Appeal type: Medical necessity
Decision: Overturned

Diagnosis: diffuse large B-cell lymphoma (DLBCL of nasopharynx).

Treatment: Radiation therapy (proton beam). 

The insurer denied coverage for radiation therapy (proton beam). 

The denial is overturned.

According to the medical records, this is a male with stage IE diffuse large B-cell lymphoma (DLBCL of nasopharynx) status post R-CHOP (rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy. Proton beam therapy (PBT) 50 Gray (Gy) in 25 fractions to the affected nasopharyngeal area is requested. PBT is provided in prospective registry trial. 

This patient has lymphoma in the nasopharynx which is in close proximity to the optic chiasm, orbit, frontal/temporal lobe, and pituitary gland. Thus, it is critical to achieve sharp radiation dose gradient between targeted tumor volume and optic chiasm/pituitary gland/brain in order to avoid radiation complications to these critical normal tissues.  Compared to photon beam radiation therapy (RT), PBT can achieve significantly sharper dose gradient due to its Bragg peak patterns of energy release and thus can deliver therapeutic high dose to target with significantly better dose conformity and sparing of adjacent normal tissues. PBT has advantage of being able to deposit high dose of radiation to tumor with sharp dose fall off from normal tissues, thus improving probability of local control with reduced complication. Medical documents demonstrate the comparison of intensity modulated radiation oncology (IMRT) plan and PBT plan, which demonstrated significantly lower dose to optic nerve/chiasm.

The 2017 ASTRO Proton Beam Therapy Model Policy states that PBT is an advanced type of external-beam radiation therapy that uses proton rather than photon beams to deliver radiation doses to a tumor. Proton therapy offers a high degree of precision, which allows radiation oncologists to target an escalated dose of radiation directly on a tumor and spare nearby healthy tissue. Proton therapy is particularly beneficial for patients with tumors that are near critical structures, such as lung tumors near the heart.

The PBT in this case is provided on a national registry trial. Therefore, the request meets the 2017 ASTRO (American Society for Radiation Oncology) policy for PBT as it is provided on a registry trial.      

Radiation therapy (proton beam) for non-Hodgkin's lymphoma is considered medically necessary for this patient. This member's clinical condition is similar to skull base chordoma with tumor located in the base of skull near optic nerve. The dose of radiation required to control diffuse large B-cell lymphoma has high risks of damage to optic nerve/chiasm and dysfunction of pituitary gland and can result in permanent visual loss, hypopituitarism with hormonal deficiency and brain necrosis. 

PBT, therefore, can be considered as a form of delivering superior conformal RT. Thus, PBT in this case can reduce risks of radiation induced blindness and hormonal dysfunction of pituitary gland in this male with good prognosis. There are several single institutional studies of proton radiotherapy for nasopharyngeal cancer and these studies demonstrate at least equivalent tumor control with minimum complications.

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

The insurer's denial of coverage for radiation therapy (proton beam) for non-Hodgkin's lymphoma is overturned. Medical Necessity is substantiated.