Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Metastatic breast cancer

Treatment: Gamma knife stereotactic radiosurgery

The insurer denied coverage for gamma knife stereotactic radiosurgery.

The denial is overturned. 

This is a female patient diagnosed with breast cancer metastasized to the brain. The patient has had prior treatment with letrozole, Zometa, and Ibrance. The patient's positron emission tomography (PET) scan showed significant response to therapy. However, the patient's magnetic resonance imaging (MRI) of the brain revealed an enhancing mass to the posterior medial left cerebellum measuring 3.4 x 3.2 x 3.1 centimeters (cm). The patient underwent a suboccipital craniotomy with resection and radiation to the surgical bed and a follow-up MRI revealed new lesions which were small and discrete. The patient has been utilizing Xeloda which she tolerates well. It has been recommended that she undergo stereotactic radiosurgery (SRS).

Based on the review of the medical record, this patient has metastatic breast cancer to the brain, with 3 lesions documented on the follow-up MRI of the brain. The patient is to be evaluated for SRS treatment of the disease. SRS, a form of intensity-modulated radiation therapy (IMRT) is a reasonable option in this situation. SRS is designed to deliver a single or limited number of large doses of radiation to a small, precisely defined target. As per the American Society for Radiation Oncology (ASTRO) 2014 guidelines, SRS is indicated for primary and secondary central nervous system (CNS) malignancies, generally used as a boost or salvage therapy for lesions less than 5 cm. In this case, the patient has discrete new lesions that are occupying an acceptable treatment volume. The total volume of brain/cranial regions that would be treated to include all the lesions is less than 15 cubic centimeters (cc), which is within SRS planning criteria, making it appropriate to be treated with small fields suitable for SRS. As per the patient's treating physician, the patient's clinical status was stable enough to warrant palliative CNS treatment. The proposed plan is to treat the lesions using stereotactic radiosurgery (SRS)/ stereotactic radiation therapy (SRT). Guidelines allow for treatment of single or multiple lesions if other criteria as noted above are present and the patient's overall status is stable enough to warrant treating the limited CNS disease. The actual number of lesions is not specified in the ASTRO criteria, making the other criteria more important.

According to literature review, SRS/stereotactic radiation therapy (SRT) offers the safe, appropriate management in this situation. SRS can be delivered in a palliative intent and be expected to provide a response without normal tissue toxicity. The lesion should respond better to large fractionation that SRS can provide as opposed to standard fractionation IMRT or whole brain radiation. SRS is the method in which to deliver partial brain radiation in this situation to limit both short and long-term side effects. SRS/SRT can be used to limit the amount of normal brain treated, sparing the patient from adverse side-effects. The National Comprehensive Cancer Network (NCCN) Guidelines for Central Nervous System Cancers, V 3.2020 recommends SRS/SRT as the preferred treatment method for limited brain metastases. For these reasons, SRS/SRT is considered medically indicated and reasonable, and this treatment method for this patient's lesions would be consistent with standard of care. 

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for gamma knife stereotactic radiosurgery is substantiated. The insurer's denial should be overturned.