Takeda’s Ninlaro knocked back by NICE for second time
pharmafile | September 5, 2017 | News story | Research and Development, Sales and Marketing | Ninlaro, Takeda, biotech, drugs, pharma, pharmaceutical
NICE has revealed that the outcome of its consultation process for Ninlaro (ixazomib), Takeda’s treatment for relapsed or refractory multiple myeloma, was to reject the drug for the second time in the indication.
The sticking point, as is often the case with NICE, was based on cost-effectiveness, with concerns that the company did not have enough data to significantly back up its claims that it prolongs life compared with current treatments.
NICE adjudged that despite opting for an indication to treat people who had been treated with one or more previous therapies, it was likely to be used in people who had previously received treatment with two or three. It calculated that estimations on the cost-effectiveness of the produced varied between £125,000 and £274,000 per QALY, noting that it was likely to be at the higher end of this estimate.
Takeda struck a conciliatory note when it published its response to the decision, expressing ‘disappointment’ at the delays for patient access to Ninlaro but reflecting that it remains “fully committed to working closely with NICE”.
Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow and usually help the body fight infection by producing antibodies. The condition is incurable and can lead to severe problems with the bones, such as fractures and breakages.
Adam Zaeske, Managing Director UK & Ireland at Takeda UK Ltd, commented: “We will continue to work constructively and flexibly with NICE and NHS England to ensure ixazomib becomes available to patients who need it as soon as possible. We felt that our proposed confidential offer addressed the uncertainties NICE had in the first ACD and are disappointed with the committee’s latest draft decision. Whilst we acknowledge that NICE face significant challenges when assessing novel combination regimens, we are committed to finding a solution and will be responding robustly during the next stages of the process.”
The confidential offer was a reduction in price that NICE deemed to not be sufficient to make the drug cost-effective and was therefore ‘”not suitable for use within the Cancer Drugs Fund.”
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