NICE ISSUES POSITIVE FINAL APPRAISAL DETERMINATION FOR COSENTYX®▼ (SECUKINUMAB)
Aug 04, 2016
For UK consumer, medical and trade media only
Frimley, UK, 4 August 2016 - Novartis announces today that the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Determination (FAD) recommending the use of Cosentyx®▼ (secukinumab) by the NHS in England and Wales, to treat adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
“Novartis welcomes the news that patients in England and Wales are one step closer to gaining access to Cosentyx for the treatment of ankylosing spondylitis. This decision acknowledges the significance of clinical data supporting this innovative treatment and highlights the potential of Cosentyx as the new standard of care for AS” said Hugh O’Dowd, Country President and General Manager - United Kingdom and Ireland, Novartis Pharmaceuticals Ltd. “Symptoms of this condition are often chronic and painful, impacting on patients’ daily lives and Novartis is committed to helping alleviate the burden that this condition brings to patients and their loved ones.”
AS is a long-term (chronic) condition in which the spine and other areas of the body become inflamed. There are around 200,000 people in the UK who have been diagnosed with the condition. It is painful and often progressively debilitating and could result in irreversible damage.3, Up to 70% of patients who go on to develop severe AS will form spinal fusions, a condition in which the bones grow together, over 10 to 15 years, which significantly reduces mobility.
As well as this, because it is a complex condition that can affect many parts of the body, it can cause complications. The symptoms of AS can vary by person but usually include back pain and stiffness, pain and swelling in other parts of the body, such as hips, knees and ribs and fatigue (extreme tiredness). AS can lead to additional health conditions, such as, osteoporosis, inflammation of the eye, inflammation of the aortic valve, and intestinal inflammation.2 AS can also impact upon people’s personal relationships and is associated with anxiety and depression. ,
The new final guidance follows earlier NICE advice for Cosentyx for restricted use within the NHS in England and Wales to treat adults with moderate to severe plaque psoriasis. The Scottish Medicines Consortium (SMC) published advice for Cosentyx in June 2015 for restricted use within NHS Scotland to treat adult patients with moderate to severe plaque psoriasis, and in July 2016 to treat adult patients with active AS who have responded inadequately to conventional therapy. ,
A Technology Appraisal Guidance (TAG) document will be published later this year that will give a final decision on whether the NHS is legally obliged to fund and resource Cosentyx within the NHS. Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS and are categorised into recommended, optimised, only in research and not recommended.
Notes to editors
About ankylosing spondylitis (AS) AS is a painful, progressively debilitating condition caused by inflammation of the spine. Up to 70% of patients with severe AS develop spinal fusion (where the bones grow together) over 10 to 15 years, which significantly reduces mobility and quality of life.5 AS occurs in approximately 200,000 people in the UK and typically affects people aged 20-30.3
About Cosentyx (secukinumab) Cosentyx is a fully human monoclonal antibody that selectively neutralises circulating IL-17A. Cosentyx is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and AS. Research shows that IL-17A plays an important role in driving the body’s immune response in psoriasis, PsA and AS. , In Europe, Cosentyx is licensed in adult patients with moderate to severe plaque psoriasis, active PsA and active AS.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. The company is the largest commercial sponsor of clinical trials in the UK with over £16million spent on R&D in the UK in 2015. For more information, please visit www.novartis.co.uk.