Draft guidance consultation
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1 Recommendations
1.1 Ruxolitinib is not recommended, within its marketing authorisation, for treating polycythaemia vera in adults who cannot tolerate hydroxycarbamide (also called hydroxyurea) or when the condition is resistant to it.
1.2 This recommendation is not intended to affect treatment with ruxolitinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Standard treatment to control blood cell count (cytoreductive therapy) in polycythaemia vera is hydroxycarbamide or interferon alfa. Ruxolitinib would be used for people who cannot tolerate hydroxycarbamide or when the condition is resistant to it.
Results from clinical trials suggest that ruxolitinib is more effective than standard treatment at controlling blood cell counts and reducing spleen size. But whether it increases how long people live is uncertain.
There are uncertainties in the company's cost-effectiveness model, particularly around its structure and how survival is modelled. This means that it is not possible to determine the most likely cost-effectiveness estimates. But all possible estimates are considerably above the range that NICE usually considers an acceptable use of NHS resources. So, ruxolitinib is not recommended.
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