Navigation

Hypercholesterolemia - mipomersen [ID524]

Mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolemia

Status: Suspended
Expected date of issue: TBC
Referral date: May 2012
Process: STA
Notes:

Scoped as part of Batch 22

Topic area:
  • Cardiovascular
  • Endocrine, nutritional and metabolic
 

NICE project team

Executive Lead: Andrew Dillon
Technical Lead: Anwar Jilani
Communications manager: Shalu Kanal
Project manager: Kate Moore
Top


 

Provisional schedule

Closing date for invited submissions / evidence submission: TBC
1st appraisal committee meeting: TBC
Top


 

Consultees and commentators

Consultees Commentators (no right to submit or appeal)


Manufacturers/sponsors

  • Genzyme, a sanofi company  (mipomersen)

Patient/carer groups

  • HEART UK

Professional groups

  • British Cardiovascular Society
  • British Heart Foundation
  • Royal College of Nursing
  • Royal College of Pathologists
  • Royal College of Physicians

Others

  • Department of Health
  • Welsh Government


General

  • Commissioning Support Appraisals Service
  • Department of Health, Social Services and Public Safety - Northern Ireland
  • Healthcare Improvement Scotland
  • Medicines and Healthcare products Regulatory Agency

Comparator manufacturers

  • B Braun Avitum UK (HELP apheresis system) (confidentiality agreement not signed, not participating)
  • Fresenius Medical Care (DALI = Direct Adsorption of Lipoproteins) (confidentiality agreement not signed, not participating)
  • Kaneka Pharma Europe N.V.(DX-21, MA03 machine) (confidentiality agreement not signed, not participating)
  • L.IN.C Medical Systems (Double Filtration) (confidentiality agreement not signed, not participating)
  • Miltenyi Biotec (TheraSorb [Life 18 machine])
  • Pall Life Sciences (Heparin HyperD Affinity Sorbent) (confidentiality agreement not signed, not participating)
  • Pocard (LDL Lipopak, Lp (a) Lipopak) (confidentiality agreement not signed, not participating)

Relevant research groups

  • None

Evidence Review Group

  • Kleijnen Systematic Reviews
  • National Institute for Health Research Health Technology Assessment Programme

Associated guideline groups

  • None

Associated public health groups

  • None

Top


 

Project history

Date Update

29 April 2013

 

The Department of Health asked the Institute to conduct an appraisal of mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolaemia and to provide guidance on its use to the NHS in England and Wales. 

The Institute has noted that the Committee for Medicinal Products for Human Use (CHMP) recently re-examined its initial negative opinion for mipomersen and has confirmed the refusal of the marketing authorisation.

NICE has therefore decided to suspend this appraisal indefinitely.

As this topic has been referred to the Institute we will continue to monitor any developments and will update this webpage if the situation changes.

5 July 2012

 

The manufacturer of mipomersen has informed NICE that they will not provide an evidence submission for this appraisal. NICE has therefore suspended this appraisal.

 

Top


 

Key documents

This page was last updated: 29 April 2013

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.

Selected, reliable information for health and social care in one place

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.