NICE rejects adjuvant use of Perjeta post-surgery

The National Institute for Health and Care Excellence says adjuvant use of Roche’s breast cancer drug Perjeta in patients who have had surgery is not cost effective for the NHS.

In draft guidelines the cost watchdog has turned down NHS funding for Perjeta (pertuzumab) for treating early HER2-positive breast cancer after surgery in people who have a high risk of the disease recurring.

Perjeta, given with trastuzumab and chemotherapy, is already recommended by NICE for treating early HER2-positive breast cancer before surgery, as well as for treating HER2-positive breast cancer that has either recurred in the breast following initial treatment or has spread from the breast to elsewhere in the body.

However, the Institute concluded that adding Perjeta to trastuzumab and chemotherapy after surgery made only "a small difference" in the proportion of patients who remained free of invasive disease, "and this effect was itself uncertain".

NICE also highlighted "a lack of evidence" on the effect of the drug on overall survival.

"There was a great deal of uncertainty in the available evidence of clinical effectiveness compared to existing treatments which led the committee to conclude that pertuzumab as adjuvant treatment may not result in meaningful additional benefits for patients," said Meindert Boysen, director of the Centre for Technology Evaluation at NICE.

"We’re therefore not currently able to recommend pertuzumab as a clinically and cost effective option for people who have a higher risk of their cancer returning."

"Although we are disappointed in the draft guidance published, we won’t walk away from this group of women living with HER2-positive, early breast cancer who have a high-risk of their breast cancer returning and who could benefit from adding Perjeta to their treatment-regimen," said Richard Erwin, Roche’s general manager, commenting on the decision.

"This medicine has been shown to offer value to high-risk patients and physicians should have the option to use the medicine if they feel it will help to prevent breast cancer from returning. The fact that it has already been approved by regulatory organisations in the US and EU and recognised by international treatment guidelines is testament to its potential," he stressed.

The firm said around 5,000 high-risk HER2-positive early breast cancer patients could benefit from treatment with Perjeta, and that it would  work with NICE, NHS England and the wider patient group community to find a way forward to ensure patients in England are able access the medicine in this setting, "as quickly as possible."