PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel) Treatment for Acne Vulgaris Receives Positive Reimbursement Recommendations from Canada's Drug Agency and Quebec's INESSS
Bausch Health Canada announced positive reimbursement recommendations from Canada's Drug Agency (CDA) and Quebec's INESSS for PrCABTREO, their triple-combination topical treatment for acne vulgaris. The gel, containing clindamycin phosphate, adapalene, and benzoyl peroxide, is approved for patients 12 years and older. As the first and only triple-combination topical acne treatment approved by Health Canada, CABTREO combines three mechanisms of action. The company will now work with the pan-Canadian Pharmaceutical Alliance to finalize reimbursement terms for Canada's public drug plans. The prescription therapy is currently available through pharmacies across Canada.
Bausch Health Canada ha annunciato raccomandazioni positive per il rimborso da parte dell'Agenzia dei Farmaci canadese (CDA) e di INESSS del Quebec per PrCABTREO, il loro trattamento topico a tripla combinazione per l'acne vulgare. Il gel, contenente fosfato di clindamicina, adapalene e perossido di benzoile, è approvato per pazienti di età pari o superiore ai 12 anni. Essendo il primo e unico trattamento topico per l'acne a tripla combinazione approvato da Health Canada, CABTREO combina tre meccanismi d'azione. L'azienda lavorerà ora con l'Alleanza farmaceutica pan-canadese per finalizzare i termini di rimborso per i piani farmaceutici pubblici del Canada. La terapia prescrittiva è attualmente disponibile tramite le farmacie in tutto il Canada.
Bausch Health Canada anunció recomendaciones de reembolso positivas por parte de la Agencia de Drogas de Canadá (CDA) y de INESSS de Quebec para PrCABTREO, su tratamiento tópico de triple combinación para el acné vulgar. El gel, que contiene fosfato de clindamicina, adapaleno y peróxido de benzoilo, está aprobado para pacientes de 12 años en adelante. Siendo el primer y único tratamiento tópico para el acné de triple combinación aprobado por Health Canada, CABTREO combina tres mecanismos de acción. La compañía ahora trabajará con la Alianza Farmacéutica Pan-Canadiense para finalizar los términos de reembolso para los planes de medicamentos públicos de Canadá. La terapia prescrita está actualmente disponible en farmacias de todo Canadá.
바우쉬 헬스 캐나다가 캐나다 약국국(CDA) 및 퀘벡 INESSS의 긍정적인 재정 지원 권고를 발표했습니다. PrCABTREO는 여드름 치료를 위한 3중 복합 외용요법입니다. 클린다마이신 인산염, 아다팔렌, 벤조일 과산화물을 포함하는 이 젤은 12세 이상의 환자에게 승인되었습니다. 캐나다 보건부에서 승인한 첫 번째이자 유일한 3중 복합 여드름 치료인 CABTREO는 세 가지 작용 메커니즘을 결합합니다. 이 회사는 이제 캐나다 공공 약제 계획을 위한 재정 지원 조건을 완료하기 위해 범캐나다 제약 동맹과 협력할 것입니다. 처방 치료는 현재 캐나다 전역의 약국에서 제공됩니다.
Bausch Health Canada a annoncé des recommandations de remboursement positives de l'Agence Canadienne des Médicaments (CDA) et de l'INESSS du Québec pour PrCABTREO, leur traitement topique à triple combinaison pour l'acné vulgaire. Le gel, contenant du phosphate de clindamycine, de l'adapalène et du peroxyde de benzoyle, est approuvé pour les patients de 12 ans et plus. En tant que premier et unique traitement topique pour l'acné à triple combinaison approuvé par Santé Canada, CABTREO combine trois mécanismes d'action. L'entreprise va maintenant collaborer avec l'Alliance Pharmaceutique Pan-Canadienne pour finaliser les conditions de remboursement pour les régimes publics de médicaments du Canada. La thérapie sur ordonnance est actuellement disponible dans les pharmacies à travers le Canada.
Bausch Health Canada gab positive Erstattungsempfehlungen von Canadas Arzneimittelagentur (CDA) und INESSS von Quebec für PrCABTREO, ihre topische Dreifachkombination zur Behandlung von Akne vulgaris, bekannt. Das Gel, das Clindamycinphosphat, Adapalen und Benzoylperoxid enthält, ist für Patienten ab 12 Jahren zugelassen. Als erste und einzige topische Aknebehandlung in Dreifachkombination, die von Health Canada genehmigt wurde, kombiniert CABTREO drei Wirkmechanismen. Das Unternehmen wird nun mit der pan-kanadischen Pharmaceutical Alliance zusammenarbeiten, um die Erstattungsbedingungen für die öffentlichen Arzneimittelpläne Kanadas abzuschließen. Die verschreibungspflichtige Therapie ist derzeit über Apotheken in ganz Kanada erhältlich.
- Received positive reimbursement recommendations from two major Canadian health agencies
- First and only triple-combination topical acne treatment approved by Health Canada
- Product already available through pharmacies across Canada
- None.
Insights
The positive reimbursement recommendations from Canada's Drug Agency and Quebec's INESSS for PrCABTREO represent a significant milestone for Bausch Health. This triple-combination acne treatment's potential inclusion in public drug plans could substantially expand market access across Canada. The therapy combines clindamycin phosphate, adapalene and benzoyl peroxide in a unique formulation that addresses multiple aspects of acne pathogenesis.
The reimbursement pathway through pCPA negotiations typically leads to broader market penetration and increased prescription volumes. Given that acne affects approximately
LAVAL, QC / ACCESSWIRE / November 18, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE/TSX:BHC), today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel
The recommendations are an important element in the process to achieve reimbursement of a new medication by Canada's public drug plans operated by the provinces, territories and federal government. Bausch Health, Canada will now work with the pan-Canadian Pharmaceutical Alliance (pCPA) to agree on the particulars regarding the reimbursement of CABTREO by Canada's public drug plans.
CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action - an antibiotic, a retinoid and an antibacterial agent - to provide a safe and effective treatment.1
"The positive recommendations of both CDA and INESSS are important steps in achieving the inclusion of CABTREO on Canada's public drug plans and recognize this new treatment's value in helping Canadians with acne," said Amy Cairns, General Manager, Bausch Health, Canada. "We look forward to working with the pCPA to finalize the terms of eventual drug plan listings to increase the availability of CABTREO to Canadians who might benefit from it."
"We are thrilled that Canadians with acne will soon have access to new treatment options that may improve their quality of life," said Kathy Giangaspero, Executive Director of the Acne and Rosacea Society of Canada. "Acne is a chronic skin condition and can greatly impact a person's physical, emotional and social well-being."
CABTREO is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene, and the oxidizing agent benzoyl peroxide which has a broad-spectrum bactericidal activity.1 The prescription therapy is available now through pharmacies across Canada.
About Acne Vulgaris
Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3
CABTREO Clinical Data and Safety Information
CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately
The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn's disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1
Health Canada has not authorized CABTREO for pediatric use under the age of 12 years.CABTREO is for topical use only and is not for oral, ophthalmic use or intravaginal use.1
About Dermatology at Bausch Health, Canada
Bausch Health, Canada has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products.
CABTREO is the fourth new dermatology treatment from Bausch Health, Canada approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene) lotion,
All four treatments - CABTREO, ARAZLO, BRYHALI and DUOBRII - are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC), is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on LinkedIn.
The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.
Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words "will," "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
REFERENCES
1 Bausch Health, Canada Inc., CABTREO Product Monograph, https://pdf.hres.ca/dpd_pm/00076715.PDF.
2 Canadian Dermatology Association, Acne, Quick Facts, https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%
3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024.
4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.
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SOURCE: Bausch Health Companies Inc.
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FAQ
What reimbursement recommendations did Bausch Health (BHC) receive for CABTREO?
What is unique about CABTREO's approval for Bausch Health (BHC)?
When will CABTREO be available through Canadian public drug plans for Bausch Health (BHC)?
