Review decision - July 2018

Decision to move the existing guidance to the static list

We would like to update you on the decision made regarding the review of the existing guidance on TA339; Omalizumab for treating previously treated chronic spontaneous urticarial.

No new evidence was identified that is likely to change the existing recommendations in TA339. The lack of trial data comparing omalizumab with immunosuppressants and long term data on relapse rates were identified as areas of uncertainty in TA339. However, we have found no relevant new trial evidence that addresses these areas of uncertainty.

The company has confirmed that no changes in the marketing authorisation are anticipated and are not aware of any new evidence that would change the existing recommendations.

It is therefore proposed that TA339 is moved to the static list because no evidence has been identified that is likely to alter the conclusions of the guidance (that is, lead to a change in the clinical and cost effectiveness of omalizumab to treat chronic spontaneous urticaria).

NICE’s Guidance Executive has decided to proceed with this proposal without consultation.

Consequently TA339 will move to the ‘static list’ of technology appraisals.

Review decision paper

Matrix of stakeholders

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