Gastroenterologists can now add tofacitinib (Xeljanz) to their list of PBS-subsidised ulcerative colitis (UC) treatments.
From 1 July, the Janus kinase (JAK) inhibitor will be available on the PBS for moderate to severe ulcerative colitis (MSUC) in people who are aged 18 years or over, have failed to achieve adequate responses to conventional therapies and have Mayo clinic scores greater than or equal to six.
The listing was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) at its November 2020 meeting at which it concluded that tofacitinib was as safe and effective as agents such as other biologics, and for some patients provides a significant improvement in efficacy in the induction phase compared to adalimumab.
GESA IBD faculty chair, Associate Professor Jake Begun, welcomed tofacitinib’s PBS listing, and highlighted the importance of new therapies for patients who may not respond, or be suited to, existing conventional, biologic or targeted therapies.
“The approval of tofacitinib represents a first-in-class approval of a JAK inhibitor in ulcerative colitis, which has a novel mechanism of action compared to available therapies currently on the market,” he told the limbic.
“It’s also the first oral medication to be approved for patients who have failed conventional therapy and that, in clinical trials, has shown similar efficacy, although it can’t be directly compared to available biologics currently.”
Associate Professor Begun said the PBS application criteria and authority application process should be the same as for injectable and intravenously-administered UC biologics, such as anti-TNF agents adalimumab, golimumab and infliximab, and the anti-integrin drug vedolizumab.
Tofacitinib’s PBS listing is also expected to “fit well” into the Targeted Therapies Alliance Value in Prescribing program’s gastroenterology arm, according to Associate Professor Begun.
“The program is about optimising the use of conventional therapies before you move onto targeted therapies and biologics and it fits in well in aligning with those goals for sure.”
“With respect to value in prescribing for biologics, it fits in with the overall goals of making sure that our patients are treated efficaciously to prevent long term complications including disability, hospitalisation and surgery,” he said.
Associate Professor Jake Begun is on medical advisory boards for several companies, including Pfizer, which manufactures tofacitinib.