The National Institute for Health and Care Excellence (NICE) is currently appraising trastuzumab emtansine (Kadcyla, manufactured by Roche) as a treatment option for 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.

Draft guidance, published for consultation, says that despite some evidence of clinical efficacy, trastuzumab emtansine does not work well enough to justify its high cost and it therefore should not be recommended for routine NHS use.

Sir Andrew Dillon, NICE Chief Executive, said: “We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS.

“This drug is already being funded through the special Cancer Drugs Fund. Our job is to recommend whether it should transfer into the NHS budget. We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly. We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer.”

The independent Appraisal Committee, which develops recommendations on behalf of NICE, considered evidence from the manufacturer, doctors and patient experts. It heard that trastuzumab emtansine is most likely to be given as a ‘second-line' treatment[2] and could potentially help to extend life by nearly 6 months[3] compared with the treatment combination of lapatinib plus capecitabine. However, a course of treatment with trastuzumab emtansine is expected to cost £90,831 per patient[4] - tens of thousands of pounds more than other currently available second-line treatments[5]. Considering the high cost of the drug, the committee concluded that it could not recommend trastuzumab emtansine as a cost-effective use of NHS money.

Sir Andrew continued: “We hope the manufacturer will act in the best interests of patients and use this consultation period to look again at their evidence and consider if there is more they can do.”

Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until Monday 19 May 2014. All comments received during this consultation will be considered by the committee and a second draft of the guidance will then be published. If there are no objections at that stage, NICE will publish final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

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.

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.

2. 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 committee heard from clinical experts that doctors would opt for trastuzumab emanstine as the next treatment (thus using it as a second-line treatment) rather than trying other options first.

Trastuzumab emtansine is a new kind of targeted treatment and works in 2 ways. It stops cancer cells overexpressing the HER2 protein, which stops them growing and spreading. It then delivers a targeted shot of chemotherapy directly into the cancerous cells. It is not a cure for advanced breast cancer, but can help to control the disease.

Trastuzumab emtansine is administered intravenously. The recommended dose is 3.6 mg/kg body weight administered every 3 weeks (21-day cycle). People should continue with this treatment until the breast cancer progresses or they can no longer cope with the drug's side effects.

3. Interim results from the EMILIA clinical trial, which were submitted by the manufacturer, found that medianoverall 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.

1. Trastuzumab emtansine costs £1,641.01 per 100mg vial and £2,625.62 per 160mg vial (excluding VAT). 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).
2. Doctors told the Appraisal Committee that they anticipate that trastuzumab emtansine would be used second line instead of continued trastuzumab plus chemotherapy or lapatinib plus capecitabine.

Trastuzumab costs £407.40 per 150mg vial (excluding VAT) compared with £2,625.62 for a 160mg vial (excluding VAT) for trastuzumab emtansine. The cost of chemotherapy drugs (which would be given with trastuzumab as a second-line treatment) is also vastly cheaper than trastuzumab emtansine.

The treatment combination of lapatinib plus capecitabine also costs considerably less than trastuzumab emtansine. The cost of lapatinib is £11.49 per 250mg tablet: this equates to approx. £20,969 per patient per year. Meanwhile, the annual cost of capecitabine, when taken with lapatinib, is about £3,150 per patient per year (the recommended dose when taken with lapatinib is 2000mg/m2 per day taken on days 1-14 of a 21-day cycle).

The cost of all of these drugs may vary in some areas due to negotiated discounts.

About the guidance

• The draft guidance on trastuzumab emtansine (after trastuzumab and a taxane) for HER2-positive, unresectable, metastatic breast cancer is available here
• The Appraisal Committee considered the best incremental cost-effectiveness ratio (ICER) for trastuzumab emtansine to be £185,600 per quality-adjusted life year (QALY) gained compared with the treatment combination, lapatinib plus capecitabine. The Appraisal Committee agreed that this ICER is too high for the treatment to be considered as a cost-effective use of limited NHS resources.

About NICE

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