This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the manufacturer of ofatumumab has informed us that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal and we will provide further updates when they are available.
 
Status Suspended
Process STA pre-2018
Referral date 01 July 2014

Provisional Schedule

Closing date for invited submissions / evidence submission: TBC
1st appraisal committee meeting: TBC

Project Team

Project lead Stephanie Yates

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
03 February 2017 As you will be aware, the Department of Health has asked us to conduct a Single Technology Appraisal of ofatumumab within its licensed indication for the maintenance treatment of relapsed chronic lymphocytic leukaemia. However, the company have advised that they will not be pursuing a licensing application for ofatumumab from the European Medicines Authority for this indication at this time. Therefore, NICE has decided to suspend this appraisal on its work programme. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes.
06 September 2016 This appraisal remains suspended following an update from the company (Novartis). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided not to approve ofatumumab for the maintenance treatment of relapsed chronic lymphocytic leukaemia. NICE will continue to monitor for any developments and will provide an update when necessary.
02 November 2015 Suspended, This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the manufacturer of ofatumumab has informed us that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal and we will provide further updates when they are available.
30 December 2014 Please note that following on from advice received from the company this appraisal has been rescheduled.Therefore, we now anticipate that the appraisal will begin during late October 2015 when we will write to you about how you can get involved. The deadline for submissions is expected in approximately early January 2016.

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance