Tumor Treatment Field Therapy Contractor Advisory Committee Key Questions

For each Key Question, please use the following scale identifying your level of confidence with a score of 1 being low or no confidence and 5 representing high confidence.

1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

For all questions posed below, the term "newly diagnosed glioblastoma multiforme" and the use of Tumor Treatment Fields Therapy refers to patients who receive Tumor Treatment Field Therapy (TTFT) as an adjuvant modality following initial treatment with debulking surgery or biopsy, followed by chemoradiation with concomitant temozolomide and radiotherapy.

How confident are you that there is sufficient evidence to determine that TTFT for newly diagnosed GBM can provide net positive health outcomes in the Medicare-eligible population?
1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

  • Discussion questions:
    • Discuss the impact, if any, of TTFT on:
      • Progression-free survival (PFS)
      • Overall survival (OS)
      • Quality of Life (QoL)
    • What are the strengths and weaknesses of the available evidence supporting positive health outcomes?
    • Have a statistically-significant number of Medicare-eligible patients with newly diagnosed GBM been studied to draw conclusions about the health outcomes associated with TTFT?

How confident are you that the available evidence demonstrates adequate predictors of success in Medicare-eligible population?
1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

  • Discussion question:
    • Discuss the impact of each of the following predictors of success and the correspondent strength of evidence:
      • Tumor methylation status
      • Karnofsky Performance Score (KPS)
      • Adjuvant chemotherapeutic regimens, including optimal #cycles
      • Adherence to therapy (e.g., TTFT wear schedule)
      • Others?

How confident are you that TTFT is generally accepted by the medical community for newly diagnosed GBM?
1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

  • Discussion question:
    • What factors support your assessment that TTFT does, or does not, have acceptance by the medical community for newly diagnosed GBM in the Medicare-eligible population?

How confident are you that scientific evidence supports mitotic spindle disruption and cellular apoptosis as the mechanism of action of TTFT?
1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

  • Discussion question:
    • Is the mechanism of action sufficiently accepted in the basic science literature?

How confident are you that there are no significant evidence gaps that may impact positive health outcomes in the Medicare-eligible population?
1      -      2      -      3      -      4     -      5
Low                 Intermediate                 High
Confidence                                         Confidence

  • Discussion question:
    • Are there evidence gaps that impact the important health outcomes in the Medicare-eligible population?
    • If there are evidence gaps, what evidence gaps require additional study?
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