Fedratinib [FED1]

For the treatment of patients with myelofibrosis previously treated with ruxolitinib where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with fedratinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. This patient is an adult with a diagnosis of primary myelofibrosis (also known as chronic idiopathic myelofibrosis) or post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Please enter below as to which type of myelofibrosis applies to this patient:

• primary myelofibrosis or
• post polycythaemia vera myelofibrosis or
• post essential thrombocythaemia myelofibrosis

3. This patient’s myelofibrosis has a risk category that is either intermediate-2 or high risk. Please enter below which myelofibrosis risk category applies to this patient:

• intermediate-2 or
• high risk

4. The patient has symptomatic disease-related splenomegaly and/or constitutional symptoms of myelofibrosis.
5. The patient has been previously treated with ruxolitinib. Please enter below the reason as to why the patient discontinued the ruxolitinib whether for disease progression or intolerance of ruxolitinib:

• disease progression on ruxolitinib or
• patient intolerance of ruxolitinib Note: although the marketing authorisation of fedratinib includes patients who are either treatment naïve to JAK inhibitor therapy or who have been treated with ruxolitinib, the company’s submission to NICE was only for patients previously treated with ruxolitinib

6. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
7. The prescribing clincian is aware that patients must have thiamine (vitamin B1) levels tested both before and during fedratinib therapy and that thiamine deficiency must be corrected before treatment starts and during fedratinib therapy.
8. In terms of active systemic therapy fedratinib is being given as monotherapy.
9. The patient has not previously received fedratinib unless the patient has received fedratinib via a company early access scheme and the patient meets all the other criteria listed here.
10. Fedratinib is to be continued until loss of clinical benefit or unacceptable toxicity or patient choice to stop treatment.
11. The prescribing clinician is aware that fedratinib has clinically important interactions with drugs which affect the CYP3A4, CYP2C19 and CYP2D6 enzyme systems (as set out in sections 4.4 and 4.5 of fedratinib’s Summary of Product Characteristics).
12. A formal medical review as to how fedratinib is being tolerated and whether treatment with fedratinib should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
13. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
14. Fedratinib is to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 18 February 2025

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA1018 (20 February 2025)

Current Form Version

Note

The data on this page was produced using version 1.348 of the CDF list, downloaded from an archive of NHS England’s website on 19 February 2025 at 18:00.

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.

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