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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Proposed Single Technology Appraisal
Abiraterone for the treatment of chemotherapy naïve metastatic castrationresistant prostate cancer
Consultee and commentator comment form
Please use this form for submitting your comments on the draft remit, draft scope and
provisional matrix of consultees and commentators. It is important that you complete
and return this form even if you have no comments otherwise we may chase you for a
response.
Enter the name of your organisation here: The Prostate Cancer Charity
Comments on the draft remit and draft scope
The draft remit is the brief for a proposed appraisal. Appendix B contains the draft remit. The
draft scope, developed from the draft remit outlines the question that the proposed appraisal
would answer.
Please submit your comments on the draft remit and draft scope using the table below. Please
take note of any questions that have been highlighted in the draft scope itself (usually
found at the end of the document).
If you have been asked to comment on documents for more than one proposed
appraisal, please use a separate comment form for each topic, even if the issues are
similar.
If you do not have any comments to make on the draft remit and draft scope, please state this in
the box below.
Comment 1: the draft remit
Section
Notes
Appropriateness It is important that
appropriate topics are
referred to NICE to
ensure that NICE
guidance is relevant,
timely and addresses
priority issues, which will
help improve the health
of the population. Would
it be appropriate to refer
this topic to NICE for
appraisal?
Your comments
It would be appropriate to refer this topic to NICE for
appraisal. Treatment options for men with metastatic
castration-resistant prostate cancer are limited and it
would be desirable to increase the range of effective
treatments available for these patients, particularly if
this leads to extended overall and progression-free
survival. Should the proposed appraisal recommend
that abiraterone is effective for the above indication,
it will help to provide standardised access and
increased treatment choice to a group of patients
who currently have a restricted range of treatments
available once their cancer becomes castration-
Comment form
Section
Your comments
Notes
resistant.
Wording
Does the wording of the
remit reflect the issue(s)
of clinical and cost
effectiveness about this
technology or
technologies that NICE
should consider? If not,
please suggest
alternative wording.
We would like NICE to reconsider the use of the
terms ‘castrate-resistant' and 'castration-resistant'
prostate cancer, when providing information to
patients. Although we acknowledge that these are
clinically accurate terms used amongst health
professionals, we know that people affected by
prostate cancer are generally detered by them. A
recent survey of 27 of the Charity's Prostate Cancer
Voices network found that 24 of the respondents
said they would prefer to see a different phrase used
to describe this type of prostate cancer. 21
respondents said they found the phrase "castration"
was an unhelpful way of describing the treatments or
type of prostate cancer.
Timing Issues
What is the relative
urgency of this proposed
appraisal to the NHS?
The timing of this appraisal appears appropriate.
However it should be noted that treatment options
for this patient population are limited. Only docetaxel
is licensed for this point in the treatment pathway.
The results of the appraisal could improve treatment
choice for these patients (should abiraterone be
considered effective for this indication) and so
should be conducted promptly.
Abiraterone has recently been recommended for use
in metastatic castration-resistant prostate cancer by
the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP). Market
authorisiation is therefore likely to occur in the near
future and be available for prescribing in England
and Wales. It is essential that the appraisal is
conducted rapidly, so that appropriate guidance is
available for commissioners, clinicians and patients
and to ensure equity of access.
Any additional comments on the draft remit
None
Comment 2: the draft scope
Section
Background
information
Notes
Consider the accuracy
and completeness of this
information.
Your comments
The Prostate Cancer Charity welcomes the inclusion
of information on the number of men with prostate
cancer who will go on to develop metastatic disease.
This information provides context to assess the need
for this technology and the number of patients who
may be eligible.
Comment form
Section
Notes
Your comments
Anti-androgens and GnRH antagonists (e.g.
degarelix) should be included in the list of standard
hormonal treatments for metastatic disease.
"Hormone-resistant" should be included in the list of
terms which are commonly used to describe prostate
cancer that has become reistant to standard hormonal
therapy. While the term is not as clinically accurate as
the terms already listed in the draft scope, we know
that patients prefer "hormone-resistant" rather than
the phrase "castration-resistant", as outlined above.
It would be helpful to provide a reference for the
percentage of men with metastatic prostate cancer
who initially respond to hormonal therapy to provide
appropriate evidence and context.
The
technology/
intervention
Is the description of the
technology or
technologies accurate?
Abiraterone has now been recommended for the
treatment of metastatic castration-resistant prostate
cancer following docetaxel treatment by the European
Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP). Its brand name is
Zytiga so the description should be updated to reflect
this.
It would be helpful to mention the use of abiraterone
in the post-chemotherapy indication, its favourable
trial result and its licensing, here.
It is difficult to comment further on the technology at
present as the results of the relevant phase III clinical
trial on this indication have not yet been published.
Population
Is the population defined
appropriately? Are there
groups within this
population that should be
considered separately?
Biologic therapy should be defined to provide context
to the definition of the population.
Comparators
Is this (are these) the
standard treatment(s)
currently used in the NHS
with which the technology
should be compared?
Can this (one of these) be
described as ‘best
alternative care’?
We do not have enough evidence to comment on this
aspect without the published phase III trial data for
this indication.
Outcomes
Will these outcome
measures capture the
most important health
related benefits (and
harms) of the technology?
We agree with the clinical outcomes identified in the
draft scope. However, it is important that healthrelated quality of life and adverse effects are
considered with an equal standing to the other
outcomes. Patient-reported outcomes should also be
considered, to ensure that the agent is not only
clinically effective but also improves outcomes of
importance to this patient population.
Comment form
Section
Your comments
Notes
Health-related quality of life is particularly crucial at
this point in the cancer journey for a man with castrate
resistant disease. Aspects that relate to quality of life
should be specifically considered, including the impact
of the treatment regimen on number of hospital
appointments, method of delivering treatment (e.g.
oral, intravenous etc.) and side effects. For example,
as abiraterone is an oral agent, its administration is
likely to be comparatively more straightforward than,
for example, chemotherapy, and can offer a man with
advanced disease greater flexibility to lead a more
'normal' life for the period of benefit.
Economic
analysis
Comments on aspects
such as the appropriate
time horizon.
We do not have evidence to enable us to comment on
this area
Equality
Suggestions for factors
which may help promote
equality and eliminate
unlawful discrimination.
These may include issues
with the intended use of
the technology (including
factors relating to
assessment, delivery and
follow up) amongst e.g.
people of different race,
disability, religion and
sexual orientation.
It will be important to ensure that access to this
technology is equitable and discrimination does not
occur solely on the basis of age, ethnicity or socioeconomic status. Prostate cancer is more common in
men aged over 60 and African Caribbean men are
three times more likely to develop prostate cancer
than white men of the same age in the UK.
Furthermore, men from lower socioeconomic
backgrounds are less likely to survive prostate cancer
than men from more affluent backgrounds. It will be
important to ensure that eligible patients from these
populations are not denied access to this technology
(if approved) because of factors related to their age,
ethnicity and socio-economic status. Information and
communication strategies must also be considered
and patients consulted to ensure that access can be
as equitable as possible
Suggestions for additional
Other
considerations issues to be covered by
None
the proposed appraisal
are welcome.
Questions for
consultation
Do you consider the
technology to be
innovative in its potential
to make a significant and
substantial impact on
health-related benefits
and how it might improve
the way that current need
is met (is this a ‘stepchange’ in the
management of the
condition)?
Do you consider that the
use of the technology can
result in any potential
significant and substantial
health-related benefits
that are unlikely to be
included in the QALY
Yes, the technology could potentially change the
management of castration-resistant prostate cancer
but we are not able to comment further without seeing
the relevant phase III trial data.
Comment form
Section
Notes
Your comments
calculation?
Please identify the nature
of the data which you
understand to be
available to enable the
Appraisal Committee to
take account of these
benefits.
Please answer any of the
questions for consultation
if not covered in the
above sections. If
appropriate, please
include comments on the
proposed process this
appraisal will follow
(please note any changes
made to the process are
likely to result in changes
to the planned time lines).
It would be helpful to relate this appraisal to the
technology appraisal in preparation on abiraterone (in
comination with prednisolone) for the treatment of
metastatic castrate resistant prostate cancer following
previous cytotoxic chemotheraphy. Conducting the
appraisals together would help avoid duplication of
effort and confusion over the similar appraisals.
Any additional comments on the draft scope
There is a mistake in the second sentence of the second paragraph in the section 'The
technology' on page 2. It should read: "It is being studied in clinical trials..."
Comment 3: provisional matrix of consultees and commentators
The provisional matrix of consultees and commentators (Appendix C) is a list of organisations
that we have identified as being appropriate to participate in this proposed appraisal. If you
have any comments on this list, please submit them in the box below.
As NICE is committed to promoting equality and eliminating unlawful discrimination Please let
us know if we have missed any important organisations from the lists contained within the
matrix, and which organisations we should include that have a particular focus on relevant
equality issues.
If you do not have any comments to make on the provisional matrix of consultees and
commentators, please cross this box:
Comments on the provisional matrix of consultees and commentators
Please return this form, preferably by e-mail, to [email protected] by Monday 8 August
2011.
Where email is not possible, please copy this completed form onto a CD-ROM and send to:
Michelle Adhemar, Project Manager, NICE, Level 1A, City Tower, Piccadilly Plaza, Manchester,
M1 4BD to arrive on or before the deadline. Further contact details are (Phone: 44 (0)207
045 2239; fax 44 (0)20 7061 9732)
Comment form