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Chronic lymphocytic leukaemia - ofatumumab

Ofatumumab for the treatment of refractory chronic lymphocytic leukaemia

Status: History
Expected date of issue: October 2010
Referral date: September 2009
Process: STA
Notes:

Scoped within Batch 8

Topic area:
 

NICE project team

Executive Lead: Peter Littlejohns
Technical Lead: Jennifer Priaulx
Communications manager: Laura Gibson
Project manager: Jeremy Powell
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Provisional schedule

Closing date for invited submissions / evidence submission: 28 January 2010
1st appraisal committee meeting: 05 May 2010
2nd appraisal committee meeting TBC
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Consultees and commentators

Consultees Commentators (no right to submit or appeal)

Manufacturers/sponsors

  • GlaxoSmithKline (ofatumumab)

Patient/carer groups

  • Chronic Lymphocytic Leukaemia Support Association (CLLSA)
  • Macmillan Cancer Support
  • South Asian Health Foundation

Professional groups

  • British Society for Haematology
  • Cancer Research UK
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians, Medical Oncology Joint Special Committee
  • Royal Pharmaceutical Society
  • United Kingdom Chronic Lymphocytic Leukaemia Forum

Others

  • Department of Health
  • Welsh Assembly Government

General

  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety for Northern Ireland
  • NHS Quality Improvement Scotland

Possible comparator manufacturers

  • Actavis (prednisolone) (not participating – no confidentiality form)
  • Alliance Pharmaceuticals (prednisolone) (not participating – no confidentiality form)
  • Amdipharm (prednisolone) (not participating – no confidentiality form)
  • Arrow Generics (prednisolone) (not participating – no confidentiality form)
  • Baxter Healthcare (cyclophosphamide) (not participating – no confidentiality form)
  • Cephalon (doxorubicin)
  • Eli Lilly and Company (vincristine) (not participating – no confidentiality form)
  • Hameln Pharmaceuticals  (doxorubicin)
  • Hospira (doxorubicin, vincristine) (not participating – no confidentiality form)
  • Kent Pharmaceuticals (prednisolone) (not participating – no confidentiality form)
  • Medac UK (doxorubicin)
  • Pfizer (cyclophosphamide, doxorubicin, methylprednisolone)
  • Roche Products (rituximab)
  • Schering-Plough (doxorubicin) (not participating – no confidentiality form)
  • Sovereign Medical (prednisolone) (not participating – no confidentiality form)
  • Teva UK (doxorubicin, prednisolone, vincristine) (not participating – no confidentiality form)
  • Winthrop Pharmaceuticals UK (prednisolone) (not participating – no confidentiality form)
  • Wockhardt  (doxorubicin, prednisolone) (not participating – no confidentiality form)

Relevant research groups

  • Leukaemia & Lymphoma Research

Evidence Review Group

  • Peninsula Technology Assessment Group (PenTAG)
  • National Institute for Health Research Health Technology Assessment Programme

Associated Guideline Groups

  • National Collaborating Centre for Cancer

Associated Public Health Groups

  • None

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Project history

Date Update

28 May 2010

 

The manufacturer included a proposed Patient Access Scheme (PAS) in their evidence submission. The DH has received final advice on the proposed PAS but it has not been possible to receive formal sign-off before the ACD meeting because of the election. The DH had advised that the Appraisal Committee can consider the proposed PAS and develop the preliminary recommendation, however NICE can only issue the ACD once formal sign off of the PAS has been received from DH.

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Key documents

This page was last updated: 25 October 2010

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.