Bristol-Myers Squibb’s chronic myeloid leukaemia treatment Sprycel (dasatinib) has been approved for NHS use in England and Wales by the National Institute for Health and Care Excellence.
Overturning its former ruling against the oral therapy, NICE recommended Sprycel in final guidance for first- and second-line treatment of adults with CML.
The watchdog’s decision is based on two phase III clinical trials of newly-diagnosed CML patients and patients who have developed resistance or intolerance to previous treatment.
Of those receiving Sprycel as a first-line treatment, 77% reached a complete cytogenetic response, where blood levels of platelets and white blood cells returned to normal within 12 months, compared to 66% of patients taking Novartis’ Gleevec (imatinib), the current standard care.
Meanwhile 90% of second-line patients with chronic, accelerated or blast phase CML produced haematological and cytogenetic responses to BMS’ protein kinase inhibitor.
Sandy Craine, founder of online patient community The CML Support Group, said: “For people fighting this disease, timely access to potentially lifesaving targeted therapies such as dasatinib will very likely enable them to gain control over their disease and live our their normal lifespan.
“Access to targeted therapies like dasatinib not only has the potential to extend their life expectancy but also represents a cost-effective use of NHS resources.
“This is a progressive and forward-thinking decision by NICE and will be welcomed by patients and clinicians alike throughout England.”
With a list price of £30,000 per patient per year, Sprycel was originally rejected due to its lack of cost-effectiveness, and NICE approved the cheaper Gleevec.
BMS has now agreed a patient access scheme for Sprycel, which brought in sales of $472m this year, according to the company’s third quarter report.
CML accounts for 15% of all adult leukaemia with approximately 750 people diagnosed in England every year, and around 200 deaths annually from the disease.