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Comment form 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