RRMS, actively expanding coverage of drugs

Relapsing-remitting MS (RRMS)

Benefit applied when Aubagio meets McDonald diagnostic criteria

Mavenclad, administered twice for 2 years, annual recurrence rate reduction benefits

There is news of expanding coverage of oral RRMS (Relapsing-remitting multiple sclerosis) drugs.

 

According to industry sources on the 8th, after Mavenclad (Cladribine, Merck) was listed in insurance benefits in the second half of last year, Sanofi Genzyme's primary drug Aubagio was expanded from February.

 

In the case of Aubagio, additional benefits are applied to patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who meet McDonald's diagnostic criteria through examination by a neurologist and who can go to the outpatient clinic.

 

The key to the expansion of this benefit standard is to be able to follow the judgment of experts based on the McDonald standard diagnosis of multiple sclerosis.

 

Aubagio's provisions that only benefit from having two or more neurological dysfunctions in the past two years have been deleted, so that patients with multiple sclerosis can benefit from Aubagio early, and access to treatment is expected to improve significantly.

 

Mavenclad, which is recently prescribed in general hospitals, is the first to show a significant effect in terms of the progression of physical disorders, annual recurrence rate, number of active lesions shown on MRI (magnetic resonance imaging), and major disease activity indicators of RRMS patients.

 

As a short-term oral treatment, it is taken twice for 2 years.

 

The drug's clinical trial program included long-term follow-up data from the 8-year prospective observation registry PREMIERE study, as well as the CLARITY Phase 3 study and CLARITY EXTENSION, ORACLE MS, and ONWARD Phase 2 study corresponding to the CLARITY extended clinical trial.

 

As a result of post-hoc analysis of patients with high disease activity in the CLARITY 2,3 study conducted for two years, the annual recurrence rate of patients receiving Mavenclad decreased by 67%, and the Extended Disability Status Scale (EDSS), which indicates the degree of disability progression.

 

Also, the Mavenclad treatment group showed a 82% decrease compared to the control group.

 

However, when Mavenclad is administered, lymphopenia and shingles can occur as significant adverse reactions.

 

Therefore, patients with multiple sclerosis must measure their lymphocyte counts before and during Mavenclad administration.

 

Mavenclad administration is contraindicated in certain populations, including patients with impaired immune function and pregnant women.

 

A KSNI official said, "The data showed that the sales of oral drugs were far superior to those of injections in just one year.

 

As such, patients would have chosen oral drugs in many cases."