The National Institute of Health and Clinical Excellence (NICE) has said it is still unable to recommend the use of either GlaxoSmithKline (GSK)'s Tyverb (lapatinib) or Roche's Herceptin (trastuzumab), when used alongside hormone therapy, in certain postmenopausal breast cancer patients.
In its latest draft guidance, NICE says that the clinical and cost-effectiveness of Tyverb and Herceptin, when used in these patients as a first-line treatment for a specific type of advanced metastatic breast cancer in combination with an aromatase inhibitor, has not been clearly demonstrated.
This combination of treatment is used when the breast cancer cells have receptors for the hormone oestrogen and also high levels of human epidermal growth factor receptor 2 (HER2). Postmenopausal women who choose not to have chemotherapy, or for whom it is not a suitable option, are most likely to be offered aromatase inhibitors, either by themselves or in combination with one of these drugs.
Following a public consultation on its initial findings last December, NICE says in its latest draft guidance (the Final Appraisal Determination: FAD) that it is still unable to recommend the use of either drug with aromatase inhibitors as NHS treatment options, although it adds that women who are already receiving either Tyverb or Herceptin with aromatase inhibitors should be able to continue to do so until they and their doctors consider it appropriate to stop.
"Doctors treating women with metastatic breast cancer hope to relieve their symptoms, prolong survival and maintain a good quality of life with minimal side effects," commented NICE's chief executive, Sir Andrew Dillon.
However, he added: "unfortunately, the manufacturers of lapatinib and trastuzumab didn't give our independent committee convincing evidence to show how much using either drug with an aromatase inhibitor could benefit these women more than using the aromatase inhibitors by themselves. The cost-effectiveness of the drugs was also significantly uncertain."
The draft guidance, which has now been published on NICE's website, specifically looks at "metastatic hormone-receptor-positive breast cancer that over-expresses HER2." Alternative first-line treatments for women with this type of cancer could include chemotherapy or aromatase inhibitor monotherapy, the Institute notes.
Registered stakeholders who wish to appeal NICE's provisional recommendations, or "highlight any factual errors," have until July 15 to do so. If no appeals are received, NICE says it expects to publish its final guidance for the NHS on August 24.