14 February 2006
Roche Position Statement Regarding Herceptin
Roche Products (NZ) Limited is working proactively and constructively with both Medsafe and Pharmac to ensure the
fastest possible access to Herceptin for HER2 positive women with early breast cancer in New Zealand. The regulatory
submission to permit the extension of licensed use of Herceptin for early breast cancer was submitted to Medsafe in
November.
The clinical evidence dossier required as part of the reimbursement process for Herceptin in early stage disease was
submitted to Pharmac in December.
We are currently completing an additional dossier for Pharmac to demonstrate the cost-effectiveness of Herceptin in
this setting and aim to have this completed by early March. Roche cannot speculate on the expected timelines these
processes may take, but we commit to responding as promptly as possible to any additional requests for information that
either agency may require as part of their assessment process.
ENDS