Otezla gains NICE approval for psoriatic arthritis

NICE has issued a final appraisal determination recommending Celgene's Otezla for adults with active psoriatic arthritis, reversing an earlier decision to reject the drug.

The oral drug is Celgene's offering in a crowded inflammation and immunology market, and part of a wave of new drugs looking to supercede the TNF inhibitors, led by AbbVie's Humira.

NICE'S change of heart means Otezla can now compete with the TNF drugs as an option for patients who have had an inadequate response to or have been unable to tolerate Disease Modifying Anti-Rheumatic Drugs (DMARDs).

Otezla does not require pre-screening for tuberculosis or regular laboratory monitoring, unlike some other treatments for the condition.

An estimated 296,000 people in the UK are affected by psoriatic arthritis, an incapacitating disease that can affect skin and joints and impede sufferers from everyday activities.

NICE first rejected Otezla in September 2015 but has been reappraised under the NICE Rapid Review process.

A price discount via a Patient Access Scheme helped the company secure an approval from the cost effectiveness body.

Otezla, alone or in combination with DMARDs, is now recommended with a Patient Access Scheme for adults with active psoriatic arthritis.

The decision brings access for patients in England and Wales in line with those in Scotland, where Otezla was recommended by the Scottish Medicines Consortium (SMC) in June 2015.

Dr Dani Thomas, Medical Director, Celgene UK & Ireland, commented: "We are delighted that patients in England and Wales can now access Otezla via the NHS, bringing availability in line with patients in Scotland. Otezla's novel mechanism of action and oral administration provides psoriatic arthritis patients with a much needed treatment option."

The Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) trial programme found Otezla to be superior to placebo but "compared with TNF-alpha inhibitors, apremilast was the least clinically effective for treating psoriatic arthritis," according to NICE.

NICE had originally ruled that while some costs were saved by use of an oral rather than an injectable drug, there was not enough evidence that apremilast was able to slow progression of the psoriatic arthritis compared to TNF-alpha inhibitors.

Celgene has some stiff competition from other companies. Most notably, NICE is set to issue guidance on Novartis' Cosentyx (secukinumab) and USB Cimzia (certolizumab) in the same indication in February 2017.