Mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolemia
 
Status Suspended
Process STA
Referral date 01 May 2012
Topic area
  • Cardiovascular
  • Endocrine, nutritional and metabolic
Description

Scoped as part of Batch 22

Provisional Schedule

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

Project Team

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

Consultees

Manufacturers/sponsors Genzyme, a sanofi company (mipomersen)
Others Department of Health
  Welsh Government
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

Commentators

Associated guideline groups None
Associated public health groups None
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)
Evidence Review Group Kleijnen Systematic Reviews
  National Institute for Health Research Health Technology Assessment Programme
General Commissioning Support Appraisals Service
  Department of Health,Social Services and Public Safety - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
Relevant research groups None

Timeline

Key events during the development of the guidance:

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.


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