Roche's Kadcyla wins NICE backing in early breast cancer use

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate sailed through a new NHS funding review that now puts it in line for earlier breast cancer use.

Kadcyla has won National Institute for Health and Care Excellence (NICE) backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting. It’s meant for patients who still have residual tumor cells after presurgery neoadjuvant treatment with Roche's Herceptin and chemo.

Like all other drugmakers that secure NICE recommendations, Roche has offered a confidential discount off its average per-patient list price of £51,000 (about $63,100).

Kadcyla broke into the adjuvant arena with an FDA nod in May 2019, followed by a European green light at the end of the year. The approvals are based on results from the phase 3 Katherine trial, which showed that at the three-year mark, Kadcyla had kept breast cancer from returning in 88.3% of patients, compared with 77% for Herceptin.

Previously, Roche’s Perjeta won NICE backing for adjuvant use in HER2-positive patients whose disease has spread to their lymph nodes. In contrast, Kadcyla represents “an alternative adjuvant treatment for people with node-negative and node-positive disease,” experts at the England cost watchdog said in its appraisal document (PDF).

NICE estimates that around 800 people will be eligible for this new use each year.

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Kadcyla had quite a hard time winning full coverage in its original indication of second-line HER2-positive breast cancer after Herceptin and a taxane chemo. It went through more than four years of disagreements between Roche and NICE and finally secured routine funding in 2017 after heavy lobbying from advocacy groups and an undisclosed discount.

Since megablockbuster Herceptin lost patent protection, Roche has been counting on Perjeta and Kadcyla for HER2 business growth. The two newer meds raked in CHF 1.01 billion ($1.04 billion) and CHF 428 million ($441 million), respectively, in the first quarter. Together, they surpassed Herceptin, whose CHF 1.21 billion ($1.25 billion) Q1 haul marked a 12% decline over the same period last year.

But now, Roche’s HER2 franchise is also facing a formidable newcomer: AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu. While Enhertu is currently only allowed in patients who have failed on at least two other treatments, the developers are running a head-to-head study against Kadcyla in the second-line setting in an attempt to show superiority. In the first quarter, Enhertu sales amounted to $30 million.