NICE U-turn on Roche leukaemia drug
pharmafile | December 2, 2014 | News story | Sales and Marketing | Gazyvaro, MabThera, NHS, NICE, Roche, leukaemia, obinutuzumab
NICE has reversed its decision on Roche’s chronic lymphocytic leukaemia (CLL) drug Gazyvaro only two months after rejecting the drug.
The initial October knock-back was due to ‘uncertainties in [Roche’s] submission’ and high costs, according to the pricing watchdog. The list price of Gazyvaro (obinutuzumab) is £3,312 per 1000 mg vial, with a course of treatment costing £26,496 in total.
NICE now says that Roche has agreed a patient access scheme with the Department of Health and submitted revised cost-effectiveness analyses, allowing Gazyvaro to be recommended in preliminary guidance. The exact size of the discount remains confidential, however.
Professor Carole Longson, centre for health technology evaluation director at NICE says: “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 CLL.
“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.”
Professor Chris Bunce, research director at Leukaemia & Lymphoma Research adds: “The decision by NICE to reverse their stance regarding Gazyvaro is very welcome news. Chronic lymphocytic leukaemia is the most common type of adult leukaemia in the UK. The disease remains largely incurable but Gazyvaro has been proven to significantly prolong survival times for many patients.
“It is encouraging to see drug companies and NICE showing persistence in working together in order to ensure that patients can benefit from new treatments.”
Around 2,700 people are diagnosed with CLL each year. The disease causes the overproduction of abnormal white blood cells, which replace the normal cells in the bone marrow but are unable to function properly. Gazyvaro works by attaching itself to the surface of the abnormal cells and killing them.
There are several other medicines for CLL – including Janssen’s Imbruvica (ibrutinib), Gilead’s Zydelig (idelalisib), and Arzerra (ofatumumab) from GlaxoSmithKline and Genmab. None of these have yet been recommended by NICE for this indication, however.
Roche’s own MabThera (rituximab) is approved for the treatment of CLL but is set to start losing its patents in 2015. With trial results showing Gazyvaro as more effective than MabThera, Roche will be hoping it can replace the ageing drug if NICE’s approval is finalised.
The Scottish Medicines Consortium has not yet published advice on the use of Gazyvaro, but a decision is expected from the body on 8 December.
George Underwood
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