Negotiations with NHIS on Actemra have been completed

The MOHW revised the regulations for severely ill patients, and officially debuted as a COVID-19 drug

Full support is provided without patient's copayment, and additional overseas manufacturers are added

Actemra (Tocilizumab), a treatment for rheumatoid arthritis by JW Pharma, has been officially recognized as a treatment for COVID-19 in Korea.

 

The drug, which has been used in patients with severe COVID-19 for purposes other than permission, will also be covered by health insurance benefits from March.

 

On the 24th, the MOHW announced that Actemra is preparing to revise the regulations so that benefits can be applied as a treatment for COVID-19.

 

Earlier, the NHIS negotiated with JW Pharma, a domestic importer and seller, to apply benefits.

 

Through this, it is possible to apply benefits to severely ill patients with COVID-19.

 

According to the revision of the MOHW, medical care benefits are recognized when administered to COVID-19 patients aged 2 or older beyond the scope of the existing permits of Actemra (excluding SC injections).

 

"If a patient is admitted to an intensive care unit or a hospital room within 48 hours and needs respiratory treatment of HFNC (High Flow Nasal Canula) or higher," alternatively, it corresponds to "the case of administration to patients who rapidly deteriorate to a state in which respiratory treatment above High Flow Nasal Cannula (HFNC) is required even though they have been treated with steroid therapy and low flow oxygen therapy." Full support is provided through health insurance without the patient's copayment.

 

Actemra, unlike in Korea, is already used as a treatment for COVID-19 abroad.

 

The U.S.

 

FDA decided on Actemra as a treatment for COVID-19 in June last year.

 

The European Commission also approved it as a treatment for COVID-19 in December last year.

 

Recently, the WHO also added Actemra to the Pre-qualification Review List for COVID-19 Treatment for reference by middle and low-income countries that have difficulty in independent drug screening.

 

It has been used as an offline in Korea, but the problem is that the patient had to pay the full price of the drug because it was not paid.

 

Other COVID-19 treatments approved in Korea are purchased entirely by the state and have no Pt's payment.

 

Therefore, the medical community also requested the purchase of Actemra to the state in terms of equity.

 

Actemra achieved 20 billion won in domestic sales last year, up 24.9% year-on-year.

 

Currently, Actemra 80mg's price is 134,263 won, Actemra 200mg's price is 306,166 won, and Actemra 400mg's price is 537,060 won, while SC (subcutaneous injection) product is 345,682 won.

 

Until now, patients have paid all the drug prices, but if health insurance benefits are applied, the patient will not be burdened with the drug prices.

 

Actemra is also pushing for a change in permission to expand manufacturing sources limited to Japan due to the recent shortage of supply.

 

It is also known that EUA plans as a treatment for COVID-19 are being considered.

 

Meanwhile, JW Pharma also announced on the 25th that Actemra's benefit range will be expanded for the purpose of treating COVID-19 (COVID-19) in accordance with the revision announced by the MOHW.

 

The company explained that the new revision, which will take effect on March 1, has changed its standards to reflect the status of overseas permits such as FDA EUA, clinical research literature, and related academic opinions.

 

An official from JW Pharma said, "Considering the recent surge in confirmed cases of Omikron mutant virus, we have been closely discussing with health authorities to expand the benefits of Actemra.

 

The EUA is also quickly proceeding with the MFDS." Actemra is an antibody treatment that treats diseases such as rheumatoid arthritis and pediatric idiopathic arthritis by inhibiting the binding of IL-6 and its receptors, a protein that causes inflammation in the body.

 

It has been shown that it effectively lowers the mortality rate of severely ill and critically ill patients with COVID-19 and reduces hospitalization time in global clinical trials, a complication of excessive immune responses.

 

JW Pharma acquired Actemra's domestic development and exclusive sales authority from Chugai under Roche Group in 2009 and has since been selling it since 2013 through phase 3 clinical trials for rheumatoid arthritis patients.