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NICE rejects adjuvant use of breast cancer drug

Draft guidance dubs Perjeta ‘not cost effective’

Jo Carlowe

Friday, 15 June 2018

The National Institute for Health and Care Excellence (NICE) has today rejected the adjuvant use of pertuzumab for HER2-positive breast cancer post-surgery.

In its newly published draft guidance for consultation the Institute does not recommend pertuzumab (Perjeta, Roche) for treating early HER2-positive breast cancer after surgery in people who have a high risk of the disease recurring.

Pertuzumab, given with trastuzumab and chemotherapy, is already recommended by NICE for treating early HER2-positive breast cancer before surgery. NICE also recommends it 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 committee concluded that adding pertuzumab to trastuzumab and chemotherapy after surgery made only a small difference in the proportion of people who remained free of invasive disease, and this effect was itself uncertain. In addition, NICE described a lack of evidence on how long, “if at all”, adding pertuzumab might improve overall survival.

“The most likely cost-effectiveness estimate is therefore likely to be much higher than would normally be considered a good use of NHS resources,” NICE stated.

Approximately 14% of people diagnosed with early breast cancer have HER2-positive disease, meaning that approximately 7,900 patients in the UK are diagnosed with this type of breast cancer each year.

The NICE appraisal focused on patients post-surgery with node-positive disease and on those with hormone-receptor negative disease. The estimated 5000 people in these two subgroups have a higher risk of their cancer returning. The company argued that these patients would be more likely to benefit from adding pertuzumab to existing treatments after they have had surgery.

Meindert Boysen, director of the Centre for Technology Evaluation at NICE, said: “The company estimates that for around one in four people with early breast cancer their cancer will return despite being treated with surgery, chemotherapy and adjuvant trastuzumab. There is clearly a need for effective treatments that can prevent people developing incurable, late-stage breast cancer.

“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.

“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. We would welcome further discussions with the company about what steps can be taken to address the concerns raised by the committee.”

Consultees, including the company, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until 6 July. All comments received during this consultation will be considered by the committee at its meeting in July. Final guidance is expected to be published in October.

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