Action and inputs detailed in the briefing to the Chief Medical Officer of 25 May 2022 in respect of Evusheld
Dear NHS England,
A briefing for the Chief Medical Officer (CMO) was prepared as the result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure prophylaxis National Expert Group Meeting of 19 May. This briefing which is dated 25 May 2022 states (on page 2, item 1, bullet 4) that
“There were concerns that high-risk groups may modify their behaviour to less risk avoidant after taking a prophylactic agent - with particular implications is such an agent is of limited effectiveness”
Please provide the behavioural analysis reports, related data and/or other information provided to this meeting (or to the person(s) presenting this information to the meeting) to explain/support the concern above.
Please include any NHS hospitalisation data forecasts if these were included as part of this consideration.
Yours faithfully,
Penelope Crouch
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Dear Penelope Crouch,
NHS England has assessed your communication as a request under the Freedom
of Information (FOI) Act 2000. Your request is being dealt with under the
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the following reference number: FOI-2301-1911564.
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0300 3 11 22 33, [2][NHS England request email].
Yours sincerely,
Freedom of Information
Communications Team
Strategy Directorate
NHS England
PO Box 16738
REDDITCH
B97 9PT
Tel: 0300 311 22 33
Email: [3][NHS England request email]
Dear Penelope Crouch ,
We are writing with regard to your Freedom of Information (FOI) request
dated 21/01/2023.
Please accept our apologies for the delay in responding to your request.
NHS England is not in a position to respond to your request at this time.
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Pleasedo not reply to this email. This message has beensent from a central
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are progressed correctly. Their postal address, telephone numberand email
details are as follows: PO Box 16738, Redditch, B97 9PT; 0300 3 11 2233,
[3][NHS England request email].
Yourssincerely,
Freedomof Information
CorporateCommunications Team
Transformationand Corporate Operations Directorate
NHSEngland
POBox 16738
REDDITCH
B979PT
Tel:0300 311 22 33
Email:[4][NHS England request email]
‘Health and high quality care for all,now and for future generations’
Dear Penelope Crouch,
We refer to your email of 21 January 2023 in which you requested
information under the FOI Act from NHS England.
Please note that section 12(5)a of the FOI fees regulations state that two
or more requests to a public authority from one person can be aggregated
for the purposes of calculating costs if they are for the same or similar
information. The fees regulations are available on the
[1]Legislation.go.uk web page.
Information on aggregating requests is also set out in section 12(4)a of
the FOI Act which states that:
“Where two or more requests for information are made to a public authority
by one person the estimated cost of complying with any of the requests is
to be taken to be the total cost of complying with all of them.”
On this basis, we are aggregating all your requests for the purposes of
determining whether or not disproportionate cost would be involved in
answering them, as we deem the requests for “the same or similar
information”.
This response is an aggregated response to your FOI requests: FOI -
2301-1911564, FOI - 2301-1911580 and FOI - 2301-1911581.
Please accept our sincere apologies for the delay in responding to your
request.
Your request
You made the following request:
“1 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May. This briefing which
is dated 25 May 2022 states (on page 2, item 1, bullet 4) that
“There were concerns that high-risk groups may modify their behaviour to
less risk avoidant after taking a prophylactic agent - with particular
implications is such an agent is of limited effectiveness”
Please provide the behavioural analysis reports, related data and/or other
information provided to this meeting (or to the person(s) presenting this
information to the meeting) to explain/support the concern above.
Please include any NHS hospitalisation data forecasts if these were
included as part of this consideration.
2 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May.
In this briefing for the Chief Medical Officer there are two
recommendations. Recommendation 2 was that “The necessity of generating
meaningful clinical data was reiterated. There is the need for more
in-human data on the clinical effectiveness of tixagevimab/cilgavimab in
the current UK population and present pandemic context. This could be in
the form of a pragmatic clinical trial, which would likely be
observational using a high-risk patient population. Within such a trial
there is an imperative to examine PD/PK data in a sub-group of high-risk
patients, so as to helpfully inform clinical pharmacological knowledge.”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.
Please note that this request would have been directed to NHS Improvement
prior to its merger into NHS England in July 2022.
3 - In the briefing for the Chief Medical Officer (CMO) which was prepared
as the result of the COVID-19 tixagevimab/cilgavimab (Evusheld)
pre-exposure prophylaxis National Expert Group Meeting of 26 April 2022
there are three conclusions
Conclusion 2 was that “The group noted the unmet need of the
immunocompromised patients outlined by the IAG and proposed the
expeditious establishment of a platform trial to support evidence
generation in this group of patients at highest risk within the current UK
pandemic context. The group recommended that the study design be
future-proofed to enable the addition of other PrEP (or therapeutic)
agents to the study and be applicable to other new (sub)variants as they
emerge”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.”
Our response to your FOI request
NHS England holds some information in regard to your request.
1 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May. This briefing which
is dated 25 May 2022 states (on page 2, item 1, bullet 4) that
“There were concerns that high-risk groups may modify their behaviour to
less risk avoidant after taking a prophylactic agent - with particular
implications is such an agent is of limited effectiveness”
Please provide the behavioural analysis reports, related data and/or other
information provided to this meeting (or to the person(s) presenting this
information to the meeting) to explain/support the concern above.
Please include any NHS hospitalisation data forecasts if these were
included as part of this consideration.
NHS England holds this information.
Please see attached all information which NHS England holds in relation to
your request including the Meeting Minutes (which include attendance data)
for the meeting on the 19 May 2022 along with the meeting papers. The only
documentation held by NHS England in respect of the conclusions and
actions from the meetings is the CMO briefing which is also attached.
We are withholding the names, job titles and contact details of NHS
England staff members at or below band 9 and those external to NHS
England, as well as the contact details for all other NHS England staff
under section 40 of the FOI Act as the information constitutes personal
data.
Section 40(2) states that requested information is exempt from disclosure
if the first or the second condition at section 40(3A)(a) of the FOI Act
is satisfied. This is on the grounds that it amounts to personal data and
the first condition under section 40(3A)(a) is satisfied, namely that
disclosure would amount to a breach of the first data protection principle
(personal data should be processed lawfully, fairly and in a transparent
manner) as the individuals concerned would have a reasonable expectation
that these particular items of personal information would not be disclosed
into the public domain. Section 40 is an absolute exemption and
consideration of the public interest test in disclosure is not required.
It may also assist you if we explain that some information relating to UK
wide interim clinical access policies published following consideration of
advice from the EWG, in particular, is already available in the public
domain and can be viewed at the following links: [2]CAS-ViewAlert
(mhra.gov.uk) (8^th Dec 2021) and [3]CAS-ViewAlert (mhra.gov.uk) (16^th
Dec 2021)
In regard to Questions 2 and 3 NHS England does not hold this information.
We have no record of a response from the CMO regarding these briefings.
Copyright
NHS England operates under the terms of the Open Government Licence (OGL).
Terms and conditions can be found on the following link:
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Review rights
If you consider that your request for information has not been properly
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Act.
A request for an internal review should be submitted in writing to
[5][NHS England request email]
Yours sincerely,
Freedom of Information
NHS England
Dear NHS England
I am writing to request an internal review of the response to my three FOIA requests. I have no objection to their being amalgamated for cost assessment reasons. I am asking for an internal review for the reasons set out below:
The numbering of the FOIAs corresponds with those used in your response
FOIA number 1 asked specifically for the behavioural analysis reports, related data and/or other information provided to this meeting … to explain /support the concern at the meeting of 19 May that “high-risk groups may modify their behaviour to less risk avoidant after taking a prophylactic agent”
It was notable that the title of the section of the report in which this statement was made in the report to the CMO was “Summary of current clinical evidence”
You have provided me with numerous clincial papers which are already in the public domain. None of which address any form of behavioural analysis of this high risk group. I am asking on what clincial evidence this specific statement was made, as it clearly formed part of the decision not to recommend deployment of Evusheld to the CMO.
Please therefore address this point.
FOIA number 2 asked for the response by the CMO to the briefing of the National Expert Group Meeting of 19 May 2022 which made 2 recommendations. The request was specific to recommendation 2, that “the necessity of generating meaningful clinical data was reiterated. … This could be in the form of a pragmatic clinical trial”
FOIA number 3 asked for the response by the CMO to the briefing of the National Expert Group Meeting of 26 April 2022 which had three conclusions. The request was specific to Conclusion 2, that “The group noted the unmet need of the immunocompromised patients … and proposed the expeditious establishment of a platform trial to support evidence generation in this group … at highest risk”
NHS England has responded that “We have no record of a response from the CMO regarding these briefings”
How can this be the case?
This Expert Working Group, according to its terms of reference (which are already in the public domain), was convened to develop a national clinical policy for a specific drug or sometimes to provide further relevant advice. The EWG is chaired by a senior NHS staff member, and the membership included UK-wide national experts and frontline clinicians, officials from the Devolved Governments were involved throughout.
Why would such senior experts and officials meet not once on 26 April, but for a second time on 19 May, without any feedback from the CMO to their first report?
The EWG is a group of 25 people brought together at the public expense. The meetings, as evidenced by the supporting documents, considered a lot of evidence, including reports from Portland Down, and therefore devoted a lot of time and resource to these issues. Are you really saying that the reports went to the CMO and sat on his desk unread and unanswered?
The senior staff member who chaired these meetings was Professor Anthony Kessel, Clinical Director, National Clinical Policy, NHS England and NHS Improvement. The request asked for “the response (whether by memorandum, email or noted conversation) of the CMO to the report”
Please detail whether NHS England
- performed a data search of both the CMO’s and Professor Kessel’s department’s computer records to identify what occurred?
- checked the email and WhatsApp communications between these individuals to identify whether any communication took place?
I look forward to receiving the outcome from your review of these important points
Yours faithfully,
Penelope Crouch
Penelope Crouch left an annotation ()
Request amalgamated with FOI-2301-1911580 and FOI-2301-1911581 by NHS. Referred to ICO on 24 July due to delay in response to request for internal review.
Freedom of Information Internal Review outcome
Our Ref: FOI-2301-1911564 | FOI-2305-1973773 IR
Dear Penelope Crouch,
We write further to your email of 10 May 2023 in which you requested an
internal review under the Freedom of Information Act 2000 (FOI Act).
The FOI Management team has reviewed your request and this letter provides
an outcome of this review. Please accept our apologies for the delay in
processing your request.
FOI request
On 21 January 2023, you requested the following information which was
aggregated under one request:
“1 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May. This briefing which
is dated 25 May 2022 states (on page 2, item 1, bullet 4) that
“There were concerns that high-risk groups may modify their behaviour to
less risk avoidant after taking a prophylactic agent - with particular
implications is such an agent is of limited effectiveness”
Please provide the behavioural analysis reports, related data and/or other
information provided to this meeting (or to the person(s) presenting this
information to the meeting) to explain/support the concern above.
Please include any NHS hospitalisation data forecasts if these were
included as part of this consideration.
2 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May.
In this briefing for the Chief Medical Officer there are two
recommendations. Recommendation 2 was that “The necessity of generating
meaningful clinical data was reiterated. There is the need for more
in-human data on the clinical effectiveness of tixagevimab/cilgavimab in
the current UK population and present pandemic context. This could be in
the form of a pragmatic clinical trial, which would likely be
observational using a high-risk patient population. Within such a trial
there is an imperative to examine PD/PK data in a sub-group of high-risk
patients, so as to helpfully inform clinical pharmacological knowledge.”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.
Please note that this request would have been directed to NHS Improvement
prior to its merger into NHS England in July 2022.
3 - In the briefing for the Chief Medical Officer (CMO) which was prepared
as the result of the COVID-19 tixagevimab/cilgavimab (Evusheld)
pre-exposure prophylaxis National Expert Group Meeting of 26 April 2022
there are three conclusions
Conclusion 2 was that “The group noted the unmet need of the
immunocompromised patients outlined by the IAG and proposed the
expeditious establishment of a platform trial to support evidence
generation in this group of patients at highest risk within the current UK
pandemic context. The group recommended that the study design be
future-proofed to enable the addition of other PrEP (or therapeutic)
agents to the study and be applicable to other new (sub)variants as they
emerge”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.”
NHS England responded to your FOI request on 2 May 2023.
Internal review request
On 10 May 2023, you submitted the following request for an internal
review:
“I am writing to request an internal review of the response to my three
FOIA requests. I have no objection to their being amalgamated for cost
assessment reasons. I am asking for an internal review for the reasons set
out below:
The numbering of the FOIAs corresponds with those used in your response
FOIA number 1 asked specifically for the behavioural analysis reports,
related data and/or other information provided to this meeting … to
explain /support the concern at the meeting of 19 May that “high-risk
groups may modify their behaviour to less risk avoidant after taking a
prophylactic agent”
It was notable that the title of the section of the report in which this
statement was made in the report to the CMO was “Summary of current
clinical evidence”
You have provided me with numerous clincial papers which are already in
the public domain. None of which address any form of behavioural analysis
of this high risk group. I am asking on what clincial evidence this
specific statement was made, as it clearly formed part of the decision not
to recommend deployment of Evusheld to the CMO.
Please therefore address this point.
FOIA number 2 asked for the response by the CMO to the briefing of the
National Expert Group Meeting of 19 May 2022 which made 2
recommendations. The request was specific to recommendation 2, that “the
necessity of generating meaningful clinical data was reiterated. … This
could be in the form of a pragmatic clinical trial”
FOIA number 3 asked for the response by the CMO to the briefing of the
National Expert Group Meeting of 26 April 2022 which had three
conclusions. The request was specific to Conclusion 2, that “The group
noted the unmet need of the immunocompromised patients … and proposed the
expeditious establishment of a platform trial to support evidence
generation in this group … at highest risk”
NHS England has responded that “We have no record of a response from the
CMO regarding these briefings”
How can this be the case?
This Expert Working Group, according to its terms of reference (which are
already in the public domain), was convened to develop a national clinical
policy for a specific drug or sometimes to provide further relevant
advice. The EWG is chaired by a senior NHS staff member, and the
membership included UK-wide national experts and frontline clinicians,
officials from the Devolved Governments were involved throughout.
Why would such senior experts and officials meet not once on 26 April, but
for a second time on 19 May, without any feedback from the CMO to their
first report?
The EWG is a group of 25 people brought together at the public expense.
The meetings, as evidenced by the supporting documents, considered a lot
of evidence, including reports from Portland Down, and therefore devoted a
lot of time and resource to these issues. Are you really saying that the
reports went to the CMO and sat on his desk unread and unanswered?
The senior staff member who chaired these meetings was Professor Anthony
Kessel, Clinical Director, National Clinical Policy, NHS England and NHS
Improvement. The request asked for “the response (whether by memorandum,
email or noted conversation) of the CMO to the report”
Please detail whether NHS England
- performed a data search of both the CMO’s and Professor Kessel’s
department’s computer records to identify what occurred?
- checked the email and WhatsApp communications between these individuals
to identify whether any communication took place?”
Decision
We have reviewed your request for an internal review and the original
decision has been upheld.
Reasons for decision
NHS England has reviewed your concerns and can confirm all information
that was held in scope of your original request has been considered and
disclosed to you. We have only withheld some elements which constituted
personal data as explained in our original response.
It may be helpful to explain that the FOI Act applies to recorded
information held by a public authority at the time of a request, we are
not obliged to create new information under the law and do not generate
new information to answer requests considered under this legislation.
Therefore, if no information is held within the scope of your request,
then there is no further action required for NHS England to be compliant
with the FOI Act when responding to your specific FOI request.
In respect of parts 2 and 3 of your FOI request, we have already confirmed
that NHS England does not hold any records of a response received from the
Chief Medical Officer (CMO) regarding these briefings.
Please note, the CMO is not an employee of NHS England and we are unable
to search his records. If you have not already done so, you may find it
useful to submit a request for information to the Department of Health and
Social Care via the contact details available on their website:
[1]https://www.gov.uk/government/organisati...
We can confirm we have searched Professor Anthony Kessel’s records and all
information that was in scope of this request has been released (subject
to the removal of direct contact information and personal data relating to
non-senior staff members).
You may also find it helpful to note that the Expert Working Group (EWG)
met in line with the Terms of Reference (TOR) to review new evidence and
the role of the EWG is outlined in the TOR. The EWG members attended
voluntarily and were not reimbursed for their time by NHS England.
Review rights
We hope that this explains our handling of your FOI request. However, if
you are not content with our response, you have the right to apply
directly to the Information Commissioner for a decision. The Information
Commissioner’s Office (ICO) can be contacted at the following weblink:
[2]https://ico.org.uk/make-a-complaint/foi-...
Please do not reply to this email. This message has been sent from a
central mailbox. All correspondence should be sent to
[3][NHS England request email].
Yours sincerely,
Freedom of Information
NHS England
Freedom of Information request
Our Ref: FOI-2301-1911564 | FOI-2305-1973773 IR
ICO Ref: IC-250852-W4R1
Dear Penelope Crouch,
We write further to your FOI request dated 21 January 2023.
FOI request
On 21 January 2023, you requested the following information which was
aggregated under one request:
“1 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May. This briefing which
is dated 25 May 2022 states (on page 2, item 1, bullet 4) that
“There were concerns that high-risk groups may modify their behaviour to
less risk avoidant after taking a prophylactic agent - with particular
implications is such an agent is of limited effectiveness”
Please provide the behavioural analysis reports, related data and/or other
information provided to this meeting (or to the person(s) presenting this
information to the meeting) to explain/support the concern above.
Please include any NHS hospitalisation data forecasts if these were
included as part of this consideration.
2 - A briefing for the Chief Medical Officer (CMO) was prepared as the
result of the COVID-19 tixagevimab/cilgavimab (Evusheld) pre-exposure
prophylaxis National Expert Group Meeting of 19 May.
In this briefing for the Chief Medical Officer there are two
recommendations. Recommendation 2 was that “The necessity of generating
meaningful clinical data was reiterated. There is the need for more
in-human data on the clinical effectiveness of tixagevimab/cilgavimab in
the current UK population and present pandemic context. This could be in
the form of a pragmatic clinical trial, which would likely be
observational using a high-risk patient population. Within such a trial
there is an imperative to examine PD/PK data in a sub-group of high-risk
patients, so as to helpfully inform clinical pharmacological knowledge.”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.
Please note that this request would have been directed to NHS Improvement
prior to its merger into NHS England in July 2022.
3 - In the briefing for the Chief Medical Officer (CMO) which was prepared
as the result of the COVID-19 tixagevimab/cilgavimab (Evusheld)
pre-exposure prophylaxis National Expert Group Meeting of 26 April 2022
there are three conclusions
Conclusion 2 was that “The group noted the unmet need of the
immunocompromised patients outlined by the IAG and proposed the
expeditious establishment of a platform trial to support evidence
generation in this group of patients at highest risk within the current UK
pandemic context. The group recommended that the study design be
future-proofed to enable the addition of other PrEP (or therapeutic)
agents to the study and be applicable to other new (sub)variants as they
emerge”
Please provide the response (whether by memorandum, email or noted
conversation) of the CMO to the report.”
NHS England responded to your FOI request on 2 May 2023.
NHS England conducted an internal review and informed you of its outcome
on 30 August 2023.
ICO Complaint
Parts 2 and 3 of your original request asked for “the response from the
CMO to the report”. We interpreted this to mean you were requesting
information NHS England had received from the CMO directly.
However, in light of your correspondence to the ICO, it appears that you
intended for your FOI request to cover information from the CMO directly
as well as anyone who works within the CMO’s office.
We have conducted further searches and have located two emails in scope of
your request. Please refer to the attached material. Personal data has
been withheld under section 40(2) of the FOI Act.
Review rights
If you are not content with our response, you have the right to apply
directly to the Information Commissioner for a decision. The Information
Commissioner’s Office (ICO) can be contacted at the following weblink:
[1]https://ico.org.uk/make-a-complaint/foi-...
Please do not reply to this email. This message has been sent from a
central mailbox. All correspondence should be sent to
[2][NHS England request email].
Yours sincerely,
Freedom of Information
NHS England
Penelope Crouch left an annotation ()
Correspondence continuing with the ICO as to whether the NHS has responded adequately to this request
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Penelope Crouch left an annotation ()
I referred this request to the ICO and the Commissioner has issued a decision notice that NHS England has breached section 10(1) of FOIA in that it has failed to provide a valid response to the request within the statutory time frame of 20 working days