Biotech Values

[DewDiligence]

UK’s NICE Approves Pradaxa for VTE Prevention

[This was fast work: Pradaxa was approved for marketing by the EU in March 2008 (#msg-27956748), and NICE frequently takes longer than six months to approve a new, premium-priced drug.

Some handy factoids from this PR:
1) Approx. 30% of surgical patients are affected by DVT.
2) Annual UK deaths following development of blood clots in hospitals exceed the combined total deaths from breast cancer, AIDS, and car accidents and are >25x the annual deaths from MRSA.

For background information on anticoagulants in development, please see #msg-32382362.]

http://biz.yahoo.com/prnews/080924/3746876en_public.html

›Nice Approves Pradax (Dabigatran Etexilate) - First New Oral Anticoagulant in the UK for Over 50 Years

Wednesday September 24, 3:23 am ET

LONDON, September 24 /PRNewswire/ -- Clinicians and patient groups have welcomed today's announcement by the National Institute of Health and Clinical Excellence (NICE) recommending Pradaxa® (dabigatran etexilate) as an option for the primary prevention of venous thrombembolic events in adults who have undergone elective total hip or total knee replacement surgery. This positive NICE appraisal coincides with the recent publication of a government venous thromboembolism (VTE) risk assessment tool recommended for all patients admitted to hospital in England by the Department of Health. Routine risk assessment is a fundamental step in ensuring patients at risk of developing VTE receive the appropriate therapy and management. VTE is a potentially fatal blood clotting disease which includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

VTE is the most common cause of preventable hospital death in the UK. Up to 32,000 patients die every year in the UK after developing blood clots in hospital and a recent analysis by the All Party Parliamentary Thrombosis Group revealed that over 10,700 UK hospital patients may have died from blood clots in just seven months during 2007 as a result of clinical guidelines not being implemented.

Until now, anticoagulant therapy to prevent blood clots after major orthopaedic surgery has generally required administration by injection. Pradaxa® is the first new oral anticoagulant to be launched in the UK for over 50 years. It is a fixed dose, once daily capsule that may be taken with or without food. NICE concluded that Pradaxa®, as an oral therapy, without the need for monitoring, would reduce National Health Service (NHS) administration costs and may support adherence to treatment.

The charity AntiCoagulation Europe welcomed NICE's recommendation. Chief Executive, Eve Knight, said:

"We are delighted with today's NICE announcement, and also very pleased that the long awaited Risk Assessment Tool has finally been published. It is appalling that patients are still developing and dying from VTE, which could be prevented by risk assessing every patient on admission to hospital and giving preventative treatment where needed. Pradaxa, a once daily oral therapy for use in post orthopaedic surgery, will enhance the treatment options available and enable clinicians and patients to make decisions on choice of treatment appropriate to their clinical needs."

Key facts

- NICE has recently reported that approximately 30 per cent of surgical patients are affected by DVT

- During 2006/7, 131,378 patients underwent hip and knee replacement surgery in the UK

- Total deaths (32,000) following development of blood clots in hospital, including those related to hip and knee replacement, exceed the combined total deaths from breast cancer, AIDS and road traffic accidents and equate to more than 25 times the annual deaths from MRSA

- In contrast to the number of deaths, the NHS spends ten times as much on MRSA prevention as prevention of VTE from all causes

- VTE is estimated to cost the NHS a total of GBP640 million every year to manage. 60 - 80 per cent of this could be saved through preventative measures

- Although guidelines recommend preventative therapy for 10-35 days, clinical practice varies widely and therapy is often not maintained following hospital discharge.

VTE is known internationally as the 'silent killer' as often the first manifestation may be a potentially fatal PE. This means risk assessment and prevention strategies are crucial. The new Department of Health risk tool aims to create a standardised national preventive strategy to make the goal of reducing death from VTE in all patients more attainable, potentially saving thousands of lives every year.

On confirmation of the NICE recommendation, Des Turner, Member of Parliament for Brighton Kemptown and Secretary of the All Party Parliamentary Thrombosis Group commented:

"Currently lives are being lost because of inadequate clot-prevention therapy. Research by the All Party Parliamentary Group on Thrombosis showed that over 10,700 UK hospital patients may have died from blood clots in just seven months during 2007 as a result of clinical guidelines not being implemented. NICE approval for Pradaxa will provide a real boost to patients undergoing hip and knee replacement surgery where potentially fatal clotting is a real risk. I will continue to campaign to ensure VTE is given the political and public prioritisation it deserves."

Pradaxa® was approved by the EMEA for marketing in all EU member countries in March 2008 and since then swift progress has been made with positive recommendations from local Health Technology Assessment bodies in Scotland (Scottish Medicines Committee), Denmark (Danish Medicines Agency) and The Netherlands (The Health Care Insurance Board). To date, Pradaxa® has been launched in a total of eleven countries.

Pradaxa® is one of a new class of drugs to tackle DVT and PE called direct thrombin inhibitors (DTI). DTIs directly block the enzyme thrombin which is central to the clotting process.

Full details of the NICE guidance can be accessed via http://www.nice.org.uk

Dabigatran etexilate, within its marketing authorisation, is recommended as an option for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip replacement surgery or elective total knee replacement surgery.

The Committee acknowledged that oral administration of dabigatran etexilate, without the need for monitoring, would reduce administration costs and may support adherence to treatment. The Committee therefore concluded that dabigatran etexilate should be recommended as an option in the circumstances in which LMWH (or fondaparinux as an alternative) may be offered.

Standard Recommended Dosage of Pradaxa® in VTE Prevention

The standard recommended dosage of Pradaxa® in VTE prevention is a fixed oral dose of 220 mg given once daily. A single capsule of 110 mg (half-dose) is administered orally between 1 and 4 hours following surgery, continuing with 2 capsules once daily thereafter for a total of 10 days in total knee replacement patients and 28-35 days in total hip replacement patients. A second approved dosage of 150 mg taken as two capsules of 75 mg is recommended for specific patient populations, including patients over 75 years of age and those with moderate renal impairment.

Further Indications Under Investigation

Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa® within the global RE-VOLUTION(TM) clinical trial programme which involves over 38,000 patients. Pradaxa®'s efficacy and safety is being assessed for:

- Stroke prevention in atrial fibrillation (SPAF) in the RE-LY(TM) trial - the largest SPAF trial to date. Enrollment of a total of 18,113 patients for the RE-LY(TM) trial was completed in December 2007. Results are expected in 2009

- Treatment of acute VTE - results expected in 2009

- Secondary prevention of VTE

- Prevention of cardiac events in patients with acute coronary syndrome

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 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.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit http://www.boehringer-ingelheim.co.uk‹