Roche breast cancer drug Perjeta rejected by NICE
pharmafile | August 6, 2013 | News story | Sales and Marketing | Cancer, NICE, Perjeta, Roche
NICE is not recommending Roche’s next generation breast cancer drug Perjeta as a treatment for a particular type of advanced breast cancer.
In draft guidance the pricing watchdog says it does not recommend Perjeta (pertuzumab) because clinical trial data could not predict how long the drug might extend people’s lives for, but costs much more than current NHS treatments.
NICE is assessing whether the NHS should fund the Swiss firm’s new treatment, when used in combination with Roche’s ageing drug Herceptin (trastuzumab) and chemotherapy agency docetaxel, for HER2-positive tumours that have either recurred in the breast or spread to other parts of the body.
NICE found that Perjeta plus Herceptin and docetaxel seemed to delay the growth and spread of the breast cancer for around six months more than Herceptin and docetaxel alone.
But it said that 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”.
In an unusual move, NICE has now opened a consultation on this draft guidance with organisations including charities, patient groups, NHS trusts and drug manufacturers being asked for their views.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 and around one in five tumours will be ‘HER2-positive’, a type of breast cancer that can be treated with Herceptin.
High cost
Perjeta, which works in a similar way to Herceptin, costs £2,395 per 420mg vial. The recommended dose is an initial 840mg followed every three weeks by a maintenance dose of 420mg, in combination with Herceptin and docetaxel.
Treatment should continue until either the disease progresses or the patient is unable to tolerate the side effects.
According to the BNF, Herceptin costs £407.40 per 150-mg vial while a 16-mL vial of docetaxel costs £1069.50, meaning the overall cost to the NHS of all three drugs would be extremely high.
Sir Andrew Dillon, NICE’s 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 Roche, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until 28 August.
The Institute said that all comments received during this consultation “will be considered by the committee” after which 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.
Ben Adams
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