Dasatinib & Bosotinib to be reassessed in December as to inclusion in Cancer drugs fund. This is of great concern as there is the potential it would seem to lose two very effective drugs in the UK to new patients. Is there anything we can do to affect this / likelihood do you know Sandy - David ?
You are here
Cancer Drugs Fund to be restricted - says NHS - off BBC web site today
This isn't particularly promising, in particular for about 250 Spirit 2 patients on Dasatinib who are all due to come off the trial around 2017/18 with no NHS funding for their treatment.
It has been occurring to me for a while that perhaps we need to get some kind of momentum started for ourselves regarding treatment after the trial. It would seem incredible to me if a couple of hundred people who are successfully in remission on Dasatinib are suddenly told that they can no longer be funded for a drug which clearly works for them, in favour of starting another drug which may or may not work.
If the cancer Drug Fund finance is not there, what is expected to happen to all of those on the Dasatinib arm of the trial?
Rod
Hi Rod. Prof Steve O’Brien who is part of the running of the trial has said that BMS have guaranteed 5 years supply of Dasatinib after the trial ends, and that the NHS they would not remove a patient from a drug that worked for them even if the 5 years supply was not promised, as shown by the article which says the same really for those already on a drug via the CDF.
He confirmed this again at the patients conference in Newcastle a few weeks ago. Nigel
That's good to hear - it hasn't been previously passed on to me by either the NHS consultants or the Spirit trial team - my understanding when recruited to the trial was that it was 5 years supply from the date that the last person was recruited on to the trial (i.e. their end date).
For it to be 5 years from the end of the last recruit's exit means they are guaranteeing supply out to 2022?
Hi
Sorry to be the bearer of bad news but I've been in contact with the trial team this morning and they've confirmed that the last person was enrolled on to the trial in March 2013, and so the BMS arrangement to supply Dasatinib runs until March 2018 only.
I asked for something in writing to confirm this but they wouldn't do that for me.
I'd suggest that you may wish to re-check with your own trial representatives, and I would be interested in anything which strengthens your second point that the NHS "wouldn't take someone off a drug that was working, irrespective of cost".
Rod
Hi Nigel and Rod,
There are two quite distinct issues here.
The first concerns the Cancer Drugs Fund (CDF) and the re-evaluation of the 40+ drugs on the national CDF list which include dasatinib, bosutinib and ponatinib.
Re-evaluation will involve an assessment of each drug’s clinical performance and for the first time the introduction of a cost component into the assessment.
Essentially its like a mini NICE evaluation exercise but unlike NICE all the details of the cost component part of the assessment process are to remain secret.
I have no idea what the outcome will be for the three CML drugs but my guess would be ponatinib and dasatinib will, for very different reasons, emerge from the process successfully with bosutinib having a good chance of doing so but not as good as the other two.
Any patient currently receiving treatment with any of these drugs as a result of their clinician making a successful application to the Fund will be able to continue with that treatment indefinitely.
The second issue concerns continuing access to a drug a patient was initially treated with on a clinical trial beyond the date where the company conducting the trial had agreed to continue supplying the drug.
In this situation, if the drug is not routinely available in the NHS (that is, has not be taken into what is called baseline commissioning) or lacks or continues to lack a positive recommendation for its use from NICE, an application can be made to the CDF with what is called an Individual CDF Request.
Here a patient’s clinician has to make a case based on what’s called ‘exceptionality‘ where the aim is to establish the unique set of clinical circumstances operative that result in the necessity of treatment with a particular drug not currently on the CDF list.
This would apply to any, or all, of the 3 drugs on the current list were they taken off it but not taken into baseline commissioning.
Overall I’m optimistic about all three continuing to be available because all are very successful in treating CML
In my opinion the recent activity surrounding the CDF is really directed at another class of drugs in the Fund but the issue is so sensitive it requires masking which in this case takes the form of a re-evaluation of all drugs in the Fund.
Dave
So Nigel, to clarify:
The 5 year 'guaranteed' dasatinib supply is for 5 years from last patient enrolled. Last person in was March 2013 therefore supply is guaranteed for all patients until March 2018. The CDF (potential) decision on this in December won't affect current availability.
Four years he feels dasatinib will be readily available through NICE or CDF and does not think the NHS will leave patients on existing medication high and dry. BMS have informally indicated that they ensure that patients don't go without.