HERC Coverage Guidance Advanced Imaging for Staging of Prostate Cancer Disposition of Public Comments

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1 Table of Contents Commenters... 1 Public Comments... 2 References Provided by Commenters... 6 Commenters Identification Stakeholder A Medical Imaging & Technology Alliance (MITA), Arlington, VA [Submitted October, 27, 2014] Page 1

2 Public Comments A 1 The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the Oregon Health Evidence Review Commission (HERC) Draft Guidance for advanced imaging in staging of prostate cancer. Specifically, MITA would like to address the draft guidance that PET imaging is not recommended for coverage in prostate cancer. 2 As the leading trade association representing medical imaging, radiotherapy, and radiopharmaceutical manufacturers, MITA has in-depth knowledge of the significant benefits to the health of Americans that medical imaging and radiotherapy provide. 3 With regards to prostate cancer, PET is a powerful, noninvasive tool that can be useful in the restaging and treatment planning process for prostate cancer to help determine whether it has spread to the lymph nodes or other parts of the body. Other imaging technologies, such as magnetic resonance imaging (MRI) and computed tomography (CT), are often unable to detect prostate cancer cells that have spread to lymph nodes or soft tissue in other parts of the body. 4 Both the Centers for Medicare and Medicaid Services (CMS) and the National Comprehensive Cancer Network (NCCN) recognize the value of the PET to assist in the restaging and monitoring of therapy in patients with prostate cancer. At the national level, CMS covers F-18 FDG-PET imaging for subsequent treatment strategy in prostate cancer patients as well as F-18 sodium fluoride for radionuclide bone scanning through the Coverage with Evidence Development (CED) process 1. In addition, where C-11 choline-pet imaging is available, it can be covered by local Medicare Administrative Contractors 1. Thank you for taking the time to comment. Thank you for letting us know who and what you represent. No citations provided to support this assertion. Assuming the commenter is referring only to restaging, PET is not discussed in the NICE guidance. For initial staging, the NICE guidance notes that FDG-PET does not reliably show primary prostate cancer, because of the relatively low metabolic activity in tumors which are slow-growing and because the radiopharmaceutical agent accumulates in the bladder, obscuring the prostate. The reference provided does not include clinical rationale for the CMS decision to allow coverage of FDG-PET for restaging (subsequent treatment strategy), or use of F-18 sodium fluoride PET under the Coverage with Evidence Development program. It does not mention C-11 choline PET. The HTAS makes its decisions based on evidence of effectiveness and harms, not on Page 2

3 5 The NCCN guidelines for prostate cancer suggest F-18 sodium fluoride-pet scanning to evaluate for bone metastases in patients at high risk of bone metastases at initial staging or when PSA is detectable or rising after prostatectomy. While additional data on the utility of F-18 FDG-PET and C-11 choline-pet is limited, the NCCN guidelines suggest that it can be useful for certain patients 2. As such, patients with prostate cancer should not be restricted from access to PET imaging where it may be clinically appropriate. the basis of other payers coverage policies. NCCN guidelines make the following recommendations: PET/CT using choline tracers may identify sites of metastatic disease in men with biochemical recurrence after primary treatment failure. Other choline radiotracers are under evaluation. Further study is needed to determine the best use of choline PET/CT imaging in men with prostate cancer. Oncologic PET/CT is performed typically using [FDG] In certain clinical settings, the use of FDG-PET/CT may provide useful information, but FDG- PET/CT should not be used routinely since data on the utility of FDG-PET/CT in patients with prostate cancer is limited. This is a category 2A recommendation: Based on lower level evidence, there is uniform NCCN consensus that Page 3

4 the intervention is appropriate. References supporting the text statements are from 2006 and The 2006 reference was published before the date of the NICE guideline (last search date May 2013). The HTAS bases their guidance documents on reviews of the literature that utilize the highest standards of evidence based medicine. Studies are included or excluded based on transparent, reproducible criteria; therefore the HTAS does not investigate individual studies. The HTAS assumes that the conclusions reached by the authors of these reviews weigh all the available evidence in accordance with the principles of evidence based medicine, and does not attempt to re-review the entire body of evidence to reach its own conclusions. The 2013 reference is a SR of 11C-choline and 18 flourocholine PET. The authors conclude the following: PET and PET/CT imaging with 11C-choline and 18F-fluorocholine in restaging of patients with biochemical failure after local Page 4

5 6 In consideration of the unique role that PET can play in the staging and treatment of a prostate cancer patient, we strongly recommend that you reconsider your draft guidance and instead recommend coverage for PET imaging in prostate cancer. MITA appreciates this opportunity to comment and would be pleased to answer any questions you have. treatment for PCa might help guide further treatment decisions. In staging of patients with proven but untreated, highrisk PCa, there is limited but promising evidence warranting further studies. However, the current evidence shows crucial limitations in terms of its applicability in common clinical scenarios. For HTAS discussion Page 5

6 References Provided by Commenters Commenter References 1 CMS National Coverage Determinations Manual 2 National Comprehensive Cancer Network Guidelines Page 6