Yes, I completely agree, Dennis. If the manufacturers do their part, NICE just might succumb.
For your (and everyone else's) interest, London Tonight today sent me NICE's official response:
"Background information and statement for London Tonight
NICE appraisal of dasatinib and nilotinib for chronic myeloid leukaemia
Background information:
The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of dasatinib (made by Bristol Myers-Squibb) and nilotinib (Novartis) for chronic myeloid leukaemia in patients whose treatment with imatinib has failed due to resistance and/or intolerance.
As with all NICE appraisals, an independent committee of experts and lay people considered evidence presented by the manufacturers of the medicines being appraised. In this case, very little evidence of the efficacy of either dasatinib or nilotinib compared to the current treatment – an increased dose of imatinib – was presented. The Assessment Group was unable to identify sufficient published evidence for the treatments being appraised: only one included study assessed either of the technologies under review against a relevant comparator – a randomised controlled trial comparing dasatinib with high-dose imatinib.
The cost of the treatments was also considered to be too high for the benefit they appear to provide.
The interim draft guidance, published 16 November 2009, therefore did not recommend dasatinib or nilotinib. This interim decision was then opened to consultation, and the manufacturers given the opportunity to provide further evidence for the independent committee to consider at its next meeting, on 13 January 2010.
The manufacturers also have the opportunity to propose a Patient Access Scheme, which can make it easier for the NHS to afford expensive new treatments. In recent months several pharmaceutical companies have proposed such schemes and these have led to drugs being recommended by NICE for use in the NHS.
Statement:
Professor Peter Littlejohns, Clinical and Public Health Director at NICE said:
“Although there is some evidence to suggest that dasatinib and nilotinib could be considered clinically effective in cases of chronic myeloid leukaemia (CML) where treatment with imatinib has not worked, the quality of that evidence was extremely poor. This, coupled with the very high cost of the drugs, meant that the independent appraisal committee could not recommend these drugs as an appropriate use of NHS resources.
“We hope that the pharmaceutical companies that make these medicines have been able to provide more robust evidence for the independent appraisal committee’s next meeting. And it would be heartening to hear that they are prepared to share some of the very high cost of the drugs with the NHS.”
This draft guidance has been issued for consultation: NICE has not yet issued final guidance to the NHS. NICE’s preliminary recommendations were available for public consultation from 16 November until 7 December 2009. Comments received during this consultation will be considered by the Committee and following this meeting the next draft guidance will be issued.
Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Ends
Notes to Editors
About the guidance
1.Chronic myeloid leukaemia is a very rare condition that affects around 560 people in the UK each year. Many are treated with a drug called imatinib. If this treatment does not work, the current options are an increased dose of imatinib or a bone marrow transplant.
2.Information on the NICE appraisal of dasatinib and nilotinib for the treatment of chronic myeloid leukaemia and the consultation documents are available at http://guidance.nice.org.uk/TA/Wave17/18.
3.For dasatinib there was an ICER of £104,500 per QALY gained and for nilotinib an ICER of £128,000 per QALY gained in the imatinib intolerant population when compared with the comparator interferon-alpha (IFN).
4.The acquisition cost of dasatinib is £83.50 per 100 mg tablet (excluding VAT; ‘British national formulary’ [BNF] edition 58). The cost of dasatinib treatment is £30,477.50 per year, assuming a 100 mg/day treatment regimen. Costs may vary in different settings because of negotiated procurement discounts.
5.The acquisition cost of nilotinib is £21.72 per 200 mg tablet (excluding VAT; ‘British national formulary’ [BNF] edition 58). The cost of nilotinib treatment is £31,711.20 per year assuming a 400 mg twice daily treatment regimen. Costs may vary in different settings because of negotiated procurement discounts.
About NICE
6.The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
7.NICE produces guidance in three areas of health:
public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS."
The piece wasn't on at 1.30pm, but hopefully it'll be on later today.
