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Statement from Novartis Oncology on the supply of Tasigna for ENACT trial patients

Owing to Pennie's post about the closure of the ENACT trial programme and the worries that some trial patients might now have about the continuation of therapy with Tasigna, I contacted Novartis Oncology once again to confirm the position for the UK.

They have provided me with an official statement, which I have copied below. I hope that this will help alleviate any worries that ENACT trial patients may have about their continued access to Tasigna.

Sandy

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Statement from Novartis Oncology on the supply of Tasigna for ENACT patients

Novartis Oncology would like to confirm the following with regards to the
ongoing supply of Tasigna for all those patients enrolled on to the ENACT (Expanding Nilotinib Access in Clinical Trials)
programme.
Tasigna was made commerically available (to the NHS) in the UK on 15th May 2008.
In anticipation that NHS funding would not be in place at the time of launch for many areas, Novartis Oncology is offering Tasigna free of charge for up to a period of 12 months for those patients enrolled on ENACT.

Novartis Oncology continues to work with all clinical trial investigators involved in the ENACT open access programme to assist them
in making the required funding applications, with the aim of securing local funding for each patient by the end, if not before, this time.
The information above has been clearly communicated and agreed with all ENACT sites, prior to enrolment of any patients.

It is our firm intention that no patient enrolled on ENACT prematurely stops treatment with Tasigna due to a funding block, and would like to reiterate our continued commitment to patients in this area.

Head of Oncology Communications,
Novartis Pharmaceuticals UK, Limited

Sandy
Thank you so much for getting this staement from the Oncology Communications at Novartis. It is somewhat reassuring to know that they will cover the cost of the drug for 12 months. However as I know you are very aware that will leave a gap before Tasigna gets through the NICE process and that could be a problem for those of us on the drug at the end of the 12 month period.

Guess it means we might have to get the old writing/lobbying hats out and dusted down again.

ATB
Pennie

hi Pennie,
The final two paragraphs of the Novartis statement should make you feel more secure....

"Novartis Oncology continues to work with all clinical trial investigators involved in the ENACT open access programme to assist them in making the required funding applications, with the aim of securing local funding for each patient by the end, if not before, this time....."

(i.e at or before 12 months)

"The information above has been clearly communicated and agreed with all ENACT sites, prior to enrolment of any patients....."

(so in your case the trial team at Kings would/should be able to let you know of the progress in their efforts to secure local PCT funding for you and all patients on their trial.... they have Novartis to assist them in applying for funding)

"It is our firm intention that no patient enrolled on ENACT prematurely stops treatment with Tasigna due to a funding block, and would like to reiterate our continued commitment to patients in this area."

It seems evident from this that they are firmly committed to supporting trial patients up to the NICE appraisal.

best wishes,
Sandy

Please that in Scotland, it's only 4 months free supply post SMC decision which is due in June