NICE asks for more information on Gilead's Zydelig

The National Institute for Health and Care Excellence (NICE) has rejected Gilead Sciences' chronic lymphocytic leukaemia (CLL) therapy Zydelig in draft guidance, but has also started a consultation on the verdict.

NICE said it is "minded not" to approve Zydelig (idelalisib) funding on the National Health Service (NHS) for CLL as a combination therapy with Roche's MabThera (rituximab) for patients whose cancer is resistant to other drugs.

However, it has asked the company to provide more data to help it make a final decision, giving Gilead until 15 July to submit the information, which includes an analysis of the cost-effectiveness of Zydelig plus MabThera versus MabThera alone, among other factors.

Zydelig is also approved for untreated CLL patients with a 17p deletion or TP53 mutation, as well as CLL patients whose disease has been treated but relapsed, but NICE has rejected NHS funding in these cases and has not asked for additional data.

NICE's decision for England and Wales contrasts with the recent verdict of the Scottish Medical Consortium (SMC), which gave a green light to funding Zydelig for relapsed CLL and as a first-line therapy for patients with 17p or TP53 mutations last month, but rejected it in resistant CLL cases.

At the time, Monica Izmajlowicz, chief executive of medical charity Leukaemia Care said the go-ahead was "extremely welcome news" for CLL patients in Scotland, but added that it was disappointing the drug's usage was restricted further than its licensed indication.

Zydelig is, however, still funded by the UK's Cancer Drugs Fund, escaping a cull of approved therapies earlier this year.

Along with three other new CLL therapies – Roche's Gazyva (obinutuzumab), GlaxoSmithKline's Arzerra (ofatumumab), and Janssen and Pharmacyclics' Imbruvica (ibrutinib) – Zydelig was a factor behind the American Society of Clinical Oncology (ASCO) naming CLL as its cancer Advance of the Year in January.

Professor Carole Longson, NICE Health Technology Evaluation Centre director, said: "The independent appraisal committee, which is developing the guidance on behalf of NICE, considered evidence from the company, clinical experts and patient representatives.

"It concluded there were still questions to be answered about the cost effectiveness of the treatment. We have requested further analysis from the company; we want to ensure we have as much information as possible to make an informed recommendation."

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