SMC approves Inlyta
pharmafile | November 13, 2013 | News story | Sales and Marketing | Pfizer, SMC, Sutent, inylta, rcc
Pfizer’s kidney cancer drug Inlyta has been approved by the drugs watchdog in Scotland, making it the only country in the UK where the new brand can be accessed by patients.
The decision comes after the oral selective tyrosine kinase inhibitor (TKI) was resubmitted to the Scottish Medicines Consortium (SMC), and is on the proviso that a patient access scheme continues to be available to NHS Scotland.
Inlyta (axitinib) can now be used as an option to treat adults with advanced renal cell carcinoma (RCC) after failure of prior treatment with Pfizer’s own Sutent (sunitinib) or a cytokine.
Although it has been shown to improve progression-free survival ‘significantly more’ than another targeted therapy in this setting, it does not provide significant improvement in overall survival.
NICE has already said it would not be cost-effective – and issues of price are discussed at some length in the SMC’s explanation of its decision: it concludes that the drug is value for money even though it acknowledges that ‘uncertainties’ remain.
However, despite these issues, it has approved the Inlyta for use and Pfizer will be relieved to get the drug up and running within the UK’s public health services.
The key evidence for Inlyta in RCC comes from the Phase III AXIS study which compared Inlyta to Bayer and Onyx’s Nexavar (sorafenib) in the second-line treatment of RCC.
SMC estimates the patient scheme agreed by Pfizer puts the incremental cost-effectiveness ratio (ICER) for Inlyta compared to best supportive care in patients for whom Sutent has failed at £33,837 per quality adjusted life year (QALY) gained (and £56,343 in the cytokine refractory population).
But the watchdog accepts that both ICERs are high and the figure is subject to a number of key variables in terms of patient outcomes.
The SMC has concentrated on the Sutent refractory population as this is “the most important for clinical practice” and its main concern is with the reliability of the best supportive care results produced from the simulated treatment comparison – a method not used before in SMC reviews.
Adam Hill
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