Cost regulators for the National Health Service in England and Wales are sticking with their initial decision to reject the use of GlaskoSmithKline's Tyverb and Roche's Herceptin alongside hormone therapy in certain postmenopausal breast cancer patients.

In new draft guidance published this morning (Feb 14) the National Institute for Health and Clinical Excellence says that overall survival benefit from using these drugs alongside aromatase inhibitors (AI) as a first-line treatment for postmenopausal patients whose breast cancer has spread elsewhere in the body remains uncertain.

While both Tyverb (lapatinib) and Herceptin (trastuzumab) can reduce the growth and further spread of metastatic breast cancer tumours when taken alongside the aromatase inhibitors letrozole and anastrozole, "the extent that these treatments can improve overall survival appears to be small or undefined," explained NICE chief executive Sir Andrew Dillon.

Further backing the decision, he said "independent economic analyses indicate that both treatment combinations do not appear to be cost effective for the NHS because they have uncertain clinical benefits for the price that the NHS is being asked to pay".

Treatment with the drugs certainly isn't cheap; the acquisition cost for a lifetime of treatment of Tyverb plus the aromatase inhibitor letrozole is £28,212 (£1,188 for letrozole), while that for Herceptin plus anastrozole is around £26,000 or (£1,166 for anastrozole) depending on the loading dose. 

Crucially, the incremental cost per QALY has been calculated at more than £74,000 for Tyverb and £51,000 for Herceptin compared with either AI alone, which is heads above the normal £20,000-£30,000 threshold set by NICE to determine value for money for the NHS.

The decision comes despite a second consultation after an appeal from Roche last year.