15 documents related to multiple NICE appraisals

Till Bruckner made this Rhyddid Gwybodaeth request to National Institute for Health and Care Excellence

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

Roedd y cais yn llwyddiannus.

Dear National Institute for Health and Care Excellence,

Please provide 15 documents related to multiple appraisals, as listed below. These documents are currently not available on the NICE website.

a. TA 77. Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia. Published date: 28 April 2004
https://www.nice.org.uk/guidance/ta77/hi...
Missing documents:
• Evidence Review Group report
• Manufacturer submission

b. TA 394. Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia Published date: Published date: 22 June 2016
https://www.nice.org.uk/guidance/ta394/h...
Missing documents:
• Final Appraisal Document
• Evidence Review Group report
• Manufacturer submission

c. TA 367. Vortioxetine for treating major depressive episodes. Published date: 25 November 2015
https://www.nice.org.uk/guidance/ta367/h...
Missing documents:
• Evidence Review Group report – the document is partially uploaded and all pages after page 93 are missing

d. TA 301. Fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy. Published date: 27 November 2013
https://www.nice.org.uk/guidance/ta301/h...
Missing documents:
• Evidence Review Group report from TA271 which TA301 replaces

e. TA 566. Cochlear implants for children and adults with severe to profound deafness. Published date: 07 March 2019
https://www.nice.org.uk/guidance/ta566/h...
Missing documents:
• Evidence Review Group report from TA166 which TA566 replaces

f. TA 274. Ranibizumab for treating diabetic macular oedema. Published date: 27 February 2013
https://www.nice.org.uk/guidance/ta274/h...
Missing documents:
• Evidence Review Group report from TA273 which TA274 replaces

g. TA 419. Apremilast for treating moderate to severe plaque psoriasis. Published date: 23 November 2016 https://www.nice.org.uk/guidance/ta419/h...
Missing documents:
• Evidence Review Group report from TA368 which TA419 replaces
• Manufacturer submission for TA368 which TA419 replaces

h. TA 433. Apremilast for treating active psoriatic arthritis. Published date: 22 February 2017
https://www.nice.org.uk/guidance/ta433/h...
Missing documents:
• Evidence Review Group report from TA372 which TA433 replaces
• Manufacturer submission for TA372 which TA433 replaces

i. TA 340. Ustekinumab for treating active psoriatic arthritis. Published date: 03 March 2017 https://www.nice.org.uk/guidance/ta340/h...
Missing documents:
• Evidence Review Group report from TA313 which TA340 replaces
• Manufacturer submission for TA313 which TA340 replaces

Yours faithfully,

Till Bruckner

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

1 Atodiad

Dear Till,

 

Reference No: EH-301742-S5R9H7

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for contacting the National Institute for Health and Care
Excellence (NICE) with your request for information, sent to our office on
4 October 2019, in which you asked for:

 

 1. Re: TA77

 a. Evidence review group report
 b. Manufacturer’s submission

 

 2. Re: TA394

 a. Final appraisal document
 b. Evidence review group report
 c. Manufacturer’s submission

 

 3. Re: TA367

 a. Evidence review group report

 

 4. Re: TA301

 a. Evidence review group report from TA271

 

 5. Re: TA566

 a. Evidence review group report from TA166

 

 6. Re: TA274

 a. Evidence review group report from TA273

 

 7. Re: TA419

 a. Evidence review group report from TA368
 b. Manufacturer’s submission from TA368

 

 8. Re: TA433

 a. Evidence review group report from TA372
 b. Manufacturer’s submission from TA313

 

 9. Re: TA340

 a. Evidence review group report from TA313
 b. Manufacturer’s submission from TA313

 

Your request will now be considered and you will receive a response within
the statutory timescale of 20 working days as defined by the Act, subject
to the information not being exempt or containing a reference to a third
party. In some circumstances we may be unable to achieve this deadline. If
this is likely you will be informed and given a revised time-scale at the
earliest opportunity.

 

There may be a fee payable for the retrieval, collation and provision of
the information you request. If this is the case you will be informed and
the 20 working day timescale will be suspended until we receive payment
from you. If you chose not to make a payment then your request will remain
unanswered.

 

Some requests may also require either full or partial transference to
another public authority in order to answer your query in the fullest
possible way. Again, you will be informed if this is the case.

 

I would like to take this opportunity to thank you for your interest in
NICE.

 

Yours sincerely,

 

Alex

 

Alexander Smith

Communications Executive

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United
Kingdom
Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [1]http://nice.org.uk

 

[2]20 years of NICE email banner

dangos adrannau a ddyfynnir

Dear National Institute for Health and Care Excellence (NICE),

please note that your response to this FOI request is long overdue. Please send the information requested asap.

Yours sincerely,

Till Bruckner

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Till

Thank you for your email of 30 November 2019 to NICE regarding your FOI request.

We did respond to this request at 16:42 on 1 November 2019. I am sorry that this response did not reach you.

I will re-send our reply now. If you do not receive it shortly, please email me at [NICE request email] to let me know.

Many thanks

Victoria

Victoria Wellings
Communications Manager
National Institute for Health and Care Excellence Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 0300 323 0141 | Fax: 0300 323 0149

dangos adrannau a ddyfynnir

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

1 Atodiad

Dear Till

 

Further to my earlier email this morning, I have re-sent our FOI response
to you (please see below), but have received a non-delivery message saying
that the attachments are too large, even when sent in a Zip file.

 

Do you have an alternative email address that you we could try sending the
documents to please? If not I will ask our IT department for advice on the
best way to send the attachments to you.

 

Kind regards

 

Victoria

 

Victoria Wellings

Communications Manager

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United
Kingdom
Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [1]http://nice.org.uk

 

[2]20 years of NICE email banner

 

From: National Institute for Health and Care Excellence (NICE)
Sent: 02 December 2019 11:14
To: 'Till Bruckner' <[FOI #609215 email]>
Subject: RE: Freedom of Information request - 15 documents related to
multiple NICE appraisals (reference EH-301742)

 

Dear Till

 

Further to my earlier email this morning, I am re-sending our response to
this FOI request.  

 

Kind regards

 

Victoria

 

Victoria Wellings

Communications Manager

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United
Kingdom
Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [3]http://nice.org.uk

 

 

[4]20 years of NICE email banner

 

From: National Institute for Health and Care Excellence (NICE)
Sent: 01 November 2019 16:42
To: 'Till Bruckner' <[5][FOI #609215 email]>
Subject: RE: Freedom of Information request - 15 documents related to
multiple NICE appraisals (reference EH-301742)

 

Dear Till

 

Reference No: EH-301742-S5R9H7

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for contacting the National Institute for Health and Care
Excellence (NICE) with your request for information, sent to our office on
4 October 2019, in which you asked for a copy of 15 documents related to
multiple appraisals, as listed below, with our response to each part of
your request given in turn.

 

The Freedom of Information Act relates to recorded information held by a
public authority, at the time of the request.

 

a.      TA 77. Guidance on the use of zaleplon, zolpidem and zopiclone for
the short-term management of insomnia. Published date: 28 April 2004
[6]https://www.nice.org.uk/guidance/ta77/hi...
Missing documents:
•       Evidence Review Group report

Information attached.

•       Manufacturer submission

I can confirm that, while we do hold this information, we consider that it
is exempt from disclosure under section 41 of the Freedom of Information
Act 2000. Section 41(1) states:

 

Information is exempt information if –

 

 a. It was obtained by the public authority from any other person
(including another public authority), and,
 b. The disclosure of the information to the public (otherwise than under
this Act) by the public authority holding it would constitute a breach
of confidence actionable by that or any other person.

 

Section 41(1) is an absolute exemption which means that there is no need
to consider the public interest test under the Act. However, the common
law duty of confidence contains an inherent public interest test which we
have considered in order to decide if the information that you requested
is exempt. The information was provided to NICE by the manufacturers of
the drugs being appraised, and an agreement between NICE and the
manufacturer organisations existed which stated that the information
supplied was confidential and not for publication, and that disclosure of
the information could give rise to an actionable breach of confidence.

 

The public interest test when considering a duty of confidence assumes
that information should be withheld unless the public interest in
disclosure outweighs the public interest in maintaining the confidence. In
favour of releasing the information that you have requested, we
acknowledge that it is in the interests of the public generally that all
relevant information about technologies being appraised by NICE be put
into the public domain to promote openness and transparency.

 

However, the interest in favour of disclosure has to be balanced against
the potential damage caused by disclosure of information provided in
confidence. Manufacturers  would be discouraged from submitting data to
NICE if they did not have a degree of certainty that such confidences
would be respected. Furthermore, there is a public interest in preserving
a free flow of information to a public authority where this is necessary
for the public authority to perform its statutory functions. If we were to
release information provided in confidence we would not only risk action
being taken against us by the authors of the information, but we would
also risk losing the confidence of other manufacturers that we are working
with currently, and will need to work with again in the future.

b.      TA 394. Evolocumab for treating primary hypercholesterolaemia and
mixed dyslipidaemia Published date: Published date: 22 June 2016
[7]https://www.nice.org.uk/guidance/ta394/h...
Missing documents:
•       Final Appraisal Document
•       Evidence Review Group report
•       Manufacturer submission

 

I can confirm that we do hold the documents requested, but we are unable
to provide these to you because we consider them to be exempt from
disclosure under section 22 of the Freedom of Information Act. Section 22
provides an exemption from disclosure if the information is intended for
future publication. Section 22 is a qualified exemption, which means we
must consider whether the public interest in maintaining the exemption is
greater than the public interest in disclosure.  

      

In favour of disclosure, we recognise there is public interest in our
guidance and decision-making. In favour of maintaining the exemption, the
information held is currently in an unredacted format, and in order to
maintain our duty of confidentiality with the organisations that supplied
the information, we believe that it’s important to remove any confidential
information from the document before publication. Not to do so would
damage NICE’s reputation and affect our future ability to carry out our
role for the benefit of the NHS, its users, and the public in general.

 

On balance we believe the interest in maintaining the exemption is greater
than the interest in disclosure at this time.

c.      TA 367. Vortioxetine for treating major depressive episodes.
Published date: 25 November 2015
[8]https://www.nice.org.uk/guidance/ta367/h...
Missing documents:
•       Evidence Review Group report – the document is partially uploaded
and all pages after page 93 are missing

 

Information attached.

d.      TA 301. Fluocinolone acetonide intravitreal implant for treating chronic
diabetic macular oedema after an inadequate response to prior therapy. Published
date: 27 November 2013
[9]https://www.nice.org.uk/guidance/ta301/h...
Missing documents:
•       Evidence Review Group report from TA271 which TA301 replaces

 

Information attached.

e.      TA 566. Cochlear implants for children and adults with severe to
profound deafness. Published date: 07 March 2019
[10]https://www.nice.org.uk/guidance/ta566/h...
Missing documents:
•       Evidence Review Group report from TA166 which TA566 replaces

 

Information attached.

f.      TA 274. Ranibizumab for treating diabetic macular oedema.
Published date: 27 February 2013
[11]https://www.nice.org.uk/guidance/ta274/h...
Missing documents:
•       Evidence Review Group report from TA273 which TA274 replaces

 

NICE does not hold this information; this topic was terminated, and
therefore no evidence review group report was produced.

g.      TA 419. Apremilast for treating moderate to severe plaque
psoriasis. Published date: 23 November
2016 [12]https://www.nice.org.uk/guidance/ta419/h...
Missing documents:
•       Evidence Review Group report from TA368 which TA419 replaces
•       Manufacturer submission for TA368 which TA419 replaces

 

Information attached.

h.      TA 433. Apremilast for treating active psoriatic arthritis.
Published date: 22 February 2017
[13]https://www.nice.org.uk/guidance/ta433/h...
Missing documents:
•       Evidence Review Group report from TA372 which TA433 replaces
•       Manufacturer submission for TA372 which TA433 replaces

 

Information attached.

i.      TA 340. Ustekinumab for treating active psoriatic arthritis.
Published date: 03 March
2017 [14]https://www.nice.org.uk/guidance/ta340/h...
Missing documents:
•       Evidence Review Group report from TA313 which TA340 replaces
•       Manufacturer submission for TA313 which TA340 replaces

 

Information attached.

 

If you have any questions about this response you are welcome to call me
on the enquiry handling team number: 0300 323 0141 (weekdays 09:00 –
17:00).

 

If you are unhappy with this response and want an internal review of how
we handled your request, you must write to us within 40 working days of
our response. Send your request to: Associate Director, Corporate Office,
National Institute for Health and Care Excellence, 10 Spring Gardens,
London SW1A 2BU or email: [15][email address]. When we receive your
request we will send you an acknowledgement within 5 working days.

 

The Associate Director, Corporate Office, will review your complaint and
send you a full reply usually within 20 working days. If you are
dissatisfied with the outcome of this review, you can apply directly to
the Information Commissioner for a decision at: The Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9
5AF.

 

Kind regards,

Victoria

Victoria Wellings

Communications Manager

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United
Kingdom
Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [16]http://nice.org.uk

 

[17]20 years of NICE email banner

 

 

 

dangos adrannau a ddyfynnir

Dear Victoria,

this platform does not allow email addresses to be shared. You can find my email here:
https://www.transparimed.org/about

Once you have sent the info, I will annotate the public record on WhatDoTheyKnow with a link to an upload of your data.

Thank you and all the best,

Till Bruckner

Gadawodd Till Bruckner anodiad ()

NICE provided the request files in .zip format. My Scribd page does not allow .zip uploads, so I did not place them online. If you would like to access the data NICE provided, please email me and I will send it to you.
Till Bruckner / TranspariMED
www.TranspariMED.org