19/05/2018 An introduction to Horizon Scanning Research & Intelligence Centre (HSRIC)

19/05/2018 Aims: to provide advance notice to the Department of Health (England), health service policy-making bodies and research funders of significant new and emerging technologies, up to 3 years prior to launch on the NHS, that need: further research or evaluation, consideration of clinical and cost effectiveness consideration of cost impact consideration of implementation requirements modification of clinical guidelines Remit: Pharmaceuticals (new drugs and new indications of existing drugs), devices, diagnostic tests and procedures, surgical and other interventions, rehabilitation, public health and health promotion activities.

Drug team structure Dr Claire Packer Director Dr Sue Simpson Dr Ali Cook Associate Director MedTech team lead Dr Sue Simpson Associate Director Reviews team lead Dr Derek Ward Drugs team Medical advisor Kathryn Miles Senior Analyst Dr Luan Linden Phillips Senior Analyst 6 Horizon Analysts

19/05/2018 Topics covered All interventions which are used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. Including: Pharmaceuticals – phase II, III and pre-launch Ideally 24-30 months notice prior to licensing Medical devices, implants, biomaterials etc - prior to, or within 2 years of marketing or marketed but <10% diffused or localised to a few centres Diagnostic tests and procedures Interventional procedures Public health and screening programmes Rehabilitation and other therapy

Methods: identification sources Scientific journals Commercial developers Trial registries Other horizon scanning organisations New or emerging health technologies Medical media General media Clinical experts Commercial media Patients and public

Euroscan: www.euroscan.org.uk 19/05/2018 18 worldwide member agencies Information exchange Methodology exchange

Initial filtration of pharmaceuticals 19/05/2018 Initial filtration of pharmaceuticals Consider: Appropriateness for the NHS Innovation Potential for clinical benefit Potential for high cost Government priority areas; no cancer drugs excluded The first biosimilar for each indication Exclude: HIV products and prophylactic vaccines (remit of other agencies) Generics and subsequent biosimilars

Prioritisation of pharmaceuticals 19/05/2018 Prioritisation of pharmaceuticals Based on anticipated licensing / launch timeframe: Quarter/year of possible licensing (or launch) New drugs, minimum of 20 months notice to NICE New indications for existing drugs, minimum of 15 months notice to NICE Place in clinical development - phase II or III trials Reporting date of ongoing trials

Working together to improve NHS planning for new medicines https://www.ukpharmascan.org.uk

Maintains confidentiality Collaboration engagement with stakeholders Benefits Reduces duplication Ensures consistency Corporate reputation Champion user Productivity Maintains confidentiality Relevance Improves standards Responsive Collaboration engagement with stakeholders

Intelligence on new medicines and new indications Complete and accurate information to avoid duplication of effort Confidentiality and security: Secure safeguards are in place to control access Access only to registered pharmaceutical companies and national horizon scanning organisations All organisations granted access are required to sign a user agreement that sets out roles and responsibilities, including strict adherence to commercial confidentiality To register go to https://www.ukpharmascan.org.uk/Company/Register and complete the online registration form

NICE Topic Selection process Reject or refer elsewhere (MPC / NICE Guidelines) NICE Guidance produced NIHR Horizon Scanning Research and Intelligence Centre Decision Point 1/2 for TA or HST programme

Filtration forms – scoring Will NICE Guidance add value? 19/05/2018 Filtration forms – scoring Will NICE Guidance add value? Population (1-5) The larger the population, the more important a technology is for evaluation. Disease severity (1-5) Severity of condition impacts on importance of evaluation; takes into account: life expectancy; how far the individual is away from perfect health and health states that incur social stigma. Resource impact (1-5) Potential resource impact of guidance including cost of implementing guidance, including any additional service, facilities or staff requirements. Claimed Therapeutic benefit (1-5) Extent to which a new technology claims measurable therapeutic benefit over currently available NHS treatments.

19/05/2018 Topics reaching NICE Transparent reporting of topic progress on the NICE website: Available for topic selection from January 2015, HST to follow. Updated as topics progress through scoping http://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection Timings at NICE Generally one week after a briefing arrives with NICE, the company get a letter from NICE. If the topic reaches NICE two years or more before launch, a scoping workshop normally takes place at NICE one year before licence.

Technology briefing Technology, marketing plans and timing 19/05/2018 Technology briefing Technology, marketing plans and timing Indication, patient group size, epidemiology Current treatment, service usage Current guidance and guidelines Ongoing and published research Assessment of clinical and resource impact, place in patient pathway

19/05/2018 Drugs team customers NIHR HSRIC NICE Technology Appraisals NICE Technology Appraisals for Highly specialised technologies Department of Health policy teams NHS England All non-confidential versions of briefings are published on our website

Drugs team collaborators 19/05/2018 Drugs team collaborators NIHR HSRIC NICE Medicines and Prescribing Centre (MPC) UK Medicines Information (UKMI) Scottish Medicines Consortium NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) Department of Health, Northern Ireland All Wales Medicines Strategy Group (AWMSG) Research and Development Directorate at the Department of Health

Principal information flows for HSRIC

Company contacts – HSRIC approach HTAi workshop 6th June 2010 Company contacts – HSRIC approach Exchange information Role and function of HSRIC and other relevant agencies Development stage, patient indications & regulatory plans/timelines for all company products Identify other product(s) not previously identified through scanning or prior company contacts Remove discontinued/obsolete products Request information Individual product(s) identified through other routine scanning or prior company contacts To support initial filtration, prioritisation or later preparation of full briefing outputs Development stage, patient indications & regulatory plans/timelines Around 140 companies about 220 technologies a quarter Generally one primary contact at each company Company pipeline meeting Other company contact

Patient & Public Involvement at HSRIC We aim to: To identify areas of work where we can build and strengthen mutually advantageous relationships Ensure accessibility and effective dissemination of outputs Avoid tokenism Add value PPI for the drugs team: Piloting patient comments on two briefings in 2014/2015 Developing lay summaries in 2015 Broader PPI at HSRIC detailed in our activity report and strategy 2015-2016 at: http://www.hsric.nihr.ac.uk/for-the-public/

NIHR HSRIC website http://www.hsric.nihr.ac.uk/

Confidentiality The HSRIC undertakes to: 19/05/2018 Confidentiality The HSRIC undertakes to: Keep all Confidential Information strictly confidential; Not use any Confidential Information for any purpose other than participating in the HSRIC’s processes; Restrict access to any Confidential Information to only those persons that need to know such information. Not disclose any Confidential Information to any third party other than for the purposes outlined in the text above, and where the third party is fully aware of the Confidential Information and agrees to be bound by these undertakings. Full confidentiality statement is available at: http://www.hsric.nihr.ac.uk/about-us/governance/