Anthem Blue Cross Connecticut CG-DME-44 Electric Tumor Treatment Field (TTF) Form

This document addresses the use of electrical field therapy known as tumor treatment fields (TTF). TTF therapy is created by low-intensity, intermediate frequency (100–200 kilohertz [kHz]) electric currents delivered to the malignant tumor site by insulated electrodes placed on the skin surface. TTF therapy causes tumor cell death (apoptosis) by disrupting the assembly of microtubules during later stages of cell division.

Clinical Indications

Medically Necessary:

TTF therapy is considered medically necessary when criteria A, B and C are all met:

1. An FDA approved device is used; and
2. Tumor being treated is a histologically-confirmed supratentorial glioblastoma (known also as glioblastoma multiforme [GBM] or World Health Organization [WHO] grade IV astrocytoma); and
3. Either criteria 1 or 2 are met:
   1. Newly diagnosed GBM when all the following criteria are met:
      1. Initial treatment with debulking surgery or biopsy followed by chemoradiation with concomitant temozolomide and radiotherapy has been completed with no documented tumor progression*; and
      2. TTF is used in combination with temozolomide; and
      3. Individual has Karnofsky Performance Status (KPS) score of 70 or higher or Eastern Cooperative Oncology Group (ECOG) performance status 0-1; and
      4. Individual or caregiver has been trained and is willing and able to apply and use the device at least 18 hours, per day on average. 
         or
   2. Recurrent GBM when all the following criteria are met:
      1. TTF is used as a monotherapy; and
      2. Individual has KPS score of 70 or higher or ECOG performance status 0-1; and
      3. Individual or caregiver has been trained and is willing and able to apply and use the device at least 18 hours, per day, on average.

Continuation of TTF therapy beyond the initial 90 days is considered medically necessary when both of the following criteria are met:

1. Documentation of compliant use must be reported every 90 days as evidenced by the device monitor report showing the individual is using the device at least 18 hours per day, on average; and
2. There is no documented tumor progression*, defined as at least one of the following:
   1. Tumor growth of greater than 25% of the product of 2 perpendicular diameters compared to the smallest tumor area measured; or
   2. Appearance of one or more new tumors in the brain (diagnosed radiologically as GBM).

*See discussion section regarding tumor progression.

Not Medically Necessary:

The use of devices to generate electric tumor treatment fields (TTF) is considered not medically necessary when the criteria above are not met and for all other malignant tumors.

The use of enhanced computer treatment planning software (such as NovoTal) is considered not medically necessary in all cases.