Ofatumumab (Arzerra®) is accepted for restricted use within NHS Scotland.

The Scottish Medicines Consortium (SMC) has published advice accepting  Ofatummumab for use in NHS Scotland to treat CLL  

Advice

Following a full submission assessed under the orphan process

ofatumumab (Arzerra®) is accepted for restricted use within NHS Scotland.

Indication under review: ofatumumab in combination with chlorambucil or bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

SMC restriction: for use in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy.

The combination of ofatumumab plus chlorambucil produced a statistically and clinically significant increase in progression free survival compared with an alkylating agent alone in older patients with previously untreated CLL who had co-morbidities.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ofatumumab and it is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting

 

You can access the detailed advice PDF and briefing notes on the SMC website here

 

Further information and discussion on CLLSA at HU here

CLLSA participated in this SMC appraisel and the new PACE process to provide the patient group views.