Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 50-year-old woman diagnosed with papillary thyroid cancer in July 1998. She underwent thyroidectomy followed by 150 mCi of iodine-131. A PET scan performed in December 2000 showed persistent disease. In January 2001, the patient underwent bilateral neck dissection followed by a second course of iodine-131 therapy, presumably 150 mCi. An MRI performed in October 2003 revealed a 2x 2.3 x 1.5 cm mass in the right inferior neck. In January 2004, the patient underwent a modified neck dissection and paratracheal mass excision. Post-operatively, the patient received 315 mCi of iodine-131. She was then referred for post-operative external beam irradiation, but it is not known if this took place. In January 2005, a follow-up PET scan was negative for any disease. It appears she has received 600 mCi of iodine-131 to date. The patient now wishes to undergo proton beam therapy. The Health Plan has denied the patients request on the basis the requested therapy is considered investigational.Iodine-131 is the standard of care for treatment of papillary thyroid cancer. It is used both for diagnostic and therapeutic purposes. Treatment with iodine-131 is repeated until scans are negative. Proton beam therapy is indicated for unresectable disease, which this patient does not have. Furthermore, as of January 2005, the patients PET scan was negative and there is no indication in the submitted records of any clinical recurrence. For these reasons, proton beam therapy has no role in the treatment of this patient. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 50-year-old female who has recurrent papillary carcinoma of the thyroid. She was first diagnosed with papillary carcinoma of the thyroid in 1998. She underwent surgery followed by iodine-131 therapy. The patient developed recurrent disease in December 2000. She underwent bilateral neck dissection and a second course of iodine-131 therapy. The patient had another recurrence in November 2003. She then underwent surgery in January 2004 followed by a third course of iodine-131 therapy. A PET scan in January 2005 was negative. The patient has now requested authorization and coverage for proton beam therapy. The Health Plan has denied coverage for proton beam therapy on the basis it is considered investigational for treatment of the patients medical condition.The patient has had multiple recurrent papillary thyroid cancer, status post multiple surgeries and iodine-131 therapy three times. Her PET scan of January 2005 did not reveal any gross disease in the thyroid area. This case involves treatment of possible microscopic disease, which can be treated with iodine-131 therapy. Alternatively, local external beam radiation therapy to cover post-operative tumor bed may also be considered. The disputed proton beam therapy has specific indications. Proton beam therapy is not standard of care for treatment of patients such as this patient and is not likely to result in significant clinical benefit. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3: This case involves a 50-year-old female diagnosed with papillary carcinoma of the thyroid gland in 1998. She was treated by a thyroidectomy followed by an ablative course of radioactive iodine. Follow-up with PET scan revealed recurrent/persistent disease within the neck and she underwent a subsequent bilateral neck dissection. This was followed by a second course of ablative iodine. Three years later an MRI revealed a mass in the inferior right neck. At that time, a modified neck dissection and paratracheal mass excision were performed and a third course of radioactive iodine was given. In October 2004, the patient consulted another provider who recommended external beam radiation therapy. A note by the patients otolarnygologist indicated the patient would have follow-up at Loma Linda for possible external beam radiation or another radio-iodine therapy. It is not known if the patient received this treatment.  Based upon the information provided, it appears it has now been recommended the patient receive proton beam therapy. The Health Plan has denied coverage for proton beam therapy for treatment of recurrent papillary thyroid cancer on the basis it is considered experimental/investigational.Based upon the clinical practice guidelines for papillary thyroid cancer the patient has been treated in accordance with the standard of care. Given the patients clinical history a fourth course of iodine therapy or external beam radiation therapy would be medically reasonable and appropriate. Proton beam therapy is not the usual course of treatment for recurrent papillary thyroid cancer, and is not indicated per NCCN practice guidelines. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.