Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Cancer
Treatment: Radiation Therapy (5 fractions of stereotactic body radiation therapy (SBRT)  using photons)
The insurer denied the Radiation Therapy (5 fractions of stereotactic body radiation therapy (SBRT)  using photons)
The denial is overturned

The patient is a woman. She was diagnosed of stage IV colon cancer with liver metastasis. She is status post multiple chemotherapy regimen of FOLFOX (Folic Acid, Fluorouracil, Oxaliplatin)-Avastin and FOLFIRI (Folic Acid, Fluorouracil, Irinotecan Hydrochloride)-Avastin. She was treated with stereotactic body radiation treatment (SBRT) to 1.1 cm (centimeter) metastatic lesion in the segment VI of the liver.

The patient was treated with SBRT (stereotactic body radiation treatment) to 1.1 cm (centimeter) new second metastatic lesion in the right hepatic lobe.

The patient developed a third 1.2 cm (centimeter) biopsy proven metastatic lesion in the caudate lobe of the liver. She had good performance status of ECOG (Eastern Cooperative Oncology Group) 0 and had no evidence of metastasis outside of the liver.

SBRT (stereotactic body radiation treatment) was delivered to treat 1.2 cm (centimeter) biopsy proven metastatic lesion in the caudate lobe of the liver.

Yes, the requested radiation therapy is medically necessary.
Stereotactic body radiation treatment (SBRT) is technique of delivering highly conformal radiation treatment to the target with sparing of adjacent normal tissues and it enables delivery of high dose RT (radiation therapy) in a few fractions. Published evidence has demonstrated its efficacy and safety for treatment of solitary/oligometastatic lesions in extra-cranial sites, such as in the liver and lung. Published evidence from phase I/II trials (Ref 6, 7 and 8) have demonstrated high local control rates over 90 % with low toxicity.

Multiple peer-reviewed publications including ones from prospective trials have reported on high response rates of hepatic metastasis after stereotactic body radiation treatment (SBRT) with acceptable toxicities in selected patients with limited metastatic disease in the liver.

ASTRO (American Society for Radiation Oncology) model policy for SBRT (stereotactic body radiation treatment)(ref#1) states that SBRT (stereotactic body radiation treatment) is indicated for primary tumors of and tumors metastatic to the lung, liver, kidney, adrenal gland, or pancreas as well as for pelvic and head and neck tumors that have recurred after primary irradiation when and only when each of the following criteria are met, and each specifically documented in the medical record:
1. The patient's general medical condition (notably, the performance status) justifies aggressive treatment to a primary cancer or, for the case of metastatic disease, justifies aggressive local therapy to one or more discrete deposits of cancer within the context of efforts to achieve total clearance or clinically beneficial reduction in the patient's overall burden of systemic disease.
2. The tumor burden can be completely targeted with acceptable risk to critical normal structures.

This patient had a good performance status with ECOG (Eastern Cooperative Oncology Group) 0 but has a new solitary progression of 1.2 cm (centimeter) metastatic lesion in the liver, which has is progressing despite of chemotherapy. Complete eradiation of a solitary metastatic lesion in the liver is important for durable survival and a 1.2 cm (centimeter) metastatic lesion in the liver can be completely targeted with acceptable risk to critical normal structures with SBRT (stereotactic body radiation treatment).

In this patient's clinical condition, SBRT (stereotactic body radiation treatment) is consistent with the ASTRO (American Society for Radiation Oncology) model policy for SBRT (stereotactic body radiation treatment).

NCCN (National Comprehensive Cancer Network) guideline on colon cancer includes SBRT (stereotactic body radiation treatment) as one of the treatment modalities in selected patients with liver metastasis, as in this patient's condition.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
This patient has a solitary progression in the liver despite extensive therapy with multiple standard chemotherapy regimens. She has no disease of the liver and, thus, complete eradiation of a solitary metastatic lesion in the liver is important for durable survival in this patient's condition.

NCCN (National Comprehensive Cancer Network) clinical practice guideline on colon cancer includes SBRT (Stereotactic Body Radiation Therapy) as one of the treatment modalities in selected patients with liver metastasis, as in this patient's condition.