Janssen-Cilag wins NICE approval for psoriasis drug Stelara
pharmafile | September 23, 2009 | News story | Sales and Marketing | JJ, NICE, Stelara
NICE has approved Janssen-Cilag’s Stelara as a treatment option for adults with moderate to severe plaque psoriasis.
Part of the process saw Janssen agreed a access deal with NICE and the Department of Health to make the drug more affordable to the NHS.
People who weigh more than 100 kg require a 90-mg dose of Stelara – twice the dose of their lighter counterparts. Under the new scheme the cost to the NHS 90-mg treatment will be the same as for people who require a single 45-mg vial of the drug.
NICE’s recommendation covers Stelara as a treatment option for adults with plaque psoriasis for whom biologic therapy is being considered, and when the disease is both severe, and has failed to standard systemic therapies.
The first-in-class drug received its European marketing licence in January and has been hotly anticipated by dermatologists. It is set to compete the established anti-TNF treatments for the disease, though its unique mechanism could its drive success.
Dr Tony Downs, a consultant dermatologist at Royal Devon and Exeter NHS Trust, said in clinical practice he found it effective in patients that have failed on other therapies.
He said: “Psoriasis is an incurable chronic skin condition and many patients hate the way they look and are clinically depressed.
“Stelara offers both physicians and patients an alternative treatment choice, which is important because psoriasis is not a straightforward disease. Its severity can wax and wane, it can become resistant to any treatment and patients can develop side effects to many of the current alternative treatment options.”
Because of this the autoimmune disease, which results in the overproduction of skin cells, is notoriously difficult to treat. In the UK psoriasis affects around 1.5 million people, up to 20-30% of whom suffer severely.
Stelara is the first in a new class of biologics for the disease, and Janssen says it provides visible and significant improvements in psoriasis severity.
It is a human monoclonal antibody with a new mechanism of action that targets naturally occurring proteins in the body that are important to regulating immune responses. These are known as cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), and are thought to be associated with some immune-mediated inflammatory disorders, including plaque psoriasis.
Until now the mainstay of the psoriasis market has been anti-TNFs, which are often also indicated for other autoimmune diseases. These include Enbrel from Amgen and Wyeth, Remicade from J&J, and Abbott’s Humira.
But new treatment Stelara does have the added advantage of a convenient dosing regimen for patients with just five injections per year, compared to a possible 104 injections with established option Enbrel, a widely prescribed biologic therapy.
Analysts Datamonitor earlier this year conducted an assessment of physician perception in autoimmune diseases, including psoriasis.
The results showed that dermatologists rate Stelara highly on attributes such as efficacy, with most respondents scoring it 40% above an average for all biologics in auto-immune disease in terms of predicted efficacy. There is also some evidence from one study that Stelara was superior to Enbrel, which will likely drive uptake of Janssen’s brand.
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