AIDS Wasting Tx denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Prezcobix for treatment of his human immunodeficiency virus (HIV). Findings: The physician reviewer found that Prezcobix is a combination tablet that contains both (darunavir) Prezista and (cobicistat) Tybost. Numerous studies have shown that simplified regimens for HIV can increase adherence and thus long-term successful suppression of HIV replication and more successful treatment of disease leading to decreased morbidity and increased survival. Thus, the Health Plan’s denial of this beneficial simplification is detrimental to the patient’s health and survival. The standard of care dictates that the simplified regimen is better as it can increase adherence and long-term successful suppression of HIV.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Serostim. Findings: The physician reviewer found that wasting, or cachexia, is a debilitating complication of human immunodeficiency virus (HIV). Cachexia is associated with reduced strength and functional ability, as well as a decreased ability to withstand opportunistic infections. The U.S. Food and Drug Administration (FDA) has approved Serostim, a recombinant human growth hormone for treatment of HIV-related cachexia. In addition, clinical studies support a role for Serostim in this clinical setting. The provider in this case noted that an alternative form of hormonal replacement with testosterone is not optimal for this patient, whose testosterone level is currently therapeutic.

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