NHS England and the drug’s manufacturer, Roche, have agreed to a new commercial access arrangement for the NHS. This means that NICE can now recommended the drug as cost effective for routine use on the NHS.

Trastuzumab emtansine (also called Kadcyla) is currently being funded through the Cancer Drugs Fund (CDF). If there are no appeals against the new draft guidance, the drug will move out of the CDF into routine NHS funding later this summer.

Around 1200 people with HER2-positive, unresectable, metastatic breast cancer would then be eligible to receive trastuzumab emtansine.

Cost of drug

Trastuzumab emtansine (Kadcyla), which costs around £90,000 per patient at its full list price, is licensed to treat HER2-positive breast cancer which has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.

The committee considered a new cost-effectiveness analysis that used a revised confidential commercial access agreement.

Comparable treatment

Another key factor in the decision was the committee’s agreement, following comments received during consultation on the previous draft guidance, that it was appropriate to compare trastuzumab emtansine (Kadcyla) with trastuzumab plus capecitabine because this is now considered standard treatment for people with advanced breast cancer.

Based on the clinical and cost effectiveness analysis, using this comparator, incorporating the revised commercial access agreement and applying end-of-life criteria, the drug now comes within the range considered to be a cost-effective use of NHS resources.

Petition

Professor Carole Longson MBE, director of the centre for health technology evaluation at NICE, said: "The committee acknowledged the comments received from patients during the consultation on the draft recommendations for trastuzumab emtansine (Kadcyla), in particular that 115,000 people had signed a Breast Cancer Now petition urging NICE and the company to ensure that it remains available.