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NICE backs Cosentyx for ankylosing spondylitis

The immunotherapy is on course to be “one of the most successful launches in Novartis history”

Novartis has picked up another NICE recommendation for new immunotherapy Cosentyx, with the UK cost-effectiveness agency backing routine NHS use of the drug for ankylosing spondylitis (AS).

NICE (the National Institute for Health and Care Excellence) issued draft guidance on Cosentyx (secukinumab) - the first in a new class of interleukin-17 (IL-17) inhibitors - for AS patients who have not responded adequately to conventional therapy for the disease such as TNF inhibitors.

AS is a chronic form of arthritis that mainly affects the spine and affects around 200,000 people in the UK, according to NHS England. The disease is painful and often progressively debilitating and can result in irreversible damage such as spinal fusions.

Patients with the disease will however have to wait for the publication of a Technical Appraisal Guidance (TAG) document - due later this year - that will determine whether the NHS is legally obliged to fund Cosentyx therapy.

Cosentyx was approved for use in AS in May, but is already being used on a restricted basis by the NHS in England and Wales for patients with plaque psoriasis, its first licensed indication.

In June 2015, NICE backed the drug for some adults with psoriasis if they are unable to take standard systemic therapies via a scheme that reduces Cosentyx' cost to the NHS. The list price of the drug is £9140.85 in the first year, falling to £7312.68 in subsequent years, but the nature of Novartis' access deal has not been revealed.

Meanwhile, the Scottish Medicines Consortium (SMC) arrived at the same decision as NICE in psoriasis, and last month also backed its use in AS.

Cosentyx is already on course for blockbuster status in its first indications (which also includes psoriatic arthritis), with second-quarter sales shooting up to $260m from $30m, and NICE's positive appraisal in AS bodes well for continued growth in Europe. It is predicted to grow into a $4-5bn product at peak.

Novartis chief executive Joseph Jimenez said recently that the drug appears to be taking market share from TNF inhibitors, notably AbbVie's market-leading Humira (adalimumab) and Amgen's Enbrel (etanercept), and is shaping up to be "one of the most successful launches in Novartis history".

Head-to-head superiority trials are planned versus Humira to try to demonstrate that Cosentyx should be the drug of first choice in psoriasis, psoriatic arthritis and AS patients.

Article by
Phil Taylor

5th August 2016

From: Regulatory



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