NICE U-turn means patients in England can access Imbruvica via CDF for first time

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The National Institute for Health and Care Excellence (NICE) has recommended Imbruvica® (ibrutinib), within its marketing authorisation, for use on the Cancer Drugs Fund (CDF) as an option for treating Waldenström’s macroglobulinaemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed.

Today’s positive final appraisal determination means patients in England can now access ibrutinib via the CDF for the first time.

WM is a type of non-Hodgkin lymphoma and although rare, around 400 patients are likely to be diagnosed each year in the UK.  

Prior to ibrutinib, there was no established standard of care and no licensed novel agents specifically for treating WM. 

The positive recommendation from NICE was based on clinical evidence from a Phase 2 single-arm, open-label trial in the US (PCYC-1118E). However, NICE concluded that further collection of outcomes data would be needed before the treatment was recommended for routine use on the NHS.

Roger Brown, WM (Waldenström’s Macroglobulinaemia) UK Chair said: “With this decision, patients now have access to a targeted alternative to chemotherapy, which will undoubtedly be welcome news for a condition which desperately needs new treatment options. Today’s decision also creates the opportunity for further evidence to be collected via the CDF and the dedicated Rory Morrison Clinical Registry, which we welcome.”

Jennifer Lee, Director of Health Economics, Market Access & Reimbursement and Advocacy at Janssen UK, said “This decision is welcome news for patients and healthcare professionals alike. The decision to make ibrutinib available on the CDF makes it possible for additional clinical data to be collected to add to the evidence base for WM.”

NICE also issued a negative appraisal consultation document (ACD) stating ibrutinib is not recommended, within its marketing authorisation, for treating relapsed or refractory mantle cell lymphoma in adults (MCL).

The committee had stated it would consider a proposal for inclusion in the Cancer Drugs Fund. This interim guidance is not intended to affect the position of patients whose treatment with ibrutinib was started within the NHS before this guidance was published.

Ibrutinib will remain available on the ‘old’ CDF where it has been available to patients for nearly three years and as a result has become the standard of care for MCL treatment. 

Ms Lee added: “This is particularly discouraging news for patients with MCL in the UK, as the medicine is already routinely available to patients with the same condition in Scotland, following the Scottish Medicines Consortium (SMC) recommendation last year. Janssen remains committed to working with NICE and NHS England to ensure access to ibrutinib for patients with relapsed or refractory MCL.”