NICE Issues Interim Appraisal Consultation Document (ACD) Recommending Xarelto®▼ (rivaroxaban) 2.5mg as an option for Secondary Prevention in ACS
SOURCE: bayer
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NICE Issues Interim Appraisal Consultation Document (ACD) Recommending Xarelto®▼ (rivaroxaban) 2.5mg as an option for Secondary Prevention in ACS                                                                                         

  •  UK NICE ACD guidance recommends 2.5mg Xarelto® twice daily in combination with aspirin alone or aspirin plus clopidogrel or ticlopidine as an option for secondary prevention in acute coronary syndrome (ACS) in patients with elevated cardiac biomarkers1 without prior stroke or TIA.
  • The Final Appraisal Determination (FAD) will follow in the coming months

Newbury, UK, 23rd October, 2014: The National Institute for Health and Care Excellence (NICE) today issued its Appraisal Consultation Document (ACD) recommending Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS). Bayer HealthCare is pleased with the outcome, which highlights the improved patient outcomes using Xarelto as a treatment option on top of dual antiplatelet therapy*, and hopes that this decision is reflected in the Final Appraisal Determination (FAD) which is to follow.

Coronary heart disease is the leading cause of death in the UK and worldwide, and is responsible for around 74,000 deaths annually in the UK alone.2 ACS itself results in over 114,000 hospital admissions each year3 demonstrating that the incidence of death as a result of cardiovascular events or myocardial infarction remains high for those who have suffered an ACS event, even when treated with dual antiplatelet therapy*.

“Patients with ACS remain at risk even though there have been a number of advances in treatment over the past few years, including newer antiplatelet agents. This is evidenced by the high incidence of cardiovascular death, myocardial infarction and stroke in patients following an ACS event. Rivaroxaban offers an option for secondary prevention in this patient group, and we hope that selected patients in the UK will be able to benefit from this advance in therapy” said Luis Felipe Graterol, Medical Director, Bayer Plc.

The positive ACD is based on a thorough review of the clinical effectiveness of 2.5mg rivaroxaban twice daily in the randomised controlled landmark ATLAS ACS 2 TIMI 51 trial in which Xarelto has shown significant advantages in the secondary prevention of ACS in patients with elevated cardiac biomarkers without prior stroke or TIA.1

Among patients with elevated cardiac biomarkers and no prior stroke or transient ischemic attack (TIA), Xarelto 2.5 mg twice daily on top of dual antiplatelet therapy* demonstrated statistically significant reductions in the primary outcome of death from cardiovascular causes, myocardial infarction or stroke in patients with a recent acute coronary syndrome (ACS) compared with a placebo ((20%) ARR 2.1; HR 0.80(0.68-0.94), P = 0.007; NNT 48) as well as CV death by 45% RRR (ARR 2.0; HR 0.55 (0.41-0.74), P < 0.001; NNT=50) and all-cause death by 42% RRR (ARR 2.1; HR 0.58 (0.44-0.77), P < 0.001; NNT=49).4,6

The dual pathway treatment strategy tested in ATLAS ACS 2 TIMI 51 recognises the importance of thrombin generation following ACS events, and confirmed the clinical benefits that Xarelto 2.5mg twice daily can deliver on top of dual antiplatelet therapy*.  This offers an innovative approach in the prevention of atherothrombotic events and delivers an important mortality benefit.

*(in combination with aspirin alone or aspirin plus clopidogrel or ticlopidine)

The NICE announcement is in alignment with the current European Guidelines for the treatment of STEMI, set by the European Society of Cardiology and the approval by the European Medicines Agency. The option of treatment with 2.5mg Xarelto twice daily will be available on the NHS from 22nd October 2014. 

Media contacts:
Hayley Knight,Bayer UK                  
Tel. +44 (0)1635 563522                   
Mobile: +44 (0) 7788 365833             
E-Mail: hayley.knight@bayer.com    

Notes to Editors:

About Xarelto (rivaroxaban) 

Xarelto is the most broadly indicated NOAC and is marketed under the brand name Xarelto. To date, Xarelto has been approved for use in more than 125 countries, across all indications, and in the UK specifically to date across the following indications:5

  • The prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors
  • The treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE in adults
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery
  • The prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, without prior stroke or TIA, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine

Since the first approval of Xarelto in the orthopaedic setting in 2008, more than 10 million patients worldwide have received the product in daily clinical practice.6

Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).

Anticoagulant medicines are potent therapies used to prevent and/or treat blood clots, the consequences of which can be very serious, or to treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a ‘Prescriber’s Guide’ for physicians and a ‘Xarelto Patient Card’ for patients to support best practice.

About Bayer HealthCare 

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries.

Forward-Looking Statements 

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

  1. The ATLAS study investigators. Rivaroxaban in Patients with a recent Acute Coronary Syndrome. N. Engl. J. Med. 2012; 366: 9-19
  2. NHS Choices – Healthy Hearts. Available from: http://www.nhs.uk/Livewell/Healthyhearts/Pages/ Healthyheartshome.aspx
  3. Patient UK – ACS. Available from: http://www.patient.co.uk/health/acute-coronarysyndrome
  4. Mega J.L., Braunwald E., Murphy S. et al. Rivaroxaban in patients after an acute coronary syndrome with cardiac biomarker elevation:         insights from the ATLAS ACS 2 TIMI 51 trial. Presented at: European Society of Cardiology (ESC), 30 August–03 September, 2014; Barcelona, Spain
  5. Xarelto SmPC
  6. Data on file, Bayer HealthCare
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