Dear National Institute for Health and Care Excellence,

this FOI request is related to the document "STA Palbociclib in combination with an aromatase inhibitor for previously untreated metastatic, hormone receptor-positive, HER2-negative breast cancer" [ID915]

The original document can be found here:
https://www.nice.org.uk/guidance/ta495/d...

1. Please provide the information redacted from the following paragraph by providing the full text of the original paragraph before any redactions were made:

"Survival probability at 1 year was ************************* in the palbociclib plus
letrozole arm, and ***** in the letrozole alone arm ******************** and at 2 years
was ************************* in the palbociclib plus letrozole arm, and ***** in the
letrozole alone arm ******************** At 3 years, survival probability was
************************* in the palbociclib plus letrozole arm, and ***** in the letrozole
alone arm ********************"

2. Please provide an explanation for why the redactions in the above paragraph were originally made.

Yours faithfully,

Till Bruckner

NICE Mail, National Institute for Health and Care Excellence

Dear Till,

 

Reference No: EH99324

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 5 December 2018, in
which you asked NICE for the following information:

 

This FOI request is related to the document "STA Palbociclib in
combination with an aromatase inhibitor for previously untreated
metastatic, hormone receptor-positive, HER2-negative breast cancer"
[ID915]

 

The original document can be found here:

https://www.nice.org.uk/guidance/ta495/d...

 

1. Please provide the information redacted from the following paragraph by
providing the full text of the original paragraph before any redactions
were made:

 

"Survival probability at 1 year was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** and at 2 years was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** At 3 years, survival probability was

************************* in the palbociclib plus letrozole arm, and *****
in the letrozole alone arm ********************"

 

2. Please provide an explanation for why the redactions in the above
paragraph were originally made.

 

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,

Natalie

 

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [1]http://nice.org.uk   

 

 

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NICE Mail, National Institute for Health and Care Excellence

Dear Till,

 

Reference No: EH99324

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 5 December 2018, in
which you asked NICE for the following information:

 

This FOI request is related to the document "STA Palbociclib in
combination with an aromatase inhibitor for previously untreated
metastatic, hormone receptor-positive, HER2-negative breast cancer"
[ID915]

 

The original document can be found here:

[1]https://www.nice.org.uk/guidance/ta495/d...

 

1. Please provide the information redacted from the following paragraph by
providing the full text of the original paragraph before any redactions
were made:

 

"Survival probability at 1 year was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** and at 2 years was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** At 3 years, survival probability was

************************* in the palbociclib plus letrozole arm, and *****
in the letrozole alone arm ********************"

 

2. Please provide an explanation for why the redactions in the above
paragraph were originally made.

 

 

The Freedom of Information Act relates to recorded information held by a
public authority, at the time of the request. Please find below our
response to your request.

 

Additional background information has also been included (provided outside
the scope of the FOI Act) in order to be helpful.

 

Question 1: Please provide the information redacted from the following
paragraph by providing the full text of the original paragraph before any
redactions were made:

 

"Survival probability at 1 year was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** and at 2 years was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** At 3 years, survival probability was

************************* in the palbociclib plus letrozole arm, and *****
in the letrozole alone arm ********************"

 

 

Following a search of our records, we can confirm that NICE holds the
information that meets the scope of this request. However, we consider the
information to be exempt under Sections 41 and 43 of the Freedom of
Information Act 2000.

 

Section 41

 

Section 41 sets out an exemption in regard to information provided in
confidence (only if this would constitute an actionable breach of
confidence). This is an absolute exemption and not subject to the public
interest test.

 

The information requested was provided to NICE by Pfizer, during the
development of the technology appraisal of [2]palbociclib with an
aromatase inhibitor for previously untreated, hormone receptor-positive,
HER2-negative, locally advanced or metastatic breast cancer, under a duty
of confidentiality. NICE is under a duty to keep the information
confidential (a 'duty of confidence'), and there will be a ‘breach of
confidence’ if we make an unauthorised disclosure of the information.

 

Section 43

 

Section 43 applies to commercial interests. Section 43 of the Act sets out
an exemption from the right to know if the information requested is a
trade secret, or release of the information is likely to prejudice the
commercial interests of any person. (A person may be an individual, a
company, the public authority itself or any other legal entity). Section
43 is a qualified exemption and is subject to the public interest test,
and so we have considered whether the balance of the public interest
favours disclosing or withholding the information.

 

Public Interest Test

 

The public interest test is applied to determine whether the public
interest favours withholding or disclosing information. If an exemption
applies, the public interest in withholding the information has to
outweigh the public interest in releasing.

 

In favour of disclosure, we recognise that there is public interest in
ensuring transparency and accountability in relation to how NICE develops
technology appraisals and how drug companies participate in our process.
We appreciate that our decisions and recommendations have significant real
life impact, and so there will be a public interest in understanding how
our guidance recommendations have been made.

 

However, we have taken into account that the redacted information is
considered to be commercially sensitive by Pfizer and that to disclose it
could harm their commercial interests.

 

We have also considered the public interest in the ability of NICE to
maintain the confidence of manufacturers to ensure that we can continue to
carry out technology appraisals. There is a strong public interest in drug
companies participating in the development of NICE technology appraisals
to enable us to fully evaluate the clinical and cost effectiveness of a
drug for the NHS. We consider that drug companies would be less likely to
participate fully in future technology appraisals should this redacted
information be disclosed. NICE relies on the confidence of manufacturers
to provide highly sensitive commercial information. Without this
information we would not be able to fulfil our statutory functions. If we
were to release information provided in confidence we would not only risk
action being taken against us by the owners 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. 

 

On balance, we therefore believe that protecting the commercial interests
of Pfizer and of NICE outweighs the public interest in disclosure, and so
we consider the requested information to be exempt from disclosure under
Sections 41 and 43 of the Act

 

Question 2: Please provide an explanation for why the redactions in the
above paragraph were originally made.

 

The information is academic in confidence (AIC). It is the most recent
overall survival (OS) data cut from the PALOMA-1 trial. It was marked AIC
by the company, as it has not yet been published.

 

 

If you have any questions on 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 20 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: [3][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 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

Natalie

 

Natalie Whelan

Communications Executive

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [4]http://nice.org.uk 

 

 

 

From: NICE Mail
Sent: 05 December 2018 15:44
To: 'Till Bruckner' <[FOI #536915 email]>
Subject: RE: Freedom of Information request - Redacted information in NICE
appraisal: STA Palbociclib (ref EH99324)

 

Dear Till,

 

Reference No: EH99324

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on 5 December 2018, in
which you asked NICE for the following information:

 

This FOI request is related to the document "STA Palbociclib in
combination with an aromatase inhibitor for previously untreated
metastatic, hormone receptor-positive, HER2-negative breast cancer"
[ID915]

 

The original document can be found here:

[5]https://www.nice.org.uk/guidance/ta495/d...

 

1. Please provide the information redacted from the following paragraph by
providing the full text of the original paragraph before any redactions
were made:

 

"Survival probability at 1 year was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** and at 2 years was ************************* in the
palbociclib plus letrozole arm, and ***** in the letrozole alone arm
******************** At 3 years, survival probability was

************************* in the palbociclib plus letrozole arm, and *****
in the letrozole alone arm ********************"

 

2. Please provide an explanation for why the redactions in the above
paragraph were originally made.

 

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,

Natalie

 

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence

Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149

Web: [6]http://nice.org.uk   

 

 

This message may contain confidential information. If you are not the
intended recipient please inform the sender that you have received the
message in error before deleting it. Please do not disclose, copy or
distribute information in this e-mail or take any action in relation to
its contents. To do so is strictly prohibited and may be unlawful. Thank
you for your co-operation.

All messages sent by NICE are checked for viruses, but we recommend that
you carry out your own checks on any attachment to this message. We cannot
accept liability for any loss or damage caused by software viruses.

http://www.nice.org.uk

References

Visible links
1. https://www.nice.org.uk/guidance/ta495/d...
2. https://www.nice.org.uk/guidance/ta495
3. mailto:[email address]
4. http://nice.org.uk/
5. https://www.nice.org.uk/guidance/ta495/d...
6. http://nice.org.uk/

Dear National Institute for Health and Care Excellence,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of National Institute for Health and Care Excellence's handling of my FOI request 'Redacted information in NICE appraisal: STA Palbociclib'.

I am requesting an internal review due to the following reasons:

SECTION 41 (INFORMATION PROVIDED IN CONFIDENCE)

NICE stated that:

“NICE is under a duty to keep the information confidential (a 'duty of confidence'), and there will be a ‘breach of confidence’ if we make an unauthorised disclosure of the information.”

The requirements for establishing a breach of confidence as set out in Coco v A N Clark (Engineers) Ltd [1969] RPC 41 include that “there must be an unauthorised use of that information to the detriment of the person communicating it.”

The IC’s guidance on s41 states that "for commercial information, the authority will be expected to put forward an explicit case for detriment.”
https://ico.org.uk/media/for-organisatio...

NICE has stated that disclosure could harm Pfizer’s commercial interests, but has not explained how. Thus, NICE has not put forward an explicit case for detriment.

SECTION 43 (COMMERCIAL INTERESTS)

NICE stated that:

“The information is academic in confidence (AIC). It is the most recent overall survival (OS) data cut from the PALOMA-1 trial. It was marked AIC by the company, as it has not yet been published.”

NICE has not provided an explanation as to how it defines AIC. Also, while NICE has stated that the company has claimed that the data is sensitive, NICE has not clarified whether NICE itself has taken any steps to satisfy itself as to the sensitivity of the data.

Note that NICE’s use of AIC as a category appears to be unique among HTAs in Europe:
https://www.ncbi.nlm.nih.gov/pmc/article...

Note also that the company already holds a marketing license for this drug for the indication in question

PUBLIC INTEREST TEST

NICE identified “a public interest in understanding how our guidance recommendations have been made” as a factor favouring disclosure, but failed to take into consideration the very strong interest of doctors and patients in accessing information that would allow them to better assess the potential benefits of taking the drug.

The data redacted by NICE is highly salient to clinical decision-making involving a drug already on the UK market. Patients considering whether or not to take Palbociclib (in consultation with their doctors) require access to all currently available information on the drug’s efficacy to inform their treatment choices. This entails balancing Palbociclib’s harms against its benefits. The trial data cited by NICE in its assessments shows that many patients taking the drug will experience significant harms.

When deciding whether to accept the risk these harms pose, patients need to be able to assess the potential benefits of Palbociclib. While PFS may (or may not) be a benefit that patients will take into account during the decision-making process, patients certainly will take into account whether or not Palbociclib seems likely to extend their overall survival (OS). The data redacted by NICE is the best currently available data in terms of assessing the likelihood of potential OS benefit. NICE itself implicitly acknowledged that this data has clinically salient implications by deciding to take that data into account during its own assessment of the drug.

NICE’s arguments against a public interest in disclosure are also flawed. NICE argued that there was a “risk [of] losing the confidence of other manufacturers that we are working with currently, and will need to work with again in the future,” and that without this confidence NICE “would not be able to fulfil our statutory functions”. Essentially, NICE argues that UK patients’ access to new medicines would be decreased if it released the OS data from the clinical trial in question.

While the above line of argumentation may (or may not) have merit regarding pricing information, it does not have merit with regard to OS data from the clinical trial in question. The German HTA, IQWIG, routinely discloses all efficacy data that it uses in its assessments. Thus, if IQWIG had taken the same OS data into account in an assessment, it would subsequently have publicly disclosed this OS data:
https://www.transparimed.org/single-post...

There is no evidence that German patients’ access to new medicines has decreased as a direct result of IQWIG’s long-standing approach. If NICE wishes to uphold the argument that releasing efficacy data from clinical trials would decrease UK citizens’ access to new medicines, then, considering the precedent set by IQWIG in this regard without ensuing detrimental consequences for German citizens, the burden of proof is on NICE to demonstrate that this indeed would be the case for UK citizens.

In this context, please also note that in 2016 the European Ombudsman determined that there is an overriding public interest in disclosure of any “information in a document has implications for the health of individuals (such as information on the efficacy of a medicine)” [OI/3/2014/FOR]
https://www.ombudsman.europa.eu/en/summa...

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/r...

This request for an internal review is made by myself on behalf of TranspariMED.

Yours faithfully,

Till Bruckner

David Coombs, National Institute for Health and Care Excellence

Dear Till

I have been passed your below email in which you ask for an internal
review of NICE’s response to your request under the Freedom of Information
Act made on 5 December 2018 and given reference number EH99324.

NICE responded to your request on 7 January 2019, and in this, outlined
the arrangements for requesting an internal review should you be unhappy
with the response. It stated that any request for an internal review must
be made within 20 working days of the response.

We received your request for an internal review on 18 March 2019, 50
working days after the response. Therefore, in line with our freedom of
information policy and complaints procedure we will be unable to consider
your request for an internal review.

This marks the end of NICE’s consideration of your request, and should you
wish to complain further you may contact the Information Commissioner’s
Office at [1]https://ico.org.uk/ or

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Kind regards

David

David Coombs

Associate director – corporate office

National Institute for Health and Care Excellence

 

 

show quoted sections

Dear David Coombs,

the request for an internal review was delayed due to internal capacity constraints and the need to seek expertise from external actors including the Campaign for FOI.

I understand that NICE may choose not to conduct an internal review under these circumstances. However, please be advised that TranspariMED regards this as a test case for transparency.

ICYMI:
https://www.transparimed.org/single-post...

Therefore, if NICE does not conduct an internal review on this occasion, I will identify another NICE assessment with similar redactions and file a new FOI request related to those redactions, and then file a follow-on request for internal review if NICE initially refuses to release that data too.

Thus, it would save NICE time and resources to conduct the internal review based on the present FOI request, and close the case (rather than having to respond to an additional new FOI request on top of the present FOI request).

Kindly note that I am aware of capacity constraints within NICE, and that we have a shared interest in minimising the resources NICE requires to manage FOI requests so that NICE can better focus on its core mission.

In light of the above, please advise whether NICE's refusal to conduct an internal review of the present case is NICE's final decision, or whether you wish to re-consider that decision.

Yours sincerely,

Till Bruckner

David Coombs, National Institute for Health and Care Excellence

Dear Till

Thank you for the further information provided below. I can confirm however my earlier decision stands, as I feel it is important in the interests of fairness to act in accordance with our policy.

Kind regards

David

show quoted sections

Dear David Coombs,

thank you for responding - I understand your position.

Yours sincerely,

Till Bruckner