Value through Innovation15 September 2014
01 November 2011

NICE issues Final Appraisal Determination (FAD) with unrestricted recommendation for Pradaxa® (dabigatran etexilate) for patients with non-valvular atrial fibrillation

The FAD states that Pradaxa® “is a cost-effective use of National Health Service (NHS) resources when used within its licensed indication.”

Ingelheim, Germany, 01 November 2011: Today, the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has issued a Final Appraisal Determination (FAD)1 recommending the novel oral anticoagulant, Pradaxa® (dabigatran etexilate), as a treatment option without any restrictions within its licensed indication for the prevention of stroke and systemic embolism in people with non-valvular atrial fibrillation (AF) with one or more risk factors . The FAD will form the guidance to the National Health Service (NHS) in England and Wales, which is expected to be published in December.

The novel oral anticoagulant Pradaxa® has been approved for this indication in more than 50 countries worldwide (including the U.S., Canada, Japan and the member states of European Union)2-6. Since the first launch of Pradaxa® in this new indication in October 2010, more than 450,000 patients have already been prescribed Pradaxa®.7-9

Prof. Dr. Klaus Dugi

Prof. Dr. Klaus Dugi

Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim commented, "Boehringer Ingelheim welcomes today’s recommendation by NICE, which once again confirms that Pradaxa® is both clinically effective and cost-effective in stroke prevention in AF. The NICE FAD is another important step forward to make this innovative new anticoagulant treatment option available to eligible patients with AF and to help protect more patients from the potentially devastating effects of an AF-related stroke.”

Pradaxa® was the first novel oral anticoagulant approved 2-6 for stroke prevention in AF since the current standard of care warfarin was made available approximately 55 years ago. The approvals were based on the landmark RE-LY® trial, which compared two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin in a PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial design.10-12

NOTES TO EDITORS

Pradaxa® (110mg and 75mg) is also licensed in the UK for the primary
prevention of venous thromboembolic events in adults who have
undergone elective total hip or elective total knee replacement
surgery.13,14

About AF and stroke
AF is the most common sustained heart rhythm condition,15 with one in four adults over the age of 4016 developing the condition in their lifetime. People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.16,17 Up to three million people worldwide suffer strokes related to AF each year.18-21 Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%).22 Many AF-related strokes can be prevented with appropriate antithrombotic therapy.23 AF-related strokes currently represent a significant cost to healthcare systems across Europe. Given AF-related strokes tend to be more severe this results in direct medical patient costs which are higher than non AF-related strokes annually (€11,799 vs €8,817 P < 0.001).24

About RE-LY®
RE-LY® (Randomized Evaluation of Long term anticoagulant therapY) was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) trial of 18,113 patients enrolled in over 900 centres in 44 countries designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with well controlled (INR 2.0-3.0, median TTR 67%) open label warfarin.2 Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.10,11

The primary endpoint of the trial was incidence of stroke (including haemorrhagic) or systemic embolism. Secondary outcome measures included all-cause death, incidence of stroke (including haemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).

About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)25 targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

About the dabigatran etexilate clinical trial programme
Boehringer Ingelheim’s clinical trial programme to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:

  • Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery
  • Treatment of acute VTE
  • Secondary prevention of VTE
  • Stroke prevention in AF.
  • Prevention of thromboembolism after heart valve replacement.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA or Canada.

* Previous stroke, transient ischaemic attack or systemic embolism; left ventricular ejection fraction below 40%; symptomatic heart failure of New York Heart Association (NYHA) class 2 or above; age 75 years or older; age 65 years or older with one of the following: diabetes mellitus, coronary artery disease or hypertension

References

1. NICE FAD, Accessed 1 November 2011: http://guidance.nice.org.uk/TA/Wave21/10
2. Pradaxa®, Summary of Product Characteristics, August 2011. Europe.
3. U.S. Food and Drug Administration – Pradaxa® Prescribing Information.Oct 19th, 2010.
4. Health Canada – PRADAX™ Product Monograph. Oct 26th, 2010.
5. razaxa® product information, January 2011, Japan.
6. Pradaxa®, Australian Product information, April, 2011.
7. Data on file. Boehringer Ingelheim Pharmaceuticals U.S., Inc.
8. Data on file. Boehringer Ingelheim Pharmaceuticals Canada, Inc.
9. Data on file. Boehringer Ingelheim Pharmaceuticals Japan, Inc.
10. Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009;361:1139-51.
11. Connolly SJ, et al. Newly identified events in the RE-LY® trial. N Engl J Med 2010;363(19):1875-6.
12. Ezekowitz MD, et al. Rationale and Design of RE-LY®: Randomized Evaluation of Long-Term Anticoagulation Therapy, Warfarin, Compared with Dabigatran. American Heart Journal 2009;157:805-10.
13. Pradaxa 110 mg hard capsules SPC 2011
14. Pradaxa 75 mg hard capsules SPC 2011
15. Stewart S, et al. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 2004;90:286–92.
16. Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004;110:1042-6.
17. Fuster V, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006;114:700-52.
18. Kannel WB, et al. Final Draft Status of the Epidemiology of Atrial Fibrillation. Med Clin North Am. 2008;92(1):17–40.
19. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Dec 2010 at www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf.
20. Wolf PA, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991:22(8);983-8.
21. Marini C, et al. Contribution of atrial fibrillation to incidence and outcome of ischaemic stroke: results from a population-based study. Stroke 2005;36:1115-9.
22. Lin HJ, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996;27:1760-4.
23. Hart RG, et al. Meta-Analysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Ann Intern Med 2007;146:857-67.
24. Bruggenjurgen B, et al. The Impact of Atrial Fibrillation on the Cost of Stroke: The Berlin Acute Stroke Study. Value Health 2007;10:137–43.
25. Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J Med 2005;353:1028-40.

Media contact

  • Malin
    Boehringer Ingelheim

    Media & PR
    Dr Reinhard Malin
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

Media contact

  • Malin
    Boehringer Ingelheim

    Media & PR
    Dr Reinhard Malin
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

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