NICE okays Gilead leukaemia therapy Zydelig

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The National Institute for Health and Care Excellence has approved the use of Gilead Sciences’ chronic lymphocytic leukaemia therapy Zydelig on the National Health Service in England and Wales.

The cost watchdog has published final draft guidance recommending Gilead’s Zydelig (idelalisib) in combination with Roche’s Rituxan (rituximab), for first-line use in untreated CLL patients carrying a 17p deletion or TP53 mutation. It is also recommended for all adults with CLL if their cancer has come back less than 24 months after previous treatment.

The decision follows a preliminary decision earlier this year where NICE asked the company to provide further information on the cost effectiveness of the therapy. Gilead submitted new economic analyses and also proposed a  “simple discount agreement to the list price”.

The Committee concluded that the most plausible incremental cost-effectiveness ratios for Zydelig plus rituximab versus other combinations used by the NHS fell within the range of  £36,000—£46,000 per quality-adjusted life-year gained, and compared to rituximab alone of between £31,000-£41,000 per QALY gained. The mean cost of one’s year treatment of the pill which is taken twice-daily, is £37,922 before the confidential discount.

Zydelig is the first of a new class of therapy that works by blocking the signals which help cancerous cells multiply and survive.