NICE reverses Gazyvaro rejection in latest draft guidance

NICE has issued new draft guidance recommending Roche's Rituxan (rituximab) follow-on Gazyvaro (obinutuzumab) for some people with chronic lymphocytic leukemia (CLL), just two months after issuing preliminary guidance rejecting it (scripintelligence.com, 7 October 2014).

Gazyvaro's clinical effectiveness was not in doubt. In NICE's earlier preliminary guidance, it had been unable to recommend obinutuzumab "due to uncertainties in the company's submission," said the HTA body for England and Wales. "In response to the consultation Roche submitted revised cost-effectiveness analyses and a patient access scheme which allowed the committee to recommend obinutuzumab combination therapy for some people with CLL."

NICE is recommending Gazyvaro on the basis that Roche provides the treatment to the NHS at a reduced price. The size of the discount is confidential.

The list price of obinutuzumab is £3,312 per 1000 mg vial. Roche states that a course of treatment costs £26,496.

In October, NICE estimated that the most likely incremental cost effectiveness ratios for Gazyvaro were £31,000 per quality adjusted life year (QALY) gained compared with chlorambucil monotherapy; £28,000 compared with chlorambucil plus rituximab; £49,000 compared with bendamustine monotherapy; and £48,000 compared with bendamustine plus rituximab. For the most part, these are already above NICE's usual cost-effectiveness threshold of £20,000-30,000, but on top of that NICE said that the uncertainties in Roche's model made it likely that in reality, the costs would be higher.

The NICE committee concluded that treatment with obinutuzumab plus chlorambucil did not fulfil the criterion for short life expectancy of the end of life considerations.

Jayson Dallas, general manager, Roche UK, said the company was "very pleased" that NICE has reversed its initial decision. "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, a CD-20-targeted treatment marketed as Gazyva in the US, was assessed in combination with chlorambucil for untreated CLL.

Commenting on the draft guidance, Professor Carole Longson, centre for health technology evaluation director at NICE, said: "We are pleased that Roche responded to our consultation and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 leukemia. 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."

Datamonitor Healthcare analyst Dominique Fontanilla told Scrip that NICE's latest decision will benefit advanced-stage CLL patients in the UK who are unable to tolerate treatment with fludarabine. "The decision, however, is unlikely to have a massive impact on the UK market because only 22% of intermediate and high risk CLL patients who cannot receive fludarabine therapy receive a regimen combining bendamustine and Rituxan in the first line," she explained. However, "Uptake of Gazyvaro in the UK is likely to increase with NICE's backing and Roche may be able to buffer the expected launch of Rituxan biosimilars in the first quarter of 2017 in the EU."

A decision from the Scottish Medicines Consortium (SMC) on access to Gazyvaro on the NHS in Scotland is expected on 8 December 2014.