Views sought on draft NICE guidance that says breast cancer drug is not value for money

The NHS is to be advised that it shouldn't routinely provide the drug pertuzumab (also called Perjeta and manufactured by Roche Products) as a treatment for a type of advanced breast cancer. Draft guidance by the National Institute for Health and Care Excellence (NICE) does not recommend its use because clinical trial data could not predict how long the drug might extend people's lives for yet it costs much more than current NHS treatments. NICE has now opened a consultation on this draft guidance with organisations including charities, patient groups, NHS trusts and drug manufacturers being asked for their views.

Nearly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK[1] and around one in five tumours will be ‘HER2-positive', a type of breast cancer that can be treated with trastuzumab (Herceptin). NICE is assessing whether the NHS should fund pertuzumab (when it is 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.

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.”

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.


Notes to Editors

  • The draft guidance (called an Appraisal Consultation Document, or ACD) for pertuzumab (with trastuzumab and docetaxel) for the treatment of HER2-positive, locally advanced or metastatic breast cancer will be available from the NICE website from Tuesday 6 August 2013.
  • Pertuzumab is being appraised in combination with trastuzumab and docetaxel as a treatment for HER2-positive breast cancer that is either metastatic (has spread to another part of the body) or has recurred in the breast (locally recurrent) and cannot be removed surgically, and which has not been previously treated, or has relapsed after treatment following surgery (adjuvant therapy).
  • The 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 (this is based on median figures). 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 works in a similar way to trastuzumab (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 trastuzumab and docetaxel. Treatment should continue until either the disease progresses or the patient is unable to tolerate the side effects. According to the manufacturer, pertuzumab costs £2,395 per 420mg vial (excluding VAT). Costs may vary in different settings because of negotiated discounts.
  • In 2009, NICE published a clinical guideline on the care of people with advanced breast cancer. It includes recommendations for healthcare professionals on a range of treatment options for patients.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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[1] These figures have been taken from Cancer Research UK's website and were calculated from data provided by the Office for National Statistics, the Northern Ireland Cancer Registry, Welsh Cancer Intelligence and Surveillance Unit and ISD Scotland. More information

This page was last updated: 05 August 2013

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.