MONTREAL, Nov. 08, 2018 (GLOBE NEWSWIRE) — Theratechnologies Inc. (Theratechnologies) (TSX: TH) is pleased to announce that Trogarzo® (ibalizumab-uiyk) injection has been assigned a specific J-Code. The new code will come into effect as of January 1, 2019.
J-Codes are developed and issued by the Centre for Medicare and Medicaid Services as part of the Healthcare Common Procedure Coding System (HCPCS) for reporting medical procedures and services.
The code number assigned to Trogarzo® is J-1746. Physicians will be able to use this specific code to submit claims for Trogarzo® to private and public payers.
“Obtaining a J-Code greatly facilitates administrative procedures for physicians and their staff as it standardizes the whole process from claim submission to payment. It is an integral part of any drug reimbursement strategy. This is yet another important milestone reached for Trogarzo® and it should play a part in supporting sales growth,” said Luc Tanguay, President and CEO, Theratechnologies Inc.
About Trogarzo® (ibalizumab-uiyk) injection
Trogarzo® is a CD4-directed post-attachment HIV-1 inhibitor.
Trogarzo®, in combination with other antiretroviral(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 antiretroviral regimen.
Important Safety Information
Before you receive Trogarzo®, tell your healthcare provider 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 healthcare 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 healthcare 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 healthcare provider or pharmacist.
Full prescribing information available at www.trogarzo.com
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the impact of the J-Code on the reimbursement and sales of Trogarzo®.
Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies’ control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: the J-Code will facilitate administrative procedures for physicians using Trogarzo®, sales of Trogarzo® will grow over time and Trogarzo® reimbursement will expand as a result of J-Code.
These risks and uncertainties include, but are not limited to, the risk that sales of Trogarzo® do not increase over time and that the reimbursement of Trogarzo® remains unaffected by such J-Code.
We refer potential investors to the “Risk Factors” section of our Annual Information Form dated February 6, 2018 available on SEDAR at www.sedar.com for additional risks and uncertainties about Theratechnologies, its business and products. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
Tel.: (514) 336-7800, ext. 236