Coverage Policy Manual
Policy #: 1997027
Category: Radiology
Initiated: January 1995
Last Review: October 2018
  Boron Neutron Capture Therapy

Description: Boron neutron capture therapy is a technology that attempts to use locally delivered, low-energy neutrons targeted against specific tumors, particularly glioblastoma multiforme and metastatic melanoma to the brain.  Boron-containing compounds must be used as conjugates in this process.  It is possible to synthesize a large number of boron compounds and conjugate them to tumor-seeking macromolecules, such as monoclonal antibodies or different polypeptides.  The success of boron neutron capture therapy as a tumoricidal modality is dependent on the delivery of a sufficient quantity of boron and low-energy thermal neutrons to individual cancer cells to sustain a lethal reaction.

Boron neutron capture therapy has not been shown to be as effective as other radiation therapy modalities in the treatment of glioblastoma multiforme or metastatic melanoma to the brain.

Boron Neutron Capture Synovectomy (BNCS) is a new approach to treating rheumatoid arthritis being developed by researchers at The Michigan Institute of Technology (MIT).  Rheumatoid arthritis is characterized by inflammation of the synovium (the inner layer of the joint).  Current treatment for rheumatoid arthritis is treatment with anti-inflammatory medications or surgery.  BNCS would involve injecting boron into the joint followed by neutron irradiation of the joint (Gierga 2000).

There is no CPT code specifically describing this service.

Policy/
Coverage:
Boron neutron capture therapy for the treatment of any condition and boron neutron capture synovectomy for rheumatoid arthritis is not covered because it fails to meet the Primary Coverage Criteria of scientific evidence of effectiveness.
 
For contracts without Primary Coverage Criteria boron neutron capture therapy  for the treatment of any condition and boron neutron capture synovectomy for rheumatoid arthritis is considered investigational.

Rationale:
Boron Neutron Capture Therapy has been studied as a treatment for brain tumors since the 1950’s (Sweet 1997).  Clinical trials are currently being conducted on Boron Neutron Capture therapy in the treatment of various malignancies in the United States and abroad.  A search of the Medline database yielded no literature with evidence that Boron Neutron Capture Therapy is more effective than current therapies in the treatment of glioblastoma multiforme or any other conditions.
 
Boron Neutron Capture Synovectomy has also been studied but has not been proven in clinical trials to be a safe and effective treatment for rheumatoid arthritis.
 
2010 Update
A review of the literature has been conducted through August 2010.  There was no new literature identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.  
 
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below
 
Kageji and colleagues performed a study with the purpose of to evaluate the clinical outcome of boron neutron capture therapy (BNCT) and conventional treatment in patients with newly diagnosed glioblastoma (Kageji, 2014). Since 1998 we treated 23 newly-diagosed GBM patients with BNCT without any additional chemotherapy. Their median survival time was 19.5 months; the 2-, 3-, and 5-year survival rates were 31.8%, 22.7%, and 9.1%, respectively. The clinical results of BNCT in patients with GBM are similar to those of recent conventional treatments based on radiotherapy with concomitant and adjuvant temozolomide.
 
A paper was identified written by Farias and colleagues on Boron Neutron Capture Therapy (BNCT), a radiotherapy that combines biological targeting and high LET radiation, proposing a new approach to determine treatment plans, introducing the possibility to choose the irradiation start and duration to maximize the tumour dose (Farias, 2014). A Tumour Control Probability (TCP) suited for lung BNCT as well as other high dose radiotherapy schemes was also introduced.  It consists in the enrichment of tumour with 10B and in the successive irradiation of the target with low energy neutrons producing charged particles that mainly cause non-repairable damages to the cells. The feasibility to treat Non Small Cells Lung Cancer (NSCLC) with BNCT was explored. Treatment plans were evaluated in localized and disseminated lung tumours. Semi-ideal and real energy spectra beams were employed to assess the best energy range and the performance of non-tailored neutron sources for lung tumour treatments. The optimal neutron energy is within [500 eV-3 keV], lower than the 10 keV suggested for the treatment of deep-seated tumours in the brain. TCPs higher than 0.6 and up to 0.95 are obtained for all cases. Conclusions drawn from [Suzuki et al., Int Canc Conf J 1 (4) (2012) 235-238] supporting the feasibility of BNCT for shallow lung tumours are confirmed, however discussions favouring the treatment of deeper lesions and disseminated disease are also opened. Since BNCT gives the possibility to deliver a safe and potentially effective treatment for NSCLC, it can be considered a suitable alternative for patients with few or no treatment options.
  
The search of the Medline database yielded no literature with evidence that Boron Neutron Capture Therapy is more effective than current therapies in the treatment of glioblastoma multiforme or any other conditions; nor proven in clinical trials.
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
Aihara and colleagues conducted a study that summarizes the tumor responses and the acute and late adverse effects of BNCT in the treatment of patients with both recurrent and newly diagnosed T4 salivary gland carcinoma (Aihara, 2014). Two patients with recurrent cancer and 3 with newly diagnosed T4 advanced malignancy were registered between October 2003 and September 2007, with the approval of the medical ethics committees of Kawasaki Medical School and Kyoto University. BNCT was performed, in a single fraction using an epithermal beam, at Japan Research Reactor 4. All patients achieved a complete response within 6 months of treatment. The median duration of the complete response was 24.0 months; the median overall survival time was 32 months. Three of the 5 patients are still alive; the other 2 died of distant metastatic disease. Open biopsy of the parotid gland after BNCT was performed in 1 patient and revealed no residual viable cancer cells and no serious damage to the normal glandular system. Although mild alopecia, xerostomia, and fatigue occurred in all patients, there were no severe adverse effects of grade 3 or greater. Preliminary results demonstrate that BNCT is a potential curative therapy for patients with salivary gland carcinoma.
 
2017 Update
A search of the MEDLINE database through September 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

References: Ajhara T, Morita N, Kamitani N, et al.(2014) Boron neutron capture therapy for advanced salivary gland carcinoma in head and neck. Int J Clin Oncol. 2014;19(3):437-44

Barth FR, Soloway AH, Fairchild RG, et al.(1992) Boron neutron capture therapy for cancer. Cancer 1992; 70:2995-3007.

Barth RF, Coderre JA, Vicente MG, et al.(2005) Boron neutron capture therapy of cancer: current status and future prospects. Clin Cancer Res 2005;11(11):3987-4002.

Barth RF, Soloway AH.(1997) Boron neutron capture therapy of brain tumors-current status and future prospects. J NeuroOncol 1997; 33:3-7.

Carlsson J, Sjoberg S, Larsson BS.(1992) Present status of boron neutron capture therapy. Acta Oncol 1992; 31:803-813.

Farías RO, Bortolussi S, Menéndez PR et al.(2014) Exploring Boron Neutron Capture Therapy for non-small cell lung cancer. Phys Med. 2014 Aug 27. pii: S1120-1797(14)00506-7. doi: 10.1016/j.ejmp.2014.07.342.

Gabel D.(1994) Present status and perspectives of boron neutron capture therapy. Radiother Oncol 1994; 30 199-205.

Gierga DP, Yanch JC, Shefer RE.(2000) Development and construction of a neutron beam line for accelerator-based boron neutron capture synovectomy. Med Physics J 2000; 27:203-14.

Hatanaka H, Nakagawa Y.(1997) Boron neutron capture therapy J. Neurooncol. 1997: 33: 105-115.

Henriksson R, Capala J, Michanek A, et al.(2008) Boron neutron capture therapy (BNCT) for glioblastoma multiforme: a phase II study evaluating a prolonged high-dose of boronophenylalanine (BPA). Radiother Oncol. 2008 Aug; 88 (2): 183-191.

Kageji T, Nagahiro S, Mizobuchi Y et al.(2014) Boron neutron capture therapy (BNCT) for newly-diagnosed glioblastoma: Comparison of clinical results obtained with BNCT and conventional treatment. J Med Invest. 2014;61(3-4):254-63.

Kawabata S, Miyatake S, Kuroiwa T, et al.(2008) Boron neutron capture therapy for newly diagnosed glioblastoma. J. Radiat. Res. 2008: 1-10.

Matsumura A, Zhang T, Nakai(2005) Combination of boron and gadolinium compounds for neutron capture therapy. An in vitro study. J Exp Clin Cancer Res 2005; 24(1):93-8.

Miyatake S, Kawabata S, Yokoyama K, et al.(2009) Survival benefit of boron neutron capture therapy for recurrent malignant gliomas. J Neurooncol.2009: 91:199-206.

Soloway AH, Barth RF, Gahbauer RA, Blue TE, Goodman JH.(1997) The rationale and requirements for the development of boron neutron capture therapy of brain tumors. J NeuroOncol 1997; 33:9-18.

Sweet WH.(1997) Early history of development of boron neutron capture therapy of tumors. J Neurooncol. 1997: 33:19-26

Woollard JE, Blue TE, Gupta N, et al.(2001) Development and calculation of an energy dependent normal brain tissue neutron RBE for evaluating neutron fields for BNCT. Health Phys 2001; 80:583-9.

Wu J, Chang SJ, Chuang KS, et al.(2007) Dose evaluation of boron neutron capture synovectomy using the THOR eptithermal neutron beam: a feasibility study. Phys Med Biol. 2007 Mar 21;52 (6):1747-1756.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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