The NHS is to be advised that it should not routinely provide Roche's Perjeta (pertuzumab) as a treatment for a type of advanced breast cancer, because it does not represent value for money, says new draft guidance from the National Institute for Health and Care Excellence.
The drug is not recommended because clinical data presented to NICE's independent appraisal committee could not predict how long it might extend people's lives, yet it costs much more than current NHS treatments, according to NICE, which has now opened a consultant on its draft decision.
Nearly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK, and around one in five tumours will be HER2-positive, a type of breast cancer that can be treated with Roche's Herceptin (trastuzumab).
NICE is currently assessing whether the NHS should fund Perjeta, when it is used in combination with Herceptin and docetaxel, for HER2-positive tumours which have either recurred in the breast or spread to other parts of the body.
Perjeta works in a similar way to Herceptin and is given to patients by intravenous infusion. Its recommended dose is an initial loading dose of 840mg followed every three weeks by a maintenance dose of 420mg in combination with Herceptin and docetaxel.
However, the appraisal committee could not be sure of Perjeta’s benefits, said NICE chief executive Sir Andrew Dillon.
"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 wasn't robust enough to confirm for how long pertuzumab may actually extend people's lives," he said.
Moreover, he added: "the committee also noted that even the manufacturer estimated that the treatment would not be considered cost-effective for the NHS."
The firm told the panel that Perjeta costs £2,395 per 420mg vial, excluding value-added tax, although costs may vary in different settings because of negotiated discounts. However, the analyses which it presented to the committee highlighted that there was no possibility of Perjeta plus Herceptin and docetaxel being considered cost-effective compared with Herceptin and docetaxel alone.
NICE has now opened a consultation to gather comments from interested parties - including the manufacturer, healthcare professionals and the public - to develop the guidance. The consultation runs until August 28.