NICE draft guidance rules against NHS reimbursement of Roche's Tecentriq for triple-negative breast cancer

The National Institute for Health and Care Excellence published draft guidance Thursday recommending against routine NHS use of Roche's Tecentriq (atezolizumab), in combination with Celgene's Abraxane (nab-paclitaxel), for the treatment of triple-negative, unresectable, locally advanced or metastatic breast cancer in adults whose tumours express PD-L1 at a level of 1% or more and who have not had previous chemotherapy for metastatic disease.

According to NICE's appraisal committee, study results suggest that Tecentriq plus Abraxane extends the time before the disease worsens by around 2.5 months compared to placebo plus Abraxane, with progression-free survival in the two groups of 7.5 months and 5 months, respectively. Data also showed that the addition of Tecentriq to Abraxne increases overall survival by around 9.5 months, with overall survival of 25 months versus 15.5 months for placebo plus Abraxane.

However, the appraisal committee noted that "there was no trial data directly comparing" Tecentriq plus Abraxane with other treatments currently used at this stage, such as weekly paclitaxel and docetaxel, adding that Roche's analysis indirectly comparing these treatments was "unreliable and lacked validity." NICE said that the appraisal committee could not recommend Tecentriq plus Abraxane as a cost-effective use of NHS resources, even after applying end-of-life criteria, while it does not meet the agency's criteria for the Cancer Drugs Fund.

Tecentriq carries an estimated price of around £7617 ($9374) for a 28-day course of treatment, although Roche has offered an undisclosed discount to the NHS. Meindert Boysen, director of NICE's Centre for Health Technology Evaluation, remarked "we are committed to working with the company to try to resolve the issues identified by the committee."

The PD-L1 inhibitor gained EU clearance for use in triple-negative breast cancer in August, making it the first cancer immunotherapy regimen to be available in Europe in this indication. Sales of Tecentriq reached CHF 782 million ($793 million) in the first half, growing 141% year-over-year.

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