Latest from UK CML news

November 27, 2009

This is a follow up on the information I sent you yesterday.

NICE proposes rejection of B-MS/Novartis drugs for leukaemia

17 November 2009

Bristol-Myers Squibb and Novartis are facing a giant hurdle in getting their

respective leukaemia drugs Sprycel and Tasigna funded by the National Health

Service, after the cost-watchdog issued an amber light for their use.

The National Institute for Health and Clinical Excellence has published

appraisal documents rejecting the use of Sprycel (dasatinib) and Tasigna

(nilotinib) for the treatment of chronic myeloid leukaemia in patients who

experience resistance or are intolerant to therapy with Novartis’ Glivec

(imatinib).

Glivec, a first-generation tyrosine kinase inhibitor, is currently the treatment

of choice if a stem cell transplant is not possible, based on its ability to

slow down the progression of CML and produce high rates of remission in the

chronic phase of the disease. According to NICE, the drug is associated with

improved five-year survival, boosting the rate from 27.1% in 1990-1992 to 48.7%

in 2002-2004 following its addition to routine clinical practice.

However, while only a relatively small proportion of patients - around 3% - are

estimated to either develop a resistance to Glivec or be intolerant to therapy

right from the start when the disease is in its early, or chronic phase,

effective second-line therapies are urgently needed to give these patients

another treatment option.

Sprycel is a second-generation oral tyrosine kinase inhibitor that, at nanomolar

concentrations, reduces the activity of proteins responsible for the

uncontrolled growth of leukaemia cells in patients with CML, and was introduced

to the UK market back in December 2006.

Phase III clinical trials of the drug have demonstrated a two-year estimated

progression-free survival rate of 80% and an overall survival rate of 91% (based

on Kaplan-Meier estimates). But the drug comes with a hefty price tag of £83.50

per 100-mg tablet, which equates to a yearly cost of £30,477.50 on the basis of

one pill per day.

Launched in the UK in May 2008, Tasigna also targets the tyrosine kinase enzyme

responsible for the reproduction of CML cells, and in clinical trials was

effective – i.e. blood cell counts normalised - in 77% of patients in the early

stage of CML resistant/intolerant to other therapies. In addition, 40% of

patients achieved a complete cytological response with no abnormal chromosomes –

the root cause of CML – detected in the bone marrow cells and at 12 months the

overall survival rate was 95%.

Like its competitor though the price is on the high side - £21.72 per 200-mg

tablet (excluding VAT) – and based on a treatment regimen of 400mg twice daily

this works out to be around £31,711.20 per year, NICE noted.

Too much uncertainty

While the Committee ruled that Sprycel and Tasigna are clinically effective for

the treatment of CML, despite the fact that it considered the clinical evidence

to be “of extremely poor quality”, it concluded that the uncertainty surrounding

the magnitude of this gain added to the drugs’ “exceptionally high acquisition

costs” means they “cannot be regarded as an appropriate use of NHS resources”.

Is recommendations have not been finalised and following the consultation the

Institute may well change its mind, but news of its current position will no

doubt come as a disappointment to the estimated 4,000 patients with CML in the

UK today who may not be able to take the gold standard therapy.

By Selina McKee

_________________________________

Here is a direct link to more on this subject, so if we think it can't happen

here, think again.

What do you think? Would like to hear your opinions.

http://www.nice.org.uk/guidance/index.jsp?action=article & o=46129

FYI,

Lottie Duthu

November 28, 2009

UPSETTING!!!!

Sent from my iPhone

On Nov 27, 2009, at 4:50 PM, " Lottie Duthu " <lotajam@...> wrote: