LCD Reference Article Response To Comments Article

Response to Comments: MolDX: MGMT Promoter Methylation Analysis (DL37001).

A55535

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A55535

Article Title
Response to Comments: MolDX: MGMT Promoter Methylation Analysis (DL37001).

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Response to Comments

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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) MolDX: MGMT Promoter Methylation Analysis (DL37001). Thank you for the comments.

Response To Comments

Number	Comment	Response
1	I am an anatomical/clinical and molecular pathologist who has expertise in MGMT methylation testing in primary CNS lymphomas. The qualifying tumor types (high grade gliomas- glioblastoma multiforme, anaplastic astrocytoma) should be the main and only criteria for coverage similar to the LCD for 1p/19q Deletion testing.	Agree that glioblastoma multiforme/anaplastic astrocytoma is the main criteria for coverage of this assay.
2	I have spoken to two of our neurooncologists and neurosurgeons about the second criteria. If a physician must certify that a patient is able to tolerate temozolomide or Radiation therapy before ordering the test, it will be difficult to assess performance status in the post-op period. Requiring a physician to wait to document this status before ordering the test will unnecessarily delay medical care. The usual standard of medical care is to order a needed adjunctive test immediately after the diagnosis of any tumor so that the test result is available when the patient is in the appropriate condition to be able to give consent for therapy. The documentation criteria should be dropped.	Clinical documentation of medical necessity is a central requirement for Medicare. Furthermore, if a physician does not intend to use the results of a test to benefit a given patient, the physician should not order the test. In this case, if the co-morbidities of a patient is such that the patient is not likely to tolerate temozolmide (TMZ) or RT, then the test should not be ordered. The performance status and willingness of an elderly patient to tolerate any therapy or their preference is not known until the post-operative recovery is known. It is inappropriate to test prematurely when a considerable number of patients may not wish any therapy. Furthermore, in the only randomized study restricted to elderly patients, there was a 30% drop out before any therapy, which may be even greater in the community setting. Wick W, Platten M, Meisner C, et al. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: The NOA-08 Randomised, Phase 3 Trial. The Lancet Oncology 13(7): 707–15. doi:10.1016/S1470-2045(12)70164-X.
3	The usage of the test to decide between therapies is agreed upon by physicians as part of the usual standard of care for gliomas (NCCN Guideline on CNS Cancers 2016). However, to require documentation on how a test will be used is an onerous and unnecessary precedent for denial of coverage, a documentation task for which there is no medical literature that such documentation adds anything to the performance of proper medical care. The documentation criteria should be dropped.	Clinical documentation of medical necessity is a central requirement for Medicare. Furthermore, if a physician does not intend to use the results of a test to benefit a given patient, the physician should not order the test. In this case, if the co-morbidities of a patient as such that the patient is not likely to tolerate temozolmide or RT, then the test should not be ordered. Randomized studies have shown that methylation status predicts greater benefit for TMZ than hypofractionated radiation or standard radiotherapy. Therefore, if the physician is not going to use the test result correctly, why order it in patients unable to tolerate therapy. Given the cost of the drug, the correct patients should be selected when used as monotherapy. Wick W, Platten M, Meisner C, et al. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. The Lancet Oncology 13(7): 707–15. doi:10.1016/S1470-2045(12)70164-X. Malmström A, Grønberg BH, Marosi C, et al. Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. The Lancet Oncology 13(9): 916–26. doi:10.1016/S1470-2045(12)70265-6.
4	In addition to the usage in #3, physicians also use MGMT results to help evaluate for the effect of pseudoprogression that is observed on MRI results within 90 days of the end of chemoradiation. Pseudoprogression occurs more frequently (91%) in tumors that are methylated. Thus, the LCD should state it is good to do MGMT methylation testing on all patients at the time of a diagnosis of glioma.	The policy is not intended for patients undergoing combined modality therapy where pseudoprogression is much more common. It is only intended to help in the selection of monotherapy in patients over the age of 70. The commenter is correct that pseudoprogression is more common in methylated patients, but it is not uncommon (41%) in unmethylated patients. It is unclear how this test when used for pseudoprogression helps in management or diagnosis. There have been developments in imaging that more clearly separate true progression from pseudoprogression, attesting to the fact that patients should seek out specialized neurooncological groups with the imaging capabilities.
5	Background section: The LCD address usefulness of MGMT methylation testing in patients > than 70 years of age in the text. However, the 2016 NCCN guideline on CNS Cancers (See attached on page GLIO-4) also address the usefulness in patients <70 years of age with good performance status (See attached- Brandes et al. MGMT promoter methylation status can predict the incidence and outcome of pseudoprogression after concomitant radiochemotherapy in newly diagnosed glioblastoma patients. JCO 2008:2192-2197). The LCD should incorporate this information as well.	The policy is not a comprehensive review of the literature. The content of the policy provides information that is used to make a coverage decision. The addition of MGMT usefulness in patients <70 years of age does not impact or change the coverage decision. The policy will not be changed. The NCCN recommendation in patients undergoing combined therapy in patients under 70 is not a class 1 recommendation; but rather, it is consensus. It does not change therapy. If the patient is unmethylated and can tolerate combined therapy, are you not going to give them standard of care, and maybe even offer them TTF? See: Hegi ME, Diserens AC Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in Glioblastoma. NEJM 2005;352:997-1003.
6	I concur that pyrosequencing is the best methodology for quantitative assessment of MGMT methylation status.	Comment noted.
7	First, we thank you for your decision to cover MGMT Promoter Methylation Analysis under limited circumstances. We agree with your determination that this test is medically necessary, but believe that a certain critical clinical indication, namely the conundrum of tumor pseudo-progression, as detailed below, has been overlooked. The neuro-oncology community has recently come to recognize the concept of pseudo-progression in the treatment course of high grade gliomas. In particular, pseudo-progression is a radiographically-identified, apparent post-treatment disease progression followed by subsequent improvement or stabilization without any additional treatment. Pseudo-progression is a transient phenomenon that likely represents a local tissue reaction to the therapy, and its presence has actually been shown to improve overall survival (DaCruz LCH Am J Neuroradiol 32:1978 – 85, 2011). Pseudo-progression is, therefore, a radiographic mimic of true tumor-specific disease progression and its distinction is thus critical, given that the best treatment option for pseudo-progression is to continue the current therapy, while a different glioma therapy is the best treatment option for true disease progression. Current radiographic imaging methods cannot distinguish (DaCruz LCH Am J Neuroradiol 32:1978 – 85, 2011) these two disparate diagnoses with radically different treatment ramifications, and a brain biopsy is the classic option to distinguish these two conditions. However, it has recently been determined that gliomas with MGMT promoter methylation have a significantly higher prevalence of pseudo-progression than non- methylated tumors (Brandes J Clin Oncol 26:2192-2197, 2008). In this study, 91% of patients whose original biopsies demonstrated methylated MGMT had pseudo-progression (versus 41% of patients without methylated MGMT, P = .0002), and were best managed by continuing the current therapy. The retrospective determination of MGMT promoter methylation status in the pre-treated, original biopsies can be critical in the distinction of this post-treatment effect in patients with imaging consistent with progression/pseudo-progression to ensure that effective therapies are not inappropriately terminated under the false assumption of disease progression (versus the alternative diagnosis of transient good-prognosis pseudo-progression). It is also critical in true recurrence/tumor progression that these new biopsies of treated tumors be retested for MGMT methylation status as methylation of MGMT in tumor cells renders these cells sensitive to alkylating chemotherapy. Often, but not always, recurrent tumors will exhibit altered methylation status with significant implications for therapeutic decision making (Brandes AA, et el., Neuro Oncol. 2010 Mar;12(3):283-8.). Request: We request that MGMT testing be covered for all glioma patients, including retrospective testing of MGMT status in patients with a post-treatment imaging study suggesting progression/pseudo-progression and that any ICD-10 codes relating to this progression or pseudoprogression be added to this policy to cover both retrospective (new) testing of the original biopsies and retesting of recurrent tumors.	Gliomas include a variety of tumor including, but not limited to, ependymomas, astrocytomas, oligdendrogliomas, optic nerve gliomas and other mixed gliomas. MGMT testing is indicated for high grade gliomas-glioblastoma multiforme/anaplastic astrocytoma (GM/AA). Consequently, the policy will not be changed to include all glioma patients. MGMT testing is limited to once in a lifetime. If testing is performed at the time of initial diagnosis, repeat testing to rule in/out pseudoprogression is not indicated. If testing was not performed at initial GM/AA diagnosis, retrospective testing may be indicated. In the rare situation that repeat testing is medically indicated, a denied claim can be appealed with supporting documentation of medical necessity in the patient’s medical record. It is unclear how given the 41% incidence of unmethylated cases showing pseudoprogressin, how this result would be used clinically. No guidelines suggest this test should be used for the management of pseudoprogression. Consequently, MGMT testing is not indicated to make therapeutic decisions in patients receiving combined modality therapy with it high incidence of pseudoprogression. The following review of the management (figure 1 in article) of pseudoprogression does it mention use of this biomarker. Parvez K, Parvez A, and Zadeh G. the diagnosis and treatment of pseudoprogression, radiation necrosis and brain tumor recurrence. International Journal of Molecular Sciences 2014;15(7): 11832–46. doi:10.3390/ijms150711832. The evidence regarding retesting a recurrent tumor that has become methylated, and therefore, responsive to alkylators, is derived from a single publication involving 44 patients. The greater change was to an unmethylated state which would have no bearing on alkylator response. Note, no prospective predictive data was provided for the recurrent stage. Evidence for retesting recurrent tumor is insufficient. Summary: The policy will remain unchanged.

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Associated Documents

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LCDs
L37001 - MolDX: MGMT Promoter Methylation Analysis

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