Kadcyla price too high for routine NHS funding, says NICE in final guidance
16 December 2015
NICE has issue its final guidance on the use of Kadcyla (trastuzumab-emtansine) as a treatment for a type of advanced breast cancer.
A spokesperson for NICE said: "Although Roche recently agreed a price discount with NHS England to allow Kadcyla to be retained on the Cancer Drugs Fund, they made no changes to the patient access scheme available for the NICE appraisal, which means it is still above the top of our specially extended range of cost effectiveness for cancer drugs1."
Kadcyla is licensed to treat HER2-positive breast cancer2 which has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment. It costs about £90,000 per patient at its full list price3.
This guidance does not mean that people currently taking Kadcyla will stop receiving it. They have the option to continue treatment until they and their doctors consider it appropriate to stop.
For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.
Notes to Editors
NICE published initial draft guidance in April 2014, which did not recommend the treatment to is high price. Following a public consultation on this guidance, Roche did submit a patient access scheme to make trastuzumab emtansine more cost-effective. Roche proposed a simple discount on the price of the drug, but this had a minimal effect on its cost-effectiveness. The discounted price offered by the company is confidential under the terms agreed for Patient Access Schemes (the system through which drug companies can offer price discounts), set by the Department of Health.
There are many different types of breast cancer. A tumour is referred to as 'HER2-positive' when cancer cells overexpress a protein called HER2 (human epidermal growth factor receptor 2). This stimulates the cancer cells to grow and spread. HER2-positive tumours are typically more aggressive than other types of breast cancer. Roughly 41,500 women and 300 men are diagnosed with breast cancer each year in England. About 1 in 5 cases - thousands of people - will be HER2-positive. The targeted treatment trastuzumab (Herceptin) is only effective for this type of breast cancer. The manufacturer estimates that about 1,200 people would be eligible for treatment with Kadcyla.
Trastuzumab emtansine costs £1,641.01 per 100mg vial and £2,625.62 per 160mg vial (excluding VAT; MIMS, March–May 2014). Assuming a 3 weekly dose of 3.6 mg/kg, a patient weight of 70.1 kg and an average length of treatment of 14.5 months, the manufacturer estimates that a course of treatment with trastuzumab emtansine will costs £90,831 (excluding administration costs).
The independent Appraisal Committee concluded that the institute's criteria for appraising end-of-life cancer treatments should be applied in this case. This allows the committee more scope to recommend treatments with a higher cost-effectiveness threshold. Despite this extra flexibility, the committee concluded that trastuzumab emtansine – with a revised incremental cost-effectiveness ratio (ICER) of about £166,000 per QALY gained - could not be considered cost-effective.
The guidance on trastuzumab emtansine (after trastuzumab and a taxane) for HER2-positive, unresectable, metastatic breast cancer is available at /guidance/TA371.
Trastuzumab emtansine is only licensed for use after trastuzumab and a type of chemotherapy drug called a taxane. These can be taken either in combination or separately.
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