Price cut secures NICE nod for Gazyvaro

Roche's new treatment for chronic lymphocytic leukaemia (CLL) looks set for NICE approval after the company offered a price reduction.

The UK's National Institute for Health and Clinical Excellence (NICE) rejected the drug in October, but has today issued new draft guidance, after the firm supplied revised cost-effectiveness analyses and a price cut via a so-called patient access scheme.

The list price of Gazyvaro (obinutuzumab) is £3,312 per 1000 mg vial (excluding VAT), with a course of treatment costing £26,496 (excluding VAT), but Roche have now offered to cut this price. However, such price cuts agreed via the NICE process are always confidential, so the extent of the discount has not been made public.

Roche's Gazyvaro is part of a triumvirate of new CLL treatments hitting the market, the other drugs being Gilead's Zydelig (idelalisib) and Janssen and Pharmacyclics' Imbruvica (ibrutinib).

Neither Zydelig nor Imbruvica have yet secured NICE approval, and Roche will want to get the green light well ahead of its rivals, which NICE is set to review in 2015. Another reason for its willingness to offer a discount is that another route to market – England's Cancer Drugs Fund - is set to be made stricter, with similar scrutiny of prices to NICE.

Commenting on the draft guidance, Professor Carole Longson, centre for health technology evaluation director at NICE, said: "We are pleased that Roche responded to our consultation and provided further analyses to allow us to propose recommending obinutuzumab as a treatment option for untreated chronic lymphocytic leukaemia."

Gazyvaro and the new drugs are aiming to eventually displace the two standard treatment alternatives for CLL: a three-part combination of fludarabine, cyclophosphamide and Roche's rituximab (known as FCR) or bendamustine. Gazyvaro's current licence allows it to be used in combination with chlorambucil for adult patients with previously untreated CLL who have co-morbidities which make them unsuitable for FCR.

Professor Carole Longson said: "Half of the people who need treatment for their condition are not able to use the standard first-line treatment of fludarabine combination therapy. NICE recommends alternative treatment with bendamustine but there are some patients for whom this is also unsuitable. Obinutuzumab is a clinically effective treatment which is associated with fewer adverse events and provides another option to help prevent people's disease from progressing."

Jayson Dallas, general manager of Roche UK, said: “We are very pleased that NICE has reversed its initial decision on Gazyvaro which has shown, in trials, to provide a significant survival advantage over the standard therapy available to patients with this devastating disease. The priority now is to ensure the translation of this positive draft decision into concrete final guidance to ensure that patients are able to access the drug on the NHS as soon as possible.”

NICE's draft guidance is now open to consultation until Tuesday 6 January 2015. Once finalised, the NICE recommendation will give Roche's drug a head start on its rivals. NICE currently expects to complete its review of Gilead's Zydelig in October 2015, while the cost-effectiveness body has only done preliminary scoping work on Janssen's Imbruvica in CLL.

A decision from the Scottish Medicines Consortium (SMC) on access to Gazyvaro on the NHS in Scotland is expected on 8 December.

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