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NICE turns down Celgene's Otezla once again

Concludes the drug's cost outweighs its benefit for psoriatic arthritis
Celgene

Celgene's oral immunotherapy Otezla looks unlikely to be available to psoriatic arthritis patients in England and Wales via the NHS, with cost-effectiveness gatekeeper NICE rejecting the drug in draft guidance.

The ruling adds weight to the view that Celgene will struggle to gain momentum with the drug in Europe, despite widespread predictions of blockbuster sales by the company and analysts. NICE said in June it was minded not to recommend Otezla (apremilast) as a treatment for chronic plaque psoriasis, and in May its German counterpart IQWiG delivered a similar verdict.

Once again the UK agency has concluded that its costs outweigh its benefit for patients and it is declining to recommend the use of Otezla in its approved indication - the treatment of psoriatic arthritis patients who have failed to respond to or are unable to take disease-modifying anti-rheumatic drug (DMARD) therapy.

The draft guidance notes that most patients in this category are treated with injectable  tumour necrosis factor alpha (TNF-alpha) inhibitors such as Amgen's Enbrel (etanercept), Janssen/MSD's Remicade (infliximab), AbbVie's Humira (adalimumab) and Johnson & Johnson's Simponi (golimumab).

In trials Celgene's drug was shown to be clearly superior to placebo but "compared with TNF-alpha inhibitors, apremilast was the least clinically effective for treating psoriatic arthritis," according to NICE.

While some costs were saved by use of an oral rather than an injectable drug, NICE said that a critical factor in its decision was that there was not enough evidence that apremilast was able to slow progression of the psoriatic arthritis compared to TNF-alpha inhibitors.

"The costs saved were not sufficient to justify the health losses," said Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE, which held a second appraisal committee meeting on the drug in July. A final decision on the use of Otezla in psoriatic arthritis is due in October.

Celgene is reporting strong uptake for Otezla in the US however, with sales in the second quarter rising around 50% to $90m, fuelled by use of the drug before biologics such as the TNF-alpha blockers.

The company is also developing Otezla for rheumatoid arthritis, Behcet's disease, atopic dermatitis and ulcerative colitis.

Article by
Phil Taylor

4th September 2015

From: Regulatory

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