Another NICE 'no' for cancer drug, as the UK agency rules against NHS funding for GlaxoSmithKline's Tyverb on cost grounds

In yet another negative ruling for an expensive cancer treatment, the UK's National Institute for Health and Clinical Excellence (NICE) this morning issued its Final Appraisal Determination (FAD) advising against National Health Service funding for drug giant GlaxoSmithKline's oral Tyverb (lapatinib) in combination with Roche's Xeloda (capecitabine) for the treatment of an aggressive form of advanced breast cancer (ErbB2/HER 2-positive).

In its final appraisal last year, the NICE also rejected the drug, even though GSK offered the Tyverb Patient Access Program to help ensure it was made available on the NHS (The Pharma Letter October 22, 2009). The company appealed that appraisal. GSK reiterated its commitment to the 12-week free access program, which waives the first three months of treatment costs for eligible patients, despite the ruling. The drug therapy costs around £25,000 ($36,395) a year.

Lapatinib is taken in combination with a standard chemotherapy, capecitabine and is for women with advanced disease which has returned despite treatment with standard chemotherapies and Herceptin (trastuzumab). There are no other licensed ErbB2 targeted treatment options available to suppress the advanced disease once it has stopped responding to trastuzumab. Tyverb has demonstrated that it may increase survival by around three months, compared with capecitabine alone, noted GSK.