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CML Support Group: Response to the Appeal Panel Judgement
CML Support Group: Response to the Appeal Panel judgement in favour of the NICE
decision not to recommend dasatinib as a second line treatment option for imatinib
resistant CML and in patients intolerant to imatinib, and including its use in blast
phase CML.
We are disappointed, though not entirely surprised, at the outcome of the appeal
against the recommendations of this very lengthy and complex Multiple Technology
Appraisal : Dasatinib, high-dose imatinib and nilotinib for the treatment
of imatinib resistant CML (part review of NICE TAG70), and dasatinib and
nilotinib for people with CML for whom treatment with imatinib has
failed because of intolerance.
In practical terms, the outcome is that dasatinib will no longer be routinely available
as a second line treatment after failure of standard dose imatinib. However, nilotinib
has approval as a 2nd line treatment option for use in such cases, subject to the PAS
(patient assistance scheme) as offered by the company.
It is important to note that NICE full guidance TA241, will not affect patients in chronic
phase CML who are currently treated with dasatinib or higher doses of imatinib.
There are two other routes that will remain open for patients whose clinical situation
makes dasatinib the therapy of choice, the Cancer Drug Fund and the IFR (individual
funding request) directly to the relevant PCT.
Why the appeal failed.
No one, including the NICE Appraisal Committee, has denied that dasatinib is as good
a therapy as nilotinib and that both drugs are an improvement over imatinib.
These are, after all, second generation TKIs and effect a significant improvement in
patient outcomes, showing improvements in progression free survival.
This is one reason why dasatinib is in clinical use in all over the world, as is nilotinib,
including in all EU member states, as well as Scotland.
The fundamental reason why the appeal against the FAD failed on all 3 grounds is
that at the open market list price, both 2nd generation TKIs are more expensive than
imatinib and are judged to be too expensive to recommend for use in the NHS at
that price.
It might help to put this into context. Using the upper limits quoted in NICE Guidance
(TA70) for the treatment of patients in chronic phase CML, a year’s supply of
dasatinib in 2012, would cost the NHS approximately £2,000 more than the cost of
a year’s supply of imatinib in 2003.
This 'rise' in cost represents an increase over a decade of around 7%, which, given
inflation over the same period amounted to 25%, we think is reasonable.
NICE do not agree the cost represents good value for money, even though dasatinib
is active against 21 out of the 22 mutations against which imatinib is ineffective.
This is why dasatinib (and nilotinib) represents medical progress.
We have argued that such innovation is worth paying for and wonder why NICE are
traveling backwards on medical progress whilst others continue to move forwards.
Government policy clearly recognises that the pharmaceutical industry is a key
manufacturing sector that would provide economic growth, and continued investment
in the sector will help secure future prosperity for the UK.
Other government departments (BIS) want to encourage the UK's leading role in the
research and development of cutting edge biomedical products like 2nd and 3rd
generation TKIs.
If NICE continues to act as it does, the pharmaceutical industries most innovative
products will be exported, leaving UK citizens reliant on decades old therapies
developed in the last century.
In our view this make little sense.
16th January 2012