Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 63-year-old man with thin bones (osteopenia), documented on a bone density (DEXA) scan 8.5 years ago. He was treated with Aredia, an intravenous bisphosphonate for an unknown amount of time. There is no evaluation as to the cause of the osteopenia. The patient was apparently unable to tolerate the oral bisphosphonates, Fosamax and Actonel. There is no documentation of any response to treatment. The patients primary care physician decided to restart the Aredia, apparently based on the findings of osteopenia on a lumbar spine x-ray finding performed a year before. Based upon the documentation provided, it is not known if the patients condition is progressive. It is not known if the patient was offered Forteo, which is FDA approved for severe primary osteoporosis in men. Furthermore, it is not known if this was the diagnosis arrived at after secondary causes for osteopenia were eliminated. The Health Plan has denied authorization and coverage for Aredia on the basis it has not been proven effective in treatment of osteoporosis.Off-label use of Aredia to treat osteoporosis is not considered investigational. The use of intravenous bisphosphonates in a variety of bone disorders associated with severe thinning and risk of fragility fracture of bone is well established in the endocrine community. Before the introduction of Forteo, they were the only treatments available for men with severe primary osteoporosis, who could not tolerate the oral preparations. In this case of the patient, the submitted documentation does not demonstrate a diagnosis of primary osteoporosis has been established. The patient should be referred to an endocrinologist to evaluate the etiology of the patients osteopenia to rule out other secondary causes of thin bones that would be more appropriately treated with other agents. If the diagnosis of primary osteoporosis is established, the endocrinologist could then determine whether Aredia or Forteo is a more appropriate treatment. Therefore, I have determined that based upon the information provided at this time, 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 at this time. Physician 2: The patient is a 63-year-old male with a history of prostate cancer and severe osteoporosis who appears to have been treated with oral bisphosphonates for several years and has now become intolerate with significant GI distress. A follow-up bone density scan is not included in the information provided. The patients provider has recommended use of Aredia. The Health Plan has denied coverage for Aredia on the basis it is considered investigational.The Health Plans denial should be upheld. Review of the medical literature reveals there are no adequate randomized clinical trials showing future benefit in osteoporosis with intravenous Aredia. There are appropriate standard therapies available for this patient. Based upon the severity of the patients bone disease, Forteo is a more appropriate treatment. 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: The patient is a 63-year-old male who is said to have osteoporosis. The provided records do not include detailed information regarding the patients history. There is one DEXA scan noted, but this was performed in 1996 at age 55. The results indicate T-scores for the lumbar spine and hip were in the osteoporotic range. There is no discussion of the cause of osteoporosis in this relatively young man. He is said to be intolerant of oral bisphosphonates, but this is not documented in the submitted materials. Though it is reported that the patient has been treated with Forteo at some point, the dates and outcomes are not present. He has been treated with intravenous Aredia for a few years, but no dates or outcomes are presented. In the absence of follow-up DEXA results, it is not known if the patient has responded to oral bisphosphonates, Forteo or Aredia. A request has been made for authorization and coverage for Aredia. The Health Plan has denied the request indicating the safety and efficacy of Aredia for treatment of osteoporosis has not been established.Review of published literature reveals a large number of reports concerning the treatment of osteoporosis with Aredia in patients with various pediatric conditions, adult steroid-induced osteoporosis or post-menopausal osteoporosis. Though there is a paucity of data specifically related to men, these reports are almost uniformly positive, with Aredia producing significant improvements in bone density in either or both the lumbar spine and hip, at a level comparable to that seen with standard oral bisphosphonates. Thus, there is sufficient evidence of the efficacy of Aredia to warrant its use in the treatment of osteoporosis.Notwithstanding the above, there are multiple unclear issues regarding the patients history and current condition. For instance, it is unknown why the patient developed osteoporosis at age 55, as are the results of his prior treatment with Forteo and Aredia. As such, additional follow-up is warranted to rule out a treatable reason for the patients osteoporosis. If there is not a treatable or reversible cause associated with the patients osteoporosis, and if there is documented evidence the patient is unable to use oral bisphosphonates, had an inadequate response to Forteo, and experienced previous benefit from the courses of intravenous Aredia, then the patients request for Aredia should be reconsidered.Accordingly, I have determined that based upon the information provided at this time, the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld at this time.