UK's NICE won't fund GSK's breast cancer drug Tyverb; USA's CDC backs Cervarix and Merck & Co's Gardasil for boys

Vaccines and breast cancer drug final appraisals were in focus yesterday for UK drug giant GlaxoSmithKline and US major Merck & Co with decisions on the availability of products for the two companies in both the UK and USA being issued.

The UK's National Institute for health and Clinical Excellence (NICE) issued its final appraisal determination advising against National Health Service funding for GSK's Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive). Lapatinib (in combination with Xeloda (capecitabine) offers a new treatment option for women whose disease has returned despite treatment with standard chemotherapies and Herceptin (trastuzumab), GSK notes There are very few treatment options available for these women and lapatinib offers a chance of additional time without their disease progressing. Lapatinib, which is funded by under the health care systems of 18 other European countries, is the only licensed ErbB2 targeted treatment for these patients.

GSK will consider appealing the decision. Simon Jose, general manager of GSK UK, commented: 'We disagree with the NICE decision and believe Tyverb is a valuable and important treatment for eligible women. In recognition of the cost effectiveness challenges with drugs that treat patients with a short life expectancy, we offered the Tyverb Patient Access Program to help ensure it was made available on the NHS. GSK reiterated its commitment to the 12-week free access program, which waives the first three months of treatment costs for eligible patients. The drug therapy costs around £25,000 ($40,900) a year.

US backing for Gardasil and Cervarix

Meantime, following the US Food and Drug Administration's approval on October 16 of GSK's cervical cancer drug Cervarix (human papillomavirus bivalent [types 16 and 18]) vaccine and Merck's Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for boys and young men aged nine to 26, both products have received final clearance from the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP), which recommended that funding be provided for the use of both in the USA under the Vaccines for Children program, which provides immunizations free for uninsured and underinsured children.

The panel had initially recommended that the guidelines say that Gardasil, previously approved by the FDA, and Cervarix were interchangeable. But the final approval noted that Cervarix protects against only two strains of HPV that cause cervical cancer, while Gardasil protects against those two strains plus two other strains that cause genital warts.