In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).
For a prescription drug to be commercially successful in Australia, being included on the country's government reimbursement list, the PBS is essential. The PBAC, which meets in March, July and November of each year, assesses applications for listing on the PBS. It does so not only based on comparative efficacy, but also on the relative cost-effectiveness of drugs proposed for listing.
The PBAC's November 2010 agenda shows that two antidiabetic drugs have been put forward for PBS listing for the first time: Victoza (liraglutide; Novo Nordisk) and Galvumet (vildagliptin/metformin; Novartis). Much rides on the decision that the committee will make regarding the GLP-1 agonist Victoza as Byetta (exenatide; Eli Lilly), the first drug of this class to be launched in Australia, was submitted three times before it was finally approved in November 2008. Furthermore, Byetta's actual listing was then delayed to August 2010 due to lengthy pricing negotiations with the Pharmaceutical Benefits Pricing Authority.
If it is successful in November, Victoza will become the second GLP-1 agonist for which reimbursement is available in Australia. The drug has already shown significant benefits over Byetta, including its once-daily administration compared to Byetta's twice-daily dosing. On the other hand, Eli Lilly is not far behind with its once-weekly exenatide reformulation Bydureon, which is expected to launch after 2011.
It is therefore vital for Novo Nordisk to receive PBS listing for Victoza on its first try in November. The company has requested that reimbursement be made available for its product in dual and triple combination therapy with metformin and a sulfonylurea, which is the same indication for which Byetta is listed. Hopefully, Novo Nordisk has learned from Eli Lilly's experience with Byetta and can avoid a three-year delay before the drug becomes available to Australian type 2 diabetes patients via the PBS.