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NICE backtracks on Gazyvaro rejection

Roche agrees to patient access scheme to help gain leukaemia recommendation
roche gazyva gazyvaro obinutuzumab

Roche's cancer drug Gazyvaro is now on course for use in the NHS in England and Wales to treat leukaemia after the National Institute for Health and Care Excellence (NICE) overturned previous negative guidance.

NICE issued new draft guidance today that backed the use of Gazyvaro (obinutuzumab) in people with chronic lymphocytic leukaemia (CLL) who have yet to receive treatment.

The guidance comes two months after NICE initially turned down the drug for use in CLL – the most common leukaemia in England – due to concerns over the quality of data presented by Roche.

Roche, which is the leading pharma company working in oncology, has since provided revised data concerning the drug's cost-effectiveness, as well as a discount through a patient access scheme, encouraging NICE to change its mind.

“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,” said Prof Carole Longson.

Prof Longson explained the type of patient that would benefit from treatment with Gazyvaro, noting that half of people with CLL are unable to use the standard first-line treatment of the chemotherapy fludarabine and that many patients are also unsuitable for the recommended alternative Levact (bendamustine), marketed by Astellas.

“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,” said Prof Longson.

Roche, which has been critical of NICE's stance on cancer drugs in the past, welcomed the new guidance.

The company's UK general manager Jayson Dallas 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.”

Gazyvaro was approved in Europe in July this year and in the US under the name Gazyva in November 2013.

The NICE guidance is now up for consultation until January 6, 2015, after which further draft guidance will be published.

Article by
Thomas Meek

2nd December 2014

From: Sales, Healthcare



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