Australia too mean for melanoma drug

This article is reproduced with the permission of Pharma in Focus.  It appeared in the publication ‘Instant Update’ on 3 May 2013.

Following the Pharmaceutical Benefits Advisory Committee’s deferral of Roche’s Zelboraf (vemurafenib) for metatstatic melanoma, after which the company held a fruitless post-PBAC meeting with the PBAC chair, the company has confirmed to Pharma in Focus that the drug will not be in the race for PBS listing again.

“Despite solid clinical data and a robust cost effectiveness model, it has become clear that Roche will not be able to supply Zelboraf at a price that the Australian Government is willing to pay,” a spokesperson said.

“The PBAC has indicated a price range for Zelboraf in Australia that is substantially lower than what has been accepted for public funding in many other countries, including the United Kingdom and Canada, which have similar health technology assessment processes.”

Roche said its last resubmission for Zelboraf included an updated economic model in line with advice received from the PBAC, as well as a number of additional analyses, including evaluation of non-health related economic benefits such as productivity losses, reduction in carer costs and continued employment; and the economic model accepted by the UK’s medicines assessment body, the National Institute for Health and Care Excellence (NICE), which found Zelboraf cost effective.

“Regrettably, Roche will not be making another submission for a Zelboraf Pharmaceutical Benefits Scheme listing at this time. The company is particularly disappointed for Australian patients and doctors, given that melanoma is ‘Australia’s Cancer’, and much of the research and development for Zelboraf was conducted here,” a company spokesperson said.

The company said that since the commencement of the clinical trial program in 2006, Australian sites had participated in every major development trial and Zelboraf was developed and made available to patients in less than five years, from phase I to its first regulatory approval.

Zelboraf is funded in many other countries including Germany, Ireland, Poland, Belgium, Slovenia, Denmark, Switzerland and the United States.