The need for ethics committees and evaluation agencies in coverage with evidence development: The case of crizotinib in Australia

Dr Drew Carter1, Ms Arlene Vogan1, Prof Tracy Merlin1

1Adelaide Health Technology Assessment, The University of Adelaide, Adelaide, Australia

In 2013 Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) requested a 30% price reduction from the pharmaceutical industry sponsor of crizotinib, a treatment for anaplastic lymphoma kinase-positive non-small cell lung cancer.  PBAC requested the price reduction after judging that the sponsor had over-estimated the effectiveness of the treatment.  The sponsor refused to reduce the price, so in 2014 PBAC and the sponsor agreed on a coverage-with-evidence-development (CED) arrangement.  The sponsor would collect and analyse data on a sub-set of Australian patients being treated with government-subsidised crizotinib in order to determine the effectiveness and cost-effectiveness of the treatment. Following analysis of this data, PBAC would recommend ongoing government subsidy but only at a price that was supported by the data.

The CED arrangement was innovative and testified to the feasibility of government and industry collaborating on CED in Australia.  But it also featured some problems.  In particular, we examine the following ethical issues.  Were patients aware that they could opt out of the evidence development?  Was an opt-out consent process ethically justified to begin with?  Were patients induced into participating in the evidence development?  Was the presence of any inducement ethically justified?  Who ought to have been recruiting patients into the evidence development?

We show that formal ethical review would solve a number of problems faced by CED arrangements.  We also show how engaging an independent body with relevant expertise in technology evaluation would enhance the ethical acceptability of CED arrangements.


Drew Carter is a moral philosopher and health policy researcher. He applies insights made by Ludwig Wittgenstein to illuminate bioethical issues, especially relating to resource allocation.  He has published on assisted reproductive technology and pain.  His current research focusses on intensive care triage and the managed entry of health technologies.