Research backs cheaper IBD drug alternative

The research, published in the Medical Journal of Australia, compared the clinical and safety outcomes for patients with moderate to severe inflammatory bowel disease (IBD) who were switched from originator infliximab (Remicade) to the biologically similar CT-P13 (Inflectra).
 
Biologically similar drugs are those that have shown in a lab that they work in a similar way, and for which there should be no clinically meaningful differences in the way they work in patients.
 
The prospective, open label, multicentre, parallel cohort, non‐inferiority study found switching to CT-P13 was safe and ‘clinically non‐inferior’ to continuing treatment with originator infliximab, while it also led to cost savings for the Pharmaceutical Benefit Scheme (PBS) by increasing market competition.
 
One of the main motivations for the research – which was funded by an unrestricted grant from Pfizer that did not allow the pharmaceutical company to have a role in study design, analysis, or reporting – is that Biologic (monoclonal) agents such as infliximab are expensive and can account for as much as 64% of IBD‐related healthcare costs.
 
In 2015–16 alone, an estimated $2.3 billion was spent on biologic medications in Australia, prompting the authors to cite a need for cost reduction strategies to ensure ‘the sustainability of biologic therapies’ for Australian patients.
 
‘One approach to reducing pharmaceutical expenditure is using less expensive biosimilar medicines,’ the authors, led by University of Sydney gastroenterologist Dr Craig Haifer, wrote.
 
However, while several studies have found that infliximab biosimilars are safe and clinically effective for several indications in infliximab‐naïve patients, it was not known whether non‐medical switching of patients with clinically stable IBD from originator infliximab to a biosimilar would achieve comparable clinical outcomes.
 
To measure this, Dr Haifer and colleagues switched participants with IBD who were receiving maintenance originator infliximab and been in steroid-free clinical remission for at least 12 weeks, to CT-P13.
 
The trial took place across seven Australian hospitals over 48 weeks, from May 2017 to October 2019, and involved 345 patients (including 232 with Crohn’s disease). Of these, 204 (59%) in four hospitals were switched to CT‐P13, while 141 (41%) in the three other hospitals continued to receive originator infliximab.
 
‘Ten in the control group [7%] and 16 patients switched to CT-P13 [8%] experienced clinical deterioration … [but] the adjusted risk difference [was] within our pre-specified non-inferiority margin of 15 percentage points,’ the authors reported.
 
‘Serious adverse events leading to infliximab discontinuation were infrequent in both the switch [six, 3%] and control [six, 4%] groups.’
 
Aside from indicating that non‐medical switching of Australian patients with IBD from originator to biosimilar infliximab is a ‘safe and clinically non‐inferior alternative’, the authors also wrote that their results have ‘significant health economic implications’.
 
‘At study commencement [May 2017], the PBS reimbursed $574.85 per 100 mg infliximab vial; at study conclusion [October 2019], the rate was $320.71 per vial,’ they wrote.
 
‘On the basis of six PBS-funded eight-weekly infliximab infusions over 48 weeks per patient, the estimated annualised cost to the PBS for the entire study group [total of 1547 vials] in May 2017 was $5.34 million, and $2.98 million in October 2019.
 
‘That is, the estimated annual cost to the PBS was $2.36 million lower in October 2019 [44%], or $6837 per patient-year of infliximab therapy.
 
‘This cost saving, independent of whether originator or biosimilar infliximab or CT-P13 is used for therapy, was the result of increased market competition following the introduction of biosimilar infliximab in Australia for the treatment of IBD.’
 
According to the authors, the research should be ‘reassuring’ for both clinicians and patients.
 
‘The results indicate that it is safe to switch clinically stable patients with moderate to severe IBD from originator to biosimilar infliximab,’ they wrote.
 
‘The introduction of the infliximab biosimilar CT-P13 has also led to a considerable reduction in the PBS-listed price for infliximab, resulting in millions of dollars in estimated cost savings for the PBS.
 
‘It is therefore anticipated [these results] will reassure both health professionals and patients that biosimilar infliximab is safe, clinically effective, and economical.’
 
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biologic agents IBD inflammatory bowel disease infliximab