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

Physician 1:  The patient is a 64-year-old female diagnosed with breast cancer that underwent lumpectomy and lymph node sampling in February 2006. She was staged at T1b No Mo with 9mm infiltrating ductal carcinoma, SBR 6/9. The patient was also treated with Accelerated Partial Breast Irradiation (APBI) between February 2006 and March 2006 for a total of eight sessions of 4.3 Gy per session for which she is now seeking reimbursement. The Health Plan denied her request citing the investigational nature of the therapy.The American Brachytherapy Society (ABS) and the American College of Breast Surgeons (ACBS) have suggested that partial breast irradiation is an accepted technique for early breast cancer with negative nodes.  Although a non-randomized study indicates APBI may be as effective as whole breast irradiation, additional research is still on-going. A randomized study by the National Cancer Institute led by the National Surgical Adjuvant Breast Project and the Radiation Therapy Oncology Group was begun in January 2005 and is not yet completed. As such, APBI remains investigational and based on available data it was 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 64-year-old female who presented with a palpable left breast mass and was diagnosed with early stage breast cancer. She underwent lumpectomy in February 2006 and interstitial catheters were placed at the time of surgery. She had been seen by a radiation oncologist prior to surgery and the possibility of treatment with interstitial implant was discussed. Following surgery, the patient received the prescribed APBI and has submitted a request for reimbursement. The Health Plan denied her request based upon a determination that APBI (brachytherapy) is experimental/investigational in this clinical setting.The patient was diagnosed with T1b N0 infiltrating ductal carcinoma of the left breast.  She underwent lumpectomy followed by interstitial catheter placement at the time of surgery. The patient was then treated with APBI (brachytherapy). It has been determined that most recurrence of breast tumor takes place in the tumor bed area. Recently, there is increased interest in local treatment of the tumor bed area over a short period of time by using either accelerated conformal external beam treatment or brachytherapy such as the APBI this patient received. Brachytherapy is an accepted approach for women with small tumors such as this patient. Non-randomized trials have shown similar local control with brachytherapy and external beam radiation. External beam radiation gives more radiation to the heart, especially in cases of left-sided breast tumors, and the additional exposure is avoided with brachytherapy. Therefore, I have determined that the therapy at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 63-year-old female diagnosed with an infiltrating ductal carcinoma moderately differentiated (T1, N0, Stage 1). Her provider recommended breast conservation therapy with consideration for Accelerated Partial Breast Irradiation (APBI) with hollow catheter placement at the time of surgery. The providers note states the patient had undergone breast augmentation and the breasts are of considerable size, stretching the skin quite tight. Therefore the decision to proceed with partial breast irradiation with catheters would not be determined until the time of the lumpectomy. If the patient was deemed not to be an ideal candidate for this procedure, conventional external beam radiation to the entire breast would be the recommendation. Evidently the surgery proceeded as planned and the patient received APBI (brachytherapy) treatments. She received 4.3 Gy per session to a total dose of 34.4 Gy in eight sessions. The Health Plan deemed the brachytherapy experimental/investigational and the patients request for reimbursement was denied.Referenced above are the NCCN Guidelines for treatment of invasive breast cancer for patients with negative axillary nodes. The current recommendation is for radiation to the whole breast with boost to the tumor bed. The guidelines specifically state that partial breast irradiation should be performed only as part of a high quality prospective clinical trial.  There is currently an ongoing, randomized Phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with early stage breast cancer. The purpose of this study is to evaluate the effectiveness of PBI compared to WBI in providing equivalent local tumor control in the breast following lumpectomy for early stage breast cancer. In this study, there are three options for partial breast irradiation including (1) multiple fractions using multiple catheter brachytherapy (as was done in this case); (2) mammosite balloon catheter; and (3) 3-D conformal external beam radiation.  Within the clinical trial, the fractionation for muti-catheter brachytherapy is 34 Gy in 3.4 Gy fractions. The protocol for the clinical trial states that patients with breast implants are not eligible for participation in the study.In summary, I believe that APBI is still an investigational therapy. Its use outside of a clinical trial does not follow current NCCN practice guidelines and the current randomized Phase III study is still underway. Additionally, the dose fractionation given to this patient is not similar to that given to patients on the national study. The patient received 4.3 Gy per session to a total dose of 34.4 Gy over eight sessions versus the more typical ten sessions with a lower dose per fraction. Finally, the patient had a breast augmentation with implants that would preclude her participation in the study.Based upon the information set forth above, I have determined that the therapy at issue was 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.