The new draft guidance means that the HER2 inhibitor can be given as an adjuvant therapy to people with early-stage HER2-positive breast cancer that has spread to the lymph nodes and who are at higher risk of relapse. NICE estimates there are around 2,700 patients eligible for that use.

NICE says that there is some evidence that adding Perjeta to standard adjuvant treatment with Roche’s older HER2 drug Herceptin (trastuzumab) or a biosimilar and chemotherapy reduces the risk of disease spreading, although there’s no data yet on whether that translates to extended survival.

That was the main reason why Perjeta was turned down in earlier appraisals, but a confidential, improved price cut from the company has shifted NICE’s thinking on the drug’s cost effectiveness and helped drive the drug’s quality-adjusted life year (QALY) rating – NICE’s main cost-effectiveness measure – below the £20,000 threshold.

Roche also submitted a revised economic model based on treatment only in people whose disease had spread to their lymph nodes, whereas previous guidance also included people who were not able to have treatment with hormonal therapy, as well as opting for more conservative estimates of how long the treatment benefit with pertuzumab will last.

The availability of biosimilar trastuzumab in the UK which reduced the overall cost of the adjuvant regimen contributed to the decision to back the new use.

"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," said Meindert Boysen, director of NICE’s Centre for Health Technology Assessment.

"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," he added.

Perjeta has previously been recommended by NICE for NHS use in treating early HER2-positive breast cancer before surgery, i.e. neo-adjuvant use, as well as for HER2-positive breast cancer that has recurred in the breast following initial treatment or has spread elsewhere in the body.

Perjeta has been on the European market for several years and is one of Roche’s fastest growing medicines, with sales rising 27% to around $2.8 billion last year, mainly on the back of adjuvant use.

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