition focus upstream

NICE/NHSE

Value

for

Money

Timely

Patient

Access

MANAGED ACCESS TEAM (MAT)Build on CDF team exemplar to further

expand & optimise activities across

technology types

Explore opportunities for

complementary CL(PASLU) activities in

this space

10

Office for Market AccessAssociate Director: Faye McCraken

The evolving landscape

11

?

?

Patients and healthcare systems

need access to clinically and cost

effective products as quickly as

possible

New initiatives in landscape(EAMS, PRIME, AAC, Life Sciences Industrial

Strategy, NHS Long Term Plan…)

Early engagement with healthcare system decision makers and payers is a key enabler

for the journey along the evolving product development to adoption pathway

DIT = Department for Trade and Investment

MHIR = National Institute for Health Research

EMA = European Medicines Agency

AAC – Accelerated Access Collaborative

MHRA = Medicines and Healthcare Products Regulatory Agency

AHSNs = Academic Health Science Networks

NHSI = NHS Improvement

ARCS = Applied Research Collaborations

NICEINNOVATE UK

NHS

England &

Improvement

DIT

Cancer

Drugs

Fund

P r o d u c t D e v e l o p m e n t PRODUCT

ADOPTION PRODUCT

EVALUATION

EMAMHRA

(& notified

bodies)

AHSNs

NIHR

Catapult

ARCs

OthersOthers

NHSX

Need for joined-up dialogue with the system

12

• Dialogue with NICE and other stakeholders is often limited

• Dialogue often occurs within the formal guidance process (often in high-risk

situations)

• Companies generally interact with system stakeholders individually which can lead

to conflicting information or lack of clarity Need for more coordinated

dialogue

Need for greater dialogue

Need for dialogue outside of formal guidance process

NICE OMA Engagement under Safe Harbour principles

13

Product

Development

Product

Adoption NICE

HTA

Opportunity to explore key system access questions along the development to

adoption pathway

Engagement under ‘Safe Harbour Principles’

FOR ALL TYPES OF LIFE SCIENCES TECHNOLOGIES

OMA team

• Understanding the changing healthcare landscape

• Identifying the most appropriate route to NHS access

• Exploring your value proposition with system stakeholders

NICE

Scientific

Advice

14

Managed AccessAssociate Director: Brad Groves

When is managed access considered?

Typically a managed access agreement has been identified as a consideration by the NICE appraisal committee if they identify significant uncertainties, e.g.

• Lack of clinical trial data

• Insufficient patient numbers

• Health benefits not clearly evidenced, but showing promise

A company can make a proposal for managed access if they think their product is promising and significant uncertainties exists that could be address via further data collection

NICE‘s role in developing a Managed Access Agreement

The Managed Access Team collaborates with NHS England, clinicians, academics, patient groups and others to confirm:

• The feasibility of additional data collection

• Patient eligibility criteria and defining the MAA population

• The validity of the tools to be used in the MAA population to collect clinical and other outcome data

• Whether the additional data collection burden is reasonable

• Which outcomes should be measured

• The duration of the agreement

• Ethical issues are addressed

• Patient information and consent are considered to enable data collection, analyse and sharing of results

NICE’s role during a Managed Access Agreement

Monitoring the progress towards the aims of the agreement are

achieved via regular review meetings.

Facilitating discussions with stakeholders to ensure all parties are aware

of their role and when and how their contribution is required

Communicating key aspects of the agreement to ensure patients, their

families and carers are aware of its terms

Preparing all stakeholders for the revaluation of topics in managed

access to ensure that NICE publish final guidance on whether a

treatment should be recommended for routine NHS funding before the

agreement expiry date

Overseeing a Managed Access Agreement

19

Commercial Liaison (PASLU)Associate Director: David Thomson

Developing commercial arrangements –increased need for “Liaison”

20

Simple

/

comple

x PAS

HST

All TA

BIT

CDF

NHSE&I

Companies

NICE

CL (PASLU) - function

NICE has provided:

• Budget impact assessment (BIT).

• Translation of committee decision into information to support negotiation.

• Advice on PAS feasibility and operational success

CL(PASLU) will add:

• Closer linkage between BIT and TA.

• Consistent and timely information to support negotiation.

• Advice on CAA feasibility

• Internal support for timely decisions.

• Support for earlier engagement.

21

1. Minimal delays to TA

2. Achievement of a single integrated commercial negotiation

3. Goal of a “single NICE committee meeting”

22