Big 5 to prescribe a novel antifungal drug Cresemba

DCs at Samsung Medical Center, SNUH, Severance and Asan clears the antifungal

Reimbursement listing is still the issue as the government reduces subject for PE exemption

The Big Five South Korean general hospitals have registered a novel antifungal drug Cresemba for prescription.

 

Pharmaceutical industry sources reported the Drug Committee (DC) at all of the Big Five general hospitals in South Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St.

 

Mary's Hospital and Severance Hospital, have recently passed Cresemba (isavuconazonium).

 

However, the drug faces an issue with the healthcare reimbursement.

 

In last year, the Health Insurance Review and Assessment Service (HIRA) internally revised the regulation on the pharmaceutical reimbursement subject evaluation standard and procedure.

 

HIRA narrowed the scope of prospective subject for pharmacoeconomic (PE) analysis exemption, initially suggested as ‘antibiotics,’ to ‘antibacterials.’ Both the industry and academic scholars supported the government’s plan to expand the subject scope of the PE analysis exemption.

 

But their definition of antibiotics was controversial.

 

Medically speaking, an antibiotic means antimicrobial medicines that cover antibacterial, antifungal and antiviral.

 

And the constant increase of antimicrobial resistance (AMR) is considered as the most critical public health risk around the world.

 

Due to the major public health risk, some were disputing over unifying the definition of the new PE exemption subject—antibiotics—as ‘antibacterial’ based on the variant definitions of antibiotics.

 

And the government sealed the deal by ‘limiting the exemption to ‘antibacterial’.’ Cresemba, categorized as an antifungal, is in shock of the government’s decision.

 

Including South Korea, the number of fungal infection cases around the world has been surging as more than one million people are reportedly dying annually from fungal infection.

 

However, the number of developed antifungal is limited.

 

Among all fungal infection, the invasive aspergillosis is considered as one of three most deadliest invasive fungus to the human race.

 

Even in Korea, the infection is counted as one of most frequent causes of death in patients with immune deficiency, due to increased number of patients receiving anticancer therapy and fighting against AIDS.

 

President Choi Jung-hyun (Catholic University of Korea Eunpyeong St.

 

Mary's Hospital) of Korean Society for Antimicrobial Therapy (KSAT) said, “The risk of secondary nosocomial infection increases higher, when a patient with COVID-19-like severe disease is hospitalized for a long term or uses respirator for a long term.

 

While the demand for securing sufficient amount of infectious disease drug is becoming ever more important to respond against novel infectious disease and secondary nosocomial infection, it is regretful that the government had to neglect the academic society’s advice and narrow down the definition of antibiotics.” In January last year, the Ministry of Food and Drug Safety (MFDS) has approved Cresemba, indicated to treat adult patients in age of 18 and older with invasive aspergillosis, and adult patients in age of 18 and older with mucormycosis for whom amphotericin B is inappropriate.

 

With a wide variety targeted antifungal spectrum, Cresemba can treat both invasive aspergillosis and invasive mucormycosis.

 

The drug is currently the only azole antifungal in South Korea indicated for invasive mucormycosis.