The NHS drug advisory body National Institute for Health and Care Excellence (NICE) has rejected Roche’s new breast cancer drug Kadcyla (trastuzumab emtansine) because of the treatment’s high cost.
Trastuzumab emtansine is an antibody-drug conjugate developed for treating adult patients with unresectable metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with trastuzumab and a taxane.
The drug has been shown to extend overall survival by around 5.8 months when compared with treatment with lapatinib and capecitabine. Around 1,500 women in Britain could benefit from the drug every year.
In the final draft guidance, the NICE Appraisal Committee concluded that trastuzumab emtansine is not recommended, within its marketing authorisation, for treating adults with HER2-positive, unresectable locally advanced or metastatic breast cancer.
The Committee also noted that the most plausible incremental costeffectiveness ratio (ICER) for trastuzumab emtansine (without the patient access scheme) was above the ICER range that would normally be considered a cost-effective use of NHS resources.
According to NICE, if a treatment costs more than £30,000 per quality-adjusted life years (QALY), it is not cost-effective.
Roche Kadcyla’s QALY value has been estimated at around £166,000 and is being funded at its full list price of more than £90,000 per patient through the government’s cancer drugs fund.
NICE chief executive Sir Andrew Dillon said: "Although Roche proposed a discount to the full list price of Kadcyla, it made little difference to its value for money, leaving it well above the top of our specially extended range of cost-effectiveness for cancer drugs.
"We are really disappointed that Roche were not able to demonstrate more flexibility to help us provide a positive recommendation. The company is well aware that we could not recommend Kadcyla at the price it proposed."
Last month, the Irish National Centre for Pharmacoeconomics (NCPE) ruled that Kadcyla is not cost-effective for use at the price submitted by Roche.
Image: Kadcyla combines Herceptin (trastuzamab) with a chemotherapy agent to treat women with HER2-positive breast cancer. Photo: courtesy of National Institute for Health and Care Excellence.