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The new tests can support clinical decision making when prescribing direct oral anticoagulants for stroke prevention Increased testing is needed to meet growing demand since these anticoagulants were added to the WHO list of essential medicines The new assays will utilise Roche's reagent cassette concept, ensuring high quality results and efficient sample processing ROTKREUZ, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Roche announced today that it has launched three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban and rivaroxaban in countries accepting the CE mark1. These anticoagulants were added to the World Health Organization's Model List of Essential Medicines in 20192 due to the positive benefits they can have for patients. The tests could support clinical decision making in patients treated with direct oral anticoagulants for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, coronary artery disease (CAD), peripheral arterial disease (PAD) and for the prevention and treatment of venous thromboembolism (VTE). "Diseases such as CAD and PAD can have serious consequences and urgently need better diagnosis and treatment. CAD alone accounts for about one in every five deaths3 and PAD affects over 200 million adults worldwide4," said Frank Sieben, Head of Core Lab Customer Area at Roche Diagnostics. "These numbers and our growing understanding of these diseases are leading to a sharp rise in global demand for direct oral anticoagulants. We want to help labs meet this increased need for testing to better inform patient care. Labs will also benefit from our innovative cassette concept, which will let them bring scale and speed to testing." These tests can be used for both assessing the anti-Xa activity of heparin therapy as well as the three authorised Factor Xa inhibitors. This will bring standardisation and automate the reconstitution process without lab user intervention, saving time for other activities. The tests can be run on indicated cobas® t analysers and benefit from Roche's Anti-Xa innovative cassette technology. The reagent cassette concept ensures high quality of results by reducing risk of contamination and evaporation and can lead to a more optimised use of reagents. Roche in coagulation The Roche Coagulation journey started in the early 80's with the launch of COBAS® FIBRO. In the 90's, the Point of Care instruments CoaguChek® were launched and consolidated the use for INR monitoring. In 2017, Roche launched the cobas® t 511 and cobas® t 711 coagulation analysers for laboratories with different workflow needs; those instruments use the cassette concept for coagulation reagents which avoids manual preparation. During the last 5 years, the tests menu has been in constant expansion, showcasing the recurrent investment in lab coagulation, fulfilling our commitment to patients who live with haemostatic disorders and to the healthcare system that brings them care. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Roche Diagnostics. (2023). APIX, EDOX, RIVA CalSet and ControlSet Method Sheets (version 1) [2] National Library of Medicine [internet; cited 2024, Jan 30] Available from: [3] National Library of Medicine [internet; cited 2024, Jan 30] Available from: [4] National Library of Medicine [internet; cited 2024, Jan 30] Available from: For further information please contact Jonathan Parry, Roche Diagnostics Solutions Phone: + 41 79 653 76 43 e-Mail: [email protected]

The Centers for Medicare & Medicaid Services will make its initial offers for negotiated drugs by Feb. 1. At that time, the agency will share what it considers to be the maximum fair prices for those meds. With the Inflation Reduction Act's Medicare price negotiations moving ahead (PDF) rapidly, one party not officially involved in the talks is the Institute for Clinical and Economic Review (ICER). Formed in 2006, the organization seeks to illuminate the debate around the often controversial topic of drug pricing and access. And, as the IRA commands more and more attention within the biopharma industry, ICER could end up playing a growing role in the process.  Still, one key condition would need to be met for that to happen, the cost watchdog’s new president said in a recent interview. “I think we would need some direction from [the Centers for Medicare & Medicaid Services] that they wanted the drug price negotiation program to be about value, and not just about a lower price,” ICER’s president, Sarah Emond, told Fierce Pharma on the sidelines of the 2024 J.P. Morgan Healthcare Conference. ICER produces value-based pharmaceutical economics analyses. The organization’s drug cost-effectiveness reports are based on clinical data, comparative clinical effectiveness and long-term benefits plus medicines' impacts on patients’ quality of life and the overall healthcare system. “There’s parts of the statute that look a lot like a value assessment,” Emond said of the IRA. “Therapeutic advance, unmet need, cost and cost offset, … [they] sound an awful lot like what you do in a value assessment. But we’ll have to wait and see.” The biopharma industry should know soon what goes into the CMS’ pricing assessments. By Feb. 1, the agency is set to send its initial offers for the 10 drugs involved in the first round of negotiations, laying out what it considers to be the maximum fair prices for those products. The offers are expected to include the methodology used to reach the numbers, and the government plans to set the final prices by Aug. 1. Before the CMS publishes its findings, ICER has voluntarily conducted evaluations of two oral anticoagulants affected by the IRA—Bristol Myers Squibb and Pfizer’s Eliquis and Johnson & Johnson and Bayer’s Xarelto. Rather than spelling out specific prices, ICER calculated the premiums that the two factor Xa inhibitors could command over what Medicare pays for two older comparator meds, warfarin and dabigatran. Meanwhile, ICER has spoken with officials at the CMS to volunteer some ideas on the negotiation process. The CMS team was happy to listen, Emond said, but it’s not clear how much of the feedback it’s taken in. Looking forward, Emond said she hasn’t decided whether ICER will routinely produce reports for IRA-picked drugs in the future. For now, the organization remains focused on scrutinizing new launches. “If it turns out these reports are having important impact and are working towards the goal of better access and fairer prices for Medicare recipients, then, yes, that might work into our portfolio,” she said. While the IRA targets 10 medicines for negotiations at first, the number of affected drugs will increase to up to 20 drugs annually for 2029 and beyond. If ICER commits to routine IRA-related assessments, it would have to scale up, Emond said. It took six ICER staffers about six months to complete the first project on Eliquis and Xarelto.

Octapharma is Committed to Supplying Hospitals and Medical Providers with New Prothrombin Complex Concentrate PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. Continue Reading Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers. Post this Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro®. "The availability of Balfaxar® brings a welcome new treatment option for medical providers around the country," said Josh Goldstein, MD, PhD, Professor of Emergency Medicine at Harvard Medical School and Massachusetts General Hospital. "More than 2.4 million U.S. patients are prescribed warfarin to prevent blood clots from forming in patients who are at high risk.1 Unfortunately, the main side effect of warfarin is an increased risk of bleeding, which can complicate urgent surgery or invasive procedures.2 Clinical research has demonstrated that Balfaxar® is extremely effective in restoring blood coagulation by replenishing the levels of clotting factors that are deficient in those patients on warfarin." Balfaxar® is a non-activated 4F-PCC containing vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S. "We are excited to announce the availability of Balfaxar® and are committed to providing the medical community with a valuable life-saving therapy," said Octapharma USA President Flemming Nielsen. "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future. We look forward to working with our critical care medicine partners to ensure patients receive the absolute best treatments available." The FDA approval of Balfaxar® was supported by the clinical trial LEX-209 (ClinicalTrials.gov Identifier: NCT02740335), which compared the efficacy and safety of Balfaxar® head-to-head with a control 4F-PCC (Kcentra®). The Phase III, randomized, double-blind, multicenter study randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103). Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk. The primary objective was met at the prespecified interim analysis and the study was stopped due to statistically significant efficacy results. Balfaxar® demonstrated effective hemostasis in 94.6% of patients versus 93.5% of patients for Kcentra®. International Normalized Ratio (INR) reductions and vitamin K dependent coagulation factor increases supported the primary endpoint and PCC dosing and duration of infusion were also similar. The safety profile was similar between treatment arms and consistent with previous studies.3 To study Balfaxar® further in other clinical scenarios, Octapharma is recruiting for two additional Phase III studies: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (ClinicalTrials.gov Identifier: NCT04867837) LEX-211: Active-control Randomised Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery (ClinicalTrials.gov Identifier: NCT05523297) For more information on LEX-210 and LEX-211, please visit ClinicalTrials.gov. Kcentra® is a registered trademark of CSL Behring GmbH. For more information on Balfaxar®, please contact Octapharma customer service at 201-604-1130. About Balfaxar® Balfaxar® (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. WARNING: ARTERIAL and VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events, especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Balfaxar® in clinical trials and post marketing surveillance. Monitor patients receiving Balfaxar® for signs and symptoms of thromboembolic events. Balfaxar® may not be suitable in patients with thromboembolic events in the prior 3 months. For complete boxed warning and full prescribing information, please visit Balfaxar.com/pi. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com. REFERENCES 1 - ClinCalc.com, Warfarin: Drug Usage Statistics, United States, 2013 - 2020, accessed June 19, 2023. 2 - Mayo Clinic, Warfarin side effects: Watch for interactions, accessed June 19, 2023. 3 - Ravi Sarode, Joshua N. Goldstein, Gregory Simonian, Truman J. Milling Jr; A Phase 3, Prospective, Randomized, Double-Blind, Multicenter, Non-Inferiority Study Comparing Two Four-Factor Prothrombin Complex Concentrates for Reversal of Vitamin K Antagonist-Induced Anticoagulation in Patients Needing Urgent Surgery with Significant Bleeding Risk. Blood 2022; 140 (Supplement 1): 352–353. doi: SOURCE Octapharma