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NICE rejects drug for advanced breast cancer

Draft guidelines say cost outweighs uncertainty as to how long it prolongs lives

Mark Gould

Wednesday, 07 August 2013

Draft guidelines from the National Institute for Health and Care Excellence (NICE) advise that the NHS should not routinely provide a treatment for advanced breast cancer as it costs much more than current NHS treatments yet trial data could not predict how long it might extend people's lives.

The guidance rejects routine use of pertuzumab (also called Perjeta and manufactured by Roche Products) when used in combination with trastuzumab and another drug called docetaxel for HER2-positive tumours that have either recurred in the breast or spread to other parts of the body.

NICE Appraisal Committee noted that pertuzumab (plus trastuzumab and docetaxel) seemed to delay the growth and spread of the breast cancer for around six months more than trastuzumab and docetaxel alone. But NICE says there were no firm figures to demonstrate the treatment's impact on overall survival, which meant the clinical trial data, despite suggesting a benefit, did not give a reliable estimate of how much it could extend a person's life compared with current treatments.

The Committee noted that the manufacturer's estimate of overall 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 manufacturer's analyses highlighted there was no possibility of pertuzumab (plus trastuzumab and docetaxel) being considered cost-effective compared with just trastuzumab and docetaxel.

Pertuzumab, which costs £2,395 per 420mg vial, is given by intravenous infusion with an initial loading dose of 840mg followed every three weeks by a maintenance dose of 420mg in combination with trastuzumab and docetaxel.

Sir Andrew Dillon, NICE Chief Executive, said: “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.

“The committee also noted that even the manufacturer estimated that the treatment would not be considered cost-effective for the NHS. We have now launched a consultation to gather comments from interested parties to develop the guidance further.”

NICE has now opened a consultation on this draft guidance with organisations including charities, patient groups, NHS trusts and drug manufacturers being asked for their views.

Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until Wednesday 28 August 2013. All comments received during this consultation will be considered by the committee and a second draft of the guidance will then be published. If there are no objections at that stage, NICE will publish final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

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