Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Breast Cancer. 
Treatment: Proton Beam Therapy (PBT). 
The insurer denied: Proton Beam Therapy (PBT). 
The denial is overturned. 

The patient is an adult female with invasive ductal carcinoma of the right breast metastatic to right axillary nodes. She is status post neoadjuvant chemotherapy followed by right mastectomy and sentinel node biopsy. Proton beam therapy is being requested to deliver adjuvant RT (radiation therapy) to the right chest wall and regional nodes on NIH (National Institutes of Health)-approved registry trail. 

The requested proton beam therapy is medically necessary. 

Proton radiotherapy confers significant dosimetric advantages in the treatment of malignancies that arise adjacent to critical radiosensitive structures. Multiple peer-reviewed publications have demonstrated that proton beam radiation offers significant dosimetric advantages in the treatment of malignancies that arise adjacent to critical radiosensitive structures and side effects of proton beam therapy appear to offer potentially less local side effects compared to photons in several types of malignancy, including breast cancer. 

The submitted comparison of proton beam therapy plan and photon RT (radiotherapy) plan demonstrates significantly lower dose to the lung in this adult female with good prognosis. The volume of lung receiving 20 Gy (gray) or higher (V20Gy) has shown to be a predictive factor for developing radiation pneumonitis. Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC) (Ref#8) states that the normal lung dose constraint is V20Gy (volume receiving 20 gray) of equal or less than 30% of lung volume to minimize the risks of radiation pneumonitis less than 20%. 

The provided medical records include a comparison of dose to lung between proton beam therapy plan and photon RT (radiotherapy) plan. The comparison demonstrated the V20Gy (volume receiving 20 gray) of the left lung with photon plan is 40.6 % versus V20 Gy (volume receiving 20 gray) of left lung with proton beam therapy plan of 18.5 %. Thus, photon RT (radiotherapy) plan exceeded the tolerance dose of the left lung, which will result in high risk of radiation complication to the left lung. The proton beam therapy plan resulted in dose to the left lung to within the tolerance dose and will decrease risk of radiation complication to the lung, Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC) (Ref#8) states that the normal heart dose constraint is the mean dose of 7 Gy (gray) equal or less to minimize the risks of radiation cardiac toxicities. The provided comparison of dose to heart between proton beam therapy plan and photon RT (radiotherapy) plan demonstrated the mean dose to the heart with photon plan is 18.1 Gy (gray) compared to 0.94 Gy (gray) with proton beam therapy plan. The proton beam therapy plan was able to reduce dose to the heart to under tolerance mean dose of 7 Gy (gray). The volume of lung receiving 20 Gy or higher (V20Gy) has shown to be a predictive factor for developing radiation pneumonitis. 

Quantitative Analyses of Normal Tissue Effects in the Clinic 
(QUANTEC) (Ref#8) states that the normal lung dose constraint is V20Gy (volume receiving 20 gray) of equal or less than 30% of lung volume to minimize the risks of radiation pneumonitis less than 20%. The provided comparison of dose to lung between proton plan and photon plan demonstrated the V20Gy (volume receiving 20 gray) of the right lung with photon plan is 60 % versus proton plan of 18 %. The photon beam plan exceeded the tolerance dose of normal lung, and the proton plan resulted in sparing of right lung to within the tolerance dose in this patient's case. 

Thus, based on high risks of radiation induced toxicities of heart and lung with photon RT (radiotherapy), the requested proton beam therapy with significant sparing of the heart and lung is medically necessary in this patient with good long-term prognosis.