Prescription of CGRP migraine drugs to begin in earnest?

makes progress in reimbursement among others in Korea

‘Emgality’ passes HIRA DREC deliberations

‘Ajovy’ lands in AMC and Severance Hospital

CGRP-targeted migraine treatments are gaining better access as prescriptions.

 

The first drug introduced is nearing insurance benefit listing and the second drug is landing in general hospitals.

 

According to industry sources, the Calcitonin gene-related peptide (CGRP)-targeted migraine treatment ‘Emgality (galcanezumab)’ has passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 12th.

 

The latecomer ‘Ajovy (fremanezumab)’ also applied for insurance benefits earlier this year but was not set for deliberations in the recent DREC meeting.

 

However still, Ajovy passed the drug committees (DCs) of Seoul Asan Medical Center and Sinchon Severance Hospital.

 

If Emgality successfully receives reimbursement approval, Ajovy’s reimbursement would also be plausible with the pharmaceutical companies’ will.

 

Both drugs are humanized monoclonal antibody drugs that bind to the CGRP ligand that plays a key role in inducing migraine symptoms to inhibit its binding to its receptor.

 

Although the two drugs are of the same class, Severe migraine patients are approaching the drugs with different expectations due to their differences in dosage and administration, etc.

 

Emgality can currently be prescribed in medical institutions nationwide, including the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center.

 

Meanwhile, Emgality’s approval was based on results of the EVOLVE-1 and EVOLVE-2 trials which involved 1,773 patients with episodic migraine (at least 4 to 14 migraine headaches days [MHDs] a month) for 6 months, and the REGAIN trial which involved 1,113 patients with chronic migraines (at least 15 headaches days per month with at least 8 MHDs per month) for 3 months.

 

Results of the two trials on episodic migraine patients comparing the changes in MHDs per month over 6 months showed that, compared to baseline (Emgality group 9.2 days, placebo group 9.1 days), Emgality demonstrated efficacy over placebo in treating migraines.

 

In the case of Ajovy, the drug comes in two formulations, one which is administered in a monthly dosage and the other that comes in a quarterly dosage that is administered every 3 months.

 

The drug demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients.

 

In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups.

 

WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive treatments that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs.

 

The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the condition becomes easier to treat with more targeted therapies.”