The National Institute for Health and Care Excellence (NICE) has published final draft guidance on the use of Kadcyla as a treatment for a type of advanced breast cancer.
The draft guidance follows news that the manufacturer of Kadcyla, Roche, recently agreed a significant price discount with NHS England to stop the drug being removed from the Cancer Drugs Fund.
A different, smaller discount has been offered to NICE for use in this appraisal.
Sir Andrew Dillon, NICE Chief Executive, said: “We recognise that Kadcyla has a place in treating some patients with advanced breast cancer and we have been as flexible as we can in making our recommendation. However, the price that the manufacturer is asking the NHS to pay in the long-term is too high.”
Kadcyla - which 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 - costs about £90,000 per patient at its full list price.
Although Roche has offered a discount, NICE’s independent Appraisal Committee found that it did not reduce the price enough to make it cost-effective for the NHS. This is despite using the specially extended range of cost effectiveness for cancer drugs, which allows more expensive treatments to be recommended if they are shown to benefit people reaching the end of their lives.
The Appraisal Committee was also asked to look at whether the current Pharmaceutical Price Regulation Scheme (PPRS) would affect the drug’s cost effectiveness. The committee, using NICE’s position statement on the PPRS scheme, concluded that any potential rebate to the Department of Health could not be taken into account as there is no direct connection between the rebate and the resources that the NHS needs to make available to buy Kadcyla.
NICE has not received any further offers from Roche to reduce the price of Kadcyla.
Sir Andrew said: “Despite a growing public campaign for a fair deal on the cost of important new cancer medicines, it is disappointing that there appears to have been no meaningful attempt by Roche to reconsider its price to secure Kadcyla’s long-term future in the NHS, outside of the Cancer Drugs Fund.”
This draft guidance is now subject to an appeal process whereby consultees can appeal against the recommendation, subject to certain criteria.
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
- 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.
About the guidance
- The draft guidance does not recommend trastuzuamb emtansine as a cost effective use of NHS resources. It also says that any person currently receiving the treatment can continue until they and their doctor consider it appropriate to stop.
- 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.
- 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.
- 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)..
- 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.
- Meanwhile, 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 manufacturer, Roche, lodged an appeal against the draft NICE recommendation in August 2014. It asserted that the guidance did not take the 2014 Pharmaceutical Price Regulation Scheme (PPRS) agreement sufficiently into account.
- The Appraisal Committee concluded that the proposals put forward by the company to take into account the PPRS did not represent an exception that might lead it to depart from NICE’s general position. For more details, please see the draft guidance.
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