Bausch Health Statement on Selection of XIFAXAN(R) (rifaximin) for Inflation Reduction Act's Medicare Negotiation Program
Bausch Health (NYSE/TSX: BHC) announced that XIFAXAN® (rifaximin) 550 mg tablets has been selected by the Centers for Medicare and Medicaid Services (CMS) for the second round of price negotiations under the Inflation Reduction Act. The negotiated pricing will take effect in 2027.
The company plans to engage with CMS to demonstrate XIFAXAN's healthcare system value, highlighting recommendations from The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), which gave XIFAXAN® their highest recommendation (Grade I, A,1) in practice guidelines.
Bausch Health (NYSE/TSX: BHC) ha annunciato che XIFAXAN® (rifaximina) in compresse da 550 mg è stato selezionato dai Centers for Medicare and Medicaid Services (CMS) per il secondo round di negoziazioni sui prezzi nell'ambito dell'Inflation Reduction Act. I prezzi negoziati entreranno in vigore nel 2027.
L'azienda prevede di collaborare con il CMS per dimostrare il valore di XIFAXAN per il sistema sanitario, evidenziando le raccomandazioni della American Association for the Study of Liver Diseases (AASLD) e della European Association for the Study of the Liver (EASL), che hanno conferito a XIFAXAN® la loro massima raccomandazione (Grade I, A,1) nelle linee guida pratiche.
Bausch Health (NYSE/TSX: BHC) anunció que XIFAXAN® (rifaximina) en tabletas de 550 mg ha sido seleccionado por los Centros de Servicios de Medicare y Medicaid (CMS) para la segunda ronda de negociaciones de precios bajo la Inflation Reduction Act. Los precios negociados entrarán en vigor en 2027.
La empresa tiene planes de colaborar con el CMS para demostrar el valor de XIFAXAN en el sistema de salud, destacando las recomendaciones de la American Association for the Study of Liver Diseases (AASLD) y de la European Association for the Study of the Liver (EASL), que otorgaron a XIFAXAN® su máxima recomendación (Grade I, A,1) en las guías de práctica.
바우슈 헬스 (NYSE/TSX: BHC)는 XIFAXAN® (리팍시민) 550mg 정제가 인플레이션 감축법에 따라 메디케어 및 메디케이드 서비스 센터(CMS)의 두 번째 가격 협상 라운드에 선정되었음을 발표했습니다. 협상된 가격은 2027년에 시행될 예정입니다.
회사는 XIFAXAN이 의료 시스템에서의 가치를 입증하기 위해 CMS와 협력할 계획이며, 미국 간 질환 연구 협회 (AASLD) 및 유럽 간 연구 협회 (EASL)의 추천을 강조하고 있으며, 이들은 XIFAXAN®에 대해 그들의 최고 추천(Grade I, A,1)을 제공했습니다.
Bausch Health (NYSE/TSX: BHC) a annoncé que XIFAXAN® (rifaximine) en comprimés de 550 mg a été sélectionné par les Centers for Medicare and Medicaid Services (CMS) pour le deuxième tour de négociations de prix dans le cadre de la loi sur la réduction de l'inflation. Les prix négociés entreront en vigueur en 2027.
L'entreprise prévoit de collaborer avec le CMS pour démontrer la valeur de XIFAXAN pour le système de santé, en soulignant les recommandations de l'American Association for the Study of Liver Diseases (AASLD) et de l'European Association for the Study of the Liver (EASL), qui ont attribué à XIFAXAN® leur plus haute recommandation (Grade I, A,1) dans les recommandations pratiques.
Bausch Health (NYSE/TSX: BHC) gab bekannt, dass XIFAXAN® (Rifaximin) 550 mg Tabletten von den Centers for Medicare and Medicaid Services (CMS) für die zweite Runde der Preishandelsverhandlungen im Rahmen des Inflation Reduction Act ausgewählt wurden. Die verhandelten Preise treten 2027 in Kraft.
Das Unternehmen plant, mit dem CMS zusammenzuarbeiten, um den Wert von XIFAXAN für das Gesundheitssystem zu demonstrieren und dabei die Empfehlungen der American Association for the Study of Liver Diseases (AASLD) und der European Association for the Study of the Liver (EASL) hervorzuheben, die XIFAXAN® die höchste Empfehlung (Grade I, A,1) in den Praxisleitlinien gegeben haben.
- XIFAXAN has received highest possible recommendation (Grade I, A,1) from major liver disease associations
- XIFAXAN selected for Medicare price negotiations, potentially leading to lower drug pricing and reduced revenues from 2027
- Company faces mandatory participation in CMS drug price negotiations
Insights
The selection of XIFAXAN for Medicare price negotiation represents a significant business risk for Bausch Health. XIFAXAN is one of the company's key revenue drivers, generating approximately
The timing is particularly challenging as XIFAXAN faces potential generic competition in the coming years. While the drug maintains strong clinical endorsements from leading medical associations (AASLD and EASL's Grade I, A,1 recommendation), these may have impact on price negotiations. Historical Medicare price negotiations typically result in
For everyday investors: Think of this like a landlord being forced to lower rent on their most profitable property. While the building (drug) remains valuable and well-regarded, the government-mandated price reduction will directly impact the bottom line. This creates significant uncertainty for Bausch Health's future profitability and stock valuation.
This development warrants serious investor attention as XIFAXAN represents approximately
The company's emphasis on clinical value and guideline recommendations indicates their likely negotiation strategy, but historical precedents suggest leverage against CMS's statutory authority. This could accelerate the need for pipeline diversification and may impact Bausch's ability to service its substantial debt load, which currently exceeds
LAVAL, QC / ACCESS Newswire / January 17, 2025 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals, today acknowledged that the Centers for Medicare and Medicaid Services (CMS) has selected XIFAXAN® (rifaximin) 550 mg tablets as one of the medicines for the second round of negotiation as part of the Inflation Reduction Act with an initial price applicability in 2027 of the Drug Price Negotiation program.
We look forward to engaging in open and transparent conversations with CMS, where we will share information on the value that XIFAXAN® delivers for the healthcare system in addition to sharing recommendations from The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) who gave XIFAXAN® the highest possible recommendation (Grade I, A,1) via their practice guidelines. We will continue to be driven by our commitment to patients in advocating for a healthcare environment that supports patient access to critical medications as well as encouraging future innovation.
About XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
HE (≥
10% ): Peripheral edema (17% ), constipation (16% ), nausea (15% ), fatigue (14% ), insomnia (14% ), ascites (13% ), dizziness (13% ), urinary tract infection (12% ), anemia (10% ), and pruritus (10% )IBS-D (≥
2% ): Nausea (3% ), ALT increased (2% )INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
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, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
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, including statements regarding the value or benefits of our pharmaceutical products. 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.
Investor Contact:
Garen Sarafian
ir@bauschhealth.com
(877) 281-6642 (toll free)
Media Contact:
Katie Savastano
corporate.communications@bauschhealth.com
(908) 569-3692
SOURCE: Bausch Health Companies Inc.
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FAQ
When will the Medicare price negotiations for BHC's XIFAXAN take effect?
What clinical recommendations has XIFAXAN received from liver disease associations?
How will the Inflation Reduction Act's Medicare negotiations affect BHC's XIFAXAN sales?
What is Bausch Health's response to XIFAXAN being selected for Medicare price negotiations?
