Protocols for SACT studies for drugs and indications in the Cancer Drugs Fund

The request was successful.

Helen Macdonald

Dear NHS England,

I am writing to you under the Freedom of Information Act 2000 to request a copy of the protocols for all Systemic Anti-Cancer Therapy (SACT) dataset studies, for all drugs and indications currently covered by the Cancer Drugs Fund (CDF). Official documentation about the CDF project makes clear that there is a Data Collection Agreement, and a protocol for data analysis, for each drug and indication covered by the CDF. However, I am unable to find these online. The relevant drugs and indications whose protocols I seek are listed at the bottom of this email. (If I omitted any drugs and indications or others have entered the fund since I created this list please also send them.)

For any data analysis assessing the effectiveness of a treatment one would expect to see a prespecified study protocol covering: the research question/s to be addressed; the study design; a detailed description of the methods including population, exposure, comparison, and outcome measures; a clear plan for the statistical analysis; and a publication and dissemination plan.

The document “Specification for the cancer drugs fund data collection arrangement” states that each drug and indication will have analyses using SACT data. It says that the Data Collection Arrangement will include “accountability for the protocol” for the SACT study. And, it states that “the DCA working group will prepare an analysis plan and timescales”. These analyses may quantify the benefits and toxicities of treatments, describe the number of patients treated, and can be linked to other data sets such as Hospital Episode Statistics.

The Cancer Drugs Fund specification document states there will be an a priori documentation of the following: “The population of patients to be treated, the numbers of patients needed for robust analysis in the data collection, comparators (where appropriate), the key outcomes to address the appraisal committee’s issues of uncertainty (which will subsequently be used in economic modelling in the appraisal review after the CDF), analysis plan and the timeframe for the studies and/or Public Health England data, including SACT data, will be identified by the DCA working group. Relevant stakeholders, including the company, and clinical and patient experts present at the appraisal committee meeting, will be asked to comment.”

Additional information:
Please provide the information as a PDF attached to an email. If it is not possible to provide the information requested please can you explain why. If you can identify any ways that my request could be refined please provide further advice. This request is part of an MSc project but may also be written up for publication. If you have any queries please don’t hesitate to contact me via email and I will be happy to clarify.

Yours Faithfully,
Helen Macdonald

MSc student, University of Oxford
Clinical editor, The BMJ

List of drugs and indications with the technology appraisal number which includes the Data Collection Arrangement.

Ibrutinib
Waldenstrom’s Macroglobulinaemia
TA491

Olaratumab
In combination with doxorubicin for the treatment of advanced soft tissue sarcoma in ADULT patients
TA465

Olaratumab
In combination with doxorubicin for the treatment of advanced soft tissue sarcoma in PAEDIATRIC patients
TA465

Obinutuzumab with bendamustine
Treatment of follicular lymphoma refractory to rituximab
TA472

Pembrolizumab
Untreated PD-L1 positive metastatic non-small-cell lung cancer
TA447

Osimertinib
Locally advanced or metastatic epidermal growth factor receptor and T790M mutation-positive non-small-cell lung cancer (NSCLC)
TA416

Ventoclax
Chronic lymphatic leukaemia in the PRESENCE of 17p
TA487

Ventoclax
Treatment of chronic lymphatic leukaemia in the ABSENCE of 17p deletion (and absence of TP53 mutation if tested)
TA487

Nivolumab
Previously treated locally advanced or metastatic non-squamous non-small cell lung cancer
TA484

Nivolumab
Recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum-based chemotherapy
TA490

Nivolumab
Previously treated locally advanced or metastatic squamous non-small cell lung cancer
TA483

Brentuximab
Brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multiagent chemotherapy is not a treatment option in ADULT patients
TA446

Brentuximab
Brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multiagent chemotherapy is not a treatment option in CHILD patients
?TA446

Ixazomib (with lenalidomide and dexamethasone)
Relapsed or refractory multiple myeloma
TA505

Atezolizumab
First line treatment of locally advanced or metastatic urothelial cancer in patients who are ineligible for cisplatin based chemotherapy
TA492

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FOI, England (NHS ENGLAND), NHS England

Dear Ms Macdonald,   

 

Thank you for your communication dated 29 May 2018.

 

NHS England has assessed your communication as a request under the Freedom
of Information (FOI) Act 2000. As such, please be assured that your
request is being dealt with under the terms of the FOI Act and will be
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Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [3][NHS England request email]

 

‘Health and High quality care for all, now and for future generations’

 

 

 

show quoted sections

FOI, England (NHS ENGLAND), NHS England

Dear Ms Macdonald,

 

Re:      Freedom of Information request (Our Ref: FOI-056500)

 

Thank you for your Freedom of Information (FOI) request dated 29 May 2018.

 

Your exact request was:-

 

“I am writing to you under the Freedom of Information Act 2000 to request
a copy of the protocols for all Systemic Anti-Cancer Therapy (SACT)
dataset studies, for all drugs and indications currently covered by the
Cancer Drugs Fund (CDF). Official documentation about the CDF project
makes clear that there is a Data Collection Agreement, and a protocol for
data analysis, for each drug and indication covered by the CDF. However, I
am unable to find these online. The relevant drugs and indications whose
protocols I seek are listed at the bottom of this email. (If I omitted any
drugs and indications or others have entered the fund since I created this
list please also send them.)

 

For any data analysis assessing the effectiveness of a treatment one would
expect to see a prespecified study protocol covering: the research
question/s to be addressed; the study design; a detailed description of
the methods including population, exposure, comparison, and outcome
measures; a clear plan for the statistical analysis; and a publication and
dissemination plan.

 

The document “Specification for the cancer drugs fund data collection
arrangement” states that each drug and indication will have analyses using
SACT data. It says that the Data Collection Arrangement will include
“accountability for the protocol” for the SACT study. And, it states that
“the DCA working group will prepare an analysis plan and timescales”.
These analyses may quantify the benefits and toxicities of treatments,
describe the number of patients treated, and can be linked to other data
sets such as Hospital Episode Statistics.

 

The Cancer Drugs Fund specification document states there will be an a
priori documentation of the following: “The population of patients to be
treated, the numbers of patients needed for robust analysis in the data
collection, comparators (where appropriate), the key outcomes to address
the appraisal committee’s issues of uncertainty (which will subsequently
be used in economic modelling in the appraisal review after the CDF),
analysis plan and the timeframe for the studies and/or Public Health
England data, including SACT data, will be identified by the DCA working
group. Relevant stakeholders, including the company, and clinical and
patient experts present at the appraisal committee meeting, will be asked
to comment.”

 

Additional information:

Please provide the information as a PDF attached to an email. If it is not
possible to provide the information requested please can you explain why.
If you can identify any ways that my request could be refined please
provide further advice. This request is part of an MSc project but may
also be written up for publication. If you have any queries please don’t
hesitate to contact me via email and I will be happy to clarify.”

NHS England holds recorded information in relation to this request.

 

Please find below an up to date list of indications (as at 14 June 2018)
funded via a Cancer Drugs Fund (CDF) managed access agreements (MAA),
which incorporate the relevant data collection agreement (DCA). All CDF
MAAs and DCAs are published on NICE’s website and the hyperlink for each
is extracted in the table below.

 

Each DCA is developed collaboratively in a working group by NICE, Public
Health England, NHS England and the company. Where necessary, the DCA
working group seeks input and clarification from clinical experts and
patient and professional organisations. Clinical and patient expert input
is always included via the standard NICE technology appraisal processes in
terms of written evidence submissions and verbally at the appraisal
committee meeting.

 

The DCA is structured to include details of:

 

·              The leads responsible for the DCA from NICE, Public Health
England, NHS England and the company

·              The period of the agreement and data collection

·              Patient population

·              The areas of uncertainty to be addressed by the data
collection and reports

·              Data sources

·              Outcome data required to address the uncertainty

·              Data analysis plan

·              Data ownership

·              Publication

 

Drug Indication Published        Data collection agreement
Osimertinib EGFR T790M [1]TA416 [2]https://www.nice.org.uk/guidance/ta416/r...
mutation-positive 26 October 2016
non-small cell
lung cancer
Olaratumab Soft tissue [3]TA 465 [4]https://www.nice.org.uk/guidance/ta465/r...
sarcoma 09 August 2017
Obinutuzumab Follicular [5]TA472 [6]https://www.nice.org.uk/guidance/ta472/r...
(in non-Hodgkin’s 30 August 2017
combination lymphoma
with
bendamustine)
Nivolumab Non-small cell [7]TA483 [8]https://www.nice.org.uk/guidance/ta483/r...
lung cancer 1 November 2017
(squamous)
Nivolumab Non-small cell [9]TA484  [10]https://www.nice.org.uk/guidance/ta484/r...
lung cancer 1 November 2017
(non-squamous)
Venetoclax Chronic [11]TA487 [12]https://www.nice.org.uk/guidance/ta487/r...
lymphocytic
leukaemia 8 November 2017
Nivolumab Head and neck [13]TA490 [14]https://www.nice.org.uk/guidance/ta490/r...
(squamous) after 22 November 2017
chemo
Ibrutinib Waldenstrom’s [15]TA491 [16]https://www.nice.org.uk/guidance/ta491/r...
macroglobulinaemia 22 November 2017
Atezolizumab Urothelial cancer [17]TA492 [18]https://www.nice.org.uk/guidance/ta492/r...
06 December 2017
Ixazomib (with Multiple myeloma [19]TA505 [20]https://www.nice.org.uk/guidance/ta505/r...
lenalidomide 07 February 2018
and
dexamethasone)
Daratumumab Multiple myeloma [21]TA510 [22]https://www.nice.org.uk/guidance/ta510/r...
14 March  2018
Avelumab Merkel cell [23]TA517 [24]https://www.nice.org.uk/guidance/ta517/r...
carcinoma 11 April 2018
Pembrolizumab Urothelial [25]TA519 [26]https://www.nice.org.uk/guidance/ta519/r...
(previously 25 April 2018
treated)
Pembrolizumab Urothelial Final guidance [27]https://www.nice.org.uk/guidance/gid-ta1...
carcinoma in development
(previously
untreated)
Niraparib Ovarian cancer Final guidance [28]https://www.nice.org.uk/guidance/gid-ta1...
in development
Crizotinib ROS1‑positive Final guidance [29]https://www.nice.org.uk/guidance/gid-ta1...
NSCLC in development

 

Copyright:- NHS England operates under the terms of the open government
licence. Please see the NHS England Terms and conditions on the following
link [30]http://www.england.nhs.uk/terms-and-cond...

 

We hope this information is helpful. However, if you are dissatisfied, you
have the right to ask for an internal review. This should be requested in
writing within two months of the date of this letter. Your correspondence
should be labelled “Internal Review” and should outline your concerns
and/or the area(s) you would like the review to consider. Internal Review
requests should be sent to:

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Email: [31][NHS England request email]

 

Please quote the reference number FOI-056500 in any future communications.

 

If you are not content with the outcome of the internal review, 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 Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Telephone: 0303 123 1113

Email: [32][email address]  

Website: [33]www.ico.org.uk

 

Please note there is no charge for making an appeal.

 

Please be aware that in line with the Information Commissioner’s directive
on the disclosure of information under the FOI Act, your request will be
anonymised and published on our website as part of our disclosure log.

 

Please do not reply to this email. This message has been sent from a
central mailbox. To communicate with NHS England regarding Freedom of
Information (FOI) requests, enquiries or complaints we ask these are sent
directly to NHS England’s customer contact centre. This is to ensure all
communications are progressed correctly. Their postal address, telephone
number and email details are as follows:- PO Box 16738, Redditch, B97 9PT;
0300 3 11 22 33, [34][NHS England request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [35][NHS England request email]

 

‘Health and High quality care for all, now and for future generations’

show quoted sections

Helen Macdonald

Dear FOI, England (NHS ENGLAND),

Many thanks for your reply. The reference number is FOI-056500.

I asked for the protocols for SACT studies, and you have directed my to the Data Collection Agreements (DCAs). By implication, I therefore assume that you are saying that the DCA contains the protocol.

Could you confirm for me that I have understood correctly:
1) That the information in the DCA is the pre-specified protocol?
2) That you are unaware of any other protocol for these data analyses?

Yours sincerely,

Helen Macdonald

FOI, England (NHS ENGLAND), NHS England

Dear Ms Macdonald,

 

Re:      Freedom of Information request (Our Ref: FOI-056500)

 

Thank you for your communication dated 10 July 2018 in relation to your
Freedom of Information request.

 

Your exact request was:-

 

“Follow Up: Many thanks for your reply. The reference number is
FOI-056500.

 

I asked for the protocols for SACT studies, and you have directed my to
the Data Collection Agreements (DCAs). By implication, I therefore assume
that you are saying that the DCA contains the protocol.

 

Could you confirm for me that I have understood correctly:

1) That the information in the DCA is the pre-specified protocol?

2) That you are unaware of any other protocol for these data analyses?

 

 

Original Request: I am writing to you under the Freedom of Information Act
2000 to request a copy of the protocols for all Systemic Anti-Cancer
Therapy (SACT) dataset studies, for all drugs and indications currently
covered by the Cancer Drugs Fund (CDF). Official documentation about the
CDF project makes clear that there is a Data Collection Agreement, and a
protocol for data analysis, for each drug and indication covered by the
CDF. However, I am unable to find these online. The relevant drugs and
indications whose protocols I seek are listed at the bottom of this email.
(If I omitted any drugs and indications or others have entered the fund
since I created this list please also send them.)

 

For any data analysis assessing the effectiveness of a treatment one would
expect to see a prespecified study protocol covering: the research
question/s to be addressed; the study design; a detailed description of
the methods including population, exposure, comparison, and outcome
measures; a clear plan for the statistical analysis; and a publication and
dissemination plan.

 

The document “Specification for the cancer drugs fund data collection
arrangement” states that each drug and indication will have analyses using
SACT data. It says that the Data Collection Arrangement will include
“accountability for the protocol” for the SACT study. And, it states that
“the DCA working group will prepare an analysis plan and timescales”.
These analyses may quantify the benefits and toxicities of treatments,
describe the number of patients treated, and can be linked to other data
sets such as Hospital Episode Statistics.

 

The Cancer Drugs Fund specification document states there will be an a
priori documentation of the following: “The population of patients to be
treated, the numbers of patients needed for robust analysis in the data
collection, comparators (where appropriate), the key outcomes to address
the appraisal committee’s issues of uncertainty (which will subsequently
be used in economic modelling in the appraisal review after the CDF),
analysis plan and the timeframe for the studies and/or Public Health
England data, including SACT data, will be identified by the DCA working
group. Relevant stakeholders, including the company, and clinical and
patient experts present at the appraisal committee meeting, will be asked
to comment.”

 

Additional information:

Please provide the information as a PDF attached to an email. If it is not
possible to provide the information requested please can you explain why.
If you can identify any ways that my request could be refined please
provide further advice. This request is part of an MSc project but may
also be written up for publication. If you have any queries please don’t
hesitate to contact me via email and I will be happy to clarify.”

NHS England holds recorded information in relation to this request.

 

In relation to question one, The Data Collection Agreement (DCA) provides
an outline of how NICE, Public Health England, NHS England and the company
propose to address the clinical uncertainties that were identified by the
NICE committee. The DCA is primarily concerned with the data that will be
collected and how to ensure all uncertainties are able to be addressed. It
also includes consideration of many of the factors that are likely to be
set out in a protocol as outlined in our initial response.

 

In relation to question two, the primary data source is most often the
company’s clinical trial with its associated protocol and SACT data will
be used to provide a real world perspective on results reported by the
clinical trial. The methods for pembrolizumab for first line PD-L1
positive non-small-cell lung cancer and brentuximab vedotin for
CD30-positive Hodgkin lymphoma are published on NICE’s website as part of
the committee papers for these topics and should be of interest. Public
Health England is developing a methodology for the CDF analyses that will
be reported in 2019. Public Health England will publish both their general
methodology for CDF analysis as well as specific methods for bespoke
analyses as required.

 

As such, you may wish to redirect your enquiry to Public Health England.
You can submit an FOI request to Public Health England, we have provided
their contact details below for your convenience;

 

Email:             [1][email address]

 

By Writing:     Public Information Access Office
Wellington House
133-155 Waterloo Road
London
SE1 8UG

 

We hope this information is helpful. However, if you are dissatisfied, you
have the right to ask for an internal review. This should be requested in
writing within two months of the date of this letter. Your correspondence
should be labelled “Internal Review” and should outline your concerns
and/or the area(s) you would like the review to consider. Internal Review
requests should be sent to:

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Email: [2][NHS England request email]

 

Please quote the reference number FOI-056500 in any future communications.

 

If you are not content with the outcome of the internal review, 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 Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Telephone: 0303 123 1113

Email: [3][email address]  

Website: [4]www.ico.org.uk

 

Please note there is no charge for making an appeal.

 

Please be aware that in line with the Information Commissioner’s directive
on the disclosure of information under the FOI Act, your request will be
anonymised and published on our website as part of our disclosure log.

 

To communicate with NHS England regarding Freedom of Information (FOI)
requests, enquiries or complaints we ask these are sent directly to NHS
England’s customer contact centre. This is to ensure all communications
are progressed correctly. Their postal address, telephone number and email
details are as follows:- PO Box 16738, Redditch, B97 9PT; 0300 3 11 22 33,
[5][NHS England request email].

 

Yours sincerely,

 

Freedom of Information

Corporate Communications Team

Transformation and Corporate Operations Directorate

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Tel: 0300 311 22 33

Email: [6][NHS England request email]

 

‘Health and high quality care for all, now and for future generations’

show quoted sections

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