Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Invasive ductal carcinoma (IDC) stage III

Treatment: Proton Beam Radiation

The insurer denied coverage for Proton Beam Radiation. The denial was upheld.

This patient is a female diagnosed with invasive ductal carcinoma (IDC) stage III.  The physician documentation indicated that the patient had initially presented for a consultation for consideration of therapy for her diagnosis of nonmetastatic locally advanced breast cancer. The patient originally presented for a consultation for consideration of therapy for her diagnosis of nonmetastatic locally advanced breast cancer. A work-up with a mammogram revealed an enlarged left axillary lymph node.  The biopsy showed poorly differentiated invasive ductal carcinoma triple negative and biopsy of the lymph node was also positive.  The patient had a left-enlarged internal mammary lymph node that was also noted and there was pectoral adenopathy noted on the CT of the chest, abdomen, and pelvis.  Further work-up was negative for metastatic disease.  

The patient was started on neoadjuvant chemotherapy with Adriamycin (AC) followed by Taxotere and cyclophosphamide (TC) and was later switched to gemcitabine due to a reaction to the Paxil.  Repeat imaging showed a decrease in the left breast mass in October and she underwent a left lumpectomy and axillary lymph node dissection. There was no residual disease in the lymph nodes.  .  Postoperative radiation therapy to the breast and regional lymphatics was recommended and the patient enrolled on the RADCOMP study randomized to the proton arm.  The provider stated that the patient would be treated to 50 Gy in 25 fractions followed by a 10-Gy boost.  It was noted the patient would like to participate in the randomized comparative effectiveness study to compare proton therapy to photon therapy.

The insurer denied coverage for proton beam radiation therapy. The requested service is not medically necessary for this member.  Appropriate criteria include: malignancies in children; primary therapy for melanoma of the uveal tract or ocular structures; and skull-based tumors.  Per ASTRO Guidelines, breast cancer is not a site where there is sufficient evidence to prove efficacy for the routine use of proton beam therapy compared to photon therapy.  National Comprehensive Cancer Network (NCCN) Guidelines v 3.2019 do discuss the use of conformal planning to optimize delivery of individual therapy.  They make note that when treating the internal mammary nodal volume, the dose should be evaluated to normal tissues especially heart and lung and dose constraints should be respected.  Recommendations initially should include photon therapy using either 3-D conformal planning as the primary planning method. Intensity modulated radiation therapy with photons can be considered in certain clinical situations where 3D conformal therapy cannot meet the constraints.  However, comparison of the plans does not show that intensity modulated photon therapy is clinically insufficient or significantly inferior to the intensity modulated proton therapy.  At this time, there is insufficient evidence to show that proton therapy is more efficacious than photon therapy for treatment of breast carcinoma and should be used over photon therapy without a strong reason. 

For this patient, however, proton therapy has not been shown to be the better option.  Other options, including photon therapy, will effectively cover the target volume and effectively control the tumor, while still clinically being able to reduce the incidence of normal tissue complications to reasonable levels.  Therefore, it is reasonable to deny the use of protons for this patient's clinical situation.  Proton Beam Radiation Therapy is not medically necessary for this patient.

The carrier's denial of continuation of coverage for Proton Beam Radiation Therapy is upheld.  The medical necessity is not substantiated.