The general manager and country president of Novartis Pharmaceuticals Richard Tew says a new report commissioned by the company reveals the need for change to ensure timely access to the new generation of cell and gene therapies emerging from company pipelines.
Mr Tew spoke with BioPharmaDispatch to mark the launch of the report developed by consultancy Evohealth. The report assesses and makes a number of detailed recommendations on changes it says would promote health system preparedness and patient access to cell and gene therapies.
He said it was always the intention that the report would be substantive and detailed to appropriately reflect the complexity of the issues and the "goal to make a difference."
"The first thing is that there is a burning platform around the need for change. Cell and gene therapies are not something that is coming in the future - they are here now.
"It is staggering given the number of therapies in the pipeline is around 2,000 and the FDA expects to be evaluating 10 to 20 per year by the middle of this decade.
"We know from our own experience in Australia that when you go through the process, the complexity is such that it feels like you are creating an entirely new pathway, almost like a bespoke approach.
"We are delighted with the report because it is detailed but very tangible and pragmatic. They are recommendations we can get behind as a call to action for the government but also our sector."
Mr Tew said the simple reality is that patients are waiting too long. "First of all, we look and say, patients are waiting too long," he said. "Australians are waiting too long to get access."
The company currently has two gene therapies separately navigating the Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC).
"So be it down the MSAC route, be it down the PBAC route, it is still taking a long time. We are talking more than two years since the submissions were made to the TGA. So both pathways are slow processes," said Mr Tew.
The Novartis boss said the need to manage the different jurisdictions involved in the funding of these therapies adds an "extra layer of complexity."
"We are kind of learning as we go. It is not very clear and transparent at all," he said.
On newborn screening, which will be critical to the accessibility of gene therapy, Mr Tew highlighted the differences between the states and territories.
"You imagine a baby born in Queensland, a baby born in New South Wales, their whole life trajectory just can be completely different. So it is complicated but there needs to be change throughout the system."
Mr Tew said the report highlights the need for consideration of how Australia's health technology assessment processes "deal with one-off, life long treatments with small clinical trials."
He said the company has adopted a different approach to how it resources gene therapy to reflect the unique challenge they represent. "Actually, it is a good learning for us in this area that we can apply to other areas of our business. We have resourced it differently and smaller so the team is agile in that respect," he said.
"It is a privilege to work for a company that is leading the way on cell and gene therapies. It is a privilege. It brings an obligation to shape the system, to take a leadership approach," he said.
"These are often children, that ability to just totally change the life of a patient like nothing else. Our teams that work on these projects, the level of engagement, they are so inspired."
He continued, "This is the start of a revolution on cell and gene therapies, the incredible impact on the lives of patients, the clarity of the recommendations from the report, the House of Representatives inquiry, I am hoping all of this comes together and we can drive meaningful change. It is one thing to be critical, but it is another to propose solutions. I think what is good here is we can be critical, but these therapies were not envisaged when the system was set up, nobody was thinking cell and gene therapies."
Mr Tew added, "In the end, we need something that is sustainable and that means challenging how much longer it is taking. We just want to bring these therapies to patients in Australia faster."