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

Physician 1:  The patient is a 52-year-old woman who was diagnosed with a mucinous cystoadenocarcinoma of the appendix in August 2005. In March 2006 she developed abdominal pain and MRI demonstrated recurrent disease diffusely in the abdomen. Biopsy confirmed this. The patient consulted a provider who recommended that she undergo cytoreductive surgery with intraperitoneal hyperthermic chemotherapy. The Health Plan indicates there is insufficient evidence demonstrating the effectiveness of cytoreductive surgery and intraperitoneal hyperthermic chemotherapy in this clinical setting.Cytoreductive debulking surgery is the standard of care for this type of situation. The addition of intraperitoneal chemotherapy, with or without hyperthermic chemotherapy, is investigational. Adding the hyperthermic element does not alter this categorization. Surgical debulking is the only treatment option with a known benefit relative to risk. 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 52-year-old female who was diagnosed in August 2005 with appendical adenocarcinoma with peritoneal dissemination less than one year later. She was not treated with adjuvant chemotherapy. The patients provider indicates that conventional chemotherapy has not proven to be effective for this type of cancer and recommends cytoreductive surgery and intraperitoneal heated chemotherapy. The Health Plan indicates the use of intraperitoneal heated chemotherapy in conjunction with cytoreductive surgery is considered experimental/investigational.If the patient is a surgical candidate from a medical point of view she is potentially more likely to benefit from hyperthermic than non-hyperthermic chemotherapy treatment, which adds little value in this clinical setting. Although there is a lack of outcome data due to the rarity of the patients condition, there is sufficient evidence to conclude that intraperitoneal heated chemotherapy in conjunction with surgical debulking is superior to any available standard therapy. Accordingly, I have determined that the requested therapy is 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 52-year-old female with peritoneal carcinomatosis from an appendiceal carcinoma. Her provider has recommended cytoreductive surgery in conjunction with intraperitoneal heated chemotherapy (IHC). The Health Plan indicates the efficacy of the proposed treatment for the patients diagnosis has not been established.Relevant clinical trial data in this clinical scenario have been difficult to accrue as well as to interpret given the heterogeneity of cancers leading to peritoneal carcinomatosis as well as the general rarity of this patients specific disease histology.  It is well accepted that systemic chemotherapy has limited utility given the peritoneal status of the tumor bulk in this scenario. Surgical debulking is the hallmark of therapy, and the addition of IHC is mentioned as a consideration in every review and discussion in the literature. The lack of Phase III trials demonstrating a clear improvement in survival from this aggressive intervention makes evaluation of safety and efficacy difficult.  The procedure itself has recently been FDA-approved for regionally advanced ovarian disease after years of a very similar debate.  IHC has been shown to be an effective, relatively safe adjuvant treatment when offered to patients with peritoneal carcinomatosis from other tissue origins. Additionally, IHC is routinely considered by referral centers specializing in the treatment of patients with peritoneal carcinomatosis. Furthermore, given the rate of morbidity and mortality in patients with recurrent mucinous cystoadenocarcinoma, the requested therapy is likely to be more beneficial for the patient than available standard treatment.The relevant literature regarding cytoreductive surgery and IHC includes a paper by Glehen et. al. and an abstract from the June 2006 ASCO meeting with typical, uncontrolled observation. Such reports are very numerous in the medical literature, and serve to comprise a body of literature that, although less than definitive, cannot be ignored when benefits are compared to surgical debulking alone.For the reasons set forth above, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.