AbbVie Announces Reimbursement for VRAYLAR® (cariprazine) for the Treatment of Schizophrenia under the Non-Insured Health Benefits (NIHB) Program

MONTREAL, June 7, 2023 /CNW/ - AbbVie (NYSE: ABBV), today announced that VRAYLAR is now listed as a Limited Use product on the formulary of the Non-Insured Health Benefits (NIHB)¹ program for the treatment of schizophrenia.

Information regarding the specific reimbursement criteria may be found by consulting the link below:

• Non-Insured Health Benefits Program – Drug Benefit List

This announcement comes 13 months after the authorization of VRAYLAR by Health Canada, bringing an additional treatment option to Canadians living with schizophrenia.

Schizophrenia is a severe mental illness that can impact a person's ability to function, and often presents symptoms that can change over time. Symptoms can include hallucinations, disorganized speech, social withdrawal, and catatonic behaviour. An estimated 300,000 Canadians are impacted by schizophrenia.²

About VRAYLAR^® (cariprazine)³     

VRAYLAR is an oral, once daily atypical antipsychotic indicated as monotherapy for the acute management of manic, mixed, and depressive episodes associated with bipolar l disorder in adults, as well as the treatment of schizophrenia in adults.

The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at central dopamine D3, D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding and functional activity profiles similar to the parent drug.

VRAYLAR is contraindicated in patients who are hypersensitive to cariprazine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.  VRAYLAR is also contraindicated with concomitant use with strong and moderate CYP3A4 inhibitors / inducers. Due to the slow elimination of cariprazine and its metabolites, treatment with strong and moderate CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR discontinuation.

VRAYLAR is being developed jointly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in the U.S., Canada, Japan, Taiwan and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru and Venezuela).

Please consult the Vraylar Product Monograph for important safety information on serious warnings and precautions, other warnings and precautions, adverse reactions, interactions, dosing and conditions of use. The Product Monograph is also available by calling 1-888-704-8271.

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¹ Non-Insured Health Benefits Program. https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407  Accessed June 5, 2023.

² Schizophrenia Society of Canada. Learn more about Schizophrenia. Retrieved from https://schizophrenia.ca/learn-more-about-schizophrenia/.  Accessed June 2023

³ VRAYLAR Product Monograph. AbbVie Corporation. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VRAYLAR_PM_EN.pdf  Accessed June 2023

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

SOURCE AbbVie Canada

Media: Dominique Touchette, AbbVie Canada, 438-821-3971, [email protected]