Clin Trial (II - IV) denials: what the review data shows

Where the denial was overturned

Physician 1: The patient is a 62-year-old man with advanced sarcoma status post multiple chemotherapeutic agents. He is not a candidate for radiation therapy. A request has been made for approval for participation in a clinical trial of ET 743 (Yondelis). The Health Plan has denied this request on the basis that there is insufficient scientific evidence supporting the efficacy of Yondelis in the treatment of soft tissue sarcoma.Given that this patient has exhausted all standard chemotherapeutic agents and given the published data available in well-respected journals, enrollment in this clinical trial is likely to be more beneficial than standard therapy, which is non-existent for this patient. This clinical trial is the only treatment option remaining for this patient. Given the published data, the patient’s participation in the trial is medically reasonable and appropriate.

A 46-year-old male has requested participation in Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme. Findings: The physician reviewer found that chemotherapy prolongs survival with modest gains in some patients with GBM. The standard of care is to resect the GBM maximally followed by treatment with temozolomide. The regimen of temozolomide treatment concomitant with radiation therapy was analyzed in a randomized clinical trial setting with 26.5% two-year survival, compared to 10.4% in the cohort receiving only radiation (Taphoorn, et al; Stupp, et al). Most GBM tumors recur and then the treatment options are limited.

Where the denial was upheld

Physician 1The patient is a 56-year-old woman who underwent surgery for ovarian cancer, stage III-B in 2002. She then underwent six cycles of carboplatinum-taxol. She was well until January 2004 when a rising CA-125 was noted. The patient was then apparently treated with cisplatin-cytoxan and subsequently underwent secondary cytoreductive surgery. She now apparently has progressive disease.It has been noted the results of a chemosensitivity assay suggest resistance to many of the further chemotherapy drugs that might be tried in this situation. It has now been proposed that the patient be treated with Avastin.

Physician 1:The patient is a 51-year-old woman with a history of melanoma presenting in 2003 as a pulmonary mass, which was resected. No primary site was found. She received brief adjuvant alpha interferon, which was discontinued for poor tolerance. She suffered an isolated brain recurrence, which was resected in May 2004. She received post-operative whole brain irradiation and is currently without evidence of disease and in good clinical condition. The patient’s provider has recommended the patient undergo immune treatment on a Phase II clinical trial. The Health Plan has denied authorization for this treatment on the basis that it is considered investigational.Metastatic melanoma lacks good therapy. To date, chemotherapy, alpha interferon, and IL-2 have offered benefit to a minority of patients.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Clin Trial (II - IV)when you appeal: reviewers routinely find that denials like yours didn’t hold up.