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A Legacy of Transparency

Lloyd Sansom will soon retire as Chair of the PBAC after 10 at times turbulent years. He said he was proud of the Committee’s work – its domestic and international standing – and was pleased industry had recognised the need for increased dialogue. And he noted the importance of continuing debate about the health system’s sustainability.

“One only has to see how much countries in deep economic trouble, such as US, are paying for health to realise that such levels of expenditure are unsustainable, especially with an ageing population,” Lloyd said, adding that debate needed to focus on health outcomes the nation would be prepared to fund in future.

Transparent times

Lloyd became PBAC Chair in 2001, at a time of controversy and a number of committee resignations. The lesson he learnt in this period was that the Committee needed to improve its transparency and therefore the public’s understanding of its role.

“Transparency only strengthens the PBAC,” Lloyd said.

This was highlighted again in 2007 in the media storm surrounding the issue of whether or not the cervical cancer vaccine Gardisil should be funded. The PBAC initially rejected the proposal and, despite the strong support of the then Health Minister, it was difficult to help the public understand why the Committee needed to garner a price reflecting different age cohorts. Other issues, such as whether or not the vaccine would be cost effective and how the current screening program’s participation levels would be maintained, were also clouded.

The lack of informed debate, Lloyd said, highlighted the need for even greater transparency and the importance of an independent evaluation process.

Future challenges

Lloyd said the major upcoming challenge for the PBAC would be dealing with targeted therapies such as oncology, and the need to make reimbursement judgments around issues such as saving vs. extending lives.

These issues and increased cost pressures on health budgets meant that registration no longer guaranteed reimbursement, highlighting the need for companies to provide comprehensive, relevant data. Lloyd welcomed the recent announcement of proposed ‘managed entry’ provisions as an attempt to provide new pathways to meet the challenges of targeted therapies. But, he said, this highlighted the need to ensure that data sets provided could stand up to appropriate rigor.

It remains unclear what will be the appropriate data sets for managed entry schemes; issues of surrogates, bio markets and risk sharing must all be resolved, and Lloyd noted the diversity of opinion around the validity of observational data.

Dialogue and tension

Lloyd was encouraged by the improvement in the level of interaction between payor and regulator (and also with MSAC). This implies a much higher level of dialogue and sharing of information between regulator, payor and industry, particularly with the parallel registration and reimbursement process.

Lloyd did not see any role for “industry representation” per se on the PBAC, but acknowledged that people with prior industry experience should be considered. He was encouraged also by the recent addition of new members and is confident that the Government will receive considerable interest from qualified persons to become the new, full-time Chair.

He said industry had made a real attempt over the past five years to better understand and dialogue with the PBAC. This dialogue would only grow in importance as the reimbursement process continued to evolve both nationally and internationally. Despite this improved dialogue, there would still be tension between industry and Government – and this, Lloyd said, must be recognised. He also welcomed the appointment of a number of Australian pharmaceutical health representatives to offshore postings where they could “spread the word” on health technology assessment.

A QUM advocate

Lloyd is a passionate advocate for Quality Use of Medicine (QUM), particularly as therapeutic misadventure continues to be dominated by medication mismanagement. He was disappointed that industry adoption of QUM had been slow and a “tick-a-box activity” rather than a cultural norm. The industry, he said, needed to genuinely embrace the concept and move away from its focus on demonstrating improved compliance as a means of negating possible price reductions.

“QUM needs to be a holistic approach that empowers the consumer to ask questions and to make informed decisions,” Lloyd said, adding that he was disappointed that issues he had raised about packaging and labeling over the past 40 years had not been properly addressed, and that Best Practice Guidelines had not been adequately enforced.

He is, however, particularly satisfied with how well the PBAC is regarded internationally, and that it remained at the forefront of change, e.g. its major role in Health Technology Arrangements and in the consideration of funding for targeted therapies.

Not fade away

Lloyd takes real pride in the work of the PBAC. He considered it a privilege and honor to have been Chair for the past 10 years and he said he would greatly miss the Committee’s camaraderie.

“The quality of debate has been a buzz and a highlight of my working life,” he said, adding that his greatest legacy would probably be the PBAC’s focus on transparency.

After 45 years in medicines education and policy, it is clear Lloyd will not, in his words, “fade gently into the night”. His energy levels remain high and he is keen to continue to contribute to a better Australian health system. That said, Chair of the PBAC is a demanding job and he is looking forward to spending more time with his four grandchildren.

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