To appraise the clinical and cost effectiveness of ribociclib within its marketing authorisation for treating advanced hormone-receptor positive, HER2-negative breast cancer.
 
Status In progress
Process STA 2018
ID number 1318

Provisional Schedule

Invitation to participate 24 July 2019
Expected publication 31 July 2019

Project Team

Project lead Gemma Barnacle

Email enquiries

Consultees

Companies sponsors Novartis (ribociclib)
Others Department of Health
  NHS England
  Welsh Government
Patient carer groups Breast Cancer Care
  Breast Cancer Now
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists

Commentators

Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare (capecitabine, docetaxel, exemestane, gemcitabine, paclitaxel, vinorelbine) (confidentiality agreement not signed, not participating)
  Amneal Pharma Europe Limited (exemestane) (confidentiality agreement not signed, not participating)
  AstraZeneca (fulvestrant) (confidentiality agreement not signed, not participating)
  Aurobindo Pharma (tamoxifen) (confidentiality agreement not signed, not participating)
  Celgene (paclitaxel) (confidentiality agreement not signed, not participating)
  Consilient Health (exemestane) (confidentiality agreement not signed, not participating)
  Dr Reddy's Laboratories (capetabine) (confidentiality agreement not signed, not participating)
  Eli Lilly (gemcitabine)
  Hospira (docetaxel, gemcitabine, paclitaxel) (confidentiality agreement not signed, not participating)
  Medac UK (capetabine, docetaxel, paclitaxel, vinorelbine) (confidentiality agreement not signed, not participating)
  Mylan Pharmaceuticals (capecitabine, exemestane, tamoxifen) (confidentiality agreement not signed, not participating)
  Novartis (everolimus)
  Pfizer (exemestane, palbociclib)
  Pierre Fabre (vinorelbine) (confidentiality agreement not signed, not participating)
  Roche (capecitabine)
  Sanofi (docetaxel) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (docetaxel) (confidentiality agreement not signed, not participating)
  Teva UK (docetaxel, exemestane, gemcitabine, paclitaxel, tamoxifen) (confidentiality agreement not signed, not participating)
  Wockhardt UK (tamoxifen) (confidentiality agreement not signed, not participating)
  Zentiva (exemestane) (confidentiality agreement not signed, not participating)
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
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research
  National Cancer Research Institute

Timeline

Key events during the development of the guidance:

Date Update
16 May 2019 Committee meeting: 2
10 April 2019 - 09 May 2019 Appraisal consultation
12 March 2019 Committee meeting: 1
18 July 2018 As you will be aware, the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of ribociclib in combination with fulvestrant for treating advanced hormone-receptor positive, HER2-negative breast cancer. For information, the timelines for this appraisal have been revised. The appraisal is now anticipated to begin in mid July 2018, with a submission deadline anticipated mid September 2018.
31 July 2017 In progress, DH Referral Received

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