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7 August 2013updated 22 Oct 2020 3:55pm

NICE snubs Roche’s new breast cancer drug

The UK's health cost watchdog, the National Institute for Care and Excellence, has rejected Roche's newest cancer drug Perjeta - the seventh such cancer drug to be by NICE since 2011.

By Heidi Vella

Pharma giant, Roche, and those with advanced breast cancer were dealt a blow on Tuesday by the UK’s health cost watchdog, the National Institute for Care and Excellence (NICE), when it rejected the company’s newest drug for the disease.

NICE, in its draft guidance said Roche’s drug Perjeta, for the treatment of patients with HER2-positive tumours that have either recurred in the breast or spread to other parts of the body, was not cost effective enough to be used on the National Health Service.

Roche has said it is “extremely disappointed” with NICE’s decision and criticised the watchdog for Perjeta being the “seventh such cancer treatment to be rejected by NICE” since 2011.

Breast Cancer Care, Assistant Director of Services, Liz Carroll also said those with advanced breast cancer will find the news “extremely disappointing”.

Nearly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK and around one in five tumours will be ‘HER2-positive’, a type of breast cancer that can be treated with Perjeta.

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The drug, according to Roche, offers the kind of breakthrough treatment not seen since herceptin, Roche’s second best-selling drug, which was brought to market 10 years and is also for the treatment of breast cancer.

NICE’s main problem with the drug is its cost combined with the robustness of its clinical trial results.

Perjeta costs £2,395 per 420mg vial (excluding VAT) and treatment consists of an initial loading dose of 840mg, followed every three weeks by a maintenance dose of 420mg in combination with herceptin and chemotherapy…

Roche says Perjeta has shown in trials that on average patients live 6.1 months longer, without their cancer getting worse, compared with those receiving Herceptin and chemotherapy alone. This would mean an average cost of about £23,950 for Perjeta per patient for around six months of treatment (based on 8 doses plus the initial dose). This is compared to treating one patient for a year with herceptin for £21,800.

NICE did not find the three drugs – Perjeta, Herceptin and  chemotherapy – combined cost effective by its incremental Cost-Effectiveness Ratio (ICER), which it uses to measure whether a drug is cost effective or not,  compared to just Herceptin.

The Appraisal Committee at NICE also noted that Perjeta seemed to delay growth and spread of the breast cancer for around this time but “there were no firm figures to demonstrate the treatment’s impact on overall survival.”

In July NICE also rejected breast cancer drug Afinitor from Novartis.

However, there is another life line for the Perjeta; a patient access scheme proposed by Roche, which has already been approved by NICE and has been sitting with the Department of Health waiting for ministerial ratification for several weeks now.

With the Cancer Drugs Fund, which holds money set a side for drugs not approved by NICE and therefore not available on the NHS, in England due to expire in six months the Department of Health’s decision will be a last hope for Roche and advanced breast cancer patients seeking more treatment options.

Despite criticism from Roche, the Department of Health have as yet given no indication when they will provide an answer on the proposed price plan for Perjeta.