Expertise ► Collaboration ► Innovation ► Results

Personal perspectives

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Patient Relative Healthcare Practitioner Regulatory Consultant Pharma Consultant Pharma Service Provider

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Pharma perspectives

 Patient at the Centre Centre?

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 Patent at the Centre

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Pharma ‘market access’ External stakeholders Population

Politicians

Public Bodies

Purchasers

Healthcare Providers

Physicians

Practitioners

Pharmacists

Patients

Market Access

Executive Team

Therapeutic Leadership Team

Global Functions

Project/Brand Teams

Regional Management

National Affiliates

Local Account Managers

Internal pharma stakeholders

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The outcome for big pharma?

With thanks to Defined Health © Kinapse Ltd.

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Where is their ‘Market Access’ department?

Pain in calf and short of breath

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Patient access  Empowerment  Integration

Policy Makers

Biotech companies Patient Associations

 Services Population

Politicians

Payers

Public Bodies

Hospitals Healthcare

Purchasers

Providers

Healthcare Practitioners Academic institutions

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Information services businesses

Physicians Patient

Regulators

Device/ diagnostics companies

Practitioners

Pharmacists

Pharmacists

Patients

Patient’s family / carer

Pharma companies

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Data, information, insights

Consolidation & Analysis

External

Pharma putting the ‘patient at the centre’

Economic and societal value

Evidence of value

Unifying value proposition Therapeutic and social value

Internal

Policy Makers

Payors

Patient

Regulators

HCPs

Products /services

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Generating evidence for the value proposition Clinical trial data Patient Reported Outcomes Epidemiology data Health economic studies Meta-analyses

Policy Makers

Evidence of value

Unifying value proposition

Local market insights

Payors

Patient

Regulators

HCPs

Registries and observational dbases HA/HTA Scientific advice

Patient surveys Ad Boards/ Key Opinion Leaders

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Integrating and delivering the value proposition HTA proposition Regulator proposition Payor proposition Patient proposition HCP proposition

Evidence generation

Unifying value proposition

Policy Makers

Payors

Patient

Insights Regulators

HCPs

Evidence

Guidance Service provision Risk sharing mechanisms

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The standard drug development model needs to change PV & RM

I

II

IIIa

Review HTA

Access

IIIb FIM

PoC

Ph III entry

IV Submission

P&R

Launch

Renewal

Key characteristics of the standard drug development model • Linear processes • Binary decisions External activities • Expensive • Risks deferred Sponsor activities • Delayed access © Kinapse Ltd.

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An alternative patient-centred approach based in the real world Characteristics

Benefits

 Multi-stakeholder collaboration

 Earlier access to innovative therapeutics by well-informed, consenting patients

 Evolutionary trial design

 Improved understanding of drug performance, increasing confidence of clinical efficacy, risk/benefit and value

 Use of various existing realworld data sources

 Earlier and better characterisation of risks and their management  Elimination of traditional clinical trials in Phase III and IV

 Transparency and shared access to data and analyses

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A proposed Real World Development model Patient consultation Collaborative multi-stakeholder design and evaluation

HA review

Ongoing PV & Risk Management

HTA review

Access Exploratory Trials

IIIb

IIIa Trial

IV

RWD Programme CoB Submission RWD Programme Conditional Approval © Kinapse Ltd.

CoCE

CoV

P&R agreed

P&R framework agreed 12

P&R CoCE CoV CoB

Pricing and reimbursement Confidence of Clinical Efficacy Confidence of Value Confidence of Benefit/Risk

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GPRD

The world’s largest database of high quality anonymised longitudinal patient records.

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GPRD history 1987 Launch

VAMP Research Databank

Doctors incentivised by access to innovative practice management system in return for data

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1993 Acquired by Reuters

REUTERS

Briefly owned database on acquisition of VM practice management system, but soon divested to DoH

1994 Donated to DH

DH

1999 Transferred to MCA

MCA / MHRA

Transferred and managed within Statistics Division of DH. Managed operationally by ONS.

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Established within MCA as operationally independent unit. Database redeveloped for online access

2012 Services taken over by CPRD funded by MHRA and NIHR

MHRA, NIHR

CPRD, new English NHS observational data and interventional research service, took over all activities of GPRD from April 2012

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GPRD and CPRD

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Other Real World Development case studies Efficacy (CoCE)

Alzheimer’s Disease

Women’s Health

Safety (CoB)

Evaluation of long-term efficacy and tolerability of Novartis’ Exelon among Alzheimer’s disease patients Assessment of risks associated with short and long term use of Bayer Schering Pharma’s Yasmin, a third generation oral contraceptive

Multiple Sclerosis Cardiovascular

Value (CoV)

The UK multiple sclerosis risk sharing scheme Assessment of comparative effectiveness of AstraZeneca’s Crestor vs other statins

Statistical methods to overcome unmeasured confounding in observational studies*

* Statistical methods case study was prepared to highlight the development of methods to improve the use of non-interventional studies in healthcare.

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My personal conclusions  Healthcare delivery will transform based on increased patient empowerment, improved patient access to useful information and associated services

 A strong consensus exists that the current drug development and commercialisation model must change, focused on patients’ needs  We need to make progress with Real World Development − Further definition and communication of acceptable RWD models − Selection and approval of pilot programmes − Establishment of an operational co-ordinating body, engaging: • IMI • UK government/DH/ABPI (and other Industry Associations) • NEWDIGs/MIT • Others?

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Thanks for listening Andy Black, Co-founder & CEO: +44 (0) 7787 536680 [email protected] Web site: General enquiries:

www.kinapse.com [email protected]

Kinapse UK : London Kinapse US : Philadelphia Kinapse India: Gurgaon

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Back up slides

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Pressures on Pharma ‘Me too’ products

APPROVAL

Cashflow

Generic substitutes

Increased regulatory requirements

0

Increasing competitive pressure

Time

Market access hurdles

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Pharma responses ‘Me too’ products

APPROVAL

Cashflow

Cycle time compression

Improved evidence generation Product line extensions

Increased regulatory requirements

0

Increasing competitive pressure

Generic substitutes

Launch excellence

Time

Market access hurdles

Cost savings © Kinapse Ltd.

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A commercial model based on the patient Cashflow

Time

Patent at the centre Patient at the centre

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