Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis:  Metastatic Pheochromocytoma with skull, lung and sacral metastases.
Treatment:  Stereotactic body radiation therapy.

The insurer denied the Stereotactic body radiation therapy.  The denial is overturned.

The patient is a female with a diagnosis of metastatic malignant pheochromocytoma status post prior adrenalectomy.  The patient subsequently presented with oligometastatic disease.  Local therapy to the oligometastatic lesions involving the skull, right lung and sacrum was recommended, and SBRT (stereotactic body radiotherapy) was requested.

Yes, the health plan should cover the proposed treatment. 

Yes, stereotactic body radiotherapy (SBRT) is likely to be beneficial to treat the insured's condition. 

Stereotactic radiosurgery (SRS) is a highly precise form of radiation therapy used primarily to treat tumors and other abnormalities of the brain.  The treatment involves the delivery of a single high-dose, or sometimes smaller, multiple doses, of radiation beams that converge on the specific area where the tumor or other abnormality resides.  It is a highly precise treatment, which is able to minimize the amount of radiation to surrounding healthy and critical tissues.  Extracranial stereotactic radiosurgery or stereotactic body radiotherapy (SBRT) for certain conditions has also been shown to be safe and effective as compared to the standard radiation therapy.  Some of the conditions that have shown the most potential include spinal tumors, liver tumors and inoperable stage I lung cancers.  Other conditions include
re-treatment of previous treated areas where conventional radiation in is inadequate in sparing surrounding normal tissues.  Stereotactic radiosurgery is FDA approved.  It is not subject to IRB (institutional review board) review, and its effectiveness has been proven based on clinical evidence reported in peer-reviewed medical literature.

In this case, the patient is a female with a diagnosis of metastatic malignant pheochromocytoma status post prior adrenalectomy.  The patient subsequently presented with oligometastatic disease.  Local therapy to the oligometastatic lesions involving the skull, right lung and sacrum was recommended, and SBRT (stereotactic body radiotherapy) was requested.  There is clinical data demonstrating the safety and effectiveness of stereotactic radiosurgery for oligometastatic lesions.  In fact, SBRT may provide a better local control and overall survival compared to standard fractionated radiation therapy.  A review article by Tree et al. evaluated studies on SBRT (stereotactic body radiotherapy) for oligometastatic disease.  The authors stated that "Many non-randomised studies have shown that SBRT for oligometastases is safe and effective, with local control rates of about 80%", and concluded that "SBRT offers durable local control and the potential for progression-free survival in non-liver, non-lung oligometastatic disease at a range of sites".  In addition, a multi-institution randomized trial (SABR-COMET trial [stereotactic ablative radiotherapy (SABR)- Comprehensive Treatment of Oligometastatic Cancers (COMET)]) randomized 99 patients with oligometastatic lesions (1-5 lesions) into control group vs SBRT.  Median overall survival was 28 months in the control group versus 41 months in the SABR (SBRT) group (p=0.090).  Treatment-related deaths occurred in three (4.5%) of 66 patients after SABR, compared with none in the control group.  The authors concluded that "SABR (SBRT) was associated with an improvement in overall survival, meeting the primary endpoint of this trial".

This patient has oligometastatic lesions, and if they are adequately controlled with SBRT, the patient may have a prolonged survival.  SBRT has been shown to be safe and effective for the treatment of oligometastatic lesions, and in this case, is the best option that can help with disease control.  Stereotactic body radiotherapy (SBRT) is, therefore, considered medically appropriate treatment for this patient at this time.