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NICE rejects immunotherapy drug for breast cancer

Watchdog wants manufacturer to make drug more cost-effective

Adrian O'Dowd

Friday, 04 October 2019

Drugs watchdog the National Institute of Health and Care Excellence (NICE) has provisionally rejected the use of a new treatment for advanced breast cancer on the NHS.

NICE said in draft guidance published yesterday that it did not recommend atezolizumab for treating people with a type of breast cancer that has spread to other parts of the body but it will make a final decision in November.

Atezolizumab (called Tecentriq and made by Roche), given with the chemotherapy agent nab-paclitaxel, is the first immunotherapy that specifically targets triple negative breast cancer where tumours have PD-L1 expression of 1% or more. It is given to people who have not had prior chemotherapy for metastatic disease and where surgery to remove the tumour is not possible.

Advanced triple negative breast cancer accounts for 15-20% of cases and it is estimated to affect 2,000 people in England of whom around 600 people would be eligible for treatment with atezolizumab and nab-paclitaxel.

NICE said the evidence suggests that atezolizumab plus nab-paclitaxel extends the time before the disease worsens by around two and a half months compared to placebo plus nab-paclitaxel (seven and a half months versus five months respectively).

It also suggests that atezolizumab plus nab-paclitaxel increases overall survival by around nine and a half months (25 months versus 15.5 months respectively).

However, there was no trial data directly comparing atezolizumab plus nab-paclitaxel with other treatments currently used at this stage –  weekly paclitaxel and docetaxel – and NICE said it felt that the company’s analysis indirectly comparing these treatments was unreliable and lacked validity.

Therefore, when using nab-paclitaxel as a proxy for current treatment in the NHS, NICE’s independent committee could not recommend atezolizumab plus nab-paclitaxel as a cost-effective use of NHS resources, even after applying end-of-life criteria.

The cost of a course of treatment with atezolizumab is £39,981 based on treatment for seven and a half months at its full list price but the company offered the NHS a confidential discount.

Atezolizumab with nab-paclitaxel did not meet NICE’s Cancer Drugs Fund criteria because it did not have a plausible potential to be cost effective.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “I know that today’s announcement will be disappointing for people with breast cancer, and for their families and carers. Atezolizumab provides for a new way of treating people with significant unmet need, where targeted therapies have not been available to date.

“The committee heard that the availability of a new treatment that increases progression-free survival compared with chemotherapy alone will give hope to patients because it is important to them to be able to maintain a good quality life for as long as possible.

“We are committed to working with the company to try to resolve the issues identified by the committee.”

Consultation on the draft guidance closes on 24 October.

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