Technology Appraisal at NICE - EVEROLIMUS ( AFINITOR) - by Bill Savage

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I represented The James Whale Fund at this review of the new drug Everolimus
in the NICE offices at Manchester as a " patient expert ".  The review was
the main meeting which decides whether to recommend that this new drug is
funded by the NHS. Everolimus ( Afinitor ) is produced by Novartis and was
being evaluated as the drug to be used by clinicians for advanced or
metastatic Kidney Cancer when Sunitinib ( Sutent ) has failed . In NICE
terminology this is known as "second line " treatment.

The 3 hour meeting follows a standard format and procedure. I was joined by
2 other patient experts, a clinical oncologist and a lead cancer nurse.  In
addition there were approximately 30 other attendees who heard 2 main
presentations about the clinical effectiveness and then the cost
effectiveness of Everolimus.  These presentations dominated the meeting and
as a patient expert my role was to witness the process and then to comment
on the impact on patients and the vital importance of life extending drugs.

The main outcomes were:

• Everolimus is clinically effective in extending life by over 3 months when compared to supportive care. It is a drug to be used by clinicians in an end of life setting.  It is not a cure for KidneyCancer

• The cost of Everolimus is outside the normal NICE guidelines
• Everolimus does have side -effects but they are reasonably well tolerated compared to Sutent though this can vary from individual to individual
• In January 2009 , NICE guidelines were changed for end of life drugs to make them more accessible.  Everolimus appears to fit those criteria though this decision will be made shortly by the NICE committee.

I was able to speak on behalf of The James Whale Fund at the end of the
meeting to make the following points:

• The drug is effective, reasonably tolerated by patients and is orally administered
• There are no other " second line " treatments for advanced/ metatstatic Kidney Cancer available on the NHS
• Everolimus appears to fit the new criteria for end of life drugs
• The U.K. is lagging behind the USA and Europe in the provision of these anti-Kidney Cancer drugs . NICE must respond to the intense distress of patients who are aware that new drugs are now available to prolong their lives but NOT on the NHS at present.
• Patients place immense value on the ability of treatments to extend life . This is a huge benefit to patients and their families for whom every day is special and every day is precious.

I concluded my statements with the story of my Kidney Cancer Support Group
in Oxford ( Friends of Renal Oncology Group ) which was founded in 2008 with
30 members . In the last 18 months , 19 members of the group have died ,
losing their battle against this killer disease . I reminded the NICE
committee of their and their families suffering and the need to offer some
hope to others when making their decision.

We expect to hear the NICE decision within the next few weeks. I will alert
you when the decision is made.