Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Oligoprogressive metastatic breast cancer

Treatment: Radiation therapy services; 5 fractions (treatment sessions) of stereotactic body radiation therapy (SBRT); image guided radiation therapy (IGRT)

The insurer denied coverage for radiation therapy services; 5 fractions of SBRT; IGRT.

The denial is upheld.

The treating provider has diagnosed the patient with oligoprogressive metastatic breast cancer to her left sub pectoral region. The treating provider has recommended a course of palliative radiotherapy and has requested the approval of stereotactic body radiation therapy (SBRT).

The records do not show that the patient has oligometastatic disease (OMD) [OMD and oligoprogressive disease (OPD) describe tumor states with a limited metastasization], nor has previously received radiation to an overlapping/abutting area; the use of SBRT in her setting is considered experimental.

Per Weykamp F, et al, (2020), "There are few prospective trials assessing the toxicity and tolerance of SBRT in combination with systemic therapies in patients with widespread disease. Although the prospective studies in OMD have tended to use SBRT doses with biological equivalent doses of over 100 Gray (Gy), lower doses may be appropriate in OPD, optimising the balance between achieving local lesion control and toxicity of SBRT, potentially to multiple lesions, combined with systemic therapy."

Per Lemoine P, et al, (2021), "The progression-free survival (PFS) of oligometastatic breast cancer patients treated with SBRT appears long, with low toxicity. Local control is high. SBRT for oligometastases is rarely applied in breast cancer in light of the population in our study. Phase III studies are ongoing."

Per American Society for Radiation Oncology (ASTRO) Model Policy for SBRT, (2020), "Indications for Coverage: 

SBRT is indicated for primary malignant tumors of the lung, liver, kidney, adrenal gland, pancreas, bone, and prostate, and primary malignant and benign tumors of the spine and spinal cord. The patient's general medical condition (namely, the performance status) must justify aggressive, curative treatment to a primary, non-metastatic tumor and be specifically documented in the medical record.

SBRT is indicated for treatment of (1) secondary, or metastatic, tumors and (2) recurrent tumors or (3) any tumor arising within or near previously irradiated volumes when at least one of the following criteria is met and specifically documented in the medical record:

The patient's general medical condition (namely, the performance status) justifies aggressive local therapy to one or more deposits of metastatic cancer in an effort either to achieve total disease clearance in the setting of oligometastatic disease or to reduce the patient's overall burden of systemic disease for a specifically defined clinical benefit.

Recurrent disease requiring palliation, or any tumor cannot be treated as effectively or safely by other radiotherapy methods due to proximity of previously irradiated volumes and a high level of precision and accuracy is needed to minimize the risk of injury to surrounding normal tissues."                                                         

The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient.      

The insurer's denial of coverage for radiation therapy services; 5 fractions (treatment sessions) of stereotactic body radiation therapy (SBRT); image guided radiation therapy (IGRT) is upheld. Medical necessity is not substantiated.