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  • GSK seeks HIV paradigm shift with long-acting injectable
  • by Whang, byung-woo | translator Alice Kang | Dec 4, 2024 05:56am
seeks reimbursement in Korea
Company applies for reimbursement of Vocabria+Rekambys combo to HIRA in May
Completed pharmacoeconomic evaluation, and is gaining attention on whether it will be presented to the last Drug Reimbursement Evaluation Committee this year
Has the convenience of dosing 6 times a year compared to existing therapies that require daily dosing
With the long-acting HIV drug Vocabria+Rekambys combination therapy seeking insurance reimbursement coverage, attention is being paid to whether the drug¡¯s introduction will bring about a shift in the treatment environment.

 ¡ã GSK Korea applied for the reimbursement of the Vocabria+Rekambys combination in May

According to industry sources on the 3rd, GSK Korea has completed pharmacoeconomic evaluations for its new HIV drug combination, Vocabria (cabotegravir)+Rekambys (rilpivirine), and is awaiting review by the National Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Committee.

GSK Korea filed for reimbursement review in May and may be presented as an agenda at the last Drug Reimbursement Evaluation Committee meeting of the year, which is scheduled for December.

Vocabria+Rekambys was previously approved by the MFDS in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virologic failure, and have no known or suspected resistance to either cabotegravir or rilpivirine.

Its biggest strength is convenience. While traditional HIV treatments require daily oral dosing 365 days per year, the Vocabria+Rekambys combination can be administered as a monthly or bimonthly intramuscular injection, reducing dosing frequency to up to six times per year. 

In the head-to-head SOLAR study, which directly compared the Vocabria+Rekambys combination with the conventional three-drug regimen (BIC/FTC/TAF), Vocabria+Rekambys demonstrated non-inferior virologic suppression compared to the three-drug regimen, demonstrating both efficacy and convenience. 

 ¡ã SOLAR trial¡¯s 11/12 month viral suppression results

Patients who switched to Vocabria+Rekambys reported higher treatment satisfaction at 11-12 months of treatment compared to patients who continued on their existing oral regimen.

The expected clinical benefit of the less frequent dosing is that patients may feel less anxious about disclosing their HIV status. 

According to the '2024 HIV Treatment Awareness¡¯ survey conducted by Love4One, an organization for people living with HIV, 73% of people living with HIV in Korea responded that they felt afraid of being judged by others when taking HIV medications.

In addition, 53% said they had difficulty taking the medications because of inconveniences such as having to take them on time every day or on an empty stomach. 

At the Korean Society of Infectious Diseases¡¯s Annual Fall Meeting, Yeon-Sook Kim, Professor of Infectious Diseases at Chungnam National University Hospital, said, ¡°South Korea is still one of the countries where HIV is still highly stigmatized and discriminated against, which can affect the peoples¡¯ adherence to medication, leading to virological failure or resistance to treatment.¡±

¡°In Korea, HIV remains a disease with a high unmet need in terms of adherence and quality of life (QoL), and the introduction of long-acting HIV injectables will be an important turning point in positively improving the lives of people living with HIV in Korea,¡± added Professor Kim.

The key question is whether the Vocabria+Rekambys combination, which has been already approved for 2 years, will be eligible for reimbursement coverage in Korea.

Currently, Vocabria is licensed and reimbursed in the United States (FDA approval in 2021), as well as in A8 countries and Australia, which are key reference countries used during HIRA¡¯s reimbursement evaluations. 

The cost of the two-drug combination varies by country, but in the UK and Canada, where the price is determined through health technology assessment (HTA) like Korea, the convenience of the once-every-2-month cycle regimen was recognized. 

Based on a single administration, its reimbursement price was set at approximately GBP 1637.49 (KRW 2.9 million) in the United Kingdom and approximately CAD 2568.71 (KRW 2.57 million) in Canada.
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