Health Policy & NICE Flashcards
What was the purpose of NICE when it was set up?
an attempt to end care by postcode
it was designed to standardise quality of care across the NHS and drive the uptake of new technologies
What is NICE’s role?
the national point of reference for advice on safe, effective and cost effective practice in health and social care
providing guidance, advice and standards aligned to the needs of its users and the demands of a resource constrained system
What NICE guidance is aimed at the NHS (3 categories)?
technology appraisals - entry to NHS funding:
- largely new pharmaceuticals
- robust economic analysis
guidance - advice on best practice:
- devices and diagnostics - cost-effectiveness
- medical technology guidance - cost saving
- clinical guidance - conditions and symptoms
interventional procedures - represents a ‘licence’ to use”
- safety and efficacy
What is involved in technology appraisals and funding?
- most positive recommendations for technologies appraised by NICE should be implemented within 90 days of guidance publication
- for technologies recommended by NICE with a high cost for the NHS, special arrangements may be required to better manage their implementation
- a longer time period for implementation may be reqquired for technologies with a budget impact that may exceed £20 million per year in any of the first 3 years
- NICE actively engages with NHSE to agree the implementation approach
What are the three options when it comes to funding new cancer drugs?
the NICE appraisal committee makes decisions as to whether new drugs should be funded
- NO - not routinely commissioned
- YES - baseline commissioning
- YES in CDF - cancer drugs fund
- data is then collected for a specified time period
- there is then a review of technology appraisal
What is the Cancer Drugs Fund?
What type of drugs are within this category?
access to cancer drugs where NICE indicates that there is insufficient evidence to support a recommendation for routine commissioning
the drug must display plausible potential for satisfying the criteria for routine use
What is entry into the CDF subject to?
entry into the CDF is subject to the company agreeing to fund the collection of a pre-determined data set, during a period normally lasting no longer than 24 months
and a commercial access arrangement which makes the drug affordable within the CDF budget
When may departure from standard practice as set out in NICE guidelines be justified?
- the patient has been given a full explanation of the issues, and the doctor has checked that the patient understands
- the patient gives informed consent, if they have the mental capacity
- there is clear documentation in the patient’s notes - this should include the reason why it is appropriate to depart from the guideline
- the doctor is acting in good faith
In exploring the issues with a patient, what should be remembered?
choice, risk, impracticality and benefits
What is the responsibility of a doctor with regards to the NICE guidance?
when exercising their judgement, health professionals are expected to take the guidance fully into account, alongside the individual needs, preferences and values of their patients
the application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and does not override the responsibilty of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian
What is the purpose of NICE guidelines when it comes to interventional procedures?
guidance as to whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use in the NHS
What interventional procedures are covered by NICE guidelines?
procedures used for diagnosis or treatment that involve:
- making a cut or hole to gain access to the inside of a patient’s body
- gaining access to a body cavity without cutting into the body
- using electromagnentic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light)
What are the 3 categories of interventional procedure (IP) guidance covered by NICE?
may be used:
- with the normal arrangements for consent and audit
do not use:
- not safe and efficacious enough for use
may be used:
- with special arrangements for consent, clinical governance and audit or research
What are the some other evidence-based products on which there are no recommendations?
evidence summaries:
- medtech innovation briefings
- new medicines evidence commentaries
implementation products, based on guidance:
- shared decision aids
- cost impact reports
- short guides for social care
digital:
- NICE digital
- mobile application
What type of trials in the mid 20th century had a profound impact on the practice of medicine?
What organisation was set up to review these trials?
randomised controlled trials
the Cochrane Collaboration was established in 1992 to systematically review all RCTs
What are the problems with evidence?
- there is not enough
- evidence is poor quality
- conflicting results
- the wrong sort of evidence
” evidence is inherently uncertain, dynamic, complex, contestable, and rarely complete “
What are the six internationally agreed domains of guideline production?
- scope and purpose
- stakeholder involvement
- rigour of development
- clarity and presentation
- applicability
- editorial independence
What are the 6 stages in the process of guideline development?
- topic referral
- scoping
- development
- consultation
- validation
- publication
What are the core principles of NICE guidance?
- comprehensive evidence base - not just RCTs
- expert input - from clinicians, economists, etc
- patient and public involvement
- independent advisory committees
- genuine consultation with all stakeholders
- regular review and updating
- open and transparent process with meetings held in public
What are the 5 areas of scientific evidence?
- professional expertise
- practicalities
- values
- economics
- patient or lay views
What is the past, the present and the future for scientific evidence?
the past:
- research data - facts and statistics collected together to answer specific questions
the present:
- real world data - data collected outside of formal research, increasingly being used especially for digital technologies
the future:
- extremely large data sets combined to look for patterns and trends, often using machine learning
What are the 6 principles of the NHS?
- predominantly publicly funded & owned
- supplemented by private insurance schemes
- largely free at the point of use
- comprehensive
- universally accessible
- ultimately responsible to parliament via Secretary of State for Health
Why is demand for care from the NHS growing?
a rising burden of avoidable illness from unhealthy lifestyles:
- 1 in 5 adults still smoke
- 1/3 of people drink too much alcohol
- more than 6/10 men and 5/10 women are overweight or obese
furthermore:
- 70% of the NHS budget is now spent on long term conditions
- people’s expectations are also changing
What are the 2 sources of funding for the NHS?
- 98.8% of NHS funding comes from general taxation and National Insurance
- 1.2% of NHS funding comes from patient charges
How does the money flow when it comes to funding the NHS?
- HM Treasury gives £107 billion to the Department of Health
- some of this goes to centrally managed projects and services
- arms length body funding
- public health spending
-
£96 billion of this is given to NHS England
- this pays for nationally commissioned services
-
£64 billion of the money given to NHS England is given to Clinical Commissioning Groups
- this pays for locally commissioned services
How does NICE take cost into account?
there is a need to work within a budget
need to consider the consequences - the opportunity costs?
need to consider what is best value for money?
What is meant by economic evaluation?
When does NICE tend to use it?
economic evaluation is the comparative analysis of alternative courses of action in terms of both their costs and consequences
this is largely for new or expensive treatments
costs and consequences for current treatments and new treatments are evaluated and there is a separate analysis for each patient subgroup
What is meant by the QALY concept?
with treatment, the number of quality adjusted life years is greater
How can QALYs be used to determine whether a new drug is more effective?
if the new drug provides fewer QALYs overall, then it is less effective
How does cost effectiveness affect whether a treatment is used?
when the cost per QALY rises above around £24K, it is likely to be rejected
when the cost per QALY rises above around £34K, the treatment will be rejected
usually an accepted treatment costs around £13K per QALY
Why doesn’t NICE have a fixed cost effectiveness threshold?
due to many variables combined with significant uncertainty
e.g. estimates of cost effectiveness per QALY gained can vary dependent on the extrapolation used
How does the following clinical trial act as an example of uncertainty?
“Osimertinib for treating locally advanced or metastatic EGFR T790M mutation positive non-small cell lung cancer”
- data from the non-randomised, single-arm phase II studies (AURA and AURA2)
- 12 months observed data extrapolated to 15 years in the model
- immature survival data gives uncertainty in long-term clinical effectiveness
- estimates of cost effectiveness ranged from £41,705 to £89,296 per QALY gained dependent on the extrapolation used
What is meant by NICE making decisions requiring a deliberative process?
- consideration of scientific evidence and “colloquial” evidence
- incorporating social value judgements
- weighing benefits, risks and costs
What is shown about the approval rates for new drugs from this table?
there is an 81% overall positive recommendation
What are the challenges of implementing NICE guidance?
- gaining consensus with colleagues (41%)
- training / new skills required (15%)
- lack of money (14%)
- new services or equipment required (12%)
- lack of time (9%)
- other (8%)
What was involved in the 2016 NICE implementation strategy for facilitating change?
- guidance and standards fit for our audiences’ needs
- audiences aware of our guidance and standards
- audiences motivated to make changes and drive improvements
- practical support highlighted to support local implementation
- impact and uptake is regularly evaluated
How does NICE monitor impact?
- NICE has an ongoing programme of monitoring data on uptake - from external sources
- this is published on the NICE website as Uptake Data
- data on the use of new drugs and indicators feeding into “getting it right first time”
- topic-based impact reports
What is the current target in England for suspected cancer?
there are urgent (2 week wait) referrals for suspected cancer in england
the current target is that people should be seen by a specialist within 14 days following an urgent GP referral
data about these referrals are routinely published by NHS England as part of the cancer waiting times statistics
How have NICE recommendations on BRAF V600 targeted therapy for melanoma treatment changed and why?
- vemurafenib was recommended by NICE in December 2012 for treating people with locally advanced or metastatic melanoma with a BRAF V600 mutation
- in October 2014, dabrafenib was recommended by NICE
- these medicines do not differ in clinical effectiveness, but dabrafenib has a lower incidence of photosensitivity, which may be a major problem for some patient
In general, when do doctors use NICE guidance?
- best practice advice on treating diseases and conditions (clinical guidelines)
- advice on safety and efficacy of new interventions which hospitals are required to follow and monitor use
- mandated guidance on use of drugs - doctors need to be able to communicate complex decisions
- advice on new diagnostic tests and devices
In general, when do doctors use NICE evidence?
- wide range of accredited guidance and evidence
- access to prescribing information and personalised alerts
