Time to cessation of therapy challenged for Teva and Lilly migraine medicines

Pharma News: Australian real-world evidence is reshaping the narrative around the efficacy of monoclonal antibody migraine therapy. The spotlight is on calcitonin gene-related peptide (CGRP) inhibitors, hailed as a revolutionary approach to managing migraines. However, the latest findings challenge the time to cessation of treatment.

Current constraints of the Pharmaceutical Benefits Scheme (PBS) require patients who do not achieve a 50% reduction in monthly headache days (MHD) within three months to be discontinued from therapy.

Real-world evidence from the Alfred and Austin Hospitals in Melbourne examined the long-term efficacy of Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab) in chronic migraine cases.

“CGRP mAbs were associated with significant and sustained reductions in MHD over 12-month follow-up in patients with chronic migraine,” the authors concluded.

According to the study, during the initial 3-month treatment period, over half of the participants achieved a ≥50% reduction in the frequency of their MHD. This corresponded with a median reduction of 10 MHD. Notably, there was no significant difference in treatment outcomes between Emgality and Ajovy.

However, what intrigued researchers was the sustained impact over 12 months. For patients who continued treatment, the ≥50% responder rate skyrocketed to 80%, with a median reduction of 18 MHD compared to baseline. Astonishingly, 21% of patients who had not initially responded within the first three months demonstrated the desired reduction in monthly headache days after a year of treatment.

These results challenge the existing practice of discontinuing therapy if the 50% reduction benchmark is not met within the initial three months. The findings suggest that some patients are late responders, showcasing the importance of extended assessment periods.

The study findings align with conclusions drawn by other researchers, further advocating for a shift in evaluation timelines.

“Half of non-responders to anti-CGRP mAbs at 12 weeks are indeed late responders. Efficacy of anti-CGRP mAbs should be assessed at 24 weeks, while treatment duration should be extended beyond 12 months,” stated Barbanti et al.

While the PBS listing of CGRP inhibitors has been a long and complex process, Teva’s Ajovy has seen an expansion in its PBS listing beyond chronic migraine. Since 1 November 2023, Ajovy’s is reimbursed for patients with treatment-resistant high-frequency episodic migraines.

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