Roche falls foul of NICE rules, again
pharmafile | October 3, 2014 | News story | Medical Communications, Sales and Marketing | CLL, Gazyvaro, NICE, Roche, blood cancer, oncology
Uncertainties in the data and high cost have seen NICE make an initial rejection of Roche’s new blood cancer drug Gazyvaro (obinutuzumab).
In new draft guidance NICE is saying no to Gazyvaro in combination with chemotherapy agent chlorambucil for patients with untreated chronic lymphocytic leukaemia (CLL), and who are not able to take the standard fludarabine-based therapy.
The UK NHS costs watchdog says that uncertainties in the company’s data mean it cannot recommend the treatment.
Sir Andrew Dillon, NICE’s chief executive, explains: “Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources.
“It is disappointing that we are not able to add this to the range of treatments already available. However, with limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS.”
The drug costs £3,312 per 1,000 mg vial, and Roche says that a course of treatment is £26,496 (£9,936 for cycle one and £3,312 for cycles two to six). The Swiss firm has not offered a patient access scheme to lower the price.
NICE adds that this price puts the drug above the average cost bracket that it would usually consider when assessing a new medicine.
CLL is a type of cancer that affects the cells in the bone marrow (where blood cells develop) and causes overproduction of abnormal white blood cells. The abnormal white blood cells replace the normal cells in the bone marrow but are unable to function properly.
There are already a number of medicines for CLL, including Janssen’s Imbruvica (ibrutinib), Gilead’s Zydelig (idelalisib) and Arzerra (ofatumumab), from GlaxoSmithKline and Genmab. None have yet been recommended by NICE for this particular blood cancer.
Roche does already have a medicine recommended by NICE for CLL however, namely its MabThera (rituximab) which is funded by the NHS as a first-line treatment for patients with CLL who are able to take fludarabine in combination with cyclophosphamide.
Roche rejections
This is certainly not the first time that Roche has fallen foul of NICE, and has in fact had a major public spat with the body relating to the furore around its £90,000 price tag for its breast cancer drug Kadcyla (trastuzumab emtansine), which was rejected in draft guidance in August.
Over the years the Swiss firm has seen this time and again, with its multi-licensed cancer drug Avastin (bevacizumab) – the world’s biggest selling oncology product – constantly knocked back for all five of its licences by NICE.
In recent interviews with Pharmafile, NICE’s chair Professor David Haslam says it is clear that Avastin is simply not cost-effective with minimal efficacy for its money. But the drug now alongside Gazyvaro, are both available on the government’s £280 million per year Cancer Drugs Fund.
This was recently extended from a £200 million annual injection for cancer drugs not recommended by NICE to £280 million by the UK government, as both cost and demand were skyrocketing – nearly bankrupting NHS England’s specialist commissioning budget.
But these drugs will from now have their costs assessed before being given patients, a first for the CDF, meaning Roche – by the far the biggest winner from the Fund – may no longer receive a blank cheque for expensive medicines.
The Fund is due to end in 2016 with no word on an extension. NICE is currently in the middle of a reform that could see it allow more cancer medicines through in the future, although just how this will work is yet to be ironed out.
Ben Adams
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