It is looking likely that a subgroup of patients with mantle cell lymphoma (MCL) will get routine access to Janssen’s Imbruvica on the NHS.

The National Institute for Health and Care Excellence has published new draft guidelines recommending Imbruvica (ibrutinib) to treat the condition in people who have had only one prior line of therapy.

Earlier this year, the Institute said it could not recommend Imbruvica for the entire MCL patient population as it did not offer the NHS value for money in this setting.

The therapy is currently available to patients in England via the Cancer Drugs Fund (CDF) if their disease has returned or they failed to respond to first-line treatment.

However, NICE is now recommending that it be commissioned through routine channels, as opposed to through the CDF, in the second-line setting, having determined that Imbruvica can be considered within ‘end-of-life’ thresholds and that it cost effectiveness is likely to be less than £49,848 per QALY gained.

The company initially agreed a patient access scheme with the Department of Health applying to all indications for the drug, but subsequently agreed a commercial access agreement with NHS England that replaced the PAS on equivalent terms, though these remain confidential.

“We are pleased that patients with this hard-to-treat cancer, who in the past had few treatment options beyond chemotherapy, can now finally access ibrutinib on the NHS in England and Wales,” said Jennifer Lee, director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK.

“Though the process has been lengthy, we have remained steadfast in our commitment to ensuring access to this innovative medicine for those with MCL.”

Imbruvica is the first in a class of medicines known as Bruton’s tyrosine kinase (BTK) inhibitors, which are designed to specifically block the BTK protein from causing malignant B cells to multiply and spread.