Procrit denials in California external review

What the reviewers wrote

Where the denial was overturned

The patient is a 61-year-old female with chronic hepatitis C active viral replication, genotype 1. She did not respond to treatment with interferon and ribavirin. The patient was then started on Pegasys and Copegus; however, due to side effects she was switched to PEG Intron, which she also was unable to tolerate. She was ultimately started on Infergen and Actimmune. The patient is also receiving treatment with Procrit. The Health Plan has denied coverage for Actimmune and Procrit on the basis these medications are not medically necessary.Infergen (interferon alfacon-1) is FDA approved for patients with hepatitis C who are non-responders. Actimmune (interferon gamma-1b) does not have FDA indication for hepatitis C therapy. There is insufficient evidence Actimmune is beneficial for treatment of the patient’s condition.

The patient is a 64-year-old male with end-stage renal disease and myelofibrosis with a difficult to control anemia. His anemia was most likely related both to end stage renal disease and myelofibrosis. The patient has been maintained on dosages of Procrit in the range of 60,000 units three times a week. In addition, the patient received 150 mcg of Aranesp per week. A request has been made for reimbursement for dosages of Procrit in excess of 60,000 units per week and dosages of Aranesp in excess of .45 mcg/kg per week that were received while the patient was traveling abroad. The Health Plan has denied this request indicating that the dosages the patient received exceeded the recommended amounts and therefore, were not medically necessary.The patient’s nephrologist indicates the patient has responded only to large doses of erythropoietin (Procrit).

Where the denial was upheld

The patient is a 63-year-old man who was diagnosed with gastric cancer in 1997. He had a subtotal gastrectomy in July 1997. He was then treated with chemotherapy, but suffered a recurrence in 1998. The patient underwent a complication gastrectomy, lymphadenectomy, and intraoperative radiation in July 1998. He had several complications including aortogastric fistula and upper abdominal bleeding. He had further upper GI bleeding episodes that were treated with surgery in 1999. Sometime after that, he was started on Procrit injections to maintain his hemoglobin. The submitted information includes several hemoglobin determinations, including the following: 12/30/02: Hb 14.9; 3/26/03: Hb 11.7; 10/3/03: Hb 12.4; and 1/26/04: Hb 12.7. The patient’s iron studies have been normal. A request has been made for authorization and coverage for continued use of Procrit.

The patient is a 56-year-old female with an illness dating to mid 2001 manifested by numbness and tingling of the head, hands and feet. The patient’s provider’s notes indicate that she had EMG and nerve conduction studies, which suggested Guillain-Barre syndrome. The provider considered HSV, another neurological disease or an autoimmune illness. No documentation for any specific diagnosis has been submitted. The CDC criteria for chronic fatigue are not mentioned or demonstrated in the patient’s medical records. The patient is seeking authorization for Procrit.In September 2003, the patient’s red cell mass was 33% less than predicted and blood volume was approximately 15% less than predicted. The patient’s red cell count and hemoglobin have been normal.A search of medical literature reveals no evidence of any data to support the use of Procrit for this patient.

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 Procrit, then check the rights and deadlines that apply to your plan.