|Referral date||01 November 2008|
|Expected publication||06 December 2017|
|Project lead||Jeremy Powell|
- If you have any queries please email firstname.lastname@example.org
|Companies sponsors||Merck Serono|
|Others||Department of Health|
|Patient carer groups||Multiple Sclerosis Society|
|Multiple Sclerosis Trust|
|Professional groups||Association of British Neurologists|
|Primary Care Neurology Society|
|Royal College of Physicians|
|UK Clinical Pharmacy Association|
|UK Multiple Sclerosis Specialist|
|Associated public health groups||Public Health England|
|Public Health Wales|
|Comparator companies||Bayer Pharma (beta-interferon) (not participating)|
|Biogen (dimethyl fumarate, natalizumab, daclizumab, beta-interferon)|
|Genzyme Therapeutics (alemtuzumab, teriflunomide)|
|Novartis (interferon beta-1b,fingolimod)|
|Sanofi Genzyme (alemtuzumab, teriflunomide)|
|Teva UK (glatiramer acetate)|
|General commentators||All Wales Therapeutics and Toxicology Centre|
|British National Formulary|
|Department of Health, Social Services and Public Safety for Northern Ireland|
|Healthcare Improvement Scotland|
|Welsh Health Specialised Services Committee|
|03 November 2017 - 16 November 2017||Final appraisal determination|
|20 September 2017||Committee meeting: 1|
|25 July 2017||Draft scope documents|
|24 April 2017||Invitation to participate|
|10 January 2017||In progress, As you will be aware the Department of Health referred the appraisal of oral cladribine monotherapy within its licensed indication for the treatment of relapsing-remitting multiple sclerosis in April 2009. During February 2011 the appraisal was suspended as the Committee for Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion and adopted a final negative opinion, recommending that cladribine should not be granted a marketing authorisation. Following on from advice received from the company this appraisal has now been rescheduled back into the work programme. The appraisal is expected to start in approximately mid-February 2017 with a consultation on the draft scope. It is then anticipated that the final scope will be released along with an invitation to participate in the appraisal during mid-April 2017. The deadline for submissions is expected in approximately mid-June 2017.|
|16 November 2009||Following advice received from the manufacturer, this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during mid February 2010. The deadline for submissions is expected in approximately late April 2010.|
|30 April 2010||
Based on further information about the regulatory procedure for this technology, the appraisal has been delayed.
The key revised dates are as follows:
|24 August 2010||Please note, following on from further advice received from the manufacturer, this appraisal has been rescheduled to align with latest regulatory expectations. Therefore the first committee meeting for this topic will be on 25 November 2010.|
|4 October 2010||Following an update on the regulatory status of the technology which has received a negative CHMP opinion, the November committee meeting discussion for this appraisal has been cancelled. We are monitoring this situation and will provide an update as soon as possible.|
|25 October 2010||Further to the update of 4 October, this Technology Appraisal has been rescheduled into the work programme. The committee meeting dates and expected date of issue have been updated on this web page.|
|24 January 2011||
Due to resource constraints and efficiency scheduling requirements for the current work programme, NICE has had to decide to re-schedule the first Appraisal Committee meeting for a number of the technology appraisal topics.
In rescheduling these topics we have been careful to maintain our ability to issue timely recommendations.
The appraisal of cladribine for the treatment of relapsing-remitting multiple sclerosis is one of the topics that has been identified.
The first appraisal committee discussion will now take place on 6 July 2011. The second committee meeting (if required) will also be rescheduled.
|7 February 2011||
Please note that this appraisal has now been suspended and the appraisal committee discussion that was due to take place on 6 July 2011 has been cancelled. This is due to an update on the regulatory status as the Committee for Medicinal Products for Human Use (CHMP) recently confirmed its previous negative opinion and adopted a final negative opinion, recommending that cladribine should not be granted a marketing authorisation.
The manufacturer of this technology has informed NICE that further clinical evidence is in development.
We will continue to monitor any development and will update this webpage if the situation changes.
For further information on how we develop guidance, please see our page about NICE technology appraisal guidance