DECISION MAKERS AND DECISION-MAKING PROCESSES DIAGRAM
Description of the UK Health Care System
The UK comprises England, Scotland, Wales and Northern Ireland. Since 1998, a process of devolution has given decision-making powers over healthcare provision and purchasing medical technologies to the devolved governments of Scotland, Wales and United Ireland. Hence the healthcare systems in these parts of the UK have developed differences over the past 10+ years. The description below principally covers the largest area England with approximately 51 million people (~ 83.5% of the UK population), but where clear differences exist they are described.
The Department of Health (DoH) registers products, whereas the ‘National Health Service’ (NHS) assesses and buys the vast majority of medical devices in the UK. The NHS is a department of the government’s DoH - the NHS is funded from general taxation (76%), national insurance contributions (15%) and user charges (5%). Other sources of funding come from private health insurance (1%), out-of-pocket payments (11%) and other sources such as charitable donations, etc (<1%) – see Fig. 1.
Fig. 1 Sources of Funding Healthcare in the UK
The government, through the NHS is therefore the dominant purchaser of medical technologies in the UK, but there are multiple providers.
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DECISION-MAKERS AND INFLUENCERS
Approximately 85% of the UK National Health Service (NHS) budget in England is distributed to Primary Care Trusts (PCTs) that are responsible for providing health care and health improvements within a local area. PCTs report into regional Strategic Health Authorities (SHAs); these authorities help develop local NHS strategy and provide a link between PCTs and the national DoH.
PCTs have their own budgets and set their own priorities, within the overarching priorities and budgets set by the relevant SHAs and ultimately the national DoH. PCTs are key stakeholders in healthcare funding, and preside over a range services provided by:
- Hospitals (20 and 30 care)
- Primary care networks - -including specialty services such as asthma clinics, diabetes clinics, ante-natal care, etc
- Community care services such as nursing homes, care at home, midwifery, psychiatric care, etc.
The providers can sometimes purchase healthcare products based on their own selection criteria, but usually purchasing medical devices is governed by the Primary Care Trusts (PCTs) and the wider NHS organization.
The differences in responsibilities between those who provide the funds for purchasing healthcare products and those who purchase and use products is described in Fig. 2 and Table 1 below:
Table 1: Key Decision Makers and Influencers in Funding Healthcare in England
Fig 2: Funding Authorities and Providers in England
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Regulatory Pathway/Market Approval Process
Regulatory approval is required through CE marking from the Medical and Healthcare Products Regulatory Agency, MHRA – part of the DoH. The main steps for obtaining a CE Mark are:
- Classify the medical device
- Select and Follow appropriate Conformity Assessment Procedure
- Apply for Certification by a Notified Body
- Ensure that the medical device complies with Essential Requirements
- Establish Technical Documentation
- Issue Declaration of Conformity and affix CE Marking.
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Reimbursement and Coverage/Payment Flow Map and Procurement Process
In theory, once a healthcare product is approved for use within the NHS (i.e. registered by the MHRA) it can be used by providers and funded by PCTs.
There are 3 main mechanisms used by PCTs to pay for healthcare products and services:
Payment-by Results (PBR) - essentially a DRG system, introduced in 2003(?) to established fixed prices (prospective payments) for hundreds (now approximately 1400) of hospital procedures. Since it’s introduction the DoH has extended the PBR system to cover treatments and procedures provided to patients as day cases and outpatients. Certain services are funded as “unbundled” payments in the latest payments schedule (HRG4) in order to allow different payments for different parts of the care pathway, e.g. diagnosis, treatment, rehabilitation, etc. Hence the system of PBR, originally intended for paying for paying form products and services used to treat inpatients may eventually be extended to provide prospective payments for a range of out-of-hospital services.
Block Contracts – agreements between care providers and PCTs to use and pay for a certain product or service.
Global Budgeting - healthcare providers can purchase products or services from their own budgets.
PRICING AND REIMBURSEMENT APPROVAL PROCESS
Manufacturers are free to set the price of their products in the UK, except for products classified as pharmaceuticals (e.g. diagnostic imaging contrast agents) which are subject to supply-side control by the DoH’s Pharmaceutical Price Regulatory Scheme (PPRS). However, funding is tightly controlled by the PCTs - PCTs are charged with financial responsibility to provide optimal care across primary, secondary and community healthcare services and stay within a given budget. Device manufacturers are therefore free to set price but have to negotiate funding with the providers or directly with the PCTs .
As the majority purchaser, the NHS has put in place a variety of mechanisms to evaluate and assess the value-for-money (cost effectiveness) of medical technologies.
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Each of the four regions in the UK (England, Scotland, Wales and United Ireland) has its own approach to HTA. A separate description of the process in Scotland and the Scottish Medicines Consortium (SMC) is provided as part of this roadmap. Here we describe the methods of the National Institute for Health and Clinical Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG). NICE and the National Coordinating Centre for Health Technology Assessment (NCCHTA) are the key national HTA organizations for England, Wales and United Ireland.
NATIONAL HTA ORGANIZATIONS & STAKEHOLDERS
- THE NATIONAL HORIZON SCANNING CENTRE (www.pcpoh.bham.ac.uk/publichealth/horizon/topic.shtml)
The National Horizon Scanning Centre (NHSC) aims to provide advanced notice to the English DoH and national policy makers, including NICE, of selected key new and emerging health
DoH and national policy makers, including NICE, of selected key new and emerging health technologies that might require evaluation, consideration of clinical and cost impact or modification of clinical guidance prior to launch.
The scope of the horizon scanning activity includes pharmaceuticals, medical devices, diagnostic tests and procedures, therapeutic interventions, rehabilitation and therapy, public health and health promotion interventions. For any non-pharmaceutical technology, the notice period the NHSC provides to the NHS is approximately 12-18 months prior to UK marketing.
THE NATIONAL COORDINATING CENTRE FOR HEALTH TECHNOLOGY ASSESSMENTS (www.ncchta.org)
The NCCHTA produces HTA reports covering the effectiveness, costs and broader impact of healthcare treatments and tests to inform those who plan, provide or receive care in the NHS. ‘Health technologies’ are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. HTA report produced by the NCCHTA directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’. The HTA programme is needs led in that it fills gaps in the evidence required by the NHS. NCCHTA’s HTA reports are published in the journal series Health Technology Assessment after peer review by independent expert referees. The journal’s 2008 Impact Factor (5.010) ranked it in the top 10 per cent of medical and health-related journals.
NATIONAL INSTITUTE OF HEALTH & CLINICAL EFFECTIVENESS (http://www.nice.org.uk/)
NICE was established in 1999 as a department of the NHS to produce national guidance on specific health technologies including both medicines and medical devices (through its Technology Appraisal process) and clinical practice (through its Guidelines development process). It has subsequently assumed additional responsibilities for public health.
In contrast to the methods of healthcare evaluation in other countries, NICE does not evaluate all interventions as they reach the market. NICE has published guidelines on how it will select interventions for review; this includes:
- Is the technology likely to result in a significant health benefit, taken across the NHS as a whole, if given to all patients for whom it is indicated?
- Is the technology likely to result in a significant impact on other health related government policies (e.g. reduction in health inequalities)?
- Is the technology likely to have a significant impact on NHS resources (financial or other) if given to all patients for whom it is indicated?
- Is the Institute likely to be able to add value by issuing national guidance? For instance, in the absence of such guidance is there likely to be significant controversy over the interpretation or significance of the available evidence on clinical and cost effectiveness?
NICE - HEALTH TECHNOLOGY APPRAISAL
Health technologies can be appraised by NICE via two routes:
- Multiple Technology Appraisal (MTA): MTAs examine a disease area or class of drugs and contain either new evidence gathered after the launch of a drug or include new economic modeling. The MTA process is based on evidence from any number of registered consultees, including manufacturers, healthcare professionals and patient/carer representatives. The MTA process is based on input from a broad range of stakeholders, with emphasis on the Assessment Group who critically reviews the available evidence and produces an Assessment Report. The Assessment Group comprises a panel of independent, academic experts from one of a number of academic centres that is commissioned by NICE to appraise the group of technologies.
- Single Technology Appraisal (STA): STAs were introduced in 200???? to provide early guidance for new products targeting a single indication, as well as for new applications of products already marketed. The STA has been introduced to reduce the effect of NICE blight and products intended to improve life expectancy are likely to be prioritized. The STA is more streamlined than the MTA process, with greater emphasis on manufacturer’s evidence. An independent Evidence Review Group is commissioned to evaluate manufacturer’s submissions and inform the Appraisal Committee.
Both the MTA and STA processes consider evidence on the health effects, costs and cost-effectiveness of the health technology. NICE provides clear guidance on their expectations of what should be included in an MTA submission, which is available on the website (give reference). In contrast, the principal source of evidence for the STA is the manufacturer’s submission and its content is primarily dictated by a prescriptive template supplied by NICE (give reference). For both MTA and STA processes the major sections of information required include: Background, Clinical evidence, Cost-effectiveness and Impact on the NHS. NICE has published on its website a series of guides on the Technology Appraisal process, including details of: timelines, stakeholders and the preparation of submissions for both the MTA and STA processes (give references to MTA and STA).
IMPACT OF NICE GUIDANCE
NICE can influence the growth of products already on the market. The NICE appraisal of statins for the prevention of cardiovascular events is estimated to have increased prescription volume
of these agents by 2.5% (PPA Update, 2006).
Since January 2002, it has been a mandatory requirement for NHS organizations in England and Wales to provide funding for medicines and treatment recommended by NICE in its Technology Appraisal guidance. Additionally, NHS organizations must review clinical management following publication of NICE clinical guidelines. The National Health Law of 2003 states that all technologies recommended by NICE are supposed to be funded by the PCTs in England and the health authorities in Wales. However, use of new technologies by providers still depends on adequate funding from PCTs, which is tightly controlled by the NHS and the DoH (as a public service). Hence even if NICE gives a favorable recommendation uptake is not guaranteed.
A number of issues have been identified that occur before and after the publication of NICE guidance, which can affect patient access to medicines. NICE ‘blight’ refers to when prescribers defer prescribing or the inclusion of an intervention on their formulary until after NICE guidance is published. ‘Postcode prescribing’ refers to how location differences can affect adaptation of NICE recommendations.
NICE assesses only a very few medical devices (See Fig 3 below).
Fig 3: Medical Technologies Evaluated by NICE
There is growing evidence that NICE guidance is also referred to by other countries, often because of the perceived robust methodology of their review process and also because their guidance can be available before a drug has gained approval in another country.
NICE is commissioned to do work on behalf of other countries under the auspices of NICE International (see www.nice.org.uk).
NICE has been asked by the DoH to coordinate the evaluation of innovative medical devices and diagnostics used by the NHS. The new work programme follows recognition in Lord Darzi’s Next Stage review of the need to improve the process of identifying, evaluating and adopting effective new medical devices and diagnostics.
The new evaluation process for medical devices and diagnostics will provide a coordinated suit of guidance on the clinical effectiveness, cost effectiveness and efficient use of selected technologies. It will include an implementation component to facilitate and accelerate diffusion of appropriate new technologies and ensure more consistent NHS-wide uptake.
A key element of the new evaluation process for medical devices and diagnostics will be the establishment of an independent Medical Technologies Advisory Committee (MTAC), which will have three distinct functions:
- Selecting products for evaluation and routing them through one of the assessment channels (initially the technology appraisal processes and the interventional procedure process, or the soon to be introduced diagnostics evaluation process)
- Arrange evaluations of medical devices with an emerging “thin” evidence base. All diagnostic products will be evaluated through the new diagnostics programme.
- Recommend further research for a small number of technology areas.
- SCOTTISH MEDICINES COMMITTEE (SMC)
A separate description of the process in Scotland and the SMC is provided as part of this roadmap.
ALL WALES MEDICINES STRATEGY GROUP (AWMSG):
The AWMSG has been established to advise the devolved Welsh Assembly of future developments in healthcare to assist in its strategic planning; develop timely, independent and authoritative advice on new drugs and on the cost implications of making these drugs routinely available on the NHS in Wales; advise the Assembly on the development of a prescribing strategy for Wales and advise the Assembly on the implementation of a range of strategic recommendations.
Initially the AWMSG appraisal process focused on high-cost medicines (i.e. those costing >£2000 per patient per annum), but has now increased its capacity to conduct up to a total of 32 appraisals per year. These comprise appraisals of not only high-cost medicines, but also new cardiac and cancer medicines.
Manufacturers must submit a Form A as an ‘intention to submit’. The AWMSG Steering Committee uses this information to decide whether the product requires full appraisal. The timing of submission of Form A is the decision of the manufacturer. The AWMSG aims to make a recommendation as soon as possible after the launch of the product. Form A should be completed regardless of whether a submission has been forwarded to the SMC or NICE. If the AWMSG decides a full appraisal is required the manufacturer must submit Form B. Form B provides comprehensive information and is used by the AWMSG, together with additional relevant information, in the preparation of their assessment report. In contrast to the NICE process, the AWMSG appraisal meeting is held in public.
The AWMSG aims is to make a recommendation soon after the launch of a product and the timescales involved require the submission to be made ahead of product launch.Full details of the process, timelines and templates for Form A and B are available on the AWMSG website at www.wales.nhs.uk/awmsg/.
The AWMSG acknowledges the NICE future work program, including the STA process, when considering whether a product will be appraised. AWMSG will not normally consider appraising a product if NICE intend to publish their final appraisal of the same product within an 18 month period from receipt of AWMSG Form A. AWMSG guidance is interim to NICE guidance should this be subsequently published.
TECHNOLOGY ADOPTION CENTRE (www.technologyadoptionhub.nhs )
The role of the NTAC is to establsih how best to implement new technologies with the NHS environment. The Centre's team will then work with a range of organisations to promote the uptake of technologies that have become standard of care.
CENTRE FOR EVIDENCE-BASED PURCHASING
The Centre for Evidence-based Purchasing (CEP) provides impartial and objective information about medical technology to help the NHS make better purchasing decisions.
NATIONAL SERVICE FRAMEWORKS (www.nhs.uk/NHSEngland/NSF/Pages/Nationalserviceframeworks.aspx )
NSFs were introduced in 1998 to address variations in standards of care and to achieve greater consistency in the availability and quality of services by putting in place mechanisms which would enable best care to be provided to all. NSFs cover some of the highest-priority conditions such as the UK's biggest killers - cancer and coronary heart disease - as well as other common conditions including mental health and diabetes. There are also NSFs for some of the key patient groups including children and older people. NSFs have several key roles:
- Set national standards and define service models for a condition or care group;
- Identify key interventions for defined services or care groups
- establish performance measures against which progress within agreed timescales will be measured.
The devolved government in Wales has developed a series of separate NSFs for Wales (www.wales.nhs.uk/nsf )
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AWMSG: All Wales Medicines Strategy Group
CEP: Center for Evidence-based Purchasing
DoH: Department of Health
DRG: Diagnosis-Related Group
GP: General Practitioner (aka Gatekeeper)
HRG: Health Resource Group
HTA: Health Technology Assessment
MHRA: Medicines and Health Products Regulatory Agency
MTA: Multiple Technology Appraisal
NCCHTA: National Coordinating Centre for Health Technology Assessment
NHS: National Health Service
NHSC: National Horizon Scanning Centre
NICE: National Institute for Health and Clinical Excellence
NSF: National Service Framework
NTAC: National Technology Adoption Centre (aka National Technology Adoption Hub)
PbR: Payment by Results (prospective payment system)
PCT: Primary Care Trust
PPRS: Pharmaceutical Price Regulation Scheme
SHA: Strategic Health Authority
SMC: Scottish Medicines Consortium
STA: Single Technology Appraisal
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AUTHORS & CONTRIBUTORS
Geoffrey Wilson MSc, BSc, DPhil, Reimbursement Leader, Europe, Middle East, Africa Region, GE Healthcare, UK
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