Roche’s new breast cancer treatment Perjeta has been launched in the UK, less than ten days after it was approved by the European Medicines Agency. 

Perjeta has a licence to treat patients with previously untreated advanced HER2-positive breast cancer in combination with Roche’s ageing breast cancer drug Herceptin and the chemotherapy agent docetaxel.

This authorisation is based on data from the Phase III CLEOPATRA study, which showed that patients live on average 6.1 months longer without their cancer getting worse, compared with those receiving Herceptin and chemotherapy.

“This license authorisation has been much anticipated and will be welcome news for patients with HER2-positive breast cancer in the UK,” said David Miles, a consultant oncologist, Mount Vernon Cancer Centre, London.

“Perjeta has been shown to extend survival and control cancer for longer than the current standard of care – showing a magnitude of benefit that has not been seen since the launch of Herceptin more than ten years ago. This marks a significant step forward in the treatment of this aggressive, difficult-to-treat disease.”

NICE battle?

Roche says it now “looks forward to working with NICE and the Scottish Medicines Consortium to ensure patients and clinicians can routinely access Perjeta through the NHS”.

But in reality Roche has had a tough time with both of these health technology assessors, and has an on-going spat with NICE in particular over its refusal to recommend any of Avastin’s five cancer licences for use on the NHS.

Both NICE and the SMC have been cautious on recommending cancer drugs that generally only extend survival by several months, but are priced highly. The cost of Perjeta in the USA, where it has been available since June last year, is $5,900 (£4,000) a month, or about $71,000 a year, according to Roche. Herceptin’s price tag is $54,000 a year, meaning the drug’s total cost is an eye-watering $115,000 (£77,000) for a year’s treatment in the USA.

This overall cost is less costly in the UK, with a spokesperson telling PharmaTimes UK News that the list price of Perjeta will be £2,395 per month.The spokesperson added that it was already working with NICE, and had put forward a confidential patient access scheme to lower its overall cost to the NHS.

But NICE does not recommend Avastin which costs around £20,000 per year - which also has a patient access scheme - so Roche may have to be ready for another tough ride with the watchdog.

Cancer Drugs Fund

But in the meantime, patients in England should be able to access Perjeta via the Cancer Drugs Fund England, which injects an extra £200 million a year for drugs that are being assessed by the watchdog, or are not recommended for use. It is, however, about to enter its last year of funding in April, meaning this option will no longer be available from 2014.

The drug is being touted as a potential blockbuster, with analyst estimating $600 million to $1 billion in peak annual sales. The drug is also being studied for further licences, meaning sales could reach a peak of $8.5 billion per year, according to recent estimated by Jeffries analysts.

Perjeta is the first in a new class of personalised treatments known as ‘HER2 dimerisation inhibitors’ and works in a different way to any other cancer medicine. It works together with Herceptin to block cancer cell survival and growth signals, specifically targeting the HER2 receptor – a protein found in high quantities on the surface of cells in HER2-positive breast cancers.