Serostim denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a 52-year-old male with HIV related lipodystrophy. He is requesting coverage for Serostim injections to alleviate symptoms and side effects relative to fat accumulation including respiratory distress, limited range of motion, and need to modify sitting/sleep position. Prior interventions including diet, exercise, metformin and testosterone provided no benefit. The Health Plan indicates Serostim injections are considered investigational for treatment of lipodystrophy. Given the well-documented morbidity associated with the patient’s abdominal lipodystrophy, a trial of therapy with Serostim is indicated. It does not appear there is an alternative intervention for this patient with a severe condition that continues to worsen despite multiple interventions.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Serostim 4 mg vial. The records provided for review document that this patient has a history of panhypopituitarism following resection of a pituitary adenoma many years ago. The patient has been treated with multiple therapeutic agents including hydrocortisone, levothyroxine, and growth hormone replacement therapy. The provider charted that the patient is experiencing worsening quality of life due to fatigue related to her panhypopituitarism since she stopped taking growth hormone therapy. Her provider has recommended treatment with Serostim.

Where the denial was upheld

The patient is a 54-year-old male who is HIV-infected and is being treated with appropriate anti-HIV therapy with good virological result. He has requested authorization and coverage for recombinant growth hormone (Serostim) for management of AIDs related wasting and weight loss. He reports that at 188 pounds he is more than 10% below his ideal weight of 220 pounds. He also states that his records include documentation of a normal serum testosterone while on testosterone therapy. There is a level of 125 ng/dL (low) in December 2005, and elevated levels in April and June 2005.At issue is whether Serostim is medically necessary for treatment of the patient’s medical condition.The patient does not meet medical necessity criteria for use of recombinant growth hormone.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Serostim for treatment of the enrollee who has a history of human immunodeficiency virus. Findings: The physician reviewer found that There is a lack of support for the requested medication in this clinical setting. The current guidelines do not provide specific recommendations for the medication Serostim in treatment of HIV patients who may be experiencing unintentional weight loss. The U.S. Food and Drug Administration approved this medication “for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.” In this patient’s case, depending on the formula used, this patient’s ideal body weight would be between 152 to 159 pounds. The patient’s weight was 160 pounds.

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