Transcript UK PharmaScan Briefing Slide Deck

Working together to improve NHS
planning for new medicines
Why UK PharmaScan?
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Better NHS planning has been shown to improve speed of medicines uptake
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NHS needs advance information on new medicines for budget and service planning
National planning:
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Health Technology Assessment (HTA) in England, Scotland and Wales
Local planning:
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Formulary development and service design
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Development of commissioning policies for new medicines
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All six horizon scanning organisations in UK need the same information to:
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Inform HTA processes and timetabling
Provide information to local NHS organisations for financial and service planning
Pharmaceutical companies need to provide the same information to all six
organisations:
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Avoids duplication
Consistent information
Dialogue focused on sharing factual information not on its interpretation
UK PharmaScan – the vision
Industry and NHS working together to improve uptake of
new medicines through better NHS planning
Better quality information:
• Single source of information for key horizon scanning bodies collecting and
interpreting information on new medicines
• Information that is:
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Accurate and current
To consistent standards
Complete – what the company knows at the time
Improved efficiency of information provision:
• Reduced time on provision of factual information
• Dialogue between horizon scanning organisations and companies focused on
interpretation of information and data
UK PharmaScan – driving quality and efficiency
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UK PharmaScan has focused pharmaceutical companies on consolidating key
information on new medicines to meet the needs of NHS budget and service planning
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Improved awareness of customer needs
Alignment with other aspects of company market access activities
More systematic approach to information collection and consolidation
Improved internal processes
More consistent information
Richer dialogue
Essential component of market access for medicines
Phase II
(-3-5 yrs)
Pharmaceutical
Company
Phase III
(-1-3 yrs)
Regulatory
submission (-1 yr)
Marketing
Authorisation and
launch (0)
Advance Budgetary Notification to local NHS
AWMSG Form A
Data entry and updates on to UK PharmaScan
Horizon Scanning
HTA
Early
identification
and profiling
NIHR HSC Briefings
to NICE & DH on
priority medicines
Filtering &
prioritisation
SMC Forward Look
MPC Evidence Summary
New Medicines
UKMi Prescribing Outlook
NICE topic selection
NHS England
Specialised Services
Input to SMC HTAs
HTA processes and decisions
AWMSG appraisal planning
NHS
3 year planning and
prioritisation
Budget allocations
for following year
ADTC processes and
formulary decisions
Who has access?
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NHS England Specialised Services
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National Institute for Health Research (NIHR) Horizon Scanning Centre
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NICE (Topic Selection, Medicines and Prescribing Centre, Technology Appraisal
Scoping and Guidance Information Services)
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UK Medicines Information (UKMi)
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Scottish Medicines Consortium (SMC)
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All Wales Medicines Strategy Group (AWMSG)
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Northern Ireland Health and Social Care Board
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Specialised Services NHS England
How does it work?
Companies
Database
(NHS Evidence)
Horizon scanning
bodies
NHS and HTA
organisations
Data interpretation and consultation on outputs
Overseen by Oversight and Governance Committee: Department of Health; ABPI; horizon scanning
organisations: NICE (Topic Selection, Medicines & Prescribing Centre), NIHR Horizon Scanning Centre,
UKMi, SMC, AWMSG, DHSPSS Northern Ireland; NHS prescribing lead; pharmaceutical company
representatives; lay member; database host (NHS Evidence)
Funded by Department of Health and subscriptions from horizon scanning bodies
Confidential and secure
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Registered companies can only view their own technologies and not those from other
companies
Data entered accessible only to registered company, NHS Evidence database
managers and horizon scanning organisations
Within NICE:
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No sharing of information by NHS Evidence team managing database
NICE Topic Selection receives information as horizon scanning user
Registered companies (data inputters) and horizon scanning bodies (data accessors)
covered by specific confidentiality provisions in User Agreements
Security safeguards to ensure controlled access:
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Approval required by Department of Health (horizon scanning bodies) / ABPI (companies)
before user access is granted
Secure authentication certification associated with a specific user name and password
User Agreement for data accessors sets out responsibilities to maintain information
confidentiality
What’s in the database?
UK PharmaScan content
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General information on the medicine and indication (generally one record per
indication)
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Clinical trial information
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Regulatory information
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Costs and budget impact information
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Variety of field types (text boxes, drop-down lists)
The information provided to UK PharmaScan does not exceed historical manual systems
• Information supplied is now consolidated in one place
• Provision is proactive rather than reactive
• Most information is in the public domain (e.g. in clinical trials registers, analysts
reports, SCRIP)
Technology information
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Indication
Formulation
Mode of action
Technology status (e.g. new chemical
entity)
Route/method of administration
Presentation
Proposed dose
Proposed dosing regimen
BNF Class
Disease state
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Is the drug considered a personalised
medicine?
Current treatment options
Likely comparators
Health Technology Appraisal (has this
product been formally selected)
Who is the originator company?
Which company will market the
product in the UK?
Is the drug being co-marketed?
Contact details
Clinical trial information
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Phase
Study name
National clinical trial number for
ClinicalTrials.gov/Trial not published
on ClinicalTrials.gob
Trial start date
Number of participating countries
Participating countries
Patient population
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Study design
Primary objective
Primary outcomes
Secondary outcomes
Anticipated date of study completion
Anticipated date of study publication
Publications
Regulatory information
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Orphan Drug Status in EU
Date orphan drug status granted
Current EU stage of development
Regulatory procedure
CHMP opinion and date
EU reference member state
Estimated (and actual) regulatory
submission date
Estimated (and actual) licence date
Estimated (and actual) UK availability
date
EU fast track application anticipated
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Information on EMA/MHRA
decisions
Date of and reason for withdrawal of
EU marketing authorisation (where
relevant)/ to include any plans for
trials/re-filing?
Date of and reason for
discontinuation of development in
EU (where relevant)
Development in the US (including
date response letter issued, if FDA
fast tracked, if FDA organ drugs
status)
Up-to-date regulatory information is the top priority for horizon scanning organisations –
companies should update immediately new information becomes available
Cost and budget impact
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Propose average dose
Place in therapy (e.g. substitute, add on…)
Estimated length of treatment
Drug cost range (per patient per year or patient per episode if less
than one year)
Confirmation of any planned patient access scheme
Is the technology available on a compassionate basis?
Service impact
Impact on patient carers
UK patient population and eligible patient population
Budget impact details
Budget impact information is a key priority for horizon scanners - a best
estimate should be given even if plans are not finalised; horizon scanning
organisations will treat it as such
Horizon scanning organisations’
perspective
Essential to UK horizon scanning organisations
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Information essential to:
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NICE – topic selection, timetabling, production of timely guidance
SMC – advance notification to Area Drugs and Therapeutics Committees of new medicines
for budget/service planning; appraisal planning
AWMSG – appraisal planning
NHS organisations budgeting for and managing entry of new medicines, new indications and
new formulations into local health economies
England
NIHR Horizon
Scanning Centre
Briefings to DH
and NICE
MPC Evidence
Summaries New
Medicines
Scotland
Forward Look
reports for ADTCs
Input to SMC
appraisals
Wales
AWMSG TDA
planning
UKMi ‘Prescribing
Outlook’ reports
Northern
Ireland
NICE Topic
Selection process
and timetable
Forward planning
for commissioning
processes
What horizon scanning organisations need
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Available information/data on medicines in phase III clinical development and/or three
years from estimated UK launch
Full and accurate information that is available to the company at the time
Up-to-date information
Priorities:
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Up-to-date regulatory information - foundation for all horizon scanning activities
Budget impact assessment - key to outputs for Department of Health, HTA and NHS:
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Recognise price for new medicine only available near to launch
Estimates/order of magnitude welcomed
Information not provided by companies will be obtained and/or estimated using other sources, which
may be neither as current or accurate as information available from companies
For some fields (e.g. UK launch date, budget impact) a best estimate is welcomed where plans are not
finalised - and will be treated as such
Horizon scanning organisations want relationships and dialogue with companies based on
interpretation of factual information, not chasing for the basics
Feedback from horizon scanners
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NIHR Horizon Scanning Centre: we have used 300UK PharmaScan records as the basis for
writing outputs (as of 5 September 2012). UK PharmaScan is now the preferred way of receiving
data on new medicines.
NICE: UK PharmaScan is a vital component to inform and update the planning and scoping of
potential topics for guidance production.
AWMSG: UK PharmaScan helps enable the All Wales Therapeutics and Toxicology Centre to
identify new medicines and licence extensions which may meet AWMSG appraisal criteria - the
information provided is detailed and easily accessible and enables us to update our internal
database improving the accuracy and efficiency of our in-house horizon scanning process.
SMC: we use UK PharmaScan in the production of our annual horizon scanning report, Forward
Look, which informs financial planning for emerging new medicines in all Scotland’s Health
Boards.
Northern Ireland Health and Social Care Board and Public Health Agency: we use UK
PharmaScan as a vital tool in the development of briefings for presentation to commissioners to
facilitate forward planning.
Medicines and Prescribing Centre: we have used UK PharmaScan to inform topic selection
and prioritisation for MPC Evidence Summaries New Medicines, particularly to identify the
proposed indication, licensing timelines and published clinical trials.
UKMi: we use UK PharmaScan to help determine the content of Prescribing Outlook, our annual
horizon scanning publication for medicines management and commissioners in primary and
secondary care.
Management by companies
Getting the basics right
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Data on all new technologies (products / indications / formulations / licence
extensions) three years from launch or entering phase III clinical development,
whichever is earlier
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Update of specified regulatory fields immediately information available to company
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All other fields to be updated every three months
Data entry is simple and intuitive – database Release 3 has improved
functionality and simplified data entry following feedback from companies
Company registration process
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All pharmaceutical companies are required to select an appropriate person to be the
Champion User
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Champion User completes registration form on UK PharmaScan website (including
provision of secure password)
ABPI approves request
UK PharmaScan creates record for company and Champion User
Activation email, including link to a download certificate, sent to Champion User
Champion User downloads certificate on to computer: access only provided once
certificate has been downloaded.
In parallel Champion User gets User Agreement signed and returned to NICE
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Making it work
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Alignment with company HTA and managed entry processes:
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Internal Standard Operating Procedures:
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UK PharmaScan as an essential component of NHS managed entry is a vital element of
company market access processes, outputs and timelines
Maintaining and updating data
Appointment (and replacement) of Champion User
Senior oversight:
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Prioritisation in line with other market access activities
Reflected in performance management systems and objectives for individuals and teams
For some companies UK PharmaScan has been a valued opportunity for
a complete review of how it provides new product information to horizon
scanning organisations and the NHS
Achieving the ambition
As of December 2014:
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Over 145 companies registered
Over 850 technology records
Please support us in ensuring that patients have timely access to new
medicines through entry on UK PharmaScan of accurate, comprehensive
And up-to-date information for NHS financial and service planning
Resources
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Guidance Document
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Training Site
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Provides details of how to register and enter data
Includes examples of ideal records
Facility where new and existing users can practise using UK PharmaScan before entering
data on live database
NICE Helpdesk - 0845 003 9183
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Available to users from 9am to 5pm Monday to Friday to assist with any access and/or
technical issues
Further information
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Website: https://www.ukpharmascan.org.uk/Static/About