Reimb applied for new HIV drug 'Vocabria+Rekambys'

2 years after approval

GSK leads the insurance listing process

Long-acting formulation provides the advantage of improving convenience

Long-acting HIV treatment 'Vocabria+Rekambys' combination therapy aims to be listed for insurance reimbursement after receiving approval in South Korea two years ago.

 

Industry sources said that GSK Korea and Janssen Korea have applied for reimbursement for the combination therapy of Vocabria (cabotegravir) and Rekambys (rilpivirine), which each company owns.

 

GSK will be responsible for the overall reimbursement process.

 

In February 2022, two drugs were approved by the Ministry of Food and Drug Safety (MFDS) as a combination therapy for the treatment of adult patients with HIV-1 infection who are virologically suppressed with no history of treatment failure and with no known or suspected drug tolerance to either cabotegravir or rilpivirine.

 

In South Korea, Vocabria +Rekambys combination therapy was approved as injection therapy with intervals of monthly or bimonthly administration.

 

The advantage of this combination therapy is its convenience.

 

Previously, patients had to take a tablet formulation drug once daily for conventional HIV treatments.

 

However, with the marketing approval of these two injectables, the treatment frequency has been reduced to monthly or bimonthly as an intramuscular injection, resulting in high patient satisfaction and reduced patient burden.

 

These two drugs were initially developed as oral formulations and later developed as injectables.

 

As a long-acting injection therapy, these drugs cannot cure HIV injection but target white blood cells, helping to lower and maintain AIDS virus replication.

 

The combination therapy was approved in Europe in December 2020 after a clinical trial demonstrated its efficacy and safety in a patient group treated once every 4 weeks or once every 8 weeks.

 

The most common adverse reactions observed in a group treated with Vocabria+Rekambys combination therapy include injection site reaction, headache, fever, nausea, fatigue, general malaise, and muscle aches.

 

Consequently, it remains to be seen whether the government agency will approve the combination therapy of these two drugs for their advantage in convenience and whether the therapy will later become listed for reimbursement.