NICE rejects Otelza but SMC recommends it


Draft guidance issued by NICE has seen rejections for products including Celgene’s Otelza and Astellas Pharma’s Xtandi, and a call for more information from Lundbeck on one of its depression treatments.

NICE has refused to recommend Celgene’s plaque psoriasis treatment Otezla (apremilast) for NHS patients in England – however, patients in Scotland will be able to access it.

The Scottish Medicines Consortium (SMC) has given the drug, the first in its class, the green light for the treatment of adults with moderate-to-severe chronic plaque psoriasis and active psoriatic arthritis.

The oral treatment targets phosphodiesterase 4 (PDE4), a key enzyme that modulates several of the inflammatory mediators targeted individually by other injectable treatments.

The manufacturer points out that it may reduce hospital visits, because it does not require pre-screening for tuberculosis or regular blood tests.

Meanwhile NICE has decided that Astellas’ prostate cancer brand Xtandi (enzalutamide) is not a cost-effective, pre-chemotherapy treatment because there are “too many uncertainties associated with the evidence provided” by the company.

Astellas has expressed its disappointment at the decision, saying that it denies men with metastatic castration-resistant prostate cancer (mCRPC), after failure of androgen deprivation therapy, in whom chemotherapy is not yet clinically indicated, “a much-needed treatment option”.

At present this means Xtandi is available in England only via the Cancer Drugs Fund in this setting.

“The clinical trial results showed enzalutamide can extend life when compared with placebo, but it was not clear for how long,” explained Sir Andrew Dillon, NICE chief executive.

While draft decisions are not set in stone, they undoubtedly represent a setback. Astellas is “hopeful that this draft recommendation will be overturned as the process moves forward”.

In other decisions, NICE has asked Lundbeck to provide more information about its drug Brintellix (vortioxetine) for treating major depressive episodes in adults.

Acknowledging that there is a need for more treatment options, NICE said there was “no convincing evidence to show that vortioxetine was any more or less effective than other antidepressants”.

It also felt Lundbeck needed to define more clearly how the drug would be used in the NHS.

Adam Hill

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