Mr. John Leasure reports

THERATECHNOLOGIES' IBALIZUMAB DEMONSTRATES COST-EFFECTIVENESS AS AN ADDITION TO ROUTINE CLINICAL CARE IN HEAVILY TREATMENT-EXPERIENCED PEOPLE WITH HIV

Theratechnologies Inc. has released data demonstrating the cost-effectiveness of ibalizumab, a monoclonal antibody anti-retroviral therapy (ART) commercialized in the United States under the trade name Trogarzo, as an addition to optimized background regimens (OBR) in heavily treatment-experienced (HTE) people with HIV (human immunodeficiency virus). The analysis, which was presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 conference in Orlando, Fla., suggests that adding ibalizumab to routine clinical care may provide payers with a cost-effective treatment option that can substantially improve outcomes for HTE individuals with HIV.

"As there is an increasing urgency for closer management of health care costs in the U.S., payers should prioritize therapies that can clearly demonstrate cost-effectiveness," said John Leasure, global commercial officer at Theratechnologies. "Although adding ibalizumab to optimized background regimens increases the costs of care, it also increases quality-adjusted life years, making this therapy a cost-effective component of HIV for those who are heavily treatment experienced."

Researchers employed a Markov model to estimate the cost per quality-adjusted life year (QALY) gained following the addition of ibalizumab to OBR from a U.S. payer perspective. They derived estimates of comparative effectiveness through a standardized mortality rate (SMR)-weighting comparison of data from two ibalizumab clinical trials with those from a real-world, non-ibalizumab control group in the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) database. Developed by epidemiologists at Epividian, OPERA is a large electronic health record (EHR) database containing patient-level data for about 14 per cent of the total U.S. HIV population. The analysis encompassed numerous costs, including those for treatment acquisition and administration, monitoring, adverse events, opportunistic infections, and terminal care. Mortality assumptions and health-state utility values were based on disease-specific published literature and clinical trial data.

Over a lifetime horizon, the addition of ibalizumab to OBR increased the time patients' HIV remained undetectable (less than 50 copies/millilitre (mL)) or suppressed (between 50 and 200 copies/mL). The addition of ibalizumab also extended patients' QALYs compared with OBR alone. Researchers calculated a base case incremental cost-effectiveness ratio (ICER) of $169,103 (U.S.) for ibalizumab versus OBR, a ratio that fell within an acceptable cost-effectiveness range for the population size. Deterministic and probabilistic scenario analyses indicated that the result was robust to changes to structural or parameter uncertainty.

The abstract was awarded a bronze medal by the conference peer reviewers, who used a one-to-five scale of the same five criteria used by the Journal of Managed Care Pharmacy to evaluate manuscripts: relevance, originality, quality, bias and clarity. Only 20 per cent of the submitted abstracts were given an award.

Complete abstract and poster details are available on the company's website.

About Trogarzo (ibalizumab-uiyk)

Trogarzo (ibalizumab-uiyk) is a long-acting, CD4-directed, postattachment HIV-1 inhibitor. In the United States, Trogarzo, in combination with other anti-retroviral(s), is indicated for the treatment of human immunodeficiency virus Type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current anti-retroviral regimen. Trogarzo is not approved in Canada.

Trogarzo is administered by intravenous infusion as a single loading dose of 2,000 milligrams (mg) followed by a maintenance dose of 800 mg every two weeks after dilution in 250 mL of 0.9 per cent sodium chloride injection, USP. In October, 2022, the Trogarzo maintenance dose was approved by the Food and Drug Administration to also be administered as an undiluted IV push over 30 seconds.

Important safety information

Do not receive Trogarzo if you have had an allergic reaction to Trogarzo or any of the ingredients in Trogarzo. Trogarzo can cause allergic reactions, including serious reactions, during and after infusion. Tell your health care provider or nurse, or get medical help right away if you experience any symptoms of an allergic reaction. Before you receive Trogarzo, tell your health care provider about all of your medical conditions, including if you are pregnant or plan to become pregnant as it is not known if Trogarzo may harm your unborn baby, or if you are breastfeeding or plan to breastfeed as it is not known if Trogarzo passes into breast milk. Tell your health care provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins and herbal supplements.

Changes in your immune system (immune reconstitution inflammatory syndrome) can happen when you start taking HIV-1 medicines. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your health care provider right away if you start having new symptoms after starting your HIV-1 medicine. The most common side effects of Trogarzo include diarrhea, dizziness, nausea and rash. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trogarzo. For more information, ask your health care provider or pharmacist.

Full prescribing information is available on the Trogarzo website.

About Theratechnologies Inc.

Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

We seek Safe Harbor.