National Institute for Health and Clinical Excellence (NICE) has again declined to recommend Tyverb (lapatinib) and Herceptin (trastuzumab) for an advanced form of breast cancer.
The UK cost-effectiveness body's draft guidance said the ability of both GlaxoSmithKline's Tyverb and Roche's Herceptin to improve overall survival compared to existing treatments was uncertain and the drugs did not represent value for money on the NHS.
The guidance covers either drug's use alongside aromatase inhibitors as a first line treatment option to delay the growth of breast cancer that has spread to other parts of the body and where tumour cells react with the hormones oestrogen or progesterone and have high levels of a protein called HER2 on their surface.
NICE's latest draft guidance comes after an appeal from Roche against some of the committee's findings in the initial appraisal.
Although NICE chief executive Sir Andrew Dillon acknowledged that both Roche and GSK's drugs can reduce the growth and further spread of metastatic breast cancer tumours when taken alongside the aromatase inhibitors, the agency stuck with its initial negative decision.
Dillon said: [T]he extent that these treatments can improve overall survival appears to be small or undefined.”
In terms of drug costs, treatment with Tyverb using an oral dose of six 1500mg tablets per day plus aromatase inhibitor letrozole amounts to £28,212 for what NICE call a 'lifetime of treatment'.
Depending on the type of dose, a lifetime of treatment using Herceptin plus aromatase inhibitor anastrozole would cost either £26,018 or £26,832.
However, when converted to NICE's incremental cost effectiveness ratio (ICER), the most plausible cost per quality of life year (QALY) gained for Tyverb compared to using letrozole alone is £74,400, while the figure is over £51,000 for Herceptin compared to anastrozole alone. Both are well over NICE's £30,000 limit for QALY cost-effectiveness.
Herceptin is already recommended for use on the NHS in several indications, including for women who have early-stage HER2-positive breast cancer after they have had surgery and chemotherapy, as well as for HER2-positive metastatic gastric cancer. Tyverb is currently only recommended by NICE for use in clinical trials.
The latest draft guidance on the two drugs will be open for consultation, with comments accepted on NICE's website, until March 6, 2012.