SMC rejects breast cancer drug Perjeta®(pertuzumab) for use post-surgery

image of a hand holding a gavel about to hit it to show CMA welcomes EU Court ruling in pay-for-delay drug case

The Scottish Medicine Consortium (SMC) has rejected the use of pertuzumab for use in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC), at high risk of recurrence.

People living with HER2-positive, early breast cancer where the disease has spread beyond the primary tumour to nearby lymph nodes are especially at risk of their cancer returning.

Perjeta has been shown to reduce the risk of disease recurrence among these high-risk patients when added to trastuzumab and chemotherapy in the adjuvant setting, with a safety profile comparable to that of previous trials.

Perjeta was approved before surgery for Scottish breast cancer patients by the SMC in December 2018. SMC recommended that Perjeta® (pertuzumab) should be made available to HER2-positive early breast cancer patients before surgery, also known as the neoadjuvant setting. This meant that people in Scotland living with HER2-positive, locally advanced, inflammatory or early stage breast cancer at high risk of recurrence could benefit from Perjeta, in combination with trastuzumab and chemotherapy, on the NHS.

The latest decision means that eligible patients in Scotland will not be able to access this treatment that could reduce the risk of their aggressive disease coming back.

Richard Erwin, General manager, Roche Products Ltd, said: “We have worked closely with all stakeholders in Scotland to find a route to make Perjeta available. Given the terms offered to the SMC are aligned to those accepted in England, Wales and Northern Ireland, we are frustrated and disappointed that the SMC has declined to make Perjeta available in this adjuvant indication.

“Roche is committed to finding a solution to ensure that access is granted as soon as possible. We will meet the SMC this week to discuss the reasons why the medicine was declined and make a decision on our next steps from there.”