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NICE gives nod to Gilead’s Zydelig

First class of drug to be recommended for leukaemia

NICE has recommended Gilead's Zydelig in combination with rituximab for adults with chronic lymphocytic leukaemia.

Zydelig (idelalisib) has been indicated in final draft guidance for patients whose leukaemia has come back less than 24 months after previous treatment.

The decision follows a preliminary rejection earlier this year when NICE asked Gilead to provide further information regarding the cost-effectiveness of the drug.

Gilead responded by forming new economic analyses - a simple discount agreement to Zydelig's list price having been included in the initial submission.

NICE health technology evaluation centre director Carole Longson said: “ We are delighted that Gilead Sciences responded to our consultation by providing further information for our independent appraisal committee and that they had agreed to provide idelalisib to the NHS at a reduced price in the initial submission.

“For people whose cancer has returned less than two years after their last treatment, their options are currently limited. With this new positive recommendation, the NHS will have another clinically effective option for treating adults with chronic lymphocytic leukaemia.

NICE concluded that the most plausible cost-effectiveness ratios for Zydelig plus rituximab versus other combinations used by the NHS were between £36,000 and £46,000 per quality adjusted life year (QALY).

In comparison, rituximab alone stands at £31,000 to £41,000 per QALY, making the Zydelig and rituximab combination acceptable for end-of-life considerations.

Zydelig is the first of a new class of drugs, known as phosphoinositide 3-kinase (PI3K) inhibitors, and offers a new mechanism as it works by blocking the signals that help cancerous cells multiply and divide.

The drug has been available to a restricted number of patients since January 2015 via the Cancer Drugs Fund and this new decision by NICE signals its long term availability on the NHS in England and Wales, leaving it in line with Scotland.

Article by
Nikhil Patel

24th September 2015

From: Regulatory



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