NICE has published final draft guidance which now recommends pertuzumab (Perjeta, Roche) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes.

This positive recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes (node-positive disease). The estimated 2700 people in this subgroup have a higher risk of their cancer returning.

The evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery (adjuvant use) increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.

Following consultation on the draft guidance, the company proposed an improved discount to the price of pertuzumab. They also submitted a revised economic model which included only people whose disease had spread to their lymph nodes (the previous draft guidance also included people who can’t have treatment with hormonal therapy), as well as using the committee’s preferred, more conservative estimates of how long treatment benefit with pertuzumab will last.  

The resulting cost-effectiveness estimate is below £20,000 per QALY gained. Therefore adjuvant pertuzumab is recommended for HER2-positive early breast cancer in people with node-positive disease.

Meindert Boysen, director of the Centre for Health Technology Assessment at NICE said: “We’re pleased that we’ve been able to work with the company to address the uncertainties of pertuzumab as a treatment for early HER2-positive breast cancer.

“Their response means that people who have a high risk of their cancer returning now have a new treatment option that could reduce the risk of that happening.”

Pertuzumab, given with trastuzumab and chemotherapy, is already recommended by NICE for treating early HER2-positive breast cancer before surgery (neo-adjuvant use). NICE also recommends it with trastuzumab and docetaxel 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.

Final guidance is expected to be published in March.