Emgality passes DREC review… what about Ajovy?

Has applied for reimbursement earlier but was not deliberated by DREC… is coordinating opinion with HIRA

Both are same-class of migraine drugs… has different dosage and method of administration

With Emgality nearing insurance reimbursement in Korea, what path Ajovy will walk is also gaining attention.

 

Teva-Handok Pharma had applied for the reimbursement of its calcitonin gene-related peptide (CGRP) targeting migraine drug Ajovy (fremanezumab) earlier this year.

 

However, Ajovy’s reimbursement was not deliberated as an agenda at the DREC meeting that was held in May this year, the same meeting at which Emgality (galcanezumab) passed deliberations.

 

The gap could be reasonable when considering Emgality applied for reimbursement in March last year, but as the reimbursement discussion period for the two drugs had coincided somewhat, the industry had predicted that the two agendas will be deliberated at the same time, but saw different results.

 

As a result, the company is awaiting DREC deliberation on the reimbursement of Ajovy and is in discussion with the HIRA.

 

Both drugs are currently prescribed without reimbursement.

 

Although Emgality and Ajovy are same class drugs, they differ in dosage and administration, allowing patients to be prescribed the drugs according to their individual characteristics.

 

Emgality is administered in a loading dose of 240mg (two consecutive subcutaneous injections of 120 mg each) followed by monthly doses of 120mg injected subcutaneously.

 

Ajovy is administered in a monthly dosage of one 225 mg subcutaneous injection each month or a quarterly dosage of 675mg subcutaneous injection (three consecutive 225mg injections) every 3 months.

 

Ajovy 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 placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups.

 

The proportion of patients with a 50% reduction in migraine days was also higher for the Ajovy administered group than the placebo group.

 

The proportion of subjects that showed a 50% or more reduction in migraine days was 47.7% in the monthly Ajovy and 44.4% in the quarterly Ajovy group, compared to the 27.9% in the placebo group.

 

In the HALO CM study, the monthly average reduction in migraine days in the monthly dosing Ajovy group was 4.6±0.3 days, and the quarterly dosing Ajovy group was 4.3±03 days, a significant reduction compared to the placebo group’s 2.5±0.3 days.

 

WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive drugs 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 more the patient receives the targeted therapy, the easier it is to treat.”