Status In progress
Process STA
ID number 64
Referral date 01 November 2008
Topic area
  • Central nervous system

Provisional Schedule

Expected publication 06 December 2017

Project Team

Project lead Jeremy Powell

Email enquiries

Consultees

Companies sponsors Merck Serono
Others Department of Health
  NHS England
  Welsh Government
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

Commentators

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

Timeline

Key events during the development of the guidance:

Date Update
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:

  • Deadline for submissions: 20 May 2010
  • Appraisal Committee meeting: 28 September 2010 (previously 27 July 2010)
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