NHSI
8 June 2011 National Institute for
Health and Clinical Excellence
Dear Mr Clappison
Thank you for your e-mail received on 17 May 2011, on behalf of your constituent Steven Davies regarding our draft guidance on dasatinib, high- dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (CIVIL).
We know that our draft proposals have caused a great deal of distress to people living with this condition, as well as those who care for, and who treat them. We are aware that is not what patients had hoped for, and I would like to provide reassurance that the independent Appraisal Committee will give full consideration to all comments received on the draft recommendations. Although it would not be appropriate for me to respond to the individual points that have been raised during this consultation period, I do think it's important for me to address a number of common concerns that have been raised by you and also by other MPs on behalf of their constituents.
Firstly, the draft guidance relates to the treatment of imatinib-resistant CIVIL only. It does not include dasatinib and nilotinib for the treatment of CIVIL in people who are intolerant to imatinib, and the recommendations do not suggest that standard-dose imatinib for first-line treatment should be stopped. For those patients that are currently receiving dasatinib, high dose imatinib or nilotinib, I would like to provide reassurance that our draft guidance does not mean that these treatments will be withdrawn. Our draft guidance recommends that they will have the option to continue treatment until they or their clinicians consider it appropriate to stop.
Secondly, our appraisal process is designed to produce robust evidence- based recommendations for the NHS that take into account both the clinical and cost-effectiveness of a technology as well as a wide range of factors including comparisons with other available treatments and potential subgroups that may require special consideration. Part of the Committee's role is to make a judgement on whether or not the technology should be recommended as a clinically and cost-effective use of NHS resources. Giving consideration to any limitations of the evidence base forms part of this decision process.
On the issue of cost and availability in other countries, it is important to note that the Committee can only make a decision using the price available at the time of the committee meeting. The availability of drugs in the UK compared to other countries differs as different healthcare systems fund the provision of drugs to reflect their own unique circumstances and priorities. Although it may be true that the drugs in this appraisal are available in some other countries, it may not be the case that it is available free at the point of use.
With regards to concerns about the relevant experience of the Committee, the Appraisal Committees are standing advisory committees of NICE and members are appointed for a 3-year term. Although this Committee does not include a standing cancer specialist, Professor Jane Apperley, Professor of Haematology and Professor Richard Clark, Consultant Haematologist were invited to and participated in the Committee discussions and provided evidence to inform the deliberations. They gave their expert personal view on dasatinib, high-dose imatinib and nilotinib for the treatment of chronic myeloid leukaemia by attending the initial Committee discussion and/or providing written evidence.
Finally, it is important to note that we have not yet issued final guidance to the NHS. Until NICE issues final guidance, local Primary Care Trusts are expected to make their own decisions about whether or not to provide the drugs, based on their own assessment of their effectiveness. Consultants who feel that the above drugs may work better in an individual patient than the available evidence suggests are able to apply for exceptional funding from their local PCT or from the Cancer Drugs Fund.
Following the close of our consultation, the Committee will meet again on 9 June 2011 to discuss the response to our draft guidance. Whether or not the final guidance is different from the draft recommendations, the members of the committee will be fully aware of what you and your constituents think about this important decision.
Yours sincerely,
Sir Andrew Dillon Chief Executive