Roche's Kadcyla (trastuzumab emtansine)should soon be available on the NHS as a treatment option for patients with HER2-positive early breast cancer having won the backing of the National Institute for Health and Care Excellence (NICE).
Around 7,000 people are diagnosed each year in England with early breast cancer have HER2-positive disease. If untreated, it is associated with increased tumour size, a higher risk of disease return and poorer clinical outcomes compared to HER2-negative disease.
NICE's appraisal is considering use of the drug in people who have already had neoadjuvant therapy to shrink their tumour, but where some cancer cells still remain in the breast or surrounding lymph nodes prior to surgery to remove the tumour. These people are at higher risk of the disease coming back.
Clinical trial evidence shows that in people who still have some cancer cells remaining after neoadjuvant therapy with a taxane (a type of chemotherapy) and HER2-targeted treatment, Kadcyla increases the time people remain free of disease compared with trastuzumab alone, the Institute noted.
However, it is not known if the drug expands the length of time people live 'because the final trial results are not yet available'.
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'.
Lesley Hugo, who leads the Breast Cancer Franchise at Roche Products Limited, said the decision
“means that patients with early breast cancer will continue to benefit from the latest advancements in cancer care, where receiving effective treatment early in the disease is crucial to prevent recurrence.”
Around 800 people will be eligible for treatment with Kadcyla following publication of final guidance, which is expected next month.