You are here

Update on NICE approval of dasatinib/nilotinib plus template letter for MP

Update on the situation regarding NICE approval of dasatinib (Sprycel) and nilotinib (Tasigna).

The situation as it stands to date (February 2008) is that NICE are waiting for a final approval from the DH to go ahead (or not) with an MTA (multi technology appraisal) of both dasatinib and nilotinib.

The DH have answered that they are still waiting for the summary of the consultations and scoping that NICE have been carrying out since October. This procedure finished at the end of January 08.
NICE have confirmned that they have still to send the DH their summary.
NICE said that they do not expect to hear from the DH until April/May which must be because of their assessment of the length of time it will take to write their summary and present it for consideration to the DH.
Things work slowly at NICE!
If one were cynical it may also be because the Qualy threshold will be redused this year, I think by April. A Qualy is the measure that is used to assess any therapy that is appraised by NICE. It measures value in terms of cost as well as clinical and quality of life benefit. At the moment it is set at £30,000 but will be reduced to £20,000.
We all know that these drugs are expensive so draw your own conclusions.
However, there are so few CML patients who do not respond to Glivec that the overall costs to the NHS are not significant.

As the DH have requested an MTA rather than an STA it means that a decision is even further away. NICE have told me that this sort of appraisal takes 14.5 months from the date of final approval to publication of their decision.
The best estimate is that the whole process will take at least 17.5 months which will be too late for some of the Glivec resistant patients who are unlucky to live in Primary Care Trust/Strategic Health Authority areas of England who have consistantly refused to fund dasatinib as an alternative therapy.
These patients are left with very little choice of effective therapy.

Dasatinib is approved in Scotland for use in Glivec resistant chronic stage CML.

Wales has gone even further:
"The All Wales Medicines Strategy Group (AWMSG) has recommended... use within NHS Wales for the treatment of adults with chronic or accelerated phase chronic myeloid leukaemia (CML), where there is resistance or intolerance to prior therapy including imatinib mesylate."
see newswire for the full quote and more information.

This is why it is important to get a NICE appraisal for both of these drugs.

Nilotinib will come out of trial in April and although Novartis have guarenteed to continue to provide the drug to all trial patients for 12 months after the trial closures, this will not coincide with the NICE appraisal if the timeline above is not improved which is highly unlikely.

It is also unlikely that Novartis would take the step of stopping the drug in cases where a patient cannot secure funding from their PCT and judging by the past behaviour of this company, they will keep supplying their drug to the very small number of patients in the UK that live in areas like the North East and Surrey, West Midlands and others, where funding is consistantly refused.

In cases where patients need to access therapy with either one of these drugs and who's PCT/hospital Trust refuses funding the only recourse is to take their case to a Patient Tribunal. In many cases this has been successful but it is stressful and some people are not aware that they have this right. There is one patient member of this group who has fought his case this way. He and his wife have offered to advise others on how best to proceed. I will pass on the contact details should anyone request them.

I will also try to find some information about how to proceed with one of these tribunals and upload the information here.

Meanwhile, please keep the pressure on and write to your MP. Urge them to ask a question in the House with a written or oral answer, preferably oral.

You can use this template as a basis for contacting your MP to make them aware of the situation regarding the proposed NICE appraisal for both dasatinib and nilotinib (you will need to update it with the information I have written above).
It is crucial that as many people as possible help put pressure on the Health Dept. to agree to an appraisal for both of these drugs. A NICE appraisal will ensure NHS funding and therefore access to alternative life saving therapy for Glivec resistant CML patients.

Also:
Read a copy of CML Support's letter to Alan Johnson, Secretary of State for Health

Read a copy of CML Support's letter to Dr. Ian Gibson, chair of the All Party Parliamentary Group on Cancer

The APPG-Cancer website link .....here