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Date Printed: December 17, 2017: 04:28 PM

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02-61000-10

Original Effective Date: 10/15/15

Reviewed: 03/23/17

Revised: 04/15/17

Subject: Tumor Treatment Fields Therapy for Glioblastoma

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Glioblastomas, also known as glioblastoma multiforme (GBM), are the most common form of malignant primary brain tumor in adults. They comprise approximately 15% of all brain and central nervous system tumors and more than 50% of all tumors that arise from glial cells. The peak incidence for GBM occurs between the ages of 45 and 70 years. GBMs are grade IV astrocytomas, and are often resistant to standard chemotherapy.

The primary treatment for GBM is debulking surgery to remove as much of the tumor as possible. At that time, some individuals may undergo implantation of the tumor cavity with a carmustine (bischloroethylnitrosourea [BCNU])‒impregnated wafer. Depending on the individual’s physical condition, adjuvant radiotherapy, chemotherapy (typically temozolomide), or a combination of the 2 are sometimes given. After adjuvant therapy, some may undergo maintenance therapy with temozolomide.

No standard treatment exists for recurrent GBM. In those with disease that recurs after these initial therapies, additional debulking surgery may be used if recurrence is localized. Other treatment options for recurrent disease include various forms of systemic medications such as bevacizumab, bevacizumab plus chemotherapy (eg, irinotecan, BCNU/chloroethylnitrosourea [CCNU], temozolomide), temozolomide, nitrosourea, PCV (procarbazine, CCNU, vincristine), cyclophosphamide, and platinum-based agents. External beam radiotherapy (EBRT) also may be used to treat recurrent GBM. Response rates in recurrent disease are less than 10%, and progression-free survival rates at 6 months are less than 20%.

TTF therapy is a noninvasive technology that is intended to treat GBM on an outpatient basis using electrical fields. TTF therapy exposes cancer cells to alternating electric fields of low intensity and intermediate frequency, which are purported to both selectively inhibit tumor growth and reduce tumor angiogenesis. TTF are proposed to inhibit rapidly dividing tumor cells by 2 mechanisms, arrest of cell proliferation and destruction of cells while undergoing division.

TTF therapy via the Optune™ (formerly NovoTTF-100A System) System is delivered by a battery-powered, portable device that generates the fields via disposable electrodes that are noninvasively attached to the individual’s shaved scalp over the site of the tumor. The device is used by the individual at home on a continuous basis for the duration of treatment, which can last for several months. The device is carried in a backpack or shoulder pack while carrying out activities of daily living.

REGULATORY STATUS

The Optune™ (formerly NovoTTF-100A System) System was approved by the FDA in April 2011, as a stand-alone treatment for adults age 22 years or older with confirmed GBM that recurs or progresses after surgical and radiation options have been exhausted. On October 5, 2015 the FDA granted approval for use of Optune™ in combination with temozolomide to treat adults age 22 years or older with newly diagnosed, supratentorial GBM after maximal debulking surgery and completion of radiation therapy, together with concomitant standard of care chemotherapy.

POSITION STATEMENT:

The use of tumor treatment fields therapy (TTF) to treat glioblastoma meets the definition of medical necessity when ALL of the following criteria are met:

The device is FDA approved

Age 22 or older

There is histologically-confirmed supratentorial glioblastoma (also known as glioblastoma multiforme [GBM] or World Health Organization [WHO] grade IV astrocytoma)

Initial treatment with debulking surgery or biopsy followed by chemoradiation with concomitant temozolomide and radiotherapy has been completed, with no documented tumor progression*

TTF is used in combination with temozolomide

Karnofsky Performance Status score of 70 or higher, OR Eastern Cooperative Oncology Group (ECOG) performance status 0-1

* Progression is defined as tumor growth greater than 25% compared to smallest measured tumor area, or the appearance of one or more new GBM lesions in the brain.

The use of tumor treatment fields therapy (TTF) to treat glioblastoma recurrence meets the definition of medical necessity when ALL of the following criteria are met:

The device is FDA approved

Age 22 or older

There is histologically-confirmed recurrence of supratentorial glioblastoma (also known as glioblastoma multiforme [GBM] or World Health Organization [WHO] grade IV astrocytoma) following treatment with chemotherapy and/or radiation

TTF is used as monotherapy

The use of tumor treatment fields therapy (TTF) for all other indications is considered experimental or investigational. There is insufficient clinical evidence in the peer-reviewed literature on this technology to support its safety, effectiveness, and long term effects on net health outcomes for other types of cancer.

BILLING/CODING INFORMATION:

HCPCS Coding

A4555

Electrode/transducer for use with electrical stimulation device, used for cancer treatment, replacement only

E0766

Electrical stimulation device, used for cancer treatment, includes all accessories, any type

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Tumor Treatment Field Therapy (TTFT) (L34823), located at cgsmedicare.com

DEFINITIONS:

Eastern Cooperative Oncology Group (ECOG) Performance Status:

A scale used to determine an individual's level of functioning:

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited self-care, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

5

Dead

Karnofsky Performance Status Score:

A scale used by healthcare providers to quickly evaluate how an individual is feeling on any given day:

100

Normal, no complaints

90

Able to carry on normal activities. Minor signs or symptoms of disease

80

Normal activity with effort

70

Care for self. Unable to carry on normal activity or to do active work

60

Requires occasional assistance, but able to care for most of his needs

50

Requires considerable assistance and frequent medical care

40

Disabled. Requires special care and assistance

30

Severly disabled. Hospitalisation indicated though death nonimminent

20

Very sick. Hospitalisation necessary. Active supportive treatment necessary

10

Moribund

0

Dead

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. NGC:010488, The role of targeted therapies in the management of progressive glioblastoma: a systematic review and evidence-based clinical practice guideline. American Association of Neurological Surgeons - Medical Specialty Society; Congress of Neurological Surgeons. July 2014.
  2. Ansstas G, Tran DD. Treatment with Tumor-Treating Fields Therapy and Pulse Dose Bevacizumab in Patients with Bevacizumab-Refractory Recurrent Glioblastoma: A Case Series. Case Rep Neurol. 2016 Jan 8;8(1):1-9.
  3. BlueCross BlueShield Association Medical Policy Reference Manual. Policy 1.01.29, Tumor-Treatment Fields Therapy for Glioblastoma (August 2016).
  4. ClinicalTrials.gov. NCT00916409. A Prospective, Multi-center Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM. Accessed 09/10/15.
  5. ClinicalTrials.gov. NCT01894061. A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma. Accessed 09/10/15.
  6. ClinicalTrials.gov. NCT01755624. A Phase II Randomized Study of TTField Therapy Versus Supportive Care in Non-small Cell Lung Cancer Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment. Accessed 09/10/15.
  7. ClinicalTrials.gov. NCT01756729. A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient. Accessed 09/10/15.
  8. ClinicalTrials.gov. NCT01954576. A Phase II Study of the NovoTTF-100A system, Enhanced by Genomic Analysis to Identify the Genetic Signature of Response in the Treatment of Recurrent Glioblastoma Multiforme. Accessed 09/10/15.
  9. Davis ME. Glioblastoma: Overview of Disease and Treatment. Clin J Oncol Nurs. 2016 Oct 1;20(5):S2-8.
  10. Hottinger AF, Pacheco P, Stupp R. Tumor treating fields: a novel treatment modality and its use in brain tumors. Neuro Oncol. 2016 Oct;18(10):1338-49.
  11. Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators.Post Hoc Analyses of Intention-to-Treat Population in Phase III Comparison of NovoTTF-100A™ System Versus Best Physician's Choice Chemotherapy. Semin Oncol. 2014 Oct;41 Suppl 6:S25-34.
  12. Kim EH, Song HS, Yoo SH, Yoon M. Tumor treating fields inhibit glioblastoma cell migration, invasion and angiogenesis. Oncotarget. 2016 Aug 18.
  13. Medicare Region C DMERC Local Coverage Article: Tumor Treatment Field Therapy (TTFT) – Policy Article A52667 – Effective August 2014.
  14. Medicare Region C DMERC Local Coverage Determination for Tumor Treatment Field Therapy (TTFT) (L34665) (effective August 1, 2014). (Retired 09/30/15).
  15. Medicare Region C DMERC Local Coverage Determination for Tumor Treatment Field Therapy (TTFT) (L34823) (10/01/15).
  16. Mrugala MM, Engelhard HH, Dinh Tran D, et al. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. Oct 2014;41 Suppl 6:S4-S13.
  17. National Cancer Institute (NCI). Adult Central Nervous System Tumors Treatment (PDQ®). Treatment of Primary Central Nervous System Tumors by Tumor Type. Accessed at https://www.cancer.gov/types/brain/hp/adult-brain-treatment-pdq#section/_792. (Last updated January 27, 2016).
  18. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers V1.2015. Accessed at http://www.nccn.org/professionals/physician_gls/pdf/cns.pdf.
  19. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Central Nervous System Cancers V1.2016. Accessed at https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf.
  20. National Institute for Health and Care Excellence. NICE interventional procedures list: TTF for glioblastoma multiforme (851 / 1). Accessed at https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-interventional-procedures-guidance/ip-list.
  21. Saria MG, Kesari S. Efficacy and Safety of Treating Glioblastoma With Tumor-Treating Fields Therapy. Clin J Oncol Nurs. 2016 Oct 1;20(5):S9-S13.
  22. Schwartz MA, Onuselogu L. Rationale and Background on Tumor-Treating Fields for Glioblastoma. Clin J Oncol Nurs. 2016 Oct 1;20(5):S20-4.
  23. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: A randomized phase III trial of a novel treatment modality. Eur J Cancer. 2012;48:2192-2202.
  24. Swanson KD, Lok E, Wong ET. An Overview of Alternating Electric Fields Therapy (NovoTTF Therapy) for the Treatment of Malignant Glioma. Curr Neurol Neurosci Rep. 2016 Jan;16(1):8.
  25. Trusheim J, Dunbar E, Battiste J, Iwamoto F, Mohile N, Damek D, Bota DA, Connelly J. A state-of-the-art review and guidelines for tumor treating fields treatment planning and patient follow-up in glioblastoma. CNS Oncol. 2016 Sep 15.
  26. Turner SG, Gergel T, Wu H, Lacroix M, Toms SA. The effect of field strength on glioblastoma multiforme response in patients treated with theNovoTTF™-100A system. World J Surg Oncol. 2014.
  27. Tuszynski JA , et al. An Overview of Sub-Cellular Mechanisms Involved in the Action of TTFields. Int J Environ Res Public Health. 2016 Nov 12;13(11).
  28. U.S. Food and Drug Administration (FDA). Tumor treatment fields. NovoTTF-10A System. Summary of safety and effectiveness data (SSED). Premarket Approval Application (PMA) No. P100034. 2011. Accessed at http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100034b.pdf.
  29. Wenger C, Salvador R, Basser PJ, Miranda PC. Improving Tumor Treating Fields Treatment Efficacy in Patients With Glioblastoma Using Personalized Array Layouts. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1137-43.
  30. Wenger C, Salvador R, Basser PJ, Miranda PC. The electric field distribution in the brain during TTFields therapy and its dependence on tissue dielectric properties and anatomy: a computational study. Phys Med Biol. 2015 Sep 21;60(18):7339-57.
  31. Wong ET, Lok E, Swanson KD Clinical benefit in recurrent glioblastoma from adjuvant NovoTTF-100A and TCCC after temozolomide and bevacizumab failure: a preliminary observation. Cancer Med. 2015 Mar;4(3):383-91.
  32. Wong ET, Lok E, Swanson KD, Gautam S, Engelhard HH, Lieberman F, Taillibert S, Ram Z, Villano JL. Response assessment of NovoTTF-100A versus best physician's choice chemotherapy in recurrent glioblastoma. Cancer Med. 2014 Jun;3(3):592-602.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/23/17.

GUIDELINE UPDATE INFORMATION:

10/15/15

New Medical Coverage Guideline.

04/15/17

Scheduled review. Revised Description section. Added coverage criteria for TTF therapy. Revised Program Exceptions section and Definitions section. Updated references.

Date Printed: December 17, 2017: 04:28 PM