Tesamorelin (Egrifta) is indicated for the treatment of excess visceral adipose tissue (VAT), as assessed by waist circumference ≥ 95 cm for males and ≥ 94 cm for females, and confirmed by a VAT level > 130 cm2 by computed tomography (CT) scan, in treatment-experienced adult HIV-infected patients with lipodystrophy. The dosage is 2 mg (two 1 mg vials) injected subcutaneously once a day. Treatment with tesamorelin should be limited to patients who failed to reduce excess VAT using diet and exercise. The submitted price is $3,085 per box of 60 vials (30-day supply). The annual cost of treatment is $37,534 per patient.
The manufacturer submitted a cost-utility analysis comparing tesamorelin with standard of care (lifestyle modifications, nutrition, and physical activity) in patients with HIV-associated lipohypertrophy over a lifetime time horizon (30 years) from the perspective of a Canadian health care payer. Baseline probabilities and the increased risk of lipohypertrophy-related clinical events, costs, and quality of life data were obtained from observational literature (see APPENDIX 5: SUMMARY OF PARAMETERS USED IN THE SUBMISSION for details). Non-adherence to HIV treatment due to lipohypertrophy was obtained from observational studies. Complete responders, as defined as per the clinical trials (≥ 8% reduction in VAT), were assumed to have no increased risk of lipohypertrophy-related clinical events (revert to the same risks as for the general population) and exhibit full adherence to HIV-treatments.
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