NHS England restrict use of Ibrutinib in relapsed CLL patients

The request was successful.

Nina Pidwill,
National Operational Lead for the Cancer Drugs Fund
NHS England,

Dear Nina Pinwill,

Freedom of Information Request: NHS England restrict use of Ibrutinib in relapsed CLL patients

We understand that NHS England is mandated to follow NICE guidelines with regard to the funding of drugs used for cancer. It appears that this has not happened in the case of Ibrutinib, which is recommended by NICE for those patients with Chronic Lymphocytic Leukaemia (CLL) who have had a prior course of chemotherapy. NHS England have, apparently, added an additional stipulation that Ibrutinib will only be funded for people with a relapse of CLL within 3 years of their previous chemotherapy treatment. There is no such restriction specified in the NICE guidance document.

It appears from the NICE the guidance document (paragraph 4.3, https://www.nice.org.uk/guidance/ta429/d...), that the committee was aware of the trial inclusion criteria and didn't feel that it was necessary to impose further restrictions compared to the marketing authorisation for ibrutinib. (This clearly differs from the NICE appraisal of Idealisib where much emphasis was placed on the trial inclusion criteria and this was subsequently reflected in the more restrictive NICE guidance for Idealisib compared to the marketing authorisation).
There seems to be no strong evidence for NHS England ignoring the statutory funding requirements placed upon them to follow NICE guidance. In fact, clinical experts have described this decision as “an irrational decision (which) has been taken without adequate discussion with expert clinicians, patients and support groups… and which makes no sense as it will result in poorer outcomes for patients and higher costs for the NHS” (Times letter “Leukaemia drug” May 18th).
It is notable that in Wales and Scotland the NICE guidelines are being followed as they stand without this additional restriction. Furthermore, Ibrutinib has been approved by the European Medicines Agency for the treatment of adult patients with CLL who have received at least one prior therapy without any time restrictions (http://www.ema.europa.eu/ema/index.jsp?c...)

We request to see the documentation regarding the process by which NHS England reached this decision. In particular, we wish to see:
a) the details of the case for restricting the use of Ibrutinib to those people whose CLL remission has lasted for 3 years or less. Without access to Ibrutinib such patients would have to be treated with a second course of chemotherapy but this may have devastating consequences for patients (letter “Leukaemia drug” from Andy Wallace, Times 21st May 2018, copied below).
b) the documentation regarding the process of consultation with clinical experts, patients and relevant patient organisations, a task which NICE conducts with particular thoroughness.
c) any additional information that NHS England reviewed, that had not been available to the NICE committee. Any such information should be in the public domain.

We look forward to hearing from you

Yours sincerely

Eileen Cann and Francis Creed

…………………………………………………………………………………………………………

Letter to the Times May 21st

Leukaemia drug

Sir, May I offer a patient’s perspective about the inequity of NHS England’s decision to deny Ibrutininb to cancer patients whose chronic lymphocytic cancer (CLL) has been in remission for more than three years (“Cancer patients denied effective drug to cut costs” May 12th and letters May 15, 16 and 18)?

I have had CLL for 11 years and have only praise for the top-rate care that I have received in Exeter. I have endured two full chemotherapy treatments, the second which left me with a permanently low neutrophil count due to bone marrow damage. This puts me at constant risk from infection and determines where I can go and what I can do. It affects family decisions and daily puts the cancer at the forefront of our minds.

The nasty spectre of neutropenic sepsis is a constant threat – any temperature above 38°C can lead to this condition – for which immediate hospitalisation is essential, it being potentially fatal if untreated. This happened to me over the Easter weekend. Had I been prescribed this game changing drug, this incident would have been avoided.

It is disgraceful that some patients are being excluded from this treatment and the decision by NHS England needs to be reversed. No matter how hard you try to ignore this cancer, for the family it never goes away.
Andy Wallace
Seaton, Devon.

CONTACTUS, England (NHS ENGLAND), NHS England

Dear Customer,
 Thank you for contacting NHS Customer Contact Centre.  We have received
your email and a member of our Customer Service team will be respond to
you in due course.
In the meantime, the following information may be able to help you access
information immediately.
NHS England commissions or buys primary care services; for example, GPs,
dentists, opticians, and pharmacy services. We also commission health and
justice, military health services plus some specialised services. We can
advise you how to access, give feedback or make a complaint about the
services we commission.
NHS England does not commission secondary care (with the exception of
Specialised Services). This includes hospital care, NHS 111 services,
mental health services, out-of-hours services and community services such
as district nursing. These services are commissioned by Clinical
Commissioning Groups (CCGs). If you need advice about accessing secondary
care, you should contact your local CCG. You can find their contact
details using the service finder on the NHS Choices
website<http://www.nhs.uk/Service-Search/> .
You may also refer to the following links for further information about
NHS England

 https://www.england.nhs.uk/about/

https://www.england.nhs.uk/ourwork/

https://www.england.nhs.uk/resources/

https://www.england.nhs.uk/commissioning/

and https://www.england.nhs.uk/contact-us for details about the Customer
Contact Centre, which also provides a number of FAQ’s.
If you require medical attention, please contact your GP, call 111 or if
you require urgent medical attention, please dial 999 or attend your local
Accident and Emergency Department.
If, after receiving this automated response, you no longer think we can
assist with your email, please reply to this email address stating ‘NO
FURTHER ACTION REQUIRED’ and we will not respond to your email.
Kind Regards
NHS England Customer Contact Centre team
* Please note our normal working hours are 08:00 to 18:00 from Monday to
Friday and we regret the delay in reply over the non-working hours.
**The Customer Contact Centre is currently experiencing a high volume of
enquiries so it may take us a little longer to respond. We are working
hard to restore normal service and would like to apologise if you
experience a delay.We will, of course, get back to you as soon as we can.
*** How we use your information: Our privacy notices explains how we use,
share and store your personal information. You can find this on the NHS
England website [1]https://www.england.nhs.uk/privacy

show quoted sections

FOI, England (NHS ENGLAND), NHS England

Dear Ms Creed,   

 

Thank you for your communication dated 26 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
answered within twenty working days.

 

For further information regarding the FOI Act, please refer to the
Information Commissioner’s Office (ICO) website. For further information
regarding NHS England and the information it publishes please visit our
website here.

 

If you have any queries about this request or wish to contact us again,
please email [1][NHS England request email] and the message will be
forwarded appropriately. Please remember to quote the above reference
number in any future communications.

 

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, [2][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: [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 Cann,

 

We are writing with regard to your Freedom of Information (FOI) request
dated 26 May 2018.

 

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.
We are still in the process of assessing your request and will provide you
with a full response as soon as possible. We will write to provide a
further update on or before 6 July 2018, if your response is not complete
by this time.

 

We apologise for any inconvenience this may cause. Please be aware that
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: [1][email address]  

Website: [2]www.ico.gov.uk

 

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, [3][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: [4][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 Cann,

 

Re: Freedom of Information Request (Our reference FOI-056489)

 

We are writing with regard to your Freedom of Information (FOI) request
dated 26 May 2018.

 

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.
We are still in the process of assessing your request and will provide you
with a full response as soon as possible. We will write to provide a
further update on or before 20 July 2018, if your response is not complete
by this time.

 

We apologise for any inconvenience this may cause. Please be aware that
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: [1][email address]  

Website: [2]www.ico.gov.uk

 

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, [3][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: [4][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 Cann,

 

Re: Freedom of Information Request (Our reference FOI-056489)

 

We are writing with regard to your Freedom of Information (FOI) request
dated 26 May 2018.

 

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.
We are still in the process of assessing your request and will provide you
with a full response as soon as possible. We will write to provide a
further update on or before 03 August 2018, if your response is not
complete by this time.

 

We apologise for any inconvenience this may cause. Please be aware that
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: [1][email address]  

Website: [2]www.ico.gov.uk

 

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, [3][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: [4][NHS England request email]

 

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

 

show quoted sections

FOI, England (NHS ENGLAND), NHS England

Dear Ms Cann,

 

Re: Freedom of Information Request (Our reference FOI-056489)

 

We are writing with regard to your Freedom of Information (FOI) request
dated 26 May 2018.

 

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.
We are still in the process of assessing your request and will provide you
with a full response as soon as possible. We will write to provide a
further update on or before 17 August 2018, if your response is not
complete by this time.

 

We apologise for any inconvenience this may cause. Please be aware that
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: [1][email address]  

Website: [2]www.ico.gov.uk

 

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, [3][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: [4][NHS England request email]

 

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

 

show quoted sections

FOI, England (NHS ENGLAND), NHS England

1 Attachment

Dear Sir or Madam,

 

Re: Freedom of Information request (Our Ref: FOI-056489)

 

Thank you for your Freedom of Information (FOI) request dated 26 May 2017.
Please accept our apologies for the delay in providing you with a
response.

 

Your exact request was:

 

a) the details of the case for restricting the use of Ibrutinib to those
people whose CLL remission has lasted for 3 years or less. Without access
to Ibrutinib such patients would have to be treated with a second course
of chemotherapy but this may have devastating consequences for patients
(letter “Leukaemia drug” from Andy Wallace, Times 21st May 2018, copied
below).

 

b) the documentation regarding the process of consultation with clinical
experts, patients and relevant patient organisations, a task which NICE
conducts with particular thoroughness.

 

c) any additional information that NHS England reviewed, that had not been
available to the NICE committee. Any such information should be in the
public domain.

 

NHS England holds information in relation to your request. The following
guides you through the information provided:

 

 

·         Ibrutinib first entered the Cancer Drugs Fund (CDF) for patients
with previously treated chronic lymphocytic leukaemia (CLL) in January
2015 following consideration by the CDF clinical expert committee, part of
NHS England’s Chemotherapy Clinical Reference Group. Documents #1 and 2
provide the National Cancer Drugs Fund Application Form and Prioritisation
document and presentation slides from December 2014 that informed the
decision to fund ibrutinib in this indication from the Cancer Drugs Fund.
 Documents #3-15 provide the additional evidence referred to by NHS
England’s clinical experts as part of the prioritisation process in
December 2014.

 

·         NICE then appraised ibrutinib for previously treated CLL in
2016. Document #16 provides the submission that NHS England made to NICE
in August 2016 in support of this appraisal.

 

·         Documents #17 and 18 provide email communication from March 2017
between NHS England’s Chemotherapy Clinical Lead and the Chronic
Lymphocytic Leukaemia Forum Chair outlining the evidence considered to set
the treatment criteria for ibrutinib in chronic lymphocytic leukaemia
following publication of positive NICE guidance in January 2017.

 

·         Document #19 provides a clinical statement from NHS England
(from June 2018) on access to ibrutinib for chronic lymphocytic leukaemia
including considerations for patients considered unsuitable for
re-treatment – also available at:
[1]https://www.england.nhs.uk/publication/p...

 

Please note that some of this information has been redacted under Section
40(2) of the FOI Act which provides for the protection of personal
information.  Section 40 prohibits a public body from disclosing
personally identifiable information as doing so would contravene data
protection principles. 

 

Under the FOI Act disclosure of this information would breach the fair
processing principle contained in the Data Protection Act (DPA), where it
would be unfair to that person/is confidential. Section 40(2) is an
absolute exemption and therefore not subject to the public interest test
when considering disclosure of information.

 

In addition some information has been redacted under Section 43
(commercial interests/sensitivity) of the FOI Act. Section 43(2) is a
prejudice based exemption and, as such, we are required to assess both the
prejudice test and the public interest test in withholding this
information against that of its release.

 

When assessing the prejudice test, NHS England need to demonstrate that
there would be an impact on the commercial interests of NHS England or
upon a third party should this information be released. In this instance
this information is commercially sensitive as its release may impact on
future contract negotiations by prejudicing pharmaceutical companies
(third parties) with whom NHS England contracts.

 

Disclosure of the information would reveal information in respect of
pharmaceutical companies and their finances to the public. In doing so, it
has the potential to give a greater level of detail about the third
parties resources, supply, volumes and potential financial position than
would normally be given. This in turn has the potential to give
competitors more detailed knowledge of the companies than they will have
of their competitors. This would be unfair to the third parties and would
be likely to put them at a competitive disadvantage. This is because in a
procurement process a competitor may have an increased level of knowledge
of the pharmaceutical companies’ positions. If the information is
disclosed a competitor or competitors could gain a level of understanding
of the third parties financial position, which could mean they had an
ability to undercut the companies in future procurement rounds. This puts
the pharmaceutical companies at an unfair competitive disadvantage as
compared to their direct competition.

 

With this in mind, on balance, NHS England is of the opinion that
disclosure of this information would be likely to prejudice the third
parties. This is due to the fact that it has the potential to give an
insight into their resource which would not otherwise be available in
general and by a private organisation. It is our opinion that disclosure
of this information would be likely to risk their commercial position and
potentially damage future procurement opportunities in a fair and
competitive environment. This would not be fair to an organisation such as
this and therefore section 43 (2) is engaged in respect of this
information.

 

NHS England is also required to conduct the public interest test, which
assesses whether releasing the information would be in the public interest
despite the prejudice test being satisfied. It is important to bear in
mind that any disclosure under the FOI Act is a disclosure to the public
at large and not just to the applicant.

 

NHS England recognises a general public interest in NHS drug costs and
spending on drugs. However, we also take into consideration the importance
of preserving a situation in which contractors such as the third parties
can contract with public authorities without prejudice to their commercial
interests. Secondly, it is our opinion that there is a public interest in
ensuring that the commercial interests of organisations such as
pharmaceutical companies are not damaged or undermined by disclosure of
information which is not common knowledge and which could adversely impact
on future business as highlighted earlier in this reply.

 

We therefore consider that releasing this information would not be in the
public interest.   

 

Copyright: NHS England operates under the terms of the open government
licence. Please see the NHS England Terms and conditions on the following
link:

[2]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 by writing to us, within two
months of the date of this letter, to:

 

NHS England

PO Box 16738

REDDITCH

B97 9PT

 

Email: [3][NHS England request email]

 

Please quote the reference number FOI-056489 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: [4][email address]  

Website: [5]www.ico.gov.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, [6][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: [7][NHS England request email]

 

show quoted sections