Regulatory Focus™ > News Articles > NICE Rejects Roche's Breast Cancer Drug Perjeta on Cost Considerations

NICE Rejects Roche's Breast Cancer Drug Perjeta on Cost Considerations

Posted 07 August 2013 | By Louise Zornoza

The UK's National Institute for Health and Care Excellence (NICE) opened a consultation on 6 August 2013 on its draft recommendation against reimbursement for Roche's breast cancer drug Perjeta (pertuzumab). 

The negative recommendation is grounded on cost, regulators said, despite the fact that the drug in combination with rastuzumab and docetaxel delays the spread of the cancer by six months more than either of the other oncology drugs alone.  NICE noted that Roche's estimate of overall patient survival resulted in an Incremental Cost-Effectiveness Ratio (ICER) that was "outside the range normally considered as a cost-effective use of NHS resources." 

The draft guidance, known as an Appraisal Consultation Document (ACD), addresses the use of pertuzumab (with trastuzumab and docetaxel) for the treatment of HER2-positive, locally advanced or metastatic breast cancer. 

Some 50,000 women and 400 men are diagnosed with breast cancer every year in the UK, with about a fifth of the tumors being 'HER2-positive', a type of breast cancer that can be treated with trastuzumab (Herceptin).

NICE Chief Executive Sir Andrew Dillon commented that "The Appraisal Committee couldn't be sure of the benefits of pertuzumab."

"The main clinical trial did not reflect current medical practice in the UK and despite the research data suggesting the treatment could help delay the growth and spread of the disease, the evidence was not robust enough to confirm for how long pertuzumab may actually extend people's lives," Dillon continued. "The committee also noted that even the manufacturer estimated that the treatment would not be considered cost-effective for the NHS."

The comment period is open until 28 August 2013.

NICE Draft Guidance on Perjeta

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Tags: Perjeta, Roche, UK, EU

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