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Scottish Sprycel approval turns spotlight on NICE

Published on 09/05/07 at 02:22pm

The Scottish Medicines Consortium has approved BMS leukaemia drug Sprycel, but patients in England could face a substantial wait for access to the treatment.

The drug is the first effective option for chronic myeloid leukaemia (CML) in patients who can't take current gold standard Glivec, but it is not on a list of forthcoming NICE appraisals.

Campaigners are concerned Sprycel's (dasatinib) lack of appraisal will lead to PCTs denying patients access to the treatment because of its cost, at over £1,000 per patient.

Tony Gavin of patient group Leukaemia CARE said: "While the SMC decision is obviously great news for Scottish CML patients eligible to receive dasatinib, we are very concerned that patients living in other parts of the UK may be denied access because of funding constraints."

Recently successful campaigns by breast cancer sufferers for expensive new cancer treatments, such as Roche's Herceptin, have unfolded on an unprecedented scale, showing the possibilities of patient power when it comes to drug access.

Leukaemia CARE's Tony Gavin said: "We must ensure that our patients don't have to campaign for potentially life-saving treatment in the way some women have had to fight for access to breast cancer medicines."

Sprycel is indicated for chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy, including Glivec (imatinib), but received a restricted approval from the SMC.

The SMC decided BMS had not provided sufficient justification of the drug's cost in the blast phase of the disease, limiting use to the chronic phase where most CML patients are diagnosed.

CML accounts for around 15% of all leukaemias and currently affects around 2,600 people in the UK. In Scotland, some 60 new cases are diagnosed each year.

BMS UK managing director Frank Pasqualone said: "We are delighted with the SMC's decision and hope that CML patients in the chronic phase with resistance or intolerance to imatinib have been given renewed optimism in their fight against this rare, but life-threatening, disease.

"Recommendations such as this make medicines more accessible to the patients who need them. Sprycel builds on our company's long legacy of providing innovative oncology medicines to patients."

The drug is the first of a new generation of oral tyrosine kinase inhibitors that blocks leukaemia cell growth through a novel, multi-targeted mode of action. It received European approval in November 2006 and was launched in the UK a month later.

A similar drug is on the horizon,. Novartis' Tasigna (nilotinib), has orphan status in both Europe and the US and is being fast-tracked by the FDA for approval.



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