Criteria for NHS cancer screening test adoption

Dear Leo Pritchard,

Thank you for your email of 12 August 2024 in which you requested
information under the FOI Act from NHS England.

Your request was:
 
“I am writing to request information under the Freedom of Information Act
2000 regarding the criteria and process NHS England uses to determine if
it can use a cancer screening test within its services.

Please provide the following information:

1. What type and level of experimental evidence must a screening test have
before being used within the NHS? Are certain types of research studies
and forms of evidence required to support the introduction of a new cancer
screening test? If so, what are they?

2. Does the NHS have minimum performance levels for a screening test, for
example, within a confusion matrix? If so, what are these thresholds?

3. What is the process for evaluating the performance of new cancer
screening programs for use in the NHS? Who carries out this process? How
long do evaluations of a new cancer screening test typically take to
complete? Are certain types of trials mandatory in this process?

4. Is a cost-benefit analysis carried out as part of the assessment of a
new screening test? If so, how? Is the cost of performing the test
assessed? Is the number of patients with the type of cancer the test
screens for considered? Is the cost of treating this type of cancer
considered?

5. Are patient outcome measures used to evaluate the impact of cancer
screening tests? If so, which such measures are used? How are these
outcomes measured and monitored?

6. Are there any criteria, other than those I have mentioned previously,
that new cancer screening tests must meet before being used within the
NHS? If so, what are they?

7. Is any of the information I requested or any other information
detailing how the NHS assesses new cancer screening tests available
publicly online? If so, where can I find this information?”
Decision

NHS England holds some of the information you have requested and has
decided to release all of the information that it holds.
 
It may help if we explain that the NHS in England is not one single
organisation. Rather, it is made up of multiple different organisations of
differing sizes, and operate at central, national, regional, and local
levels each with its own roles and responsibilities. 
  
NHS England is a single regulatory body responsible for overseeing the
funding, planning, delivery, transformation, and performance of NHS
healthcare in England. It is also responsible for providing unified
national leadership for the NHS.
 
NHS England does not directly deliver clinical services. Any recorded
information NHS England may be able to provide in response to an FOI
request will generally relate to the functions we perform. 
  
For more information on the functions carried out by NHS England and the
types of information we hold, please visit our [1]website; for further
information on the NHS, its structure and other NHS organisations please
refer either to our [2]website or the NHS [3]website. 

As such, we can only respond to your request on behalf of NHS England,
rather than the NHS as a whole.

It may also be of help if we explain that the [4]UK National Screening
Program (UKNSC) is an independent committee of experts which advises the
government and the NHS about all aspects of screening programmes. This
includes reviewing scientific evidence to assess the benefits and risks of
screening to examine whether new screening programmes should be
introduced, or if changes to existing programmes should be made.

The government of each country within the UK decides whether to implement
the UKNSC’s recommendations, and the NHS in each country is then
responsible for delivering screening in line with these.
For ease of reference, we will reply to each of your queries in turn.
 
1. What type and level of experimental evidence must a screening test have
before being used within the NHS? Are certain types of research studies
and forms of evidence required to support the introduction of a new cancer
screening test? If so, what are they?
 
NHS England does not hold this information.
 
This information may be held by [5]the UK National Screening Committee
(UKNSC), whom you may wish to contact directly.
 
2. Does the NHS have minimum performance levels for a screening test, for
example, within a confusion matrix? If so, what are these thresholds?
 
Each screening programme will use a specific testing technology. NHS
England does not set national test accuracy thresholds for screening
programmes.
 
Instead, the testing technology (but not specific products) is approved by
the UKNSC in conjunction with the wider approval for the programme. This
will usually require the test to be deployed in real life randomised
controlled trial.
 
If new test providers enter the market, they will be required to provide
tests which are comparable or superior to existing technology in terms of
accuracy and cost.

3. What is the process for evaluating the performance of new cancer
screening programs for use in the NHS? Who carries out this process? How
long do evaluations of a new cancer screening test typically take to
complete? Are certain types of trials mandatory in this process?
 
There are circumstances where NHS England may (in collaboration with
UKNSC), undertake validation testing alongside existing tests, or agree to
undertake an “in-service evaluation” (ISE), for example where a screening
test is to be changed in some way.
 
ISEs are usually used where tests have already been validated, and
therefore the assessment is about feasibility and assessment of whether it
is safe and cost effective in routine practice. Validations and ISEs
usually run for several years due to their complex nature before the
evidence from them can be considered by the UKNSC.

4. Is a cost-benefit analysis carried out as part of the assessment of a
new screening test? If so, how? Is the cost of performing the test
assessed? Is the number of patients with the type of cancer the test
screens for considered? Is the cost of treating this type of cancer
considered?
 
NHS England does not hold this information.
 
As above, you may wish to contact UKNSC.
 
5. Are patient outcome measures used to evaluate the impact of cancer
screening tests? If so, which such measures are used? How are these
outcomes measured and monitored?
 
Patient reported outcome measures (PROMs) are not used by NHS England to
evaluate the impact of cancer screening tests.
 
For more information about the limited uses of PROMs in NHS policy making,
you may wish to contact UKNSC.
 
6. Are there any criteria, other than those I have mentioned previously,
that new cancer screening tests must meet before being used within the
NHS? If so, what are they?
 
And 
 
7. Is any of the information I requested or any other information
detailing how the NHS assesses new cancer screening tests available
publicly online? If so, where can I find this information?
 
NHS England does not hold this information, which may be held by UKNSC.
 
Copyright

NHS England operates under the terms of the Open Government Licence (OGL).
[6]Terms and conditions can be found on our website.

Review rights

If you consider that your request for information has not been properly
handled or if you are otherwise dissatisfied with the outcome of your
request, you may seek an internal review within NHS England of the issue
or the decision. A senior member of NHS England’s staff, who has not
previously been involved with your request, will undertake that review.

If you are dissatisfied with the outcome of any internal review, you may
[7]complain to the Information Commissioner for a decision on whether your
request for information has been dealt with in accordance with the FOI
Act.

A request for an internal review should be submitted in writing to [8][NHS
England request email].

Yours sincerely,

Freedom of Information
NHS England

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