I concede it does seems premature to be discussing PBS approval, because if Cvac does get to that stage, it is still years away.
However, regardless of how good the Cvac trial results eventually are, patients have to be able to afford the treatment. If PRR doesn’t secure PBS approval in Australia, and the corresponding funding in other countries, the potential usage of Cvac will be very diminished imo.
I agree with kbears assessment of Yervoy’s efficacy and side effect profile. So I’m very encouraged that it still gained PBS approval.
In my view this indicates the wisdom of Prima's strategy to target afflictions with relatively unmet needs.
Macenroc. The 'issues' that I referred to were basically that the PBS initially turned down at least two applications for Yervoy funding. The committee assessing the application cited concerns with "uncertain extent of clinical benefit, uncertain clinical place in therapy and high and uncertain cost effectiveness."
http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2012-03/subsequent-decisions
A fairly concerted campaign by interest groups and private individuals was mounted to put pressure on regulators. Very pleased for those afflicted with the condition who will benefit from this decision.
http://www.melanomapatients.org.au/latest-news/melanoma-patients-disappointed-with-australian-government-advisory-committee-decision
http://www.change.org/petitions/bristol-myers-squibb-and-julia-gillard-calling-for-yervoy-ipilimumab-to-be-listed-on-the-pbs
Good luck. Herro
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