Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Sellar tumor

Treatment: Radiation Therapy for Primary Central Nervous System Neoplasms

The insurer denied coverage for Radiation Therapy for Primary Central Nervous System Neoplasms. The denial upheld.

This patient is a male who has been diagnosed with recurrent non-functioning pituitary adenoma.  The documentation indicated the patient has undergone initial resection of a large non-functioning pituitary adenoma when he presented with facial droop and visual field loss.  The patient did have improvement of symptoms after surgery. However, on follow-up the imaging did show a recurrence of disease.  The patient was having increasing problems with visual acuity and it has been recommended that the patient undergo proton beam therapy.  A pathology report indicates the final diagnosis was a sellar tumor.

If the patient is stated to be a reasonable candidate for proton therapy in the records, then he is also a reasonable candidate for Intensity-Modulated Radiation Therapy (IMRT).  IMRT has been shown to be efficacious in this situation. The AP has indicated that proton therapy can produce less overall dose to normal tissues in the head and neck region near the tumor.  In order to determine if this is actually correct, the patient should be placed on a protocol, randomized, in an effort to determine if protons have more efficacy than photon's. However, protons also create neutron contamination in tissue.  Given the significant destructive effects neutrons can have on normal tissue as well as tumor, it is not known what effect this has as far as long-term complications for proton therapy.  National Comprehensive Cancer Network (NCCN) Guidelines also recommend IMRT as the treatment for this situation wherever possible over Proton therapy.

Proton beam radiation therapy is a type precise radiation which is used to treat cancer among other conditions.  Protons compared to photons deliver a low entrance dose. The proton also has a high dose "Bragg peak" region designed to cover the tumor with minimal to no "exit dose" after passing through the tumor region.  Given protons radiobiological properties, they are useful in minimizing damage to normal tissue, potentially resulting in fewer side effects. Protons are FDA approved, not subject to IRB review.  However, per American Society for Therapeutic Radiology and Oncology (ASTRO) and NCCN guidelines, there is still insufficient clinical peer review literature to show that proton therapy is safer or more effective and standard therapy, such as IMRT, surgery or combined modalities.  

As per ASTRO or NCCN guidelines, proton therapy is not clinically superior to other accepted RT modalities.  NCCN guidelines for central nervous system tumors recommend the use of photon based IMRT.  Proton therapy is not mentioned as the standard. Therefore, without an overriding medical reason, proton therapy is still considered not medically necessary for central nervous system cancers.  It may be safe and effective.  It is not generally accepted is a national standard medical practice.  It is not necessarily the least intensive or most appropriate alternative compared to IMRT.  For these reasons, proton therapy is still considered not medically necessary in this clinical situation. The health plan acted reasonably with sound medical judgment. 

The carrier's denial of coverage for Radiation Therapy for Primary Central Nervous System Neoplasms is upheld.  The medical necessity is not substantiated.