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NICE backs two Novartis CML drugs; BMS denied

Glivec and Tasigna approved by UK authorities for use in the NHS for the treatment of chronic myeloid leukaemia as Sprycel turned down for lack of cost-effectiveness

The UK's National Institute for Health and Clinical Excellence (NICE) has given its backing to two drugs for chronic myeloid leukaemia (CML) developed by Novartis, but turned down a rival product from Bristol-Myers Squibb (BMS).

NICE gave the go-ahead for reimbursement within the UK's NHS for a standard dose of Novartis' Glivec (imatinib) and Tasigna (nilotinib) as first-line treatments for adults with chronic phase Philadelphia chromosome-positive CML.

There was bad news for BMS, however, after NICE decided against approving its Sprycel (dasatinib) drug for this indication on cost-effectiveness grounds.

"The available evidence suggests that dasatinib and nilotinib provided superior clinical benefit as measured by surrogate outcome measures than standard-dose imatinib in the first-line treatment of people with chronic phase CML," said NICE in its report, adding that there was little to choose between the two drugs in terms of efficacy.

The agency notes that treatment with BMS' drug runs at over £30,000 at typical doses, compared to £21,000 for Glivec and a little under £32,000 for Tasigna. Novartis has however negotiated an undisclosed discount on Tasigna's price with the Department of Health (DH) under a patient access scheme, convincing the agency to give a green light to reimbursement.

Earlier this year, NICE rejected NHS reimbursement for high-dose Glivec, Tasigna and Sprycel for patients with CML who are resistant to standard-dose Glivec, although it subsequently backed Tasigna in this setting after Novartis agreed to offer the discount.

Novartis bills Tasigna as a successor to Glivec, given that the latter's patents start to expire in 2013, and the new drug is growing quickly towards that goal. Third-quarter sales rose more than 70 per cent to reach $186m, and the NICE endorsement will help the drug maintain its upward momentum.

Tasigna still has some ground to cover, however, as Glivec is Novartis' second-biggest product with quarterly sales running at around $1.14bn in CML and other cancer indications.

Sprycel has also been growing strongly, adding $211m to BMS' revenues in the third quarter, although the drug had some negative news recently after the US Food and Drug Administration (FDA) said it was linked to an increased risk of pulmonary arterial hypertension.

7th December 2011

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