To appraise the clinical and cost effectiveness of caplacizumab within its marketing authorisation for treating adults experiencing an episode of acquired thrombotic thrombocytopenic purpura.
 
Status In progress
Process STA 2018
ID number 1185

Project Team

Project lead Jeremy Powell

Email enquiries

Evidence Review Group / Assessment Group Peninsula Technology Assessment Group (PenTAG), University of Exeter

Consultees

Companies sponsors Sanofi (caplacizumab)
Others Department of Health
  NHS England
  NHS Blackpool CCG
  NHS Harrogate & Rural District CCG
  Welsh Government
Patient carer groups Action for Sick Children
  African Health Policy Network
  Black Health Agency
  British Liver Trust
  Children’s Liver Disease Foundation
  Genetic Allicance UK
  Haemophilia Society
  HIV i-base
  Liver4Life
  Muslim Council of Britain
  Nam publications
  National AIDs Trust
  National Children's Bureau
  Positively UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Terrence Higgins Trust
  TTP Network
Professional groups British Association for the Study of the Liver
  British Blood Transfusion Society
  British Committee for Standards in Haematology
  British Geriatric Society
  British Psychological Society
  British Society for Haematology
  Haemophilia Nurses Association
  National Blood Service
  NHS Blood and Transplant
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Paediatrics & Child Health
  Royal College of Pathologists
  Royal College of Physicians
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Royal College of Obstetricians and Gynaecologists
  UK Forum on Haemoglobin Disorders
  UK Haemophilia Centre Doctors’ Organisation
  UK Clinical Pharmacy Association

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Baxter healthcare (cyclophosphamide)
  Roche (rituximab)
  Hospira UK (vincristine)
  Sandoz (cyclophosphamide, rituximab)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  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
  Hospital Information Services – Jehovah’s Witnesses
  Medicines and Healthcare Products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Commercial Medicines Unit
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Foundation for Liver Research
  Genomics England
  MRC Clinical Trials Unit
  Intensive Care National Audit & Research Centre
  National Institute for Health Research
  UK TTP registry

Timeline

Key events during the development of the guidance:

Date Update
09 August 2019 Invitation to participate
28 December 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of caplacizumab within its marketing authorisation for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression. Please note that following on from advice received from the company this appraisal has now been rescheduled back into the work programme. The appraisal is now anticipated to being in early August 2019.
14 June 2018 In progress, Topic referred
14 June 2018 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of caplacizumab within its marketing authorisation for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression. The timelines for this appraisal are still to be confirmed following a recent update from Ablynx related to Sanofi’s previously announced tender offers to acquire all of the outstanding shares (including shares represented by American Depositary Shares, warrants and convertible bonds) of Ablynx. Please refer to link for further information http://www.ablynx.com/uploads/data/files/press%20release_sanofi%20squeez%20out_14%20may%202018_eng_final.pdf NICE is monitoring the situation and will update interested parties as and when further information is available.
05 December 2017 Referral

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