The Department of Health has asked NICE to produce guidance on this technology in the NHS in England. This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the manufacturer of eculizumab has informed us that they will not provide an evidence submission for this appraisal. We have therefore suspended the appraisal whilst we consider the next steps.
 
Status Suspended
Process STA
ID number 1064

Provisional Schedule

Expected publication 23 May 2018

Project Team

Project lead Kate Moore

Email enquiries

Consultees

Companies sponsors Alexion (eculizumab)
Others Department of Health
  NHS Eastbourne, Hailsham and Seaford CCG
  NHS England
  NHS Greater Preston CCG
  Welsh Government
Patient carer groups Arthritis and Musculoskeletal Alliance
  Brain and Spine Foundation
  Disability Rights UK
  Leonard Cheshire Disability
  Muscular Dystrophy UK
  Muslim Council of Britain
  Myasthenia Gravis Association
  Myaware
  Neurological Alliance
  South Asian Health Foundation
  Specialised Healthcare Alliance
  The Brain Charity
Professional groups Association of Anaesthetists
  Association of British Neurologists
  Association of Surgeons of Great Britain and Ireland
  British Geriatrics Society
  British Institute of Musculoskeletal Medicine
  British Myology Society (BMS)
  British Neuropathological Society
  British Society of Rehabilitation Medicine
  Chartered Society of Physiotherapy
  Institute of Neurology
  Primary Care Neurology Society
  Royal College of Anaesthetists
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Royal Society of Speech and Language Therapy
  UK Clinical Pharmacy Association

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (methotrexate, mycophenolate mofetil)
  Allergan (azathrioprine, mycophenolate mofetil)
  Baxalta (intravenous immunoglobulin)
  Bio Products Laboratory (intravenous immunoglobulin)
  Biotest (intravenous immunoglobulin)
  CSL Behring (intravenous immunoglobulin)
  Concordia (methotrexate)
  Dexcel Pharma (ciclosporin)
  Grifols (intravenous immunoglobulin)
  Hameln Pharmaceuticals (methotrexate)
  Hospira UK (methotrexate)
  Medac GmbH (methotrexate)
  Mylan (azathrioprine)
  Octapharma (intravenous immunoglobulin)
  Orion Pharma (methotrexate)
  Napp Pharmaceuticals (rituximab)
  Nordic Pharma (methotrexate)
  Novartis (ciclosporin)
  Pfizer (methotrexate)
  Roche Products (mycophenolate mofetil, rituximab)
  Rosemont Pharmaceuticals (methotrexate)
  Sandoz (azathrioprine, methotrexate, mycophenolate mofeti)
  Sanofi (intravenous immunoglobulin)
  Santen (ciclosporin)
General commentators Allied Health Professionals Federation
  All Wales Therapeutics and Toxicology Centre
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  Neurological Alliance of Scotland
  NHS Alliance
  NHS Blood and Transplant
  NHS Commercial Medicines Unit
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
  Wales Neurological Alliance
Relevant research groups Bone Research Society
  Brain Research Trust
  Chronic Pain Policy Coalition
  Cochrane Musculoskeletal Group
  Genetic Alliance UK
  MRC Clinical Trials Unit
  National Hospital for Neurology and Neurosurgery
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
14 July 2017 Suspended, The Department of Health has asked NICE to produce guidance on this technology in the NHS in England. This appraisal has formally started now, in line with the anticipated regulatory timelines. However, the manufacturer of eculizumab has informed us that they will not provide an evidence submission for this appraisal. We have therefore suspended the appraisal whilst we consider the next steps.
07 July 2017 Invitation to participate
21 April 2017 Referral
21 April 2017 In progress, Topic referred
22 November 2016 - 20 December 2016 Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators

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