NICE ISSUES POSITIVE FINAL APPRAISAL DETERMINATION FOR COSENTYX (SECUKINUMAB)
Sep 28, 2016
Frimley, UK, 28 September 2016 – Novartis announces today that the National Institute for Health and Care Excellence (NICE) has issued a Technology Appraisal Guidance (TAG) for Cosentyx®▼ (secukinumab), recommending it as an option to treat adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.1 Clinical commissioning groups, NHS England and local authorities are now required to comply with this recommendation and ensure Cosentyx treatment is funded and accessible within 90 days.1
AS is a long-term (chronic) condition in which the spine and other areas of the body become inflamed.2,3 There are around 200,000 people in the UK who have been diagnosed.3 Symptoms 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), all of which can significantly impact on quality of life.3,4 The onset of AS usually begins in late teens and early twenties, a critical period in terms of work and relationships, with more than 50% of people identifying work as the area of their lives most affected by their condition.4,5
The primary aim of treatment and management strategies is to delay or prevent pain, functional disability and clinical deterioration.6 Current treatment options are not effective for all patients, with a proportion of them either failing to tolerate or respond.7
"NASS is delighted that NICE has recommended secukinumab (Cosentyx) for ankylosing spondylitis (AS). At the moment treatment options are very limited for people living with AS and this will offer a new option” said Debbie Cook, Chief Executive at National Ankylosing Spondylitis Society (NASS). “We hope people affected by AS will now be able to discuss the range of options with their rheumatologist and decide together which would be the best option for them."
Commenting on the announcement, Dimitrios Georgiopoulos, Chief Scientific Officer, Novartis Pharmaceuticals UK: “This news gives us the final stamp of approval to offer patients with ankylosing spondylitis a much needed treatment option and highlights the potential of Cosentyx as the new standard of care. We look forward to NHS England issuing its commissioning policy as soon as possible to allow funding and rapid patient access to Cosentyx.”
The publication of the TAG for AS 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.8 The Scottish Medicines Consortium (also 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.9,10
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.11 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.12 Cosentyx is the first fully human 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.13,14 In Europe, Cosentyx is licensed in adult patients with moderate to severe plaque psoriasis, active PsA and active AS.15
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.