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NICE rejects Roche's breast cancer drug Perjeta

Says the treatment's long-term benefits are unclear

Roche Perjeta pertuzumab 

The UK's National Institute for Health and Care Excellence (NICE) has turned down Roche's breast cancer therapy Perjeta, saying its long-term benefits are unclear.

The draft guidance suggests NICE would like to see more data on the benefits of adding Perjeta (pertuzumab) to treatment with chemotherapy or Roche's Herceptin (trastuzumab) - particularly its effect on overall survival - in people with HER2-positive breast cancer.

Perjeta is used alongside Herceptin or docetaxel to reduce the volume of breast tumours before surgery, making it easier to carry out the operation.

NICE said there was evidence that adding pertuzumab to therapy "was more successful at getting rid of cancer in the breast and lymph nodes before surgery", but the agency went on to suggest that it was "very uncertain about the extent to which this would reduce the risk of the disease recurring and result in longer survival".

The decision to reject Perjeta comes shortly after cancer charities called for sweeping reforms to NICE's appraisal process, arguing that it is based on outdated methodology and is denying thousands of patients access to effective treatments.

Perjeta is the latest in a series of new cancer treatments that have had their access restricted by NICE as it tries to cope with a stream of approvals for new medicines that represent clinical advances but are priced at a hefty premium. Other recent examples including Bristol-Myers Squibb's Opdivo (nivolumab) in lung cancer and Johnson & Johnson's leukaemia drug Imbruvica (ibrutinib).

Pertuzumab costs £2,395 per 420mg vial, according to NICE, which says the total cost of treatment with the drug ranges from £7,185 to £16,765, depending on the number of cycles needed by the patient. 

Breast cancer charities appeared on the whole to be resigned to the decision. In a statement, Breast Cancer Now said the result of the appraisal was "not unexpected" as the clinical evidence for Perjeta's role in this clinical setting is "still insufficient".

The charity expressed the hope that Perjeta would qualify for the new 'maybe' category NICE will shortly introduce for drugs that will be considered for the Cancer Drugs Fund (CDF) - and that access to the drug would be permitted while additional evidence is collected.

More than 50,000 women and around 340 men are diagnosed with breast cancer each year in the UK with around 10-15% of cases falling into the HER2-positive category. 

The preliminary recommendations are open for comment until June 13, and any patient already on Perjeta will be able to continue treatment for the time being.

Article by
Phil Taylor

20th May 2016

From: Regulatory



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