Abraxane denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for chemotherapy with immunotherapy (Carboplatin, Abraxane, and Keytruda). The National Comprehensive Cancer Network (NCCN) has broad recommendations for chemotherapy regimens used in the treatment of patients with metastatic adenocarcinoma of the lung. The NCCN guidelines include various combinations, such as treatment with a carboplatin in combination with a taxane. The guideline noted that Abraxane can generally be substituted for another taxane. In addition, there is support for treatment with pembrolizumab when there is no contraindication. In this patient, there is no evidence of a contraindication treatment with pembrolizumab. Furthermore, the patient’s assay for PDL-1 was 10-15%, which provides further indication that pembrolizumab will be effective.

A 62-year-old female enrollee has requested the medications Abraxane and Avastin for the treatment of her metastatic melanoma. Findings: Two physician reviewers found that there are few therapies available for patients with metastatic melanoma and no treatment has been found to be curative. In this clinical setting, it is appropriate to devise a reasonable treatment plan based upon the available medical data and experience. There is increasing published data on the use of carboplatin and paclitaxel in the treatment of metastatic melanoma. These agents have been found to be well-tolerated with good clinical activity. Extrapolating from this experience, clinicians have substituted Abraxane for paclitaxel. This albumin bound form of the native paclitaxel has been found to be both more tolerable and effective than the native compound in Cremophor.

Where the denial was upheld

Physician 1: The patient is a 59-year-old female with metastatic ocular melanoma diagnosed January 2004. She is status post right enucleation and guided biopsy in February 2006. It appears the patient has explored available treatment options, and wishes to proceed with Abraxane chemotherapy. The Health Plan has denied authorization and coverage for this chemotherapy on the basis that it is experimental/investigational for the treatment of metastatic ocular melanoma. The data in support of Abraxane are limited and of questionable applicability to this patient. The abstract submitted had only 13 chemo-naive patients, only 11 evaluable, and only 8 with visceral involvement. The two partial responses cited in the abstract have no information as to confirmation with follow-up scans or validation by an independent reviewer.

Physician 1: The patient is a 53-year-old male diagnosed with an ocular melanoma in November 2002 and treated with surgical excision and radiation therapy. The patient was then well until he developed pain in his shoulder in the fall of 2006. He was found to have a lytic lesion in his distal clavicle, and staging CT revealed extensive metastatic disease. The patient began treatment with Nexavar and his provider recommends the addition of Abraxane to his chemotherapy regimen. The request for authorization was denied by the Health Plan on the basis that Abraxane has not been shown to be efficacious in the treatment of ocular melanoma.Abraxane is a protein-bound form of a Taxol and is approved for the treatment of metastatic breast cancer.

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 Abraxanewhen you appeal: reviewers routinely find that denials like yours didn’t hold up.