Biosimilars are now a part of everyday clinical practice. The potential cost savings they offer create an opportunity to improve overall patient care. However, making the switch involves getting stakeholders on board and making sure robust monitoring systems are in place, an expert says.
The concept of gain-share
Speaking to the limbic at the Australian Gastroenterology Week held in Adelaide last month, UK gastroenterologist Dr Fraser Cummings said clinicians considering moving patients at their IBD service from an originator biologic to a biosimilar faced several challenges.
One challenge was navigating the complex processes involved in negotiating the cost of medicines within healthcare systems, which could sometimes lead to disincentives for secondary care providers to deliver cost effective changes in clinical practice.
This was particularly so when implementing the changes required the commitment of additional resources with no clear ways of sharing the benefits.
However, according to Dr Cummings these hurdles can be overcome by making sure all stakeholders involved in delivering medicines to IBD patients are educated about biosimilars and are incentivised to make the switch.
“The key to making the switch [from originator drug to biosimilar] is to engage with all your stakeholders, get them on board, and make sure they have an incentive to make the change,” said Dr Cummings who is a consultant gastroenterologist at the University Hospital Southampton National Health Service (NHS) Foundation Trust in the UK.
In the larger business world this is actually a well-known concept called ‘gain-share’ that relates more to profit sharing and incentivising individuals to work smarter.
But in the world of health it relates to a collaborative arrangement between all stakeholders that creates incentives that achieve both better outcomes for patients and greater efficiencies in the use of medicines.
Back in November 2015 Dr Cummings approached all stakeholders involved in the delivery of biologics within his hospital. He wanted to move his IBD patients on Remicade® to biosimilar infliximab CT-P13, but he had some convincing to do.
As a way of getting his stakeholders’ attention – fellow clinicians, hospital management, clinical care commissioners and patients – he presented some top line figures on the potential cost savings that could be made by switching patients and suggestions on how the IBD service overall could benefit.
He had worked out that switching patients to CT-P13 could equate to a cost saving of 480,000 -812,000 GBP, depending on the biosimilar discount.
12% of these savings were reinvested into the service to support a full time IBD nurse, a 0.5 WTE clerical support position, a 0.2 WTE pharmacist, and a 0.2 WTE dietitian.
Getting clinicians and patients on board
While the figures certainly looked attractive, there were still other hurdles that needed to be conquered.
Discussions with a representative patient panel on the concept of moving patients to the infliximab biosimilar revealed that patients placed particular importance in trusting the IBD team providing the service. Easy access to their clinical team was another crucial aspect of the project’s success.
Patients were also motivated by the idea that the cost savings would be reinvested in improvements to their care, such as greater access to IBD nurses and a dietitian as well as the possibility of improved access to medicines with a new mode of action in the future.
One of the biggest challenges Dr Cummings faced was addressing the concerns of clinicians, particularly as there was a lack of published data on switching from originator biologics to biosimilars in IBD at that time.
However, Dr Cummings said these concerns were addressed through a series of in-depth discussions around the basic science of biosimilars, the regulatory processes that biosimilars need to go through to get approval, and the clinical outcomes seen in other areas.
Clinicians were also more likely to support the proposal if there was a risk management plan in place, robust pharmacovigilance procedures and assurances that interchangeability was not allowed.
Managing the risks
As part of the gain-share agreement the stakeholders agreed to a managed switching program to support patients already established on Remicade® who were going to make the switch to CTP-13.
This involved pro-actively managing patient risk by asking each patient to complete a questionnaire prior to making the switch.
They were asked questions relating to IBD control patient reported outcomes measures, disease activity scoring and a questionnaire on side effects.
Anti-tumour necrosis factor drug levels and antibodies were measured before and after the switch. At each infusion, prior and during the switch, patients had access to an IBD nurse to ask any questions or voice any concerns.
Overall, 143 patients were switched to CTP-13 as part of the initial program and Dr Cummings said he had not seen an increase in adverse events or loss of efficacy between patients who had switched to the biosimilar and those that had remained on Remicade®.
However, 2 patients switched back to the originator because of abnormal liver function tests (more likely related to other medication) and a flu-like illness.
According to Dr Cummings, a robust pharmacovigilance program is key to ensuring patient safety regardless of whether a patient is on an originator biologic or a biosimilar.
As Chair of the IBD registry in the UK, Dr Cummings says the registry, which has been running for five years, and is rapidly growing with 20,000 patients currently registered and will be an important part of the long-term monitoring of patient safety.
Top tips for Australian clinicians making the switch
While acknowledging that the Australian healthcare system is different from the UK, Dr Cummings said he believed savings could only be achieved with close collaboration, transparency and trust between patients, clinicians, hospital management and care commissioners.
“My advice to Australian clinicians is to present the facts to all the stakeholders, make sure they are all incentivised, and ensure a pharmacovigilance program is in place as well as high quality, robust systems to support and monitor all patients on biologic therapy” he said.
Dr Cummings was presenting a Pfizer sponsored symposium called Making the change: switching IBD patients to biosimilar infliximab.