Mifamurtide for the treatment of osteosarcoma
| Status: |
History |
| Expected date of issue: |
October 2011 |
| Referral date: |
June 2008 |
| Wave: |
17 |
| Process: |
STA |
| Topic area:
|
NICE project team
| Executive Lead: |
Gillian Leng
|
| Technical Lead: |
Pall Jonsson
|
| Communications manager: |
Tonya Gillis
|
| Project manager: |
Bijal Joshi
|
Provisional schedule
| Closing date for invited submissions / evidence submission: |
23 October 2008 |
| 1st appraisal committee meeting: |
18 February 2009 |
| 2nd appraisal committee meeting |
18 March 2010 |
| 3rd appraisal committee meeting: |
18 August 2010 |
| 4th appraisal committee meeting: |
18 January 2011 |
| 5th appraisal committee meeting: |
18 May 2011 |
Consultees and commentators
Project history
| Date |
Update |
| 20 July 2011 |
The Board was invited to consider whether it would be helpful to the appraisal committees to clarify paragraph 5.6.2 in the Guide to the Methods of Technology Appraisal which refers to the use of discounting. The Board considered the matter and has issued a clarification to the Guide, in the following way:
‘5.6.2 The need to discount to a present value is widely accepted in economic evaluation, although the specific rate is variable across jurisdictions and over time. The Institute considers it appropriate to normally discount costs and health effects at the same rate. The annual rate of 3.5%, based on recommendations of the UK Treasury for the discounting of costs, should be applied to both costs and health effects. Where the Appraisal Committee has considered it appropriate to undertake sensitivity analysis on the effects of discounting because treatment effects are both substantial in restoring health and sustained over a very long period (normally at least 30 years), the Committee should apply a rate of 1.5% for health effects and 3.5% for costs.’
The amendment has immediate effect and will be published in due course on the Institute’s website. Given the application this amendment has to the appraisal of mifamurtide, the Appraisal Committee will be asked to take it into account in preparing the Final Appraisal Determination (FAD). It will do so at its meeting on 17th August 2011.
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| 6 April 2011 |
Mifamurtide for the treatment of osteosarcoma will be discussed at the next committee meeting on 18 May 2011.
Guidance Executive have reviewed this topic and recommended that further discussion should take place on the differential impact of discounting on costs and benefits in the context of the mifamurtide technology appraisal. |
| 18 December 2009 |
The Appraisal Committee met on 18 February 2009 to discuss the above mentioned appraisal. At that time the manufacturer of the drug, IDM Pharma, informed us that the date for the launch of this drug in the UK had not been finalised, and consequently the final price had not been formally announced. We therefore could not release the decision agreed by the Committee and the evidence documentation related to the appraisal at that time.
In June 2009 IDM Pharma Inc was acquired by Takeda Pharmaceuticals Company Group. In agreement with the NICE appraisal team, Takeda will be submitting an addendum with a new cost effectiveness analysis, including a proposed patient access scheme. Furthermore, the Evidence Review Group (School of Health & Related Research Sheffield) will critique the addendum submitted by Takeda.
In light of the above, the next Committee Meeting will be scheduled for 18 March 2010, to discuss this appraisal. The appraisal has been scheduled to produce guidance as close as possible to the anticipated launch of the product in the UK.
We will not release the decision agreed by the Committee in February 2009 because the evidence on which this decision has changed. All evidence documentation related to this appraisal will be released after the March 2010 meeting. |
| 6 May 2009 |
Mifamurtide has now received a centralised marketing authorisation from the European Commission for the treatment of osteosarcoma.
Please note that the date this drug will be launched in the UK has not been finalised and the final price of the drug has not been formally announced by the manufacturer. Therefore, we cannot release the decision agreed by the Committee and the evidence documentation related to the appraisal at this time.
This appraisal continues to be temporarily on hold, and the website will be updated once further information is available. |
| 5 March 2009 |
Mifamurtidehas not received a centralised marketing authorisation from the European Commission and therefore we are unable to circulate the Appraisal Consultation Document (ACD) for consultation. As a result we have also cancelled the Appraisal Committee Meeting scheduled for 22 April 2009. This appraisal is temporarily on hold, and the website will be updated once further information is available. |
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Key documents
This page was last updated: 26 October 2011
