Paul Edwards Posted July 15, 2015 Share Posted July 15, 2015 Last year the Australian and New Zealand Association of Urological Surgeons applied for listing on the Medical Benefits Scheme of (1) multiparametric MRI (mpMRI) scans of the prostate, and (2) MR-guided prostate biopsy in men with a high or concerning Prostate Specific Antigen (PSA) and with suspected prostate cancer. In the course of the application process the Medical Services Advisory Committee has called for public feedback on the way it proposes to assess the application. Jim and the Committee believe that it is important to support the application. Better diagnosis of prostate cancer at an earlier stage and the ability to distinguish between low risk and aggressive cancers will mean less men with advanced prostate cancer in the future. Jim and the Committee have submitted feedback on behalf of the Advanced Prostate Cancer Support Group. A copy of our submission is set out below. If the application is successful, MRIs for advanced men won’t be covered by the Medical Benefits Scheme. The first step is getting some use of MRIs for prostate cancer on the Medical Benefits Scheme. Then, hopefully, later on the situations in which MRIs for prostate cancer are covered on the Medical Benefits Scheme can be widened. The Prostate Cancer Foundation of Australia will also be submitting feedback to the Medical Services Advisory Committee. More information about the feedback process is available by clicking on this link. The public consultation process closes this Friday 17 July 2015 ********************************************************************************************************************************************************************************************************* Application 1397 - mpMRI prostate diagnostic scans and MR-guided biopsy procedures for diagnosis of prostate cancer Thank you for taking the time to complete this feedback form on a draft protocol to consider the options by which a new intervention might be subsidised through the use of public funds. You are welcome to provide feedback from either a personal or group perspective for consideration by the Protocol Advisory Sub-Committee (PASC) of MSAC when the draft protocol is being reviewed. The data collected will be used to inform the MSAC assessment process to ensure that when proposed healthcare interventions are assessed for public funding in Australia, they are patient focused and seek to achieve best value. This feedback form should take 10-12 minutes to complete. You may also wish to supplement your responses with further documentation or diagrams or other information to assist PASC in considering your feedback. Responses will be provided to the MSAC , its subcommittees and the applicant with responses identified unless you specifically request deidentification. While stakeholder feedback is used to inform the application process, you should be aware that your feedback may be used more broadly by the applicant. Please reply to the HTA Team Postal: MDP 853 GPO 9848 Canberra ACT 2601 Fax: 02 6289 3561 Phone 02 6289 7550 Email: HTA@health.gov.au Your feedback is requested by 17 July 2015 to enable the collation of responses to be provided to PASC to consider during its deliberations. PERSONAL AND ORGANISATIONAL INFORMATION 1. What is your name? _Jim Marshall_______________________________________________________ 2. Is the feedback being provided on an individual basis or by a collective group? q Individual þ Collective group. Specify name of group (if applicable) Australian Advanced Prostate Cancer Support Group What is the name of the organisation you work for (if applicable)? ____________________________________4. What is your e-mail address? jim at jimjimjimjim.com 5. Are you a: General practitioner Specialist Researcher Consumer þ Care giver Other (please specify) _______________________________________________________ MEDICAL CONDITION (DISEASE): Prostate cancer. PROPOSED INTERVENTIONS: multiparametric MRI (mpMRI) scans of the prostate and MR-guided prostate biopsy. CLINICAL NEED AND PUBLIC HEALTH SIGNIFICANCE Describe your experience with the medical condition (disease) and/or proposed interventions relating to the draft protocol? The Australian Advanced Prostate Cancer Support Group is a peer group for men with advanced prostate cancer. We are affiliated with the Prostate Cancer Foundation of Australia. Our members come from all different parts of Australia. We meet via a monthly teleconference and we discuss and exchange information on an online forum at www.jimjimjimjim.com. Many of our members have had Multiparametric Magnetic Resonance Imaging in the course of their treatment. What do you see as the benefits of the proposed interventions for the person involved and/or their family and carers? The benefits are as stated in the clinical claim contained in the Draft Protocol. What do you see as the disadvantages of the proposed interventions for the person involved and/or their family and carers? We do not see any disadvantages in the proposed interventions. How do you think a person’s life and that of their family and/or carers can be improved by the proposed interventions? The person’s life (and that of his family and carers) can be improved by much less ambiguity and anxiety with this improved diagnostic tool. It will lessen the number of biopsies and the associated risks. It will lessen the amount of overtreatment and the consequent side effects. Potentially aggressive cancers and will identified at a stage when curative treatment may still be possible and will not be missed in random biopsies. As men with advanced prostate cancer, our disease has serious impacts on our lives and those of our loved ones. Most of us can no longer work; this has adverse effects on our family’s financial position. Our quality of life is severely degraded by the side effects of the drugs that we require for the rest of our lives and, sooner or later, by the toxic chemotherapy that we have to undergo. The proposed interventions will mean that in the future there will be a significant reduction of men with advanced prostate cancer. What other benefits can you see from having the proposed interventions publicly funded on the Medicare Benefits Schedule (MBS)? Other benefits we see are: A significant saving in public health funding as a result of less men with advanced prostate cancer (men with advanced prostate cancer require ongoing treatment with very expensive specialised cancer drugs) and as a result of more men with low risk prostate cancer on active surveillance Greater patient equity; and a further gain in the goal of driving prostate cancer to the status of a chronic disease in long-term remission. INDICATION(S) FOR THE PROPOSED INTERVENTIONS AND CLINICAL CLAIMS Flowchart of current management and potential management with the proposed interventions for this medical condition can be found on pages 11-12. Do you agree or disagree with the eligible population for the proposed interventions as specified in the proposed management flowcharts? q Strongly agree q Agree þ Disagree q Strongly disagree Why or why not? Refer to our answer to Question 13. Do you agree or disagree with the comparator for the proposed interventions as specified in the current management flowchart? q Strongly agree q Agree þ Disagree q Strongly disagree Why or why not? Refer to our answer to Question 13. Do you agree or disagree with the clinical claim (outcomes) made for the proposed interventions? þ Strongly agree q Agree q Disagree q Strongly disagree Why or why not? The evidence supporting the clinical claims is outlined in the References detailed in the Draft Protocol. See also: Thompson, J. E., Moses, D.et al (2014). “Multiparametric Magnetic Resonance Imaging Guided Diagnostic Biopsy Detects Significant Prostate Cancer and could Reduce Unnecessary Biopsies and Over Detection: A Prospective Study'. The Journal of Urology Lee, DJ, Ahmed HU et al (2014) “Multiparametric Magnetic Resonance Imaging in the Management and Diagnosis of Prostate Cancer: Current Applications and Strategies” Curr Urol Rep Have all associated interventions been adequately captured in the flowchart? q Yes þ No If not, please move any misplaced interventions, remove any superfluous intervention, or suggest any missing interventions to indicate how they should be captured on the flowcharts. Please explain the rationale behind each of your modifications. Whilst the Draft Protocol states the follow up protocols for low risk cancer and negative biopsy groups are based on the guidelines in NICE (2014), as presently drafted the flowchart does not capture all of the NICE Guidelines in relation to active surveillance. The NICE Guidelines at p. 173 state “If there is concern about clinical or PSA changes at any time during active surveillance, reassess with multiparametric MRI and/or rebiopsy”. The box “Active Surveillance” contained in the flowchart should be amended to reflect the NICE Guidelines in this regard. ADDITIONAL QUESTIONS SPECIFIC TO THIS PROPOSAL Active Surveillance (defined as a surveillance programme for patients who have been previously diagnosed with prostate cancer which is regarded as low-risk and unlikely to be fatal) Is the active surveillance population sufficiently clinically distinct to warrant its own algorithm? If so, what should that algorithm look like?This question is not directed to consumers. Test Negative Follow-up Preliminary feedback raised concerns about appropriate care following a likely false negative mpMRI (PIRADS 1 or 2, done before a biopsy). In your clinical experience, which indicators would raise an high degree of suspicion of a false negative (i.e. the patient did have significant cancer) and what follow-up options would ensure appropriate care? This question is not directed to consumers. Conversely, following a likely true negative mpMRI (PIRADS 1 or 2, done before a biopsy), the current proposal does not clearly identify when an healthy patient can be discharged to primary care. In your clinical experience, which indicators would support a patient’s return to primary care? This question is not directed to consumers. ADDITIONAL COMMENTS Do you have any additional comments on the proposed interventions and/or medical condition (disease) relating to the proposed interventions? Forms of prostate cancer that produce little PSA We suggest that the statement in the draft Protocol that “Currently in Australia, the signs of prostate cancer are detected with a prostate-specific antigen test (PSA test) and/or a digital rectal examination (DRE)” is incomplete. The Draft Protocol should also cover forms of prostate cancer (eg small cell neuroendocrine phenotype) that produce little PSA. In these forms of prostate cancer, the cancer may be first detected by presenting symptoms, combined with blood tests for neuroendocrine factors such as serum chromogranin A (CgA). Descriptors of the new MBS items and the existing items should correspond The proposed descriptors of the new MBS items ( multiparametric MRI (mpMRI) scans of the prostate, and MR-guided prostate biopsy in men ) will be used in similar situations to the existing MBS items for ultrasound scans of the prostate and ultrasound-guided biopsy of the prostate. The descriptors of the existing MBS items do not make any reference to particular symptoms of prostate cancer (such as PSA level, PSA doubling time and results of DRE) but apply where “a specialist in urology, radiation oncology or medical oncology or a consultant physician in medical oncology....has......recommended the scan for the management of the patient's current prostatic disease”. We submit a similar wording should be used for the proposed descriptors of the MBS items for mpMRI scans of the prostate, namely: “Multiparametric Magnetic Resonance Imaging (mpMRI) scan of the prostate, using a standardised image acquisition protocol involving T2 weighted imaging, Diffusion Weighted Imaging, and Dynamic Contrast Enhancement on a patient who has been assessed by a specialist in urology, radiation oncology or medical oncology or a consultant physician in medical oncology who has:(i) examined the patient in the 60 days prior to the scan; and (ii) recommended the scan for the management of the patient's current prostatic disease.” Anaesthesia and patient comfort We note the statement in the Draft Protocol that “Applicant advises that MRGB does not require anaesthesia or hospital admission”. In the past ultrasound-guided biopsies of the prostate were done without anaesthesia. In recent years most ultrasound-guided biopsies of the prostate are done with anaesthesia for reasons of patient comfort. As it is intended that the proposed new MBS items (Magnetic Resonance Imaging-guided prostate biopsy) will be used in similar situations to the existing MBS item for ultrasound-guided biopsy of the prostate, we submit that the proposed MBS item descriptors for Magnetic Resonance Imaging-guided prostate biopsy should be amended to include: “Multiple services rule. (Anaes.) (Assist.)” If the proposed MBS item descriptors are not amended in this manner, patients faced with a choice of a TRUS biopsy with anaesthesia or a MRI-guided biopsy without anaesthesia may choose, for reasons of comfort, the less efficient intervention resulting in greater public health care costs in the longer term. Rebates for MRI will not increase PSA testing We believe that PSAC’s concern (that the availability of rebates for mpMRI prostate scans may increase the number of patients choosing to have regular PSA testing) is unfounded. Do you have any comments on this feedback form and process? Please provide comments or suggestions on how this process could be improved. We appreciate this opportunity to provide feedback. In terms of process improvement: the process would be more efficient if people could type their responses directly into an online form and, on completion of the online form, submit the completed form by pressing a “Submit” button; and there is also scope to make the form more user-friendly for consumers and carers (for example, although Question 5 of the form contemplates that the responder to the feedback survey form need not be a medical professional, the language of certain questions implicitly assumes that the responder giving feedback is a medical professional). Thank you again for taking the time to provide your valuable feedback. If you experience any problems completing this on-line survey please contact the HTA Team Phone 02 6289 7550 Postal: MDP 853 GPO 9848 Canberra ACT 2601 Fax: 02 6289 3561 Email: HTA@health.gov.au Link to comment Share on other sites More sharing options...
This topic is now archived and is closed to further replies.