Project information | Hypercholesterolemia - mipomersen [ID524] | Guidance

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

Please note following on from information provided to NICE by the company in July 2012, the appraisal of Mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolaemia [ID524] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.

Status	Discontinued
Technology type	Medicine
Decision	Selected
Process	TA
ID number	524
Referral date	01 May 2012
Topic area	Cardiovascular Endocrine, nutritional and metabolic

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

Email enquiries

If you have any queries please email scheduling@nice.org.uk

Timeline

Key events during the development of the guidance:

Date	Update
20 January 2023	Discontinued. Please note following on from information provided to NICE by the company in July 2012, the appraisal of Mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolaemia [ID524] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
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.

Date

Update

20 January 2023

Discontinued. Please note following on from information provided to NICE by the company in July 2012, the appraisal of Mipomersen for the prevention of cardiovascular events in people with homozygous or severe heterozygous familial hypercholesterolaemia [ID524] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.

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