Where immunotherapies used to treat cancers are subject to a separate registration and reimbursement process for every different treatment indication, governments and clinicians should begin to leverage the availability of data and the international experience to improve the speed and equity of patients’ access to treatment.
This was the viewpoint put forward by a panel of experts at a recent event hosted by The Mandarin and supported by MSD Australia, a leading pharmaceutical research and development company.
Dr Deme Karikios, Director of Clinical Trials at the Nepean Cancer Care Centre in Sydney; Ms Sharon Winton, CEO of Lymphoma Australia; and Dr Megan Bohensky, the head of market access at MSD Australia, formed the panel, which was chaired by Tom Burton from The Mandarin.
Immunotherapy treatments have introduced a radically different treatment for cancer – they inhibit the cancer proteins that prevent the immune system recognising them and attacking them, leading to the immune system, rather than the drugs as in traditional chemotherapy, targeting the cancer cells.
Immunotherapies for cancer treatment in Australia are assessed by the Pharmaceutical Benefits Advisory Committee (PBAC) individually for each new indication. Because immunotherapies can have multiple indications, this means that every indication requires a separate submission to the PBAC as if it were a new medicine.
Bohensky posed the questions “in trying to think about ways that we can reduce duplication and create efficiencies in that process, so that each individual application doesn’t have to take the same length of time essentially, that we can make the system more efficient. But … it’s not broad based, it’s not going to work for everybody, it’s not about just giving broad access to anyone who’s got cancer, we do still need to have clinical trials and data in each indication. But once we’ve met that bar of evidence, then how do we create efficiencies from there? There’s so much data everywhere; how can we somehow leverage that to improve the system?”
The panel posited that the clinical trial process must be complemented by real world data, including biomarkers, on individual patients over multiple years that can be interrogated to narrow down which patients have done particularly well and why, and propose treatments based on that data.
Winning clinician and patient trust around the use of patient data was earmarked as critical for broader acceptance of data to determine access to drugs.
“I think one of the problems is in the communication. This is a whole new area for patients as well. And for a patient to be involved, they want to understand ‘what’s in it for me?’ If we can say, ‘this is what’s going to be in it for you. This is where we can collect the identifiable data,’ … I think we’ll start to get more people wanting to come on board, whereas at the moment it’s just a bit confusing and scary,” said Winton, a view echoed by her fellow panellists.
Karikios felt that using this real world data would be of particular benefit in the case of rare cancers, or rare subtypes of common cancers, where it is difficult to find enough patients for a clinical trial, and almost impossible to conduct a large trial.
“It’s all about speed of access for clinicians … as long as there’s an agreement that the drug is not going to be harmful, it’s probably beneficial, can we twist the system a little bit where we can get that drug to patients, and then allow the assessment over time? It takes a little cooperation with a margin between the industry and government to set the rules around the program like that”.
For Winton, leveraging more global real world data for treatments is an important consideration. “We might not have the evidence here in Australia, but the evidence is there globally. How do we still get that experience in Australia before we expect the PBS to pay for that too? We want some evidence here, but we want to also be incorporating all the global data.”
As health systems become increasingly individualised, adding to the volume of submissions going through PBAC and placing greater pressure on government processes, Australia’s citizens will continue to demand faster access to immunotherapy and other new treatments. The challenge for government is to negotiate the constant tension between value for money and patient outcomes.