It has been some time coming, but as of April 1, Trexject, the methotrexate pre-filled syringe product has become available on the PBS. The syringes are available in a range of doses from 7.5mg/0.15ml to 25mg/0.5ml. Studies of oral versus subcutaneous methotrexate in patients with RA suggest that the subcutaneous formulation results in a linear […]
It has been some time coming, but as of April 1, Trexject, the methotrexate pre-filled syringe product has become available on the PBS. The syringes are available in a range of doses from 7.5mg/0.15ml to 25mg/0.5ml.
Studies of oral versus subcutaneous methotrexate in patients with RA suggest that the subcutaneous formulation results in a linear increase in systemic exposure greater than oral methotrexate at doses greater than 15mg per week and did not result in any unexpected adverse effects.
Studies have also shown that people with RA whose disease is not sufficiently controlled on oral methotrexate may subsequently improve when the method of methotrexate administration is changed to a subcutaneous injection.
Splitting the oral dose also improves the bioavailability and is an option but it can confuse patients, and rheumatologists have tended to avoid this regimen.
The US and most European countries have had access to several versions of the pre-filled methotrexate injectables for some years now.
Local rheumatologist, Dr Irwin Lim started campaigning for a local listing in Australia and PBS approval two years ago, after returning from the Eular meeting in Europe.
On his blog, Connected Care, patient testimonials include some compelling stories about how the use of subcutaneous methotrexate had changed their lives.
One patient’s mother, who lived in Ireland but was moving to Australia wrote of her disbelief that no simple pre-filled subcutaneous formulations were available here as she had witnessed how the subcutaneous injection, in her case a pen product was so much less stressful for her young son, who required the medication regularly.
Dr Lim’s initial lobbying centred around his view that subcutaneous methotrexate was used much less in Australia when compared to Europe and North America due to the lack of a convenient way to provide these subcutaneous injections.
In April last year, PBAC recommended Trexject for PBS listing. The delay in having the pre-filled syringes readily available on the PBS had prolonged the onerous burden on many RA patients who were needing to attend GP practices and have their GP or nurse practitioners make up the injections.
Associate Professor Peter Nash, from the Department of Medicine at the University of Queensland and Director of the Rheumatology Research Unit on the Sunshine Coast told Rheumatology Republic the PBS listing represented an important advance for patients.
“Over 15mg oral methotrexate is not well absorbed so we have needed to subcut for some years and the expense and health department restrictions have limited its availability,” he said.
He predicts the product will be readily adopted by the profession.
“[We can] give adequate doses and appropriate doses for the first time with proven bioavailability, dosing convenience and adequacy in a pre-filled preparation”, he said.
PBS listing will, of course, also make the use of pre-filled subcutaneous methotrexate much more affordable for patients.
