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AMMF’s Response to NICE Recommendations re SIRT for Intrahepatic Cholangiocarcinoma

NICE (National Institute for Health and Care Excellence) are currently consulting on the safety and efficacy of SIRT (selective internal radiation therapy) for intrahepatic cholangiocarcinoma, and have made their draft recommendations available for comment.

To see the draft recommendations, click here

 

 

 

 

 

 

 

These latest draft recommendations appear to be more limiting than the recommendations put forward in the 2013 Interventional Procedures Guide (IPG) despite there being more supportive data available.  The other main points in this document AMMF considered should be addressed are:

*  The draft recommendations suggest there are safety concerns, and that evidence on the efficacy of SIRT for the treatment of ICC is inadequate in quality and quantity.

*  SIR-Spheres Y-90 resin microspheres are now used globally, and SIRT is an established  intervention, with a significant amount of supporting evidence.

*  The review highlights some adverse events, and acknowledges they are rare. This conclusion is supported by evidence (in both intrahepatic cholangiocarcinoma and other indications), which also outlines recommendations for the prevention of these events.

*  Intrahepatic cholangiocarcinoma should be viewed and evaluated as a “rare disease” so the evidence should be evaluated from this perspective.

*  Related IPGs for the use of SIRT in alternative indications have reported that the evidence is “adequate for use with normal arrangements” in the NHS. Why should it be different for patients with ICC where the risks associated with SIRT remain the same? (IPG459/460/401)

An additional concern to AMMF with regard to this report is that funding for this treatment is currently under consideration by NHS England. NHS-funded SIRT had been available for patients with intrahepatic cholangiocarcinoma through the CtE (Commissioning through Evaluation) programme until this funding was withdrawn on 31st March 2017 ‘to be evaluated’.  This evaluation is ongoing.

 However, although the NICE IPG process considers only efficacy and safety and not cost-effectiveness, AMMF is concerned that NHS funding is unlikely to be restored for a treatment that is not recommended by NICE.  And so NHS patient access to this treatment will be denied.

AMMF’s Response to NICE re SIRT Recommendations

AMMF has, therefore, submitted a comment to the NICE IPG and has also written to Sir Andrew Dillon, Chief Executive of NICE.

The full text of AMMF’s response to NICE can be seen here

And the reply received from Sir Andrew Dillon is as follows:

“ … I understand the depth of your concern about the draft recommendations and I am confident the advisory committee will take them fully into account in developing their final guidance.”

 

 

Although NHS funding for treatment of intrahepatic cholangiocarcinoma by SIRT has been withdrawn, this may be accessed privately or via a clinical trial. 

For information on clinical trials for those with cholangiocarcinoma, including the SIRCCA trial, see : https://ammf.org.uk/clinical-trials/

And for further information on SIRT, see: http://www.mysirtstory.org.uk/how/nhs.htm

Abbreviations
CtE – Commissioning through evaluation
IPC – Interventional Procedure Consultation
IPAC – The Interventional Procedures Advisory Committee
IPG – Interventional Procedures Guide
NICE – National Institute for Health and Care Excellence
RTC – Randomised Control Trial
SIRT – selective internal radiation therapy

 

June 2018