NICE recommends once-daily LIXIANA® ▼ (edoxaban) for the treatment and prevention of recurrent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in adults

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Daiichi Sankyo UK Ltd

13 Jul, 2015, 08:09 GMT

GERRARDS CROSS, England, July 13, 2015 /PRNewswire/ --

NICE Final Appraisal Determination recommends that edoxaban is a cost effective use of NHS resources

The National Institute for Health and Care Excellence (NICE) has recommended a new treatment to help patients suffering from blood clots in the legs and lungs.[1]

NICE has issued a Final Appraisal Determination (FAD) for Lixiana (edoxaban) for the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.

The draft guidance states: "Edoxaban is recommended, within its marketing authorisation, as an option for treating and for preventing recurrent deep vein thrombosis and pulmonary embolism in adults."

It adds: "The Committee concluded that edoxaban could be recommended as a cost-effective use of NHS resources."

Edoxaban, made by the pharmaceutical company Daiichi Sankyo, is one of the class of blood-thinning drugs known as Non-VKA Oral Anti-Coagulants (NOACs). The drugs are used as an alternative to warfarin, which has been widely used for over 50 years but requires frequent monitoring to ensure the drug is working properly and is also associated with many food or drug interactions.

After a 5 day lead in with heparin treatment, edoxaban can be taken once a day and was shown to have comparable efficacy to warfarin but with a more  favourable safety profile.[2]

The term venous thromboembolism (VTE) is used to cover both deep vein thrombosis and the potentially fatal pulmonary embolism.

Figures from NICE say there are around 83,500 new cases of VTE each year in England. This equates to one in 500 of the population (200 per 100,000 of the population).[3]

In addition to new annual cases, there is another group of patients needing long-term treatment. This number is around 42,000.[3]

Therefore, says NICE, the annual number of patients receiving VTE treatment in England stands at some 125,500.[3]

The NICE approval comes shortly after edoxaban received European marketing authorisation for two indications:

  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

The NICE FAD called VTE "devastating" - and said some patients found the repeated checks needed with warfarin difficult.

"The Committee considered the experience of people with VTE. It noted submissions from clinical and patient experts which stated that the impact of a deep vein thrombosis or pulmonary embolism can be devastating, with patients often hospitalised, restricted in movement and unable to continue with previous activities. When recovering from VTE, patients may need further treatment and monitoring.

"It heard from the patient and clinical experts that the need for International Normalised Ratio (INR) checks when taking warfarin represents a major disadvantage, and the most important issue for patients is to have an effective treatment which minimises disruption to their day-to-day lives."

Dr Alexander Cohen, Consultant Vascular Physician from Guy's and St Thomas' Hospitals, Kings College London, who has researched edoxaban for venous thromboembolism, welcomed an additional resource to tackle the condition.

"No two patients are identical and what suits one may not suit another. Venous thromboembolism has a high rate of recurrence, which can be fatal. We need more tools to protect patients from a second incident and edoxaban will be of great use to doctors to help tailor treatments to specific patients."

Dr Simon Clough, UK General Manager for Daiichi Sankyo, said: "We are very pleased to be able to offer patients and doctors in England and Wales a new easy to use alternative in the treatment armoury against VTE. It is gratifying that NICE has found our therapy to be clinically effective and cost effective within just weeks from receiving our European authorisation."

Dr Clough added: "NICE has recognised an unmet clinical need among patients with VTE, and this recommendation confirms the value of edoxaban, which combines convenience and safety with features that patients and physicians appreciate."

The key clinical evidence for edoxaban in VTE came from a global phase 3 study, called Hokusai VTE,  which investigated the efficacy and safety of edoxaban compared with warfarin in 8,292 patients with either acute symptomatic deep vein thrombosis, pulmonary embolism, or both. This represents the largest single study carried out to date with a NOAC in this indication.[2]

Resources for the media 

To assist the media, UK-specific backgrounders are available on VTE and edoxaban. See further information details to obtain these.

About VTE 

Venous thromboembolism (VTE) is a condition in which a blood clot (a thrombus) forms in a vein, most commonly in the deep veins of the legs or pelvis. This is known as deep vein thrombosis, or DVT.[4]

The thrombus can dislodge and travel in the blood (an embolus), particularly to the pulmonary (lung) arteries. This is known as pulmonary embolism, or PE. The term VTE includes both DVT and PE.[4]

Venous thromboembolic diseases cover a spectrum ranging from asymptomatic calf vein thrombosis to symptomatic DVT. They can be fatal if they lead to PE, in which the blood supply to the lungs is blocked by the thrombus. Non-fatal VTE can cause serious long-term conditions such as post-thrombotic syndrome.[4]

About Edoxaban 

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin.

The global Phase 3 Hokusai-VTE study investigated 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. This represented the largest single VTE study carried out to date with a NOAC in this indication.[2]

The study found that edoxaban met the primary efficacy endpoint of non-inferiority compared to warfarin, following initial use of heparin in both arms, for the treatment and prevention of recurrent symptomatic venous thromboembolism (VTE).[2]

Once-daily edoxaban also demonstrated superiority compared to warfarin for the principal safety outcome of clinically relevant bleeding (the composite of major or clinically relevant non-major bleeding).[2]

Appropriate use of Edoxaban 

Haemorrhage is a common adverse effect of all anticoagulants.

  • Special care should be taken when deciding to prescribe edoxaban to patients with other conditions, procedures, and concomitant treatments, which may increase the risk of major bleeding.
  • As such, a detailed prescriber guide has been made available to HCPs to ensure correct use of the drug
  • In addition, every pack contains a patient alert card which can help alert treating HCPs in the case of routine or emergency interventions

The prescriber guide and a full list of contraindications, warnings and information on posology can be found in the edoxaban summary of product characteristics at https://www.medicines.org.uk/emc/medicine/30506

About Daiichi Sankyo  

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: http://www.daiichisankyo.com.

Forward-looking statements  

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References 

1 NICE Final Appraisal Determination. Edoxaban for treating and preventing deep vein thrombosis and pulmonary embolism. Issued 13 July 2015.

2 Büller H et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. New England Journal of Medicine 2013; 369(15): 1406-1415.

3 NICE. Support for commissioning anticoagulant therapy. Commissioning guide 49. Published 14 May 2013.

4 NICE. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. NICE clinical guideline 144. Issued June 2012.