Final NHS green light for Roche's Kadcyla

NICE has published final guidance backing NHS use of Roche's Kadcyla (trastuzumab emtansine) for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2) positive early breast cancer, that is in people who have already had therapy to shrink their tumour but have residual disease in the breast or surrounding lymph nodes prior to surgery to remove the tumour.

Clinical trial evidence shows that in people who still have some cancer cells remaining after neoadjuvant therapy with a taxane and HER2-targeted treatment, Kadcyla increases the time people remain free of disease compared with Herceptin (trastuzumab) alone, the Institute noted.

The drug's approval was based on results from the Phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause compared to Herceptin.

At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. The safety profile of Kadcyla was consistent with that observed in previous studies.

Kadcyla costs on average £51,000 per patient for a course of treatment at its full list price, but Roche has agreed a confidential commercial arrangement so that it's available to the NHS with a discount.

According to NICE's independent appraisal committee, even with some uncertainties in the cost-effectiveness estimates, 'these are unlikely to bring it above what NICE considers an acceptable use of NHS resources', and so it was able to recommend the drug.

Around 800 people will be now eligible for treatment with Kadcyla in this setting on the NHS.