Rituxan denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: This patient is a 43-year-old female who underwent renal transplant in 1992 due to focal segmental glomerulosclerosis (FSGS). She is on now on dialysis and requires a second renal transplant. A live donor is available; however the patient is highly sensitized and had a positive crossmatch with the potential donor. The patient’s transplant specialist recommends desensitization with IVIG and Rituxan prior to transplant, and indicates that plasmapheresis may also be required. The provider’s request for authorization of the desensitization protocols was denied by the Health Plan citing the experimental nature of the therapies.The proposed therapies are considered to be the standard of care and are not investigational.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Rituxan (rituximab 1000 mg every two weeks). Sharp and colleagues explain that connective tissue disease-associated interstitial lung disease often fails to respond to conventional immunomodulatory agents. In examining the results of 24 patients with interstitial lung disease patients treated with rituximab after failing to improve with standard therapy, the authors reported that lung imaging remained stable or improved for 11 patients, while worsening was observed in nine patients. The authors found that decline in forced vital capacity (FVC) improved following rituximab treatment, while diffusion capacity of carbon monoxide was stable. The authors concluded that rituximab is a therapeutic option in treatment-refractory connective tissue disease-associated interstitial lung disease.

Where the denial was upheld

Physician 1: The patient is a 36-year-old woman with biopsy-documented dermatomyositis. Her disease has progressed despite treatment over the past four years under prednisone, methotrexate, and CellCept. She has been diagnosed by her neurologist as having refractory dermatomyositis. She is now backing on prednisone and methotrexate. Based on the information provided, neither CellCept nor methotrexate spared the use of prednisone. A request has been made for authorization and coverage for Rituxan. The Health Plan has denied the request. Dermatomyositis is an autoimmune disease affecting the skin and muscles. It is a rare disease and randomized, controlled treatment trials are either lacking or based on small patient numbers.

Physician 1The patient is a 36-year-old man with focal weakness and EMG denervation, particularly in the proximal right upper extremity. The patient has a presumed diagnosis of multifocal motor neuropathy. The patient has experienced some improvement with IVIG. The patient has received Rituxan therapy in the past and wishes to continue to receive Rituxan. The Health Plan has denied authorization for the requested therapy indicating that Rituxan is considered experimental in nature.The Health Plan’s denial should be upheld. Rituxan is considered experimental in treatment of neuropathies. In addition, based upon the information provided the patient’s diagnosis is not conclusive. IVIG is the standard treatment for the patient’s symptomatology and the patient appears to have benefited from a prior course of IVIG.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Rituxan, then check the rights and deadlines that apply to your plan.