Kadcyla is currently only available (in England) through the Cancer Drugs Fund. NICE wanted to secure the treatment’s long-term future in the NHS by making a recommendation for routine funding from NHS England’s specialised commissioning budget.

Kadcyla treats people with HER2-positive breast cancer[1] that has spread to other parts of the body, cannot be surgically removed and has stopped responding to initial treatment.

The treatment is estimated to cost more than £90,000 per patient at its full list price[3].

In April, NICE published draft guidance that did not recommend trastuzumab emtansine. It concluded that its high price made it impossible for it to recommend despite evidence of its benefits to patients[4].

NICE has now issued final draft guidance reiterating that view.

Sir Andrew Dillon, NICE Chief Executive said: “Although Roche proposed a discount to the full list price of Kadcyla, it made little difference to its value for money, leaving it well above the top of our specially extended range of cost effectiveness for cancer drugs.

“We are really disappointed that Roche were not able to demonstrate more flexibility to help us make a positive recommendation. The company is well aware that we could not have recommended Kadcyla at the price it proposed.”

Sir Andrew continued: "Roche considers that the 2014 Pharmaceutical Price Regulation Scheme (PPRS) agreement includes an expectation that NICE will ignore the price a company asks for its product, because the agreement provides for a rebate to be paid by the pharmaceutical industry to the NHS where expenditure on branded drugs rises above an agreed level.

"The agreement does not contain this expectation because both the Association of the British Pharmaceutical Industry and the Department of Health agree that obtaining value for money from new drugs is in the interests of the industry and the NHS.”

Ends

For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

1. 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.
2. 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.
3. 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 cost £90,831 (excluding administration costs).
4. Interim results from the EMILIA clinical trial, which were submitted by the manufacturer, found that median overall survival was 5.8 months longer in the trastuzumab emtansine arm of the study than in the lapatinib and capecitabine arm.  At the time point the analysis was conducted 30% of people taking trastuzumab emtansine and 37% of people taking lapatinib plus capecitabine had died.

About the guidance

• 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.
• 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.
• The manufacturer did submit a patient access scheme to make trastuzumab emtansine more cost-effective. It 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.
• Despite the extra flexibility from NICE’s end of life treatments protocol, 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.