Pharmacy Prior Authorization Criteria

Egrifta (tesamorelin)

For diagnosis of Excess Abdominal Fat Reduction in HIV-associated Lipodystrophy
Indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Limitations of use: 1) Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. 2) Not indicated for weight loss management as it has a weight neutral effect. 3) There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

AND

AND

AND

AND

AND

Fasting blood glucose (FBG) levels less than or equal to 150 mg/dL (8.33 mmol/L) [B]

AND

Patient has been on a stable regimen of antiretrovirals (e.g., nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, Protease Inhibitors, Integrase Inhibitors) for at least 8 weeks [C]

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

Patient demonstrates clinical improvement (e.g., improvement in visceral adipose tissue [VAT], decrease in waist circumference, belly appearance, etc.) while on therapy

2024-05-21, 2023-07-21, 2022-07-22, 2021-07-07, 2020-07-01, 2019-12-09, 2019-07-19

Egrifta SV Prescribing Information. Theratechnologies, Inc. Montreal, Canada. February 2024.
Egrifta FDA Medical Review. September 15, 2010. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000TOC.cfm. Accessed May 20, 2021.
Falutz J, Allas S, Blot K, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357:2359-2370.
Falutz J, Allas S, Mamputu JC, et al. Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. AIDS. 2008;22:1719-1728.
Falutz J, Mamputu JC, Potvin D, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95:4291-4304.
Falutz J, Potvin D, Mamputu JC, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010; 53(3):311-22.

Study sponsors requested a waiver for pediatric studies in children less than 18 years of age, and this waiver was granted by the FDA due to concerns that among patients with open epiphyses, excess growth hormone and IGF-1 may result in linear growth acceleration and excessive growth. [2]
Both pivotal studies included patients 18 to 65 years of age (mean age, 48 years) who met the waist circumference criteria [95 cm (37.4 inches) or greater for men; 94 cm (37 inches) or greater for women], who met the waist-to-hip ratio criteria (0.94 or greater for men; 0.88 or greater for women), who had a fasting blood glucose of less than 150 mg/dL (8.33 mmol/L) criteria, and who had been on a stable antiretroviral regimen for at least 8 weeks. Patients with a BMI (body mass index) of 20 kg/m^2 or less and patients with diabetes [fasting blood glucose (FBG) levels > 150 mg/dL] were among those excluded. [2-6]
The 8 weeks of antiretroviral regimen listed in the criteria is based on the inclusion criteria in the pivotal study. [2-6]

2024-05-21: 2024 annual review: updated to spell out NRTI and NNRTI in examples with no changes to clinical intent. Updated reauth language to replace "documentation of" with "patient demonstrates".
2023-07-21: Annual review - formatting update to age criterion, removed drug name from reauth. No changes to clinical intent.
2022-07-22: Annual review: no criteria changes, removed Egrifta 1mg SOLR as target as it's now obsolete.
2021-07-07: Annual review: Background updates. No changes to criteria.
2020-07-01: 2020 Annual Review: removed Egrifta 2mg SOLR as target due to withdrawal from market. No changes to criteria.
2019-12-09: added Egrifta SV to target products
2019-07-19: P&T approved 7/17/19: AR No clinical criteria changes. Updated references and background.