Working together to improve NHS planning for new medicines

1. Working together to improve NHS planning for new medicines

2. Why UK PharmaScan? • Better NHS planning has been shown to improve speed of medicines uptake • NHS needs advance information on new medicines for budget and service planning • National planning: • Health Technology Assessment (HTA) in England, Scotland and Wales • Local planning: • Formulary development and service design • Development of commissioning policies for new medicines • All six horizon scanning organisations in UK need the same information to: • Inform HTA processes and timetabling • Provide information to local NHS organisations for financial and service planning • Pharmaceutical companies need toprovide the same information to all six organisations: • Avoids duplication • Consistent information • Dialogue focused on sharing factual information not on its interpretation

3. 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: • 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

4. UK PharmaScan – driving quality and efficiency • UK PharmaScan has focused pharmaceutical companies on consolidating key information on new medicines to meet the needs of NHS budget and service planning • 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

5. Essential component of market access for medicines Marketing Authorisation and launch (0) Phase II (-3-5 yrs) Phase III (-1-3 yrs) Regulatory submission (-1 yr) Advance Budgetary Notification to local NHS Pharmaceutical Company AWMSG Form A Data entry and updates on to UK PharmaScan Early identification and profiling NIHR HSC Briefings to NICE & DH on priority medicines Horizon Scanning MPC Evidence Summary New Medicines UKMi Prescribing Outlook SMC Forward Look Filtering & prioritisation NICE topic selection HTA NHS England Specialised Services Input to SMC HTAs HTA processes and decisions AWMSG appraisal planning Budget allocations for following year ADTC processes and formulary decisions 3 year planning and prioritisation NHS

6. Who has access? • NHS England Specialised Services • National Institute for Health Research (NIHR) Horizon Scanning Centre • NICE (Topic Selection, Medicines and Prescribing Centre, Technology Appraisal Scoping and Guidance Information Services) • UK Medicines Information (UKMi) • Scottish Medicines Consortium (SMC) • All Wales Medicines Strategy Group (AWMSG) • Northern Ireland Health and Social Care Board • Specialised Services NHS England

7. How does it work? Database (NHS Evidence) Horizon scanning bodies NHS and HTA organisations Companies 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

8. Confidential and secure • 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: • 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: • 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

9. What’s in the database?

10. UK PharmaScan content • General information on the medicine and indication (generally one record per indication) • Clinical trial information • Regulatory information • Costs and budget impact information • Variety of field types (text boxes, drop-down lists) • The information provided to UK PharmaScandoes 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)

11. Technology information • 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 • 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

12. Clinical trial information • 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 • Study design • Primary objective • Primary outcomes • Secondary outcomes • Anticipated date of study completion • Anticipated date of study publication • Publications

13. Regulatory information • 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) • 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 Up-to-date regulatory information is the top priority for horizon scanning organisations – companies should update immediately new information becomes available

14. Cost and budget impact • 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

15. Horizon scanning organisations’ perspective

16. Essential to UK horizon scanning organisations • Information essential to: • 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 NIHR Horizon Scanning Centre Briefings to DH and NICE MPC Evidence Summaries New Medicines UKMi ‘Prescribing Outlook’ reports NICE Topic Selection process and timetable England Forward planning for commissioning processes Northern Ireland Forward Look reports for ADTCs Input to SMC appraisals Scotland Wales AWMSG TDA planning

17. What horizon scanning organisations need • 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: • Up-to-date regulatory information - foundation for all horizon scanning activities • Budget impact assessment - key to outputs for Department of Health, HTA and NHS: • 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

18. Feedback from horizon scanners • NIHR Horizon Scanning Centre: we have used 300UK PharmaScan records as the basis for writing outputs (as of 5 September 2012). UK PharmaScanis now the preferred way of receiving data on new medicines. • NICE:UK PharmaScanis a vital component to inform and update the planning and scoping of potential topics for guidance production. • AWMSG:UK PharmaScan helpsenable 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 PharmaScanas a vital tool in the development of briefings for presentation to commissioners to facilitate forward planning. • Medicines and Prescribing Centre: we have used UK PharmaScanto 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 PharmaScanto help determine the content of Prescribing Outlook, our annual horizon scanning publication for medicines management and commissioners in primary and secondary care.

19. Management by companies

20. Getting the basics right • Data on all new technologies (products / indications / formulations / licence extensions) three years from launch or entering phase III clinical development, whichever is earlier • Update of specified regulatory fields immediately information available to company • 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

21. Company registration process • All pharmaceutical companies are required to select an appropriate person to be the Champion User • 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

22. Making it work • Alignment with company HTA and managed entry processes: • UK PharmaScan as an essential component of NHS managed entry is a vital element of company market access processes, outputs and timelines • Internal Standard Operating Procedures: • Maintaining and updating data • Appointment (and replacement) of Champion User • Senior oversight: • 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

23. Achieving the ambition As of December 2014: • 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

24. Resources • Guidance Document • Provides details of how to register and enter data • Includes examples of ideal records • Training Site • Facility where new and existing users can practise using UK PharmaScan before entering data on live database • NICE Helpdesk - 0845 003 9183 • Available to users from 9am to 5pm Monday to Friday to assist with any access and/or technical issues

25. Further information • Website: https://www.ukpharmascan.org.uk/Static/About