Intriductin To NICE COPY

Question 1

What is the purpose of NICE?

Answer 1

To balance the best care with value for money across the NHS and social care, to deliver for both individuals and society as a whole.

Question 2

What are some of the roles of NICE?

Answer 2

Assess evidence to produce guidance and advice for health and social care practitioners
Develop recommendations to drive innovation
Encourage the uptkae of best practise to improve outcomes for everyone

Question 3

What are the common lay opinions on NICE decision making?

Answer 3

Patient - fund everything, more treatment is better, unfair to put a value on a persons life
Tax payer - huge investment for a tiny reward is not worth it, can’t afford to raise taxes any more, should encourage better use of resources and money

Question 4

What are some of reasons why NICE was established?

Answer 4

No quality standards
Evidence overload - no guidance for professionals
Variation in availability of treatments - post code lottery
Rising costs - new expensive technologies
Innovative treatments underused.

Question 5

What is the devotation of Health Care in the UK in correlation to NICE?

Answer 5

Health ministers in Westminister are accountable for the NHS in England only.
England, Scotland, Wales and Northen Ireland each run their own health systems.
NICE is mainly used in England and some elements are used in Wales

Question 6

What is a NICE technology appraisal?

Answer 6

A review of clinical and economic evidence leading to the recommendations on the appropriate use of new and existing technologies for NHS England.
Started after referall of all significant new drugs, cancer drugs and license extensions from the Secretary of State for Health to NICE.

Question 7

What are the different types of NICE appraisal?

Answer 7

Single technology apprasial
Cost comparison
Multiple technology apprasial

Question 8

What is a single technology appraisal by NICE?

Answer 8

Reviews the use of a single technology for a single indication

Question 9

What is a cost comparison appraisal by NICE?

Answer 9

Aims to provide quicker access for patients to the most cost effective new treatment
Compares new treatments to pre-existing treatments

Question 10

What is a multiple technology appraisal by NICE?

Answer 10

Covers more than one technology
Or one technology for more than one indication.

Question 11

What method is used to calculate the effectiveness of a technology by NICE?

Answer 11

Quality Adjusted LIfe Years
Life years gained x quality of life = QALYS

Question 12

What costs do NICE consider within their appraisal?

Answer 12

Cost of drug
Cost of community care
Cost of managing adverse effects
Cost of inpatient stay
Cost of physiotherapy
Cost of outpatient visits
These are direct costs to the NHS

Question 13

What is an Incremental cost effectiveness ratio?
How does this relate to NICE decision making?

Answer 13

ICER - compares the costs and benefits of a new technology
Technologies with an ICER of <£20,000 to £30,000 per QALY gained are usually considered a good use of NHS resources.

Question 14

How do you calculate Incremental Cost Per Additional QALY?

Answer 14

new treat cost - old treat cost
divided by
new treat QALYS - old treat QALYs

Question 15

What is the use of decision modifies in NICE technology appraisals?

Answer 15

Allow to account for societal factors that cannot be made numerical or included in the cost-effectiveness calculation.
For example:
- Disease severity modifier
- Highly specialised technologies modifier

Question 16

What are the different stages of a NICE appraisal?

Answer 16

A clinical need is identified - a scope may be created to identify and form questions to be answers based on that specific need
Invitation of stakeholders
Evidence submission
Evidence Review
Committee Meeting
(preliminary recommendations are made, given 4 weeks consultation time, then hold another committee meeting)
Final guidance is submitted
If appealed goes back to committee meeting for change
Guidance is published
May be reviewed and undergo process again in the future

Question 17

What people tend to attend a NICE technology appraisal committee meeting?

Answer 17

Experts
Company (e.g pharmaceutical developer of new drug)
Academic groups (Doctors, surgeons)

Question 18

What is the use of a SCOPE document by NICE?

Answer 18

To set out the objectives of the appraisal
This includes the PICO:
Populations - population interested any, best described, any subgroups
Interventions - new technologies or areas for improvement
Comparators - existing options available
Outcomes - how can we measure success of the new intervention

Also includes an equality impact form and identifies stakeholders to be involved in the appraisal.

Question 19

What is a consultee at a NICE panel?

Answer 19

Consultee - invited to submit a statement, respond to consultations, nominate clinical specialised or patient experts and can appeal final guidance
For example - professional group, manufacturer of treatment, patients/carer groups

Question 20

What is a commentator at a NICE panel?

Answer 20

Someone able to engage in the process but are not asked to prepare and evidence submission or statement, are able to respond to consultation but are not able to appeal against the Final guidance
For example, comparator companies, public health bodies, Scottish Medical Consortium

Question 21

What type of evidence is submitted in a NICE panel?

Answer 21

Company - clinical evidence, cost-effectivness evidence/model , budget impact assessment

Evidence assessment group - critique of company submission and a report

Professional and patient submission statements

Question 22

Who makes up an appraisal comittee at NICE?

Answer 22

Voluntary membership includes a range of different expertise
Statisticians, GPs, lay members, health economists, nurses etc.

Question 23

What is the role of a committee chair at NICE?

Answer 23

Work with not for NICE
Runs the committee meeting, usually nominates a lead team who present the committee slides to the rest of the committee.
Manage stakeholders participating in the meeting
Seek the views of committee members to reach a decision

Question 24

What is the difference between the final guidance and draft guidance at a NICE panel?

Answer 24

Draft guidance - opportunity for people to submit additional evidence, adjust charges for drugs, changes are then discussed at a second committee meeting

Final guidance - can be appealed, if not appealed this is the guidance that is published

Question 25

What are the two different reasons why final NICE guidance might be appealed?

Answer 25

Ground 1: in the assessment that preceeded the recommendation NICE failed to act fairly or exceeded its powers

Ground 2: the recommendation is unreasonable in the light of evidence submitted to NICE.

Question 26

Is NICE guidance mandatory?

Answer 26

Yes - legally required to provide access to drugs from technology appraisals and highly specialised technology programmes in NHS England

No - all other guidance is advisory not mandatory, summary to aid not replace clinical judgement. For example, clinical guidelines, public health etc.

Question 27

What are the common outcomes of a NICE technology appraisal?

Answer 27

Around 80% of recommendations are positive.
4% and 1% of Single technology appraisals and specialised technology appraisals are made available via the Cancer Drug Funds which means there is promising evidence in trial but not yet enough evidence for approval.

Question 28

What is a Patient Access Scheme within NICE?

Answer 28

An agreement made a NICE liason unit and a technology/drug producing company to reduce the cost to make it more effective
Often done in the context of a NICE technology appraisal to increase likihood of a positive outcome from NICE.
THis has helped patients gain access to better quality treatment at a level the NHS can afford.

Question 29

What are some difficulties within the NICE technology appraisal process?

Answer 29

QALYS - not the only way of measuring treatment outcomes
Early data used if often poor data
Struggle to find data on correct comparator
Survival extrapolations can be inaccurate due to short lifepsan of randomised control trials.
Large amounts on uncertainty
Bias from experts