Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Metastatic renal cell carcinoma
Issue under review:  SBRT

The SBRT was medically necessary.

A recent 2019 randomized trial has shown that SBRT can improve local control, progression free survival and even overall survival for patients with oligometastatic (including renal cell carcinoma primary) lesions.

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, 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 was an adult male with a diagnosis of metastatic renal cell carcinoma s/p left radical nephrectomy and brain radiation.  He subsequently presented with a symptomatic solitary T12 spinal lesion.  Local therapy to the oligometastatic T12 lesion was recommended, and stereotactic body radiosurgery was utilized.  

There is clinical data demonstrating the safety and effectiveness of SBRT for oligometastatic lesions.  In fact, SBRT may provide a better local control and survival compared to standard fractionated radiation therapy.  A 2013 review article by Tree et al. evaluated studies on SBRT 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 2019 multi-institution randomized trial (SABR-COMET trial) randomized 99 patients with oligometastatic lesions (1-5 lesions) into control group versus SBRT.  Median overall survival was 28 months in the control group versus 41 months in the SABR (SBRT) group (p=0090).  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."

The patient had a renal cell primary that is radioresistant, and required higher dose per fraction for adequate control.  This patient had a solitary spinal lesion, and if it were to be adequately controlled with SBRT, then patient may have had a prolonged survival.  Stereotactic radiosurgery has been shown to be safe and effective for the treatment of oligometastatic/solitary lesions, and in this case, it was the best option that could help with disease control.  Stereotactic body radiotherapy (SBRT) was, therefore, medically necessary for this patient at that time. 

The health plan's denial based on the requirement that the patient have had a one-year period of remission, and that there were known extracranial metastases is not consistent with the current literature.