NAPWA applauds ruling.

AIDS: The Health Care Finance Administration (HCFA) has reversed a previous statement concerning Medicaid reimbursement for Serostim, the first biotechnology drug to be approved for treatment of AIDS wasting. The original ruling said Serostim could be a drug used for cosmetic weight gain. This gave States the right to refuse Medicaid reimbursement when the drug was used in treating AIDS wasting. However, after efforts by the National Association for People With AIDS, in concert with Serono Laboratories, patient advocates, political leaders, and other sympathetic agencies, HCFA reversed its ruling and affirmed the drug's clinical benefits in fighting AIDS wasting.^ieng

Supplementary feeding in the care of the wasted HIV infected patient.

Wasting and food insecurity are commonly seen in patients receiving antiretroviral treatment (ART) programs in sub-Saharan Africa and south Asia, and supplementary feeding is often offered in conjunction with ART. Evidence for the effectiveness of such supplementary feeding is scant. A randomised, investigator-blinded, controlled clinical trial of two types of supplementary food, corn/soy blended flour and a ready-to-use peanut butter-based lipid paste, in wasted adults in Blantyre, Malawi is described and the results summarised. A historical control group who did not receive supplementary food is described as well. Provision of about half of the daily energy requirement as a supplementary food for 14 weeks resulted in more rapid restoration of a normal BMI; and the energy-dense, ready-to-use paste was associated with more rapid weight gain than the blended flour. Survival was similar among the 3 groups. The strong association between lower BMI and survival indirectly suggests that there may well be clinical benefit from supplementary feeding in this population. No differences were seen in ART adherence or quality of life with more rapid restoration of BMI. Further research is urgently needed concerning the widespread practice of supplementary feeding in HIV/AIDS care to most effectively utilize this intervention.

Prevalence and cost of HIV-associated weight loss in a managed care population.

OBJECTIVE: To estimate the prevalence of HIV-associated weight loss among HIV patients in a US managed care population, and compare demographic and clinical characteristics of HIV patients with and without evidence of HIV-associated weight loss. RESEARCH DESIGN AND METHODS: A retrospective observational study was conducted using a large, geographically diverse US managed care population to identify commercial enrollees with HIV/AIDS from 1/1/2005-7/31/2007, based on a combination of HIV/AIDS diagnosis codes or antiretroviral treatment. HIV-associated weight loss status was defined according to an algorithm combining evidence for weight loss-associated conditions, anorexia symptoms, and various treatments for weight loss or wasting. Among HIV patients continuously enrolled in the health plan for one year, patient demographics, treatments, and comorbidities were compared between patients with and without evidence for weight loss. RESULTS: A total of 22,535 patients with HIV/AIDS were identified, including 2098 who met the criteria for weight loss (estimated prevalence 9.3%; 95% CI: 8.9% - 9.7%). Among 12,187 continuously enrolled patients with HIV, 1006 (8.3%) had evidence of HIV-associated weight loss. Patients with HIV-associated weight loss were older (44.1 vs. 42.6 years), and more men had HIV-associated weight loss than women (8.8% vs. 5.3%). A number of comorbidities were more common among patients with HIV-associated weight loss. On average, these patients also had more ambulatory (24.0 vs. 13.4), ER (1.4 vs. 0.8), and inpatient visits (0.5 vs. 0.1). Total annual health care costs for patients with HIV-associated weight loss were more than double (mean $45,686 vs. $19,960) the costs for HIV patients without weight loss. CONCLUSIONS: Despite the availability of effective antiretroviral therapy, weight loss remains a problem among patients with HIV. Based on this analysis, almost 1 in 10 managed care patients with HIV have evidence of HIV-associated weight loss. These patients tend to have more comorbidities, use more health care resources, and incur greater costs compared to patients without HIV-associated weight loss. Patients with HIV-associated weight loss were generally sicker than the non-weight loss cohort; thus, the increased costs observed in this population may not be directly or wholly attributable to HIV-associated weight loss. In addition, limitations common to analyses of administrative claims data should be considered when interpreting these results.

Cost-effectiveness of clinical interventions for AIDS wasting.

Economic studies of HIV/AIDS interventions are important for providing cost-effective care. This paper presents a costeffectiveness study of a three-arm clinical trial conducted at Tufts University School of Medicine/New England Medical Center in Boston, Massachusetts that treated 50 patients with AIDS wasting from March 1998 through January 2001. This study compared the costs and impacts of a nutritional counseling intervention alone (NC arm), the nutrition intervention with oxandrolone (OX arm), and the nutrition intervention with progressive resistance training (PRTarm) for the treatment of AIDS wasting. The cost of each intervention was derived for both the three-month clinical trial and a six-month estimated community model (ECM), its projected adaptation to community-based medical care. The cost determination involved obtaining and multiplying unit economic costs and quantities expended of each resource within each study arm. The ECM average cost per client in the cost-effectiveness analysis incorporated both institutional and societal perspectives. The costeffectiveness analysis compared the cost of each intervention to its quality-adjusted life-year (QALY) gain (Zeckhauser and Shepard, 1976). From a societal perspective, for the NC arm, the cost per client totaled US dollars 983 for the actual and US dollars 596 under the ECM. For the OX arm, the cost per client totaled US dollars 3,772 for the actual study and US dollars 3,385 under the ECM. For the PRT arm, the cost per client totaled US dollars 3,189 for the actual study and US dollars 2,987 under the ECM. Under the societal perspective the cost per QALY was US dollars 55,000 (range: US dollars 51,000 to US dollars 83,000) for the NC arm, US dollars 151,000 (range: US dollars 149,000 to US dollars 171,000) for the OX arm, and US dollars 65,000 (range: US dollars 44,000 to US dollars 104,000) for the PRTarm. When using only an institutional perspective, the cost per QALY was US dollars 45,000 (range: US dollars 42,000-US dollars 64,000) for the NC arm, US dollars 147,000 (range: US dollars 147,000 to US dollars 163,000) for the OX arm, and US dollars 31,000 (US dollars 21,000 to US dollars 44,000) for the PRTarm. This paper shows that cost and cost-effectiveness analyses can be adapted to a community setting by combining information from community practice and costs with data from a randomized trial. Compared to other AIDS treatments, such as highly active antiretroviral therapies, all three interventions were affordable, but their cost-effectiveness was intermediate. Oxandrolone was the least cost effective of the interventions, even compared to nutrition alone, as it included similar or somewhat greater costs for less of an increase in quality of life. PRT was the most cost-effective treatment for AIDS wasting, particularly from an institutional perspective. Third party payers should consider coverage of PRT.

A comparison of the clinical and cost-effectiveness of 3 intervention strategies for AIDS wasting.

OBJECTIVE: To compare oxandrolone (OX) or strength training with nutrition alone (NA) for AIDS wasting. SUBJECTS: Fifty patients with AIDS; 47 completing the study. INTERVENTIONS: Randomization to (1) NA with placebo pills, (2) nutrition with 10 mg of OX administered orally twice a day, or (3) nutrition with progressive resistance training (PRT) for 12 weeks. MAIN OUTCOME MEASURES: Midthigh cross-sectional muscle area (CSMA), physical functioning (PF), costs, and cost-effectiveness in dollars/quality-adjusted life-years (dollars/QALYs). RESULTS: The OX and PRT subjects had increases in CSMA (7.0% +/- 2.5%, P = 0.01; 5.0% +/- 2.0%, P = 0.04, respectively), although these increases did not differ significantly from the NA arm (NA: 1.0% +/- 1.0%; OX vs. NA: P = 0.09; PRT vs. NA: P = 0.26). Only PRT caused significant improvements in PF (mean +/- SE: 10.4 +/- 3.8 points on a 100-point scale) and 7 measures of strength (P values: 0.04 to <0.001). There were no overall differences between groups in PF change. Among patients with impaired baseline PF, however, OX was significantly less effective than NA and PRT was significantly better than NA. All treatments led to increases in protein intake and performance; NA and PRT also increased caloric intake. The institutional costs per subject in this trial were 983 dollars for NA, 3772 dollars for OX, and 3189 dollars for PRT. At a community-based level of intensity, the institutional costs per QALY were 45,000 dollars (range: 42,000 dollars-64,000 dollars) for NA, 147,000 dollars (range: 147,000 dollars-163,000 dollars) for OX, and 31,000 dollars (range: 21,000 dollars-44,000 dollars) for PRT. CONCLUSIONS: OX and PRT induce similar improvements in body composition, but PRT improves quality of life more than nutrition or OX, particularly among patients with impaired PF. PRT was the most cost-effective intervention, and OX was the least cost-effective intervention.