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ABPI regional industry group - NICE to know
1. ABPI Regional Industry Group
NICE to know : Information Exchange
Steve Sparks
Associate Director NICE Field Team
2. “… an expanded role for NICE
extending its remit into social care”
• April 2013
• Adults and children
• Still NICE but…….. ‘care excellence’
• Non NHS body and set in legislation
• New Chair
5. NICE Field Team
• Implementation Consultants
• Team of 7 aligned to NHS CB
regions
• 1 in Northern Ireland
• Responsible for a
geographical territory
• Field based
• Provide local connectivity
6. What we offer……
• Support organisations to use/ implement NICE
guidance, advice and standards
• Strategic advice on implementation and context
advice for senior management teams
• Promote awareness and understanding of the
entire range of NICE outputs
• Problem solving, by sharing learning across
organisations
• Advice on how to use and access NICE
implementation support resources, NICE
pathways, NICE Evidence etc
• Opportunity to feed back to NICE on local issues,
ideas and suggestions for improvement
• Facilitate stakeholder engagement with NICE
7. NICE to know …
• We facilitate and support good practice – we don’t judge
• We will meet with anyone from providers and commissioners
of NHS and social care services at their request
• National, regional and local speaker for NICE
• Lead on specific projects that deliver benefit to NICE and our
partners - often national focus
• Provide regular feedback to NICE on our findings in the field,
with recommendations for action
• Unable to work with individual pharma/medtech companies:
conversations are via ABPI/ABHI
• Evolving our support offer to meet needs in the changing
environment.
8. Who we will engage with 2013/14
April May June July August September October November December January February March
Primary Care Provision
Community Trusts and Ambulance services
AHSN Areas for collaboration
Social Care: Adults
Acute and Mental Health Trusts
Local Authorities and Directors of Public Health
Health & Wellbeing Boards
Clinical Commissioning Groups
Local Area Teams
Strategic Clinical Networks
and Clinical Senates
Social Care: Children
Academic Health Science
Networks
Public Health England
10. Innovation health and wealth
Key areas relevant to
NICE:
– A NICE Implementation
Collaborative to support the
implementation of NICE guidance
– A ‘NICE compliance regimen’ for the
funding direction attached to NICE TAs,
to ensure rapid and consistent
implementation – innovation scorecard
and work on local formularies
– Working with Academic Health
Science Networks
Climate conducive to promoting uptake
11. Technology appraisals
• Review of the available evidence on how well medicines and
treatments work (clinical effectiveness), and also of how well
they work in relation to how much they cost the NHS (cost
effectiveness)
• covers medicines and treatments such as; medicines,
medical devices, diagnostic techniques, surgical procedures,
health promotion activities
• under the NICE Regulations, where NHS England is the
appropriate health body, it must comply with a NICE
technology recommendation. This includes providing funding
usually within 3 months of the date of publication for any
patient who meets the clinical criteria. In some
circumstances, the guidance will state a longer period for
providing funding. The NHS Constitution sets out patients’
rights for access to such medicines and treatments. This is to
ensure there is equality in access irrespective of where
patients live or are being cared for.
11
Technology appraisal guidance are recommendations on the use of new and
existing medicines and treatments in the NHS
12. High Quality Care
for All
Health & Social Care
Act 2012
Developing the NHS
Commissioning Board
New focus on
quality - the
birth of NICE quality
standards
Focus on quality
retained - strengthened
role for NICE quality
standards
NICE quality
standards - underpin the
new commissioning
system
Quality standards - policy background
13. High Quality Care
for All
Health & Social Care
Act 2012
Developing the NHS
Commissioning Board
New focus on
quality - the
birth of NICE quality
standards
Focus on quality
retained - strengthened
role for NICE quality
standards
NICE quality
standards - underpin the
new commissioning
system
Quality standards - policy background
Francis Report
Fundamental, enhanced and developmental standards
Evidence based workforce/ staffing tool
14. Quality Standards
Evidence Guidance
Quality
Standards
‘Sentinel markers’
A prioritised set of concise, measureable
statements designed to drive quality
improvements across a pathway of care
A comprehensive set of
recommendations for a particular
disease or condition
16. Unsafe Substandard Adequate Good Excellent
NICE quality standards
Standard of services
Proportion of
services
CQC Registration
requirements
Fundamental
Enhanced Developmental
Standards and level of service
19. NICE pathways
1. To bring together related
guidance, between and within
topics
2. To link other products – Quality
Standards, implementation
support tools etc
3. To provide a useful format -
network of recommendations
4. To improve digital formatting for
easier access
Easier, quicker access to the
evidence
23. The future – what’s on the
horizon• Social care:
– Guidance
– Quality standards
– Support for uptake
• Technology assessment
– Value-based pricing
– Highly specialised technologies (HST)
• Adoption of new technologies
– Transfer of the NHS Technology Adoption Centre
24. Highly specialised technology
assessment (HST)
• Ministerial request to assess very high cost, low
volume drugs (and potentially other technologies) for
people with rare or very rare conditions from April
2013.
• A role previously provided by Advisory Group for
National Specialised Services - AGNSS
• Interim process likely to include:
– Current NICE appraisal topic selection process
– Company submission plus academic review
– New Advisory Committee for HST
– Adaptation of AGNSS decision making framework
– Public consultation and appeal
– Formal link to nationally commissioned specialised services
– Guidance to the NHS and funding direction
25. Value-based pricing – how it
might work
• Only new medicines launched after January 2014
• Higher price thresholds for medicines that:
– Tackle disease of high unmet need or severity
– Demonstrate greater therapeutic improvements and
innovation
– Demonstrate wider societal benefits
• Categories and weights determined by the Secretary
of State for Health:
– On the basis of empirical research
– Within a framework determined in advance
26. Health Technology Adoption Programme
• NTAC established at the end of 2007 to
provide a more systematic approach to
adoption of new technologies.
• Aims to enable organisations to better
understand and overcome their adoption
barriers.
Their mission is: “To work directly with industry and the
NHS at a clinical, managerial and procurement level to
identify and overcome the hurdles to adoption for
innovative technologies which have already
demonstrated clear benefits to patients and will
improve system efficiency.”
27. Keeping up to date
• Sign up for the NICE News
• Log on to the website and register
your details at www.nice.org.uk
• Email steve.sparks@nice.org.uk
Editor's Notes
Always done guidance TA and CG guidance Relevance of social care to ABPI – QS on medicines management in care homes for example, transfer of people health to social care (discharge and admission planning involves medicines)
Local connectivity between NICE “central” and target audience we were set up to support, and between organisations in our health economies (and nationally e.g. sharing of learning) Providing people implementing NICE guidance with updates, advice and support for your local strategies for implementation
Support – commissioners and providers of NHS services, local government, networks, NHSCB regional/area teamsContext advice – positioning in health and social care system, alignment with commissioning and other levers etcIn depth knowledge of NICE – all corners! Guidance, programmes, methodologies, resources, policy context Facilitate engagement – to pull information (NICE News), to comment on drafts, guidance development groups, F&S programme support and also to find external advice on distinct pieces of work for NICE
Trusts – acute, community, mental health or combination, and ambulanceCommissioners – NHSCB (regional/area team), CCGsNetworks – AHSNs, SCNs, Clinical Senates, clinical, medicines managementLocal government – public health, adults, children, H&WBs, providersOthers – Infection Prevention, SHALL, Health Education England and academic institutes
NIC Sometimes it's not easy to implement NICE guidance. The NIC brings together all the key players in one place to find out what's stopping NICE treatments being used and then aims to find ways to overcome these barriers. The NIC has already started working on four areas which affect a lot of people: osteoporosis (denosumab), stroke (NOAs), diabetes (insulin pumps) and heart disease (natriurectic BNP testing for heart failure) ~15 Partners will work with one another and also with other organisations and parts of the system to better understand the implementation landscape. For example. AHSN, Association of the British Healthcare Industries, ABPI, RPS, British In Vitro Diagnostics Association, NAPC, NHS Clinical Commissioners, NHSCB, NHS Confed, Foundation Trust Network etcFirst task will be to agree a Concordat that will govern its operation (published?) The NIC could have a crucial role to support implementation of guidance on medical technologies, where there are low cost high value interventions that could improve patient care, while at the same time stimulating growth in small and medium sized medical technology companies. NICE Compliance Regime to reduce variation and drive up compliance with NICE Technology Appraisals, NICE Compliance Regime for the funding direction attached to NICE Technology Appraisals.Formularies - not all local formularies include all of NICE's TAs – can lead to postcode lottery where patients miss out on drugs approved by NICE. Some PCTs are blacklisting a range of NICE-approved drugs in order to make cost savings. Sir David Nicholson said he "wants to see all NHS organisations publish information which sets out which NICE technology appraisals are included in their local formularies. PCT Clusters and Clinical Commissioning Groups will need to take the lead in working towards publication by 1st April 2013 at the very latest.“ “Formularies have an important role in underpinning safe and effective use of medicines. “However, they should not duplicate NICE assessments or challenge an appraisal recommendation. Once in formularies, there should be no further barriers to the use or prescription of technologies or medicines.”Innovation Scorecard -Health and Social Care Information centre asked to develop and publish “innovation scorecard on behalf of DH and NHSCBExperimental statistics – designed to encourage discussionData shown for 76 medicines and 6 medical technologies covered by 102 TAsEstimates of actual use and expected use of medicinesVolume of medicines used in primary care by CCG population Use of medical technologies in trusts by CCGVolumes of medicines used in trustsInteractive spread sheet - shows variation
.
Cross cutting e.g. medicines adherence, Service delivery e.g. out of hours care, Acute medical admissions in the first 48 hours, readmissionsNHS-facing quality standards on cross-cutting public health topics e.g. Smoking cessation, Physical activity, Alcohol - : preventing and managing alcohol misuseDepressionService user experience in adult mental health servicesDrug use disorderNutritionIn development – ADHD, DEPRESSION IN C&YP,Bipolar disorders, conduct disorders, eating disorders, PTSD
'Evidence summaries: new medicines' are provided to help commissioners, budget holders and groups such as Area Prescribing Committees to make informed decisions and aid local planning on the introduction of key new medicines.Quality-assured summaries of the best available evidence for selected new medicines, or existing medicines with new indications or a new formulation, that are considered to be of significance to the NHS. The topics selected are medicines that have recently gone into the UK market, or medicines that may be marketed in the UK in the next 6-12 months. 10 published to date. Two types of topics will be considered:a medicine recently marketed in the UK a medicine that may be marketed in the UK within the next 6–12 months.In both cases, topics will only be considered where a NICE technology appraisal (TA) is not planned or in progress.Topics presented to New Medicines Community of Practice for advice on the likely clinical and service impact. List then compiled using NICE topic selection criteria and Director CCP signs off – then manufacturers are notified. Invited to submit data in support of evidence review and given opp to comment on an early draft and again can comment on matters of factual accuracy, and respond to any specific questions from NICE about any information they submitted to inform the summaryUnlicensed and off-label medicines have a valuable role in the care of certain patients when there are no suitable licensed medicines available which meet their needs. However, information for healthcare professionals and patients to decide whether these medicines are safe and effective, and when they are most likely to yield good patient outcomes, can be difficult to find. It is estimated that around 1,000 specific requests for off-label drug use are made to NHS commissioners in England every year.The summaries will be the first nationally-available source of information for healthcare professionals and patients. They will allow evidence-based prioritisation, treatment and funding decisions to be made where there are no clinically-appropriate licensed alternatives.For both - the strengths and weaknesses of the relevant evidence are critically reviewed, but the summaries do not constitute formal NICE guidance.3 published to date e.g. ESUOM1 Significant haemorrhage following trauma: tranexamic acid
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