OBJECTIVES : Lipohypertrophy, is a modification in body fat distribution amongst patients living with human immunodeficiency virus (HIV) and defined by a localized intra-abdominal fat accumulation. Lipohypertrophy is independently associated with a significant increase of morbidities and mortality. The standard of care (SoC) for HIV-associated lipohypertrophy includes lifestyle changes but the results are inconsistent. The aim of this analysis was to estimate the cost effectiveness of tesamorelin, a growth hormone-releasing hormone versus SoC in HIV-associated lipohypertrophy.

METHODS : A cost–utility analysis (CUA) based on a hybrid model including a decision-tree method followed by a Markov model was constructed to evaluate tesamorelin or SoC for HIV-associated lipohypertrophy. The model took a US payer perspective and used a 30-year horizon. The efficacy endpoints and transition rates used in the Markov model, such as response, time-on-treatment, and discontinuation for SoC and tesamorelin, were based on two multicenter, double-blind, randomized clinical trials (LIPO-010 and LIPO-011). Model utilities were based on the HRQoL measures included in the clinical trial for short-term health states (response, etc.) and sourced from the literature for long-term complications. Costs were estimated for drugs, routine care, complications, adverse events, and mortality.

RESULTS : Tesamorelin showed a QALY gain of 0.59 and an overall incremental cost of $46,123 versus SoC, yielding an incremental cost-effectiveness ratio (ICER) of $77,908/QALY. Deterministic and probabilistic sensitivity analyses generally showed consistency with base case findings. Results were most sensitive to variations in the relative risk of osteoporosis and in the utility value for patient with significant decrease of visceral adipose tissue. Probabilistic sensitivity analyses showed that tesamorelin was an efficient use of resources, with 71.8% of simulations showing tesamorelin as cost-effective when using a $100,000/QALY threshold.

CONCLUSIONS : The clinical trial results, when applied in the economic analysis, showed cost effectiveness in the base case when comparing tesamorelin with SoC.