Ruxolitinib [RUX2]
For the treatment of polycythaemia vera for adult patients who are resistant to treatment with hydroxycarbamide or who cannot tolerate treatment with hydroxycarbamide where the following criteria have been met:
- This application is being made by and the first cycle of systemic anti-cancer therapy with ruxolitinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The patient has a confirmed diagnosis of polycythaemia vera (PV).
- The patient has high risk polycythaemia vera as defined by any one of the following criteria applying to this patient: • age >60 years • previous documented thrombosis (including transient ischaemic attack) or erythromelalgia or migraine (severe, recurrent, requiring medication and considered to be secondary to the PV) either after diagnosis of the PV or within the 10 years before diagnosis and regarded as being disease-related • significant or symptomatic splenomegaly • a platelet count exceeding 1000 x 10⁹/L at any point during the patient’s disease • diabetes or hypertension requiring pharmacological treatment for more than 6 months
- The patient has been previously treated with hydroxycarbamide (HC) and is resistant to it or cannot tolerate treatment with it or is both resistant to it and intolerant of it. Note: the definitions of intolerance and resistance are those used by the European LeukaemiaNet (ELN) consensus. Please mark below which one of these scenarios applies to this patient:
- the patient is resistant to HC or
- the patient cannot tolerate treatment with HC or
- the patient is both resistant to HC and intolerant of it
- The patient has either not been previously treated with ruxolitinib or has received previous ruxolitinib within the MAJIC-PV trial or via a company compassionate access scheme and all the other criteria on this form are fulfilled. Please mark below which one of these scenarios applies to this patient:
- the patient has not been previously treated with ruxolitinib or
- the patient has received previous ruxolitinib within the MAJIC-PV trial and the benefit-risk ratio for continuing treatment remains positive and all the other criteria on this from are fulfilled or
- the patient has received previous ruxolitinib within a company compassionate access scheme and the benefit-risk ratio for continuing treatment remains positive and all the other criteria on this from are fulfilled
- Treatment will be continued unless there is progression to myelofibrosis or myelodysplastic syndrome or acute myeloid leukaemia or the development of unacceptable toxicity or withdrawal of patient consent, whichever is the sooner. Note: this continuation rule was the one accepted by NICE in its assessment of clinical and cost effectiveness for ruxolitinib in this indication and is not the continuation rule for polycythaemia vera as set out in ruxolitinib’s Summary of Product Characteristics (SPC).
- The patient has an ECOG performance score of 0 or 1 or 2. NHS England does not fund the use of ruxolitinib in patients of ECOG performance score of 3.
- The prescribing clinician is aware of the potential drug interactions that may occur with ruxolitinib as set out in ruxolitinib’s Summary of Product Characteristics.
- When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break form to restart treatment will be completed.
- Ruxolitinib will otherwise be used as set out in its Summary of Product Characteristics.
NHS funded From: 16 January 2024
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.