| Status | Suspended |
| Decision | Selected |
| Process | STA pre-2018 |
| Referral date | 01 May 2012 |
| Topic area |
|
| 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 |
Stakeholders
| 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 | |
| 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 our processes and methods, please see our CHTE processes and methods manual