Lenalidomide for treating multiple myeloma after 1 prior treatment with bortezomib (part-review of TA171)
 
This guidance will partially update the following:
The release of the Final Appraisal Determination for this topic has been delayed. In light of comments from consultees over the impact of this guidance on the overall multiple myeloma treatment pathway, NICE Guidance Executive has requested that these issues are explored further by the appraisal committee.
 
Status Suspended
Process STA
Topic area
  • Cancer

Provisional Schedule

Closing date for invited submissions / evidence submission: 8 November 2013
1st appraisal committee meeting: 18 February 2014
2nd appraisal committee meeting 18 June 2014

Project Team

Project lead Jeremy Powell

Consultees

Companies sponsors Celgene
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Myeloma UK
Professional groups British Society of Haematology
  Cancer Research UK
  Royal College of Nursing
  Royal College of Physicians
  UK Myeloma Forum

Commentators

Comparator companies Accord (doxorubicin) (not participating)
  Actavis (doxorubicin) (not participating)
  Aspen (melphalan) (not participating)
  Baxter Healthcare (cyclophosphamide) (not participating)
  Genus Pharmaceuticals (vincristine) (not participating)
  Hameln Pharmaceuticals (dexamethasone) (not participating)
  Hospira UK (dexamethasone, doxorubicin, vincristine) (not participating)
  Janssen-Cilag (bortezomib)
  Medac GmbH (doxorubicin) (not participating)
  Napp Pharmaceuticals (bendamustine)
  Pfizer (cyclophosphamide, doxorubicin, ) (not participating)
  Rosemount Pharmaceuticals (dexamethasone) (not participating)
  Teva UK (vincristine) (not participating)
  Wockhardt UK (doxorubicin) (not participating)
General commentators Commissioning Support Appraisals Service
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency

Timeline

Key events during the development of the guidance:

Date Update
11 August 2017 Following the Appraisal Committee meeting on Lenalidomide for multiple myeloma after 1 prior treatment with bortezomib [ID667] in March 2017, we have suspended this appraisal. From discussions with the company we understand that it is considering alternative access options for lenalidomide, which means that the basis for the decision making is likely to change. NICE is committed to working towards a solution that ensures patients with multiple myeloma continue to have access to lenalidomide. We therefore do not consider it appropriate to release an FAD at this stage. We will provide an update on the future timelines as soon as we can.
05 May 2017 Suspended, The release of the Final Appraisal Determination for this topic has been delayed. In light of comments from consultees over the impact of this guidance on the overall multiple myeloma treatment pathway, NICE Guidance Executive has requested that these issues are explored further by the appraisal committee.
11 November 2016 - 02 December 2016 Appraisal consultation: 3
05 October 2016 Committee meeting: 4
06 April 2016 Committee meeting: 3
06 April 2016 Following the 6 April meeting of the NICE Technology Appraisal Committee to discuss lenalidomide for treating multiple myeloma after 1 prior treatment with bortezomib the Committee have decided to request additional evidence from the company. No Appraisal Consultation Document (ACD) or Final Appraisal Determination (FAD) will be issued until after the Committee have discussed this appraisal again. The date for the next Committee meeting has not been confirmed.
06 April 2016 In progress, Committee meeting : 3
20 October 2014 The company has informed NICE that it wishes to submit new information that could materially affect the recommendations. Because this appraisal is a part review of already existing guidance and the provisional recommendations in the second ACD do not differ from the published guidance (for lenalidomide use after 1 prior therapy), we will exceptionally suspend this appraisal until we have received the new information from the company. The guidance for lenalidomide use after 2 prior therapies is unaffected. We will let you know as soon as we can when this appraisal will proceed.
2 June 2014 The 2nd appraisal committee meeting has been rescheduled to the 18 June Committee meeting. This is because a large amount of new evidence that has been provided the manufacturer of lenalidomide, in response to the ACD, and this new evidence needs an independent critique before the Committee can discuss the topic.

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