Just a quick post to show the reply to 10 Downing Street’s latest reply to the Dasatinib and Nilotinib petiton and challenge to acceptance as 2nd line therapy for resistant / intolerant Imatinib (aka Glivec, Gleevec).
I am not going to comment directly here at this stage, as in my opinion there are huge flaws in the study for the judgement, however we await the full reply and go from there.
Direct quote from 10 Downing Street:
We received a petition asking:
“We the undersigned petition the Prime Minister to overturn the decision by NICE to refuse 2nd generation life saving drugs to CML patients.”
Details of Petition:
“Chronic myeloid leukaemia is a form of blood cancer. The current treatment is Imatinib (IM).
Approx. 40% of individuals may display resistance to IM. Dasatinib (DS) & Nilotinib (NL) are licensed for the treatment of adults with chronic & accelerated phase CML with resistance or intolerance to IM.
DS is also effective for Blast Crisis CML. Both received approval by the FDA & EMEA.
NICE do not accept the evidence supplied in the initial report, as they consider open label, non blinded trial designs seriously flawed.
Cost of supply is the issue. We are urging NICE to reassess their decision NOT TO fund the use of these EFFECTIVE treatments on the basis of cost – without the need for 4 arm (DS, NL, high dose IM) double blind randomised studies including a control group receiving ‘best supportive care’ – allowing none of them to crossover and no dose escalations according to how they respond.
The NICE assumed average age for CML is 60. Would you accept such a trial would be morally/ethically correct if it was aimed at young children with CML? What if your National Insurance scheme now doesn’t treat you with the best drugs because the cost is considered too high?.”
Read the Government’s response
In response to the concerns that many people have about the availability of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia, the Department of Health should stress that the National Institute for Health and Clinical Excellence (NICE) has not yet published final guidance on the use of dasatinib and nilotinib.
NICE has recently issued draft guidance that does not recommend the use of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia and registered stakeholders had until 7 December 2009 to submit comments.
NICE’s Appraisal Committee is considering the responses to the consultation and the Institute currently expects to issue its final guidance to the NHS in April 2010.
NICE is an independent body, which makes decisions on the clinical and cost effectiveness of products based on a thorough assessment of the available evidence involving extensive consultation with stakeholders and in the context of a finite NHS budget.
Some of these treatments cost thousands of pounds, so NHS bodies must find a balance between funding expensive drugs for a limited number of patients and providing services and treatments that will benefit many other people.
The Department recognises that the Institute’s decisions have serious implications for patients and their carers. These are very difficult decisions and they are made only after careful consideration.
It would therefore not be appropriate for Ministers or officials to intervene in an ongoing appraisal. However, several patient groups are registered stakeholders in this appraisal and concerned parties may wish to raise concerns about NICE’s guidance with one of these organisations. Details of stakeholder organisations can be found at: http://www.guidance.nice.org.uk/TA/Wave17/18
Where NICE guidance is not yet available for a treatment, the NHS Constitution gives patients a right to expect local funding decisions on the availability of drugs and treatments to be made rationally and on the basis of the available evidence. NHS organisations are also required to have processes in place for the consideration of exceptional cases, even where NICE has not recommended a particular drug or treatment.”